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1. Risk of multiple sclerosis relapses when switching from fingolimod to cell-depleting agents: the role of washout duration

Author: Ferraro, D., Iaffaldano, P., Guerra, T., Inglese, M., Capobianco, M., Brescia Morra, V., Zaffaroni, M., Mirabella, M., Lus, G., Patti, F., Cavalla, P., Cellerino, M., Malucchi, S., Pisano, E., Vitetta, F., Paolicelli, D., Sola, P., Trojano, M., Aguglia, U., Amato, M. P., Avolio, C., Balgera, R., Banfi, P., Bellantonio, P., Bergamaschi, R., Cargnelutti, D., Cartechini, E., Chiveri, L., Clerici, R., Cocco, E., Conte, A., Corea, F., Danni, M. C., De Luca, G., Di Sapio, A., Ferraro, E., Galgani, S., Gallo, A., Gatto, M., Gazzola, P., Granella, F., Lugaresi, A., Maimone, D., Maniscalco, G. T., Marfia, G. A., Montepietra, S., Paolo, C., Pesci, I., Pozzilli, C., Carlo, P., Protti, A., Quatrale, R., Realmuto, S., Romano, S., Romeo, M., Salemi, G., Leonardo, S., Rocco, T., Paola, V., Marika, V., Ferraro, D., Iaffaldano, P., Guerra, T., Inglese, M., Capobianco, M., Brescia Morra, V., Zaffaroni, M., Mirabella, M., Lus, G., Patti, F., Cavalla, P., Cellerino, M., Malucchi, S., Pisano, E., Vitetta, F., Paolicelli, D., Sola, P., Trojano, M., Aguglia, U., Amato, M. P., Avolio, C., Balgera, R., Banfi, P., Bellantonio, P., Bergamaschi, R., Cargnelutti, D., Cartechini, E., Chiveri, L., Clerici, R., Cocco, E., Conte, A., Corea, F., Danni, M. C., De Luca, G., Di Sapio, A., Ferraro, E., Galgani, S., Gallo, A., Gatto, M., Gazzola, P., Granella, F., Lugaresi, A., Maimone, D., Maniscalco, G. T., Marfia, G. A., Montepietra, S., Paolo, C., Pesci, I., Pozzilli, C., Carlo, P., Protti, A., Quatrale, R., Realmuto, S., Romano, S., Romeo, M., Salemi, G., Leonardo, S., Rocco, T., Paola, V., and Marika, V.
Subjects: Adult, medicine.medical_specialty, Relapsing-Remitting, Settore MED/26, Gastroenterology, Multiple sclerosis, Immunosuppressive Agent, Multiple Sclerosis, Relapsing-Remitting, Recurrence, Internal medicine, Multiple Sclerosi, medicine, Humans, Ocrelizumab, Cladribine, Alemtuzumab, Fingolimod, Rituximab, Fingolimod Hydrochloride, Immunosuppressive Agents, Middle Aged, Multiple Sclerosis, business.industry, Hazard ratio, Washout, Discontinuation, Settore MED/26 - NEUROLOGIA, Neurology, Neurology (clinical), business, medicine.drug, Human
Abstract: Background: Fingolimod (FTY) induces sequestration of lymphocytes in secondary lymphoid organs and the average lymphocyte recovery following discontinuation takes 1–2months. It has been hypothesized that the therapeutic effects of subsequent cell-depleting agents may be compromised if initiated before lymphocyte recovery has occurred. Objective: To assess the risk of relapses following FTY discontinuation and the initiation of a B/T cell-depleting agent in relation to washout duration using data from the Italian MS Register. Methods: The risk of relapses was assessed in relation to different washout durations (< 6, 6–11, 12–17 and > / = 18weeks) in patients starting alemtuzumab, rituximab, ocrelizumab or cladribine following FTY discontinuation. Results: We included 329 patients in the analysis (226F, 103M; mean age 41 ± 10years). During the cell-depleting treatment, the incidence rate ratio for a relapse was significantly greater in patients with a washout period of 12–17 and > / = 18weeks compared to the reference period (< 6weeks). The risk of a relapse was significantly influenced by the occurrence of relapses during FTY treatment and by washout length, with hazard ratios markedly increasing with the washout duration. Conclusion: The risk of relapses increases with the washout duration when switching from FTY to lymphocyte-depleting agents.
Published: 2021

2. Cost-Effectiveness Analysis of Cannabinoid Oromucosal Spray Use for the Management of Spasticity in Subjects with Multiple Sclerosis

Author: Mantovani, Lg, Cozzolino, P, Cortesi, Pa, Patti, F, Messina, S, Solaro, C, Amato, Mp, Bergamaschi, R, Bonavita, S, Bruno Bossio, R, Brescia Morra, V, Costantino, Gf, Cavalla, P, Centonze, D, Comi, G, Cottone, S, Danni, M, Francia, A, Gajofatto, A, Gasperini, C, Ghezzi, A, Iudice, A, Lus, G, Maniscalco, Gt, Marrosu, Mg, Matta, M, Mirabella, M, Montanari, E, Pozzilli, C, Rovaris, M, Sessa, E, Spitaleri, D, Trojano, M, Valentino, P, Zappia, M, Benedetti, Md, Bertolotto, A, Berra, E, Bianco, A, Buttari, F, Cerqua, R, Florio, C, Fuiani, A, Guareschi, A, Ippolito, D, Nuara, A, Palmieri, V, Paolicelli, D, Petrucci, L, Pontecorvo, S, Sacca, F, Salomone, G, Signoriello, E, Spinicci, G, Russo, M, Tavazzi, E, Trabucco, E, Trotta, M, Zaffaroni, M, Mantovani, L, Cozzolino, P, Cortesi, P, Patti, F, Messina, S, Solaro, C, Amato, M, Bergamaschi, R, Bonavita, S, Bruno Bossio, R, Brescia Morra, V, Costantino, G, Cavalla, P, Centonze, D, Comi, G, Cottone, S, Danni, M, Francia, A, Gajofatto, A, Gasperini, C, Ghezzi, A, Iudice, A, Lus, G, Maniscalco, G, Marrosu, M, Matta, M, Mirabella, M, Montanari, E, Pozzilli, C, Rovaris, M, Sessa, E, Spitaleri, D, Trojano, M, Valentino, P, Zappia, M, Benedetti, M, Bertolotto, A, Berra, E, Bianco, A, Buttari, F, Cerqua, R, Florio, C, Fuiani, A, Guareschi, A, Ippolito, D, Nuara, A, Palmieri, V, Paolicelli, D, Petrucci, L, Pontecorvo, S, Sacca, F, Salomone, G, Signoriello, E, Spinicci, G, Russo, M, Tavazzi, E, Trabucco, E, Trotta, M, Zaffaroni, M, Mantovani, Lorenzo G, Cozzolino, Paolo, Cortesi, Paolo A, Patti, Francesco, Amato, Mp, Costantino, Gf, Maniscalco, Gt, Marrosu, Mg, Benedetti, Md, Saccà, F, Zaffaroni, M., Mantovani, L. G., Cozzolino, P., Cortesi, P. A., Patti, F., Messina, S., Solaro, C., Amato, M. P., Bergamaschi, R., Bonavita, S., Bruno Bossio, R., Brescia Morra, V., Costantino, G. F., Cavalla, P., Centonze, D., Comi, G., Cottone, S., Danni, M., Francia, A., Gajofatto, A., Gasperini, C., Ghezzi, A., Iudice, A., Lus, G., Maniscalco, G. T., Marrosu, M. G., Matta, M., Mirabella, M., Montanari, E., Pozzilli, C., Rovaris, M., Sessa, E., Spitaleri, D., Trojano, M., Valentino, P., Zappia, M., Benedetti, M. D., Bertolotto, A., Berra, E., Bianco, A., Buttari, F., Cerqua, R., Florio, C., Fuiani, A., Guareschi, A., Ippolito, D., Nuara, A., Palmieri, V., Paolicelli, D., Petrucci, L., Pontecorvo, S., Sacca, F., Salomone, G., Signoriello, E., Spinicci, G., Russo, M., Tavazzi, E., Trabucco, E., and Trotta, M.
Subjects: Adult, Male, medicine.medical_specialty, Cost effectiveness, Cost-Benefit Analysis, MEDLINE, 030204 cardiovascular system & hematology, Settore MED/26, multiple sclerosis, 030226 pharmacology & pharmacy, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Cannabidiol, Dronabinol, Drug Combinations, Female, Humans, Italy, Middle Aged, Multiple Sclerosis, Muscle Spasticity, Quality of Life, Quality-Adjusted Life Years, Medicine, Pharmacology (medical), Spasticity, spasticity, multiple sclerosis, cannabinoid, health care economics and organizations, Cost-Effectiveness Analysis, Spasticity, Cannabinoid, Multiple Sclerosis, Cost–benefit analysis, business.industry, Multiple sclerosis, spasticity, General Medicine, Cost-effectiveness analysis, cannabinoid, medicine.disease, Quality-adjusted life year, Settore MED/26 - NEUROLOGIA, Physical therapy, medicine.symptom, business
Abstract: Introduction: Multiple sclerosis (MS) is a highly symptomatic disease, with a wide range of disabilities affecting many bodily functions, even in younger persons with a short disease history. The availability of a cannabinoid oromucosal spray (Sativex) for the management of treatment-resistant MS spasticity has provided a new opportunity for many patients. Objective: Our study aimed to assess the cost effectiveness of Sativex in Italian patients with treatment-resistant MS spasticity. The analysis was based on the real-world data of a large registry of Italian patients. Methods: A cost-utility analysis was conducted using data collected prospectively from an electronic registry of all patients who began to use Sativex for MS-resistant spasticity between January 2014 and February 2015 in 30 specialized MS units across Italy and were followed up for ≤ 6months. Data on drug consumption and spasticity/utility were used to estimate the incremental cost-effectiveness ratio (ICER) of Sativex, as compared with no intervention. No costs or spasticity/utility changes were assumed for no treatment intervention. The ICER was expressed as quality-adjusted life-years (QALYs) gained, using the Italian NHS perspective and a 6-month time horizon. Results: Sativex effectiveness and consumption was estimated analyzing data of 1350 patients from the registry. These patients reported a mean (SD) utility increment of 0.087 (0.069) after 1month of treatment, 0.118 (0.073) after 3months’ treatment and 0.127 (0.080) after 6months’ treatment. The 6-month cost of treating the entire population with Sativex was €1,361,266, with a €1008 cost and 0.0284 QALYs gained per patient. The estimated ICER was €35,516 per QALY gained, with little variability around the central estimate of cost-effectiveness, as shown by the cost-effectiveness acceptability curve. Conclusion: The use of Sativex could improve the quality of life of patients with a reasonable incremental cost resulting as a cost-effective option for patients with MS-resistant spasticity. These results could help clinicians and decision makers to develop improved management strategies for spasticity in patients with MS, optimizing the use of available resources.
Published: 2020

3. The Italian multiple sclerosis register

Author: Trojano, M, Bergamaschi, R, Amato, Mp, Comi, G, Ghezzi, A, Lepore, V, 7, Marrosu, Mg, Mosconi, P, Patti, F, Ponzio, M, Zaratin, P, Battaglia, Ma1, Acquistapace D, Italian Multiple Sclerosis Register Centers Group., Aguglia, U, Annunziata, P, Ardito, B, Avolio, C, Balgera, R, Bandini, F, Banfi, P, Barone, P, Bellantonio, P, Bertolotto, A, Bertora, P, Bombardi, R, Bosco Zimatore, G, Bossio, Rb, Bramanti, P, Brescia Morra, V, Brioschi, Am, Bruzzone, M, Buccafusca, M, Busillo, V, Caneve, G, Caniatti, Lm, Capone, L, Capone, F, Cappellani, A, Cargnelutti, D, Cavaletti, G, Cavalla, P, Celani, Mg, Centonze, D, Chiveri, L, Clerici, R, Clerico, M, Cocco, E, Comi, C, Coniglio, Mg, Cordera, S, Corea, F, Cortese, A, Costantino, G, Cottone, S, Crociani, P, D'Andrea, F, Danni, Mc, De Luca, G, de Pascalis, D, De Robertis, F, De Stefano, N, Di Battista, G, Di Napoli, M, Falcini, M, Fausto, F, Ferrò, Mt, Florio, C, Fortunato, M, Frittelli, C, Galgani, S, Gallo, P, Gatto, M, Gazzola, P, Geda, C, Giordano, A, Granella, F, Grasso, Mg, Grimaldi, Lme, Imperiale, D, Lo Russo, L, Logullo, Fo, Lugaresi, A, Lus, G, Maccarrone, G, Maimone, D, Malagù, S, Marconi, R, Maritato, P, Massacesi, L, Mazzoni, M, Meucci, G, Mirabella, M, Montepietra, S, Nasuelli, D, Neri, W, Orefice, G, Parodi, S, Pasquali, L, Passarella, B, Peresson, M, Perla, F, Pesci, I, Piantadosi, C, Piras, Ml, Pizio, Nr, Pozzilli, C, Protti, A, Pugliatti, M, Quatrale, R, Ragno, M, Rezzonico, M, Ribizzi, G, Riva, M, Ronzoni, M, Rosso, Mg, Rottoli, M, Rovaris, M, Salemi, G, Salvetti, M, Santangelo, M, Santangelo, G, Santuccio, G, Sarchielli, P, Scarpini, E, Sechi, Gp, Severi, S, Sinisi, L, Sola, P, Spitaleri, D, Tassinari, T, Tedeschi, G, Tonietti, S, Torri Clerici, V, Totaro, R, Traccis, S, Turla, M, Uccelli, A, Ulivelli, M, Valentino, P, Valeriani, M, Venturi, S, Vianello, M, Zaffaroni, M., Trojano M., Bergamaschi R., Amato M.P., Comi G., Ghezzi A., Lepore V., Marrosu M.G., Mosconi P., Patti F., Ponzio M., Zaratin P., Battaglia M.A., Acquistapace D., Aguglia U., Annunziata P., Ardito B., Avolio C., Balgera R., Bandini F., Banfi P., Barone P., Bellantonio P., Bertolotto A., Bertora P., Bombardi R., Bosco Zimatore G., Bossio R.B., Bramanti P., Brescia Morra V., Brioschi A.M., Bruzzone M., Buccafusca M., Busillo V., Caneve G., Caniatti L.M., Capone L., Capone F., Cappellani A., Cargnelutti D., Cavaletti G., Cavalla P., Celani M.G., Centonze D., Chiveri L., Clerici R., Clerico M., Cocco E., Comi C., Coniglio M.G., Cordera S., Corea F., Cortese A., Costantino G., Cottone S., Crociani P., D'Andrea F., Danni M.C., De Luca G., de Pascalis D., De Robertis F., De Stefano N., Di Battista G., Di Napoli M., Falcini M., Fausto F., Ferro M.T., Florio C., Fortunato M., Frittelli C., Galgani S., Gallo P., Gatto M., Gazzola P., Geda C., Giordano A., Granella F., Grasso M.G., Grimaldi L.M.E., Imperiale D., Lo Russo L., Logullo F.O., Lugaresi A., Lus G., Maccarrone G., Maimone D., Malagu S., Marconi R., Maritato P., Massacesi L., Mazzoni M., Meucci G., Mirabella M., Montepietra S., Nasuelli D., Neri W., Orefice G., Parodi S., Pasquali L., Passarella B., Peresson M., Perla F., Pesci I., Piantadosi C., Piras M.L., Pizio N.R., Pozzilli C., Protti A., Pugliatti M., Quatrale R., Ragno M., Rezzonico M., Ribizzi G., Riva M., Ronzoni M., Rosso M.G., Rottoli M., Rovaris M., Salemi G., Salvetti M., Santangelo M., Santangelo G., Santuccio G., Sarchielli P., Scarpini E., Sechi G.P., Severi S., Sinisi L., Sola P., Spitaleri D., Tassinari T., Tedeschi G., Tonietti S., Torri Clerici V., Totaro R., Traccis S., Turla M., Uccelli A., Ulivelli M., Valentino P., Valeriani M., Venturi S., Vianello M., Zaffaroni M., Trojano M, Bergamaschi R, Amato M.P, Comi G, Ghezzi A, Lepore V, Marrosu M.G, Mosconi P, Patti F, Ponzio M, Zaratin P, Battaglia M.A, Acquistapace D., Aguglia U., Annunziata P., Ardito B., Avolio C., Balgera R., Bandini F., Banfi P., Barone P., Bellantonio P., Bertolotto A., Bertora P., Bombardi R., Bosco Zimatore G., Bossio R.B., Bramanti P., Brescia Morra V., Brioschi A.M., Bruzzone M., Buccafusca M., Busillo V., Caneve G., Caniatti L.M., Capone L., Capone F., Cappellani A., Cargnelutti D., Cavaletti G., Cavalla P., Celani M.G., Centonze D., Chiveri L., Clerici R., Clerico M., Cocco E., Comi C., Coniglio M.G., Cordera S., Corea F., Cortese A., Costantino G., Cottone S., Crociani P., D’Andrea F., Danni M.C., De Luca G., de Pascalis D., De Robertis F., De Stefano N., Di Battista G., Di Napoli M., Falcini M., Fausto F., Ferrò M.T., Florio C., Fortunato M., Frittelli C., Galgani S., Gallo P., Gatto M., Gazzola P., Geda C., Giordano A., Granella F., Grasso M.G., Grimaldi L.M.E., Imperiale D., Lo Russo L., Logullo F.O., Lugaresi A., Lus G., Maccarrone G., Maimone D., Malagù S., Marconi R., Maritato P., Massacesi L., Mazzoni M., Meucci G., Mirabella M., Montepietra S., Nasuelli D., Neri W., Orefice G., Parodi S., Pasquali L., Passarella B., Peresson M., Perla F., Pesci I., Piantadosi C., Piras M.L., Pizio N.R., Pozzilli C., Protti A., Pugliatti M., Quatrale R., Ragno M., Rezzonico M., Ribizzi G., Riva M., Ronzoni M., Rosso M.G., Rottoli M., Rovaris M., Salemi G., Salvetti M., Santangelo M., Santangelo G., Santuccio G., Sarchielli P., Scarpini E., Sechi G.P., Severi S., Sinisi L., Sola P, Spitaleri D., Tassinari T., Tedeschi G., Tonietti S., Torri Clerici V., Totaro R., Traccis S., Turla M., Uccelli A., Ulivelli M., Valentino P., Valeriani M., Venturi S., Vianello M., Zaffaroni M., Trojano, Maria, Bergamaschi, Roberto, Amato, Maria Pia, Comi, Giancarlo, Ghezzi, Angelo, Lepore, Vito, Marrosu, Maria Giovanna, Mosconi, Paola, Patti, Francesco, Ponzio, Michela, Zaratin, Paola, Battaglia, Mario Alberto, Acquistapace, D, Aguglia, U, Amato, Mp, Annunziata, P, Ardito, B, Avolio, C, Balgera, R, Bandini, F, Banfi, P, Barone, P, Bellantonio, P, Bergamaschi, R, Bertolotto, A, Bertora, P, Bombardi, R, Bosco Zimatore, G, Bossio, Rb, Bramanti, P, Brescia Morra, V, Brioschi, Am, Bruzzone, M, Buccafusca, M, Busillo, V, Caneve, G, Caniatti, Lm, Capone, L, Capone, F, Cappellani, A, Cargnelutti, D, Cavaletti, G, Cavalla, P, Celani, Mg, Centonze, D, Chiveri, L, Clerici, R, Clerico, M, Cocco, E, Comi, G, Comi, C, Coniglio, Mg, Cordera, S, Corea, F, Cortese, A, Costantino, G, Cottone, S, Crociani, P, D'Andrea, F, Danni, Mc, De Luca, G, de Pascalis, D, De Robertis, F, De Stefano, N, Di Battista, G, Di Napoli, M, Falcini, M, Fausto, F, Ferrò, Mt, Florio, C, Fortunato, M, Frittelli, C, Galgani, S, Gallo, P, Gatto, M, Gazzola, P, Geda, C, Giordano, A, Granella, F, Grasso, Mg, Grimaldi, Lme, Imperiale, D, Lo Russo, L, Logullo, Fo, Lugaresi, A, Lus, G, Maccarrone, G, Maimone, D, Malagù, S, Marconi, R, Maritato, P, Massacesi, L, Mazzoni, M, Meucci, G, Mirabella, M, Montepietra, S, Nasuelli, D, Neri, W, Orefice, G, Parodi, S, Pasquali, L, Passarella, B, Patti, F, Peresson, M, Perla, F, Pesci, I, Piantadosi, C, Piras, Ml, Pizio, Nr, Pozzilli, C, Protti, A, Pugliatti, M, Quatrale, R, Ragno, M, Rezzonico, M, Ribizzi, G, Riva, M, Ronzoni, M, Rosso, Mg, Rottoli, M, Rovaris, M, Salemi, G, Salvetti, M, Santangelo, M, Santangelo, G, Santuccio, G, Sarchielli, P, Scarpini, E, Sechi, Gp, Severi, S, Sinisi, L, Sola, P, Spitaleri, D, Tassinari, T, Tedeschi, G, Tonietti, S, Torri Clerici, V, Totaro, R, Traccis, S, Trojano, M, Turla, M, Uccelli, A, Ulivelli, M, Valentino, P, Valeriani, M, Venturi, S, Vianello, M, Zaffaroni, M., Amato, M, Ghezzi, A, Lepore, V, Marrosu, M, Mosconi, P, Ponzio, M, Zaratin, P, Battaglia, M, Bossio, R, Brioschi, A, Caniatti, L, Celani, M, Coniglio, M, D’Andrea, F, Danni, M, Ferrò, M, Grasso, M, Grimaldi, L, Logullo, F, Piras, M, Pizio, N, Rosso, M, Sechi, G, and Zaffaroni, M
Subjects: Register (sociolinguistics), Adult, Male, Knowledge management, Databases, Factual, Epidemiology, media_common.quotation_subject, Disease epidemiology, Multiple sclerosis, Quality of care, Register, Longitudinal Studie, Dermatology, NO, Cohort Studies, Databases, 03 medical and health sciences, 0302 clinical medicine, Multiple Sclerosi, Humans, Quality (business), Longitudinal Studies, 030212 general & internal medicine, Registries, Epidemiology, Multiple sclerosis, Quality of care, Register, Adult, Cohort Studies, Data Collection, Databases, Factual, Female, Humans, Italy, Longitudinal Studies, Male, Multiple Sclerosis, Registries, Factual, media_common, Data collection, business.industry, Data Collection, Correction, Female, Italy, Multiple Sclerosis, General Medicine, Register data, Psychiatry and Mental Health, Observational study, Original Article, Settore MED/26 - Neurologia, Business, Neurology (clinical), Cohort Studie, 030217 neurology & neurosurgery, 2708, Human
Abstract: The past decade has seen extraordinary increase in worldwide availability of and access to several large multiple sclerosis (MS) databases and registries. MS registries represent powerful tools to provide meaningful information on the burden, natural history, and long-term safety and effectiveness of treatments. Moreover, patients, physicians, industry, and policy makers have an active interest in real-world observational studies based on register data, as they have the potential to answer the questions that are most relevant to daily treatment decision-making. In 2014, the Italian MS Foundation, in collaboration with the Italian MS clinical centers, promoted and funded the creation of the Italian MS Register, a project in continuity with the existing Italian MS Database Network set up from 2001. Main objective of the Italian MS Register is to create an organized multicenter structure to collect data of all MS patients for better defining the disease epidemiology, improving quality of care, and promoting research projects in high-priority areas. The aim of this article is to present the current framework and network of the Italian MS register, including the methodology used to improve the quality of data collection and to facilitate the exchange of data and the collaboration among national and international groups. The past decade has seen extraordinary increase in worldwide availability of and access to several large multiple sclerosis (MS) databases and registries. MS registries represent powerful tools to provide meaningful information on the burden, natural history, and long-term safety and effectiveness of treatments. Moreover, patients, physicians, industry, and policy makers have an active interest in real-world observational studies based on register data, as they have the potential to answer the questions that are most relevant to daily treatment decision-making. In 2014, the Italian MS Foundation, in collaboration with the Italian MS clinical centers, promoted and funded the creation of the Italian MS Register, a project in continuity with the existing Italian MS Database Network set up from 2001. Main objective of the Italian MS Register is to create an organized multicenter structure to collect data of all MS patients for better defining the disease epidemiology, improving quality of care, and promoting research projects in high-priority areas. The aim of this article is to present the current framework and network of the Italian MS register, including the methodology used to improve the quality of data collection and to facilitate the exchange of data and the collaboration among national and international groups.
Published: 2019

4. Associations between cognitive impairment at onset and disability accrual in young people with multiple sclerosis

Author: Carotenuto A., Moccia M., Costabile T., Signoriello E., Paolicelli D., Simone M., Lus G., Brescia Morra V., Lanzillo R., Rosa L., Barbarulo A. M., Falco F., Viterbo R. G., Lauro F., Carotenuto, Antonio, Moccia, Marcello, Costabile, Teresa, Signoriello, Elisabetta, Paolicelli, Damiano, Simone, Marta, Lus, Giacomo, Brescia Morra, Vincenzo, Lanzillo, Roberta, Carotenuto, A., Moccia, M., Costabile, T., Signoriello, E., Paolicelli, D., Simone, M., Lus, G., Brescia Morra, V., Lanzillo, R., Rosa, L., Barbarulo, A. M., Falco, F., Viterbo, R. G., and Lauro, F.
Subjects: Adult, Male, medicine.medical_specialty, Multiple Sclerosis, 020205 medical informatics, Adolescent, Population, lcsh:Medicine, 02 engineering and technology, Predictive markers, Risk Assessment, Article, 03 medical and health sciences, Disability Evaluation, Young Adult, 0302 clinical medicine, Cognition, Visual memory, Recurrence, Internal medicine, 0202 electrical engineering, electronic engineering, information engineering, medicine, Humans, Cognitive Dysfunction, Longitudinal Studies, Young adult, Age of Onset, 10. No inequality, education, lcsh:Science, Child, Retrospective Studies, education.field_of_study, Multidisciplinary, Proportional hazards model, business.industry, Multiple sclerosis, lcsh:R, Retrospective cohort study, Cognitive neuroscience, medicine.disease, Disease Progression, lcsh:Q, Female, Age of onset, business, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract: Differently from the adult multiple sclerosis (MS) population, the predictive value of cognitive impairment in early-onset MS is still unknown. We aim to evaluate whether cognitive performances at disease onset predict disease progression in young people with MS. This is a retrospective study on early onset (
Published: 2019

5. Trial of fingolimod versus interferon beta-1a in pediatric multiple sclerosis

Author: Chitnis, T, Arnold, Dl, Banwell, B, Brück, W, Ghezzi, A, Giovannoni, G, Greenberg, B, Krupp, L, Rostásy, K, Tardieu, M, Waubant, E, Wolinsky, Js, Bar-Or, A, Stites, T, Chen, Y, Putzki, N, Merschhemke, M, Gärtner, Collaborators (85): Kornberg A, J, Bajer-Kornek, B, Likhachev, S, Pereira Gomes Neto, A, Diniz, D, Paz, J, Alvarenga, R, Bojinova-Tchamova, V, Mah, J, Venkateswaran, S, Hafner, K, Gross-Paju, K, Brochet, B, Cheuret, E, Rivier, F, Deiva, K, Milh, M, Blaschek, A, Trollmann, R, Korinthenberg, R, Luecke, T, Ziemssen, T, Pozzilli, C, Patti, F, Comi, G, Marfia, G, Grimaldi, L, Trojano, M, Zaffaroni, M, Capra, R, Brescia Morra, V, Rozentals, G, Laurynaitiene, J, Vaiciene-Magistris, N, Castro Farfan, F, Quinones, S, Steinborn, B, Ujma-Czapska, B, Stasiolek, M, Jasinski, M, Craiu, D, Boyko, A, Kairbekova, E, Khabirov, F, Kuzenkova, L, Malkova, N, Nikolic, D, Jancic, J, Gebauer-Bukurov, K, Payerova, J, Gascon Jiménez, F, Izquierdo Ayuso, G, Mendibe Bilbao, M, Hintzen, R, Fernandez Sanchez VE, Meca Lallana, V, Montalban Gairin, X, Nordborg, K, Anlar, B, Yalcinkaya, C, Gucuyener, K, Terzi, M, Ozakbas, S, Yilmaz, U, Makedonska, I, Prokopenko, K, Tantsura, L, Moskovko, S, Kobys, T, Muratova, T, Nehrych, T, Prykhodko, T, Hemingway, C, Wassmer, E, Shetty, J, Desai, J, Waldman, A, Chinea Martinez, A, Ness, J, Rammohan, K, Lloyd, M, Williams, M, Ayala, R, Davis, R, Bhise, V, Brigham & Women’s Hospital [Boston] (BWH), Harvard Medical School [Boston] (HMS), McConnell Brain Imaging Centre (MNI), Montreal Neurological Institute and Hospital, McGill University = Université McGill [Montréal, Canada]-McGill University = Université McGill [Montréal, Canada], University of Pennsylvania [Philadelphia], Immunologie antivirale systémique et cérébrale, Université Paris-Sud - Paris 11 (UP11)-IFR93-Institut National de la Santé et de la Recherche Médicale (INSERM), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), and Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)
Subjects: 0301 basic medicine, [SDV]Life Sciences [q-bio], Administration, Oral, administration, oral, adolescent, brain, child, female, fingolimod hydrochloride, headache, humans, immunologic factors, infection, injections, intramuscular, interferon-beta, leukopenia, magnetic resonance imaging, male, multiple sclerosis, relapsing-remitting, secondary prevention, medicine (all), law.invention, 0302 clinical medicine, Randomized controlled trial, Interferon, law, Medicine, Secondary prevention, General Medicine, Fingolimod, 3. Good health, Settore MED/26 - Neurologia, medicine.drug, medicine.medical_specialty, Infections, Injections, Intramuscular, Adolescent, Brain, Child, Female, Fingolimod Hydrochloride, Headache, Humans, Immunologic Factors, Infection, Interferon-beta, Leukopenia, Magnetic Resonance Imaging, Male, Multiple Sclerosis, Relapsing-Remitting, Secondary Prevention, 03 medical and health sciences, Internal medicine, business.industry, Multiple sclerosis, Interferon beta-1a, medicine.disease, Clinical trial, 030104 developmental biology, Multicenter study, business, 030217 neurology & neurosurgery
Abstract: International audience; BACKGROUND: Treatment of patients younger than 18 years of age with multiple sclerosis has not been adequately examined in randomized trials. We compared fingolimod with interferon beta-1a in this population. METHODS: In this phase 3 trial, we randomly assigned patients 10 to 17 years of age with relapsing multiple sclerosis in a 1:1 ratio to receive oral fingolimod at a dose of 0.5 mg per day (0.25 mg per day for patients with a body weight of
Published: 2018

6. Grey:white matter ratio at diagnosis and the risk of 10-year multiple sclerosis progression

Author: Moccia, M., Quarantelli, M., Lanzillo, R., Cocozza, S., Carotenuto, A., Carotenuto, B., Alfano, B., Prinster, A., Triassi, M., Nardone, A., PALLADINO, RAFFAELE, Brunetti, A., Brescia Morra, V., BRUNETTI, ARTURO, Moccia, M., Quarantelli, M., Lanzillo, R., Cocozza, S., Carotenuto, A., Carotenuto, B., Alfano, B., Prinster, A., Triassi, M., Nardone, A., Palladino, Raffaele, Brunetti, A., Brescia Morra, V., and Brunetti, Arturo
Subjects: Male, Pathology, SEGMENTATION, Gastroenterology, 030218 nuclear medicine & medical imaging, 0302 clinical medicine, BRAIN ATROPHY, Gray Matter, Hazard ratio, RESONANCE-IMAGING PREDICTORS, Brain, Middle Aged, Magnetic Resonance Imaging, White Matter, medicine.anatomical_structure, Neurology, INTERFERON BETA-1A, multiple sclerosi, Disease Progression, Female, Life Sciences & Biomedicine, Adult, medicine.medical_specialty, Multiple Sclerosis, Clinical Neurology, progressive, Grey matter, White matter, 03 medical and health sciences, Young Adult, Atrophy, atrophy, Internal medicine, medicine, Humans, Retrospective Studies, Expanded Disability Status Scale, Science & Technology, Neurology & Neurosurgery, Proportional hazards model, business.industry, Multiple sclerosis, Neurosciences, Retrospective cohort study, GRAY-MATTER, 1103 Clinical Sciences, grey, white, medicine.disease, COGNITIVE IMPAIRMENT, PATHOLOGY, LESION LOAD, Neurosciences & Neurology, Neurology (clinical), business, FOLLOW-UP, 1109 Neurosciences, 030217 neurology & neurosurgery, LONG-TERM DISABILITY
Abstract: Background and purpose: Grey matter (GM) and white matter (WM) are both affected in multiple sclerosis (MS). WM is predominantly involved in inflammatory demyelination of relapsing–remitting MS (RRMS), whereas GM is predominantly involved in neurodegenerative processes of secondary progressive MS. Thus, we investigated the ratio between GM and WM volumes in predicting MS evolution. Methods: The present 10-year retrospective cohort study included 149 patients with newly-diagnosed RRMS, undergoing magnetic resonance imaging for segmentation and brain volumetry. The ratio between GM and normal-appearing WM (NAWM) volumes was calculated for each subject. Outcome measures of interest were Expanded Disability Status Scale (EDSS) progression, reaching EDSS 4.0 and conversion to secondary progressive (SP) MS. Results: During a period of 10.6 ± 2.4 years, a median 1.5 EDSS progression was observed (range 0–5.5), 54 subjects (36.2%) reached EDSS 4.0 and 30 subjects (20.1%) converted to SP. With ordinal logistic regression models, EDSS progression was associated with GM:NAWM ratio (coefficient, −2.918; 95% CI, −4.739–1.097). With Cox regression models, subjects with higher GM:NAWM ratio at diagnosis had a 90% lower rate of reaching EDSS 4.0 (hazard ratio, 0.111; 95% CI, 0.020–0.609) and of converting to secondary progressive MS (hazard ratio, 0.017; 95% CI, 0.001–0.203) compared with subjects with lower GM:NAWM ratio. Conclusions: The GM:NAWM ratio is a predictor of disability progression and of SP conversion in subjects with newly diagnosed RRMS, suggesting that GM and NAWM are variably affected in relation to disease evolution from the early phases of MS. © 2016 EAN
Published: 2016

7. Efficacy and safety of cannabinoid oromucosal spray for multiple sclerosis spasticity

Author: Patti F., Messina S., Solaro C., Amato M. P., Bergamaschi R., Bonavita S., Bruno Bossio R., Brescia Morra V., Costantino G. F., Cavalla P., Centonze D., Comi G., Cottone S., Danni M., Francia A., Gajofatto A., Gasperini C., Ghezzi A., Iudice A., Lus G., Maniscalco G. T., Marrosu M. G., Matta M., Mirabella M., Montanari E., Pozzilli C., Rovaris M., Sessa E., Spitaleri D., Trojano M., Valentino P., Zappia M., Benedetti MD, Bertolotto A, Berra E, Bianco A, Buttari F, Cerqua R, Florio C, Fuiani A, Guareschi A, Ippolito D, Nuara A, Palmieri V, Paolicelli D, Petrucci L, Pontecorvo S, Saccà Francesco, Salamone G, Signoriello E, Spinicci G, Russo M, Tavazzi E Trabucco E, Trotta M, Zaffaroni M., Patti, F, Messina, S., Solaro, C., Amato, M. P., Bergamaschi, R., Bonavita, Simona, Bruno Bossio, R., Brescia Morra, V., Costantino, G. F., Cavalla, P., Centonze, D., Comi, G., Cottone, S., Danni, M., Francia, A., Gajofatto, A., Gasperini, C., Ghezzi, A., Iudice, A., Lus, Giacomo, Maniscalco, G. T., Marrosu, M. G., Matta, M., Mirabella, M., Montanari, E., Pozzilli, C., Rovaris, M., Sessa, E., Spitaleri, D., Trojano, M., Valentino, P., Zappia, M., Patti, F., Bonavita, S., Lus, G., Benedetti, Md, Bertolotto, A, Berra, E, Bianco, A, Buttari, F, Cerqua, R, Florio, C, Fuiani, A, Guareschi, A, Ippolito, D, Nuara, A, Palmieri, V, Paolicelli, D, Petrucci, L, Pontecorvo, S, Saccà, Francesco, Salamone, G, Signoriello, E, Spinicci, G, Russo, M, Tavazzi, E Trabucco E, Trotta, M, Zaffaroni, M., Messina, S, Solaro, C, Amato, Mp, Bergamaschi, R, Bonavita, S, Bossio, Rb, Morra, Vb, Costantino, Gf, Cavalla, P, Centonze, D, Comi, Giancarlo, Cottone, S, Danni, M, Francia, A, Gajofatto, A, Gasperini, C, Ghezzi, A, Iudice, A, Lus, G, Maniscalco, Gt, Marrosu, Mg, Matta, M, Mirabella, M, Montanari, E, Pozzilli, C, Rovaris, M, Sessa, E, Spitaleri, D, Trojano, M, and Valentino, P
Subjects: Multivariate analysis, assessment, Administration, Oral, patients, 0302 clinical medicine, Drug Combination, Multiple Sclerosi, 9- δ -tetrahydocannabinol, cannabidiol, Sativex, multiple sclerosis, treatment-resistant spasticity, Italy, Cannabidiol, Medicine, Dronabinol, 030212 general & internal medicine, cannabinoid, Drug Combinations, Muscle Spasticity, Psychiatry and Mental Health, Humans, Multiple Sclerosis, Plant Extracts, Safety, Surgery, Neurology (clinical), Administration, Settore MED/26 - Neurologia, medicine.symptom, Human, medicine.drug, Oral, medicine.medical_specialty, Nabiximols, Plant Extract, 03 medical and health sciences, Arts and Humanities (miscellaneous), Rating scale, Internal medicine, Spasticity, Adverse effect, multiple sclerosis, cannabinoid, business.industry, Multiple sclerosis, medicine.disease, Physical therapy, Observational study, business, 030217 neurology & neurosurgery
Abstract: Background The approval of 9-δ-tetrahydocannabinol and cannabidiol (THC:CBD) oromucosal spray (Sativex) for the management of treatment-resistant multiple sclerosis (MS) spasticity opened a new opportunity for many patients. The aim of our study was to describe Sativex effectiveness and adverse events profile in a large population of Italian patients with MS in the daily practice setting. Methods We collected data of all patients starting Sativex between January 2014 and February 2015 from the mandatory Italian medicines agency (AIFA) e-registry. Spasticity assessment by the 0–10 numerical rating scale (NRS) scale is available at baseline, after 1 month of treatment (trial period), and at 3 and 6 months. Results A total of 1615 patients were recruited from 30 MS centres across Italy. After one treatment month (trial period), we found 70.5% of patients reaching a ≥20% improvement (initial response, IR) and 28.2% who had already reached a ≥30% improvement (clinically relevant response, CRR), with a mean NRS score reduction of 22.6% (from 7.5 to 5.8). After a multivariate analysis, we found an increased probability to reach IR at the first month among patients with primary and secondary progressive MS, (n=1169, OR 1.4 95% CI 1.04 to 1.9, p=0.025) and among patients with >8 NRS score at baseline (OR 1.8 95% CI 1.3–2.4 p
Published: 2016

8. Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial

Author: Laroni A., Brogi D., Morra V. B., Guidi L., Pozzilli C., Comi G., Lugaresi A., Turrini R., Raimondi D., Uccelli A., Mancardi G. L., Amato M. P., Appendino L., Ardito B., Avolio C., Bandini F., Batocchi A. P., Bellantonio P., Benedetti M. D., Bergamaschi R., Bortolon F., Bosco A., Buccafusca M., Cargnelutti D., Cavalla P., Cavallo R., Centonze D., Coniglio M. G., Costantino G., Cottone S., Danni M. C., De Robertis F., Deotto L., Dotta M., Di Battista G., Filippi M. M., Florio C., Francia A., Galgani S., Gallo P., Ghezzi A., Giometto B., Giuliani G., Grimaldi L. M. E., Guidotti M., Iudice A., Lenzi G. L., Lorusso L., Lus G., Maimone D., Malentacchi G. M., Mantegazza R. E., Massacesi L., Melato M., Millefiorini E., Montanari E., Patti F., Perrone P. S. M., Protti A., Provera P., Quattrone A., Rasi F., Rosati G., Rovaris M., Sacca F., Salemi G., Sarchielli P., Scarpini E. A., Schoenhuber R., Serrati C., Sinisi L., Sola P., Spitaleri D. L. A., Tedeschi G., Tezzon F., Tinebra Asti M. C., Tola M. R., Totaro R., Trojano M., Ulivelli M., Vecchio M. M., Zimatore G. B., Alice Laroni, Davide Brogi, Vincenzo Brescia Morra, Leonello Guidi, Carlo Pozzilli, Giancarlo Comi, Alessandra Lugaresi, Renato Turrini, Debora Raimondi, Antonio Uccelli, Giovanni Mancardi, EAP Investigators, Laroni, A, Brogi, D, BRESCIA MORRA, Vincenzo, Guidi, L, Pozzilli, C, Comi, G, Lugaresi, A, Turrini, R, Raimondi, D, Uccelli, A, Macardi, G., Laroni A, Brogi D, Morra VB, Guidi L, Pozzilli C, Comi G, Lugaresi A, Turrini R, Raimondi D, Uccelli A, Mancardi GL, Amato MP, Appendino L, Ardito B, Avolio C, Bandini F, Batocchi AP, Bellantonio P, Benedetti MD, Bergamaschi R, Bortolon F, Bosco A, Buccafusca M, Cargnelutti D, Cavalla P, Cavallo R, Centonze D, Coniglio MG, Costantino G, Cottone S, Danni MC, De Robertis F, Deotto L, Dotta M, Di Battista G, Filippi MM, Florio C, Francia A, Galgani S, Gallo P, Ghezzi A, Giometto B, Giuliani G Grimaldi LME, Guidotti M, Iudice A, Lenzi GL, Lorusso L, Lus G, Maimone D, Malentacchi GM, Mantegazza RE, Massacesi L, Melato M, Millefiorini E, Montanari E, Patti F, Perrone PSM, Protti A, Provera P, Quattrone A, Rasi F, Rosati G, Rovaris M, Saccà F, Salemi G, Sarchielli P, Scarpini EA, Schoenhuber R, Serrati C, Sinisi L, Sola P, Spitaleri DLA, Tedeschi G, Tezzon F, Tinebra Asti MC, Tola MR, Totaro R, Trojano M, Ulivelli M, Vecchio MM, Zimatore GB, Laroni, A., Brogi, D., Morra, V. B., Guidi, L., Pozzilli, C., Comi, G., Lugaresi, A., Turrini, R., Raimondi, D., Uccelli, A., Mancardi, G. L., Amato, M. P., Appendino, L., Ardito, B., Avolio, C., Bandini, F., Batocchi, A. P., Bellantonio, P., Benedetti, M. D., Bergamaschi, R., Bortolon, F., Bosco, A., Buccafusca, M., Cargnelutti, D., Cavalla, P., Cavallo, R., Centonze, D., Coniglio, M. G., Costantino, G., Cottone, S., Danni, M. C., De Robertis, F., Deotto, L., Dotta, M., Di Battista, G., Filippi, M. M., Florio, C., Francia, A., Galgani, S., Gallo, P., Ghezzi, A., Giometto, B., Giuliani, G., Grimaldi, L. M. E., Guidotti, M., Iudice, A., Lenzi, G. L., Lorusso, L., Lus, G., Maimone, D., Malentacchi, G. M., Mantegazza, R. E., Massacesi, L., Melato, M., Millefiorini, E., Montanari, E., Patti, F., Perrone, P. S. M., Protti, A., Provera, P., Quattrone, A., Rasi, F., Rosati, G., Rovaris, M., Sacca, F., Salemi, G., Sarchielli, P., Scarpini, E. A., Schoenhuber, R., Serrati, C., Sinisi, L., Sola, P., Spitaleri, D. L. A., Tedeschi, G., Tezzon, F., Tinebra Asti, M. C., Tola, M. R., Totaro, R., Trojano, M., Ulivelli, M., Vecchio, M. M., Zimatore, G. B., Mancardi, Gl, Brescia Morra, V, on behalf of the EAP, Investigator, and Giometto, B
Subjects: Oncology, Male, Neurology, fingolimod, multiple sclerosis, treatment, first dose, safety, administration /&/ dosage/adverse effects/analogs /&/ derivatives/therapeutic use, Immunosuppressive Agent, Sphingosine, Multiple Sclerosi, Atrioventricular Block, administration /&/ dosage/adverse effects/therapeutic use, General Medicine, Middle Aged, Tolerability, Propylene Glycol, Fingolimod, drug therapy, Anesthesia, Cohort, Adolescent, Adult, Atrioventricular Block, chemically induced/epidemiology, Drug Therapy, Combination, Female, Humans, Immunosuppressive Agents, administration /&/ dosage/adverse effects/therapeutic use, Male, Middle Aged, Multiple Sclerosis, drug therapy, Propylene Glycols, administration /&/ dosage/adverse effects/therapeutic use, Sphingosine, administration /&/ dosage/adverse effects/analogs /&/ derivatives/therapeutic use, Young Adult, Combination, Drug Therapy, Combination, Settore MED/26 - Neurologia, Female, Atrioventricular block, Bradycardia, Multiple sclerosis, Safety, Adolescent, Adult, Fingolimod Hydrochloride, Humans, Immunosuppressive Agents, Multiple Sclerosis, Propylene Glycols, Young Adult, Neurology (clinical), Atrioventricular block, Bradicardia, Multiple sclerosis, Fingolimod, Safety Tolerability, Research Article, Human, medicine.drug, medicine.medical_specialty, Clinical Neurology, Internal medicine, medicine, Neurochemistry, business.industry, medicine.disease, Clinical trial, Atrioventricular block, Bradycardia, Multiple sclerosis, Fingolimod, Safety, Tolerability, chemically induced/epidemiology, business
Abstract: BACKGROUND: In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disability progression. First dose administration of fingolimod is associated with a transient, dose-dependent decrease in heart rate (HR) in the 6 hours after drug intake.The aim of the study is to to assess safety and tolerability of the first dose of fingolimod in a cohort of Italian patients with RRMS without alternative therapeutic options. METHODS: Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hours and had their vital signs monitored hourly. Extended on-site monitoring was provided when required. RESULTS: Of the 906 patients enrolled in the study, most (95.2%) did not experience any adverse event (AE) following fingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-and second-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricular premature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoring was required in 34 patients. CONCLUSIONS: These results, in a population who better resembled real-world clinical practice in terms of concomitant diseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration of fingolimod is generally safe and well tolerated. TRIAL REGISTRATION: EudraCT 2011-000770-60.
Published: 2014

9. Quality of life, depression and fatigue in mildly disabled patients with relapsing–remitting multiple sclerosis receiving subcutaneous interferon beta-1a: 3-year results from the COGIMUS (COGnitive Impairment in MUltiple Sclerosis) study

Author: Patti, F., Lo Fermo, S., Maimone, D., Messina, S., D'Amico, E., Cimino, V., Gasperini, C., Galgani, S., Orefice, V., Brescia Morra, V., Florio, C., Amato, M., Goretti, B., Portaccio, E., Zipoli, V., Bertolotto, A., Bramanti, P., Sessa, E., Centonze, D., Cottone, S., Salemi, G., Falcini, M., Gallo, P., Perini, P., Gigli, G., Giuliani, G., Pucci, S., Grimaldi, L., Murri, L., Lugaresi, A., Monaco, F., Montanari, E., Motti, L., Neri, S., Paciello, M., Provinciali, L., Ragno, M., Rosati, G., Ruggieri, S., Bell'Antonio, P., Tola, M., Caniatti, L., Tonali, P., Batocchi, A., Trojano, M., Di Monte, E., De Caro, M., Ghezzi, A., Zaffaroni, M., Zolo, P., Zorzon, M., Signorino, M., Scarpini, E., Durelli, L., Carolei, A., Todaro, M., Todaro, R., Spitaleri, D., Tartaglione, A., Patti, F, Amato, Mp, Trojano, M, Bastianello, S, Tola, Mr, Picconi, O, Cilia, S, Cottone, S, Centonze, D, Gasperini, C, BRESCIA MORRA, Vincenzo, Lo Fermo, S, Maimone, D, Messina, S, D'Amico, E, Cimino, V, Galgani, S, Orefice, V, Brescia Morra, V, Florio, C, Amato, MP, Goretti, B, Portaccio, E, Zipoli, V, Bertolotto, A, Bramanti, P, Sessa, E, Salemi, G, Falcini, M, Gallo, P, Perini, P, Gigli, GL, Giuliani, G, Pucci, S, Grimaldi, LM, Murri, L, Lugaresi, A, Monaco, F, Montanari, E, Motti, L, Neri, S, Paciello, M, Provinciali, L, Ragno, M, Rosati, G, Ruggieri, S, Bell'antonio, P, Tola, MR, Caniatti, L, Tonali, P, Batocchi, AP, Di Monte, E, De Caro, MF, Ghezzi, A, Zaffaroni, M, Zolo, P, Zorzon, M, Signorino, M, Scarpini, E, Durelli, L, Carolei, A, Todaro, M, Todaro, R, Spitaleri, D, Tartaglione, A, Patti F, Amato MP, Trojano M, Bastianello S, Tola MR, Picconi O, Cilia S, Cottone S, Centonze D, Gasperini C, COGIMUS Study Group, and Lugaresi A
Subjects: Adult, Male, Quality of life, Longitudinal study, medicine.medical_specialty, Injections, Subcutaneous, multiple sclerosis, Relapsing-Remitting Multiple Sclerosis, Interferon beta 1a, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Adjuvants, Immunologic, Internal medicine, medicine, Humans, Young adult, Fatigue, Depression (differential diagnoses), Aged, Depression, business.industry, Cognitive function, Multiple sclerosis, Cognitive disorder, Interferon beta-1a, Interferon-beta, Middle Aged, medicine.disease, Clinical trial, Neurology, Physical therapy, multiple sclerosis, cognition, interferon beta, Female, Settore MED/26 - Neurologia, Neurology (clinical), Cognition Disorders, business, medicine.drug
Abstract: Background: The precise relationships among quality of life, depression, fatigue and cognitive impairment in multiple sclerosis (MS) are complex and poorly understood. Objective: To assess the effects of subcutaneous interferon beta-1a on quality of life, depression and fatigue over 3 years in the COGIMUS study, and to examine the relationship between these outcomes and baseline cognitive status. Methods: COGIMUS was an observational 3-year trial assessing cognitive function in 459 patients with relapsing–remitting MS treated with subcutaneous interferon beta-1a. Results: In total, 331 patients completed the study (168 received interferon beta-1a, 44 µg subcutaneously three times weekly, and 163 received interferon beta-1a, 22 µg subcutaneously three times weekly). Mean MS Quality of Life-54 (MSQoL-54) composite scores did not change over time. There were no significant differences between groups in MSQoL-54 composite scores when patients were grouped by treatment dose and baseline cognitive status. Mean (standard deviation) Hamilton Depression Rating Scale score decreased from 6.8 (4.9) at baseline to 5.8 (5.9) at year 3. Mean total Fatigue Impact Scale scores were low ( Conclusion: Quality of life, depression and fatigue remained largely stable over 3 years; no effects of treatment dose or baseline cognitive status were found.
Published: 2011

10. Natalizumab in the pediatric MS population: Results of the Italian registry

Author: Ghezzi A, Moiola L, Pozzilli C, Brescia Morra V, Gallo P, Grimaldi LME, Comi G, the MS Study Group – Italian Society of Neurology, ROCCA, MARIA ASSUNTA, FILIPPI , MASSIMO, Ghezzi, A, Moiola, L, Pozzilli, C, BRESCIA MORRA, Vincenzo, Gallo, P, Grimaldi, Lme, Filippi, M., Brescia Morra, V, Filippi, Massimo, Comi, G, the MS Study Group, – Italian Society of Neurology, and Rocca, MARIA ASSUNTA
Subjects: leukocyte count, drug safety, myalgia, hematologic disease, bone cyst, tachycardia, Natalizumab, Recurrence, Registries, nuclear magnetic resonance imaging, Depression (differential diagnoses), bilirubin blood level, relapse, education.field_of_study, child, General Medicine, brain damage, Magnetic Resonance Imaging, anemia, EMTREE drug terms: beta interferon, Expanded Disability Status Scale, female, Italy, drug withdrawal, multiple sclerosi, depression, disease registry, headache, gastrointestinal disease, medicine.drug, Research Article, dermatiti, recurrence risk, medicine.medical_specialty, Multiple Sclerosis, hypertension, Adolescent, side effect, natalizumab EMTREE medical terms: adolescent, Population, Clinical Neurology, herpes zoster, menstruation disorder, Article, glatiramer, respiratory tract disease, vertigo, Disease registry, male, Internal medicine, medicine, restlessne, Humans, follow up, controlled study, human, Glatiramer acetate, education, Adverse effect, ovary cyst, unspecified side effect, treatment duration, business.industry, Multiple sclerosis, Glatiramer Acetate, Interferon-beta, immunosuppressive agent, medicine.disease, major clinical study, infection, Surgery, drug efficacy, pruritu, immunomodulating agent, fatigue, Neurology (clinical), JC viru, weight reduction, proteinuria, business, aspartate aminotransferase blood level, urinary tract infection, drug tolerability, edema, alanine aminotransferase blood level
Abstract: Background: Natalizumab is a promising option for pediatric multiple sclerosis (MS) patients with active evolution and a poor response to Interferon-beta or Glatiramer Acetate. However, no data are available in large cohorts of patients and after a long-term follow up. Our study was planned to shed lights on this topic. Methods: A registry was established in 2007 in Italy to collect MS cases treated with Natalizumab (NA) before 18 years of age. Results: 101 patients were included (69 females), mean age of MS onset 12.9±2.7 years, mean age at NA initiation 14.7±2.4 years. Mean treatment duration was 34.2±18.3 months. During NA treatment, a total of 15 relapses were recorded in 9 patients, annualized relapse rate was 2.3±1.0 in the year prior to NA and decreased to 0.1±0.3 (p
Published: 2015

11. Natalizumab therapy of multiple sclerosis: recommendations of the Multiple Sclerosis Study Group-Italian Neurological Society

Author: GHEZZI A, GRIMALDI LM, MARROSU MG, POZZILLI C, COMI G, BERTOLOTTO A, TROJANO M, GALLO P, CAPRA R, CENTONZE D, MILLEFIORINI E, SOTGIU S, BRESCIA MORRA V, AMATO MP, LUGARESI A, MANCARDI G, CAPUTO D, MONTANARI E, PROVINCIALI L, DURELLI L, BERGAMASCHI R, BELLANTONIO P, TOLA MR, COTTONE S, SAVETTIERI G, MS SIN STUDY GROUP, TEDESCHI, Gioacchino, Ghezzi, A, Grimaldi, Lm, Marrosu, Mg, Pozzilli, C, Comi, G, Bertolotto, A, Trojano, M, Gallo, P, Capra, R, Centonze, D, Millefiorini, E, Sotgiu, S, BRESCIA MORRA, V, Amato, Mp, Lugaresi, A, Mancardi, G, Caputo, D, Montanari, E, Provinciali, L, Durelli, L, Bergamaschi, R, Bellantonio, P, Tola, Mr, Cottone, S, Savettieri, G, Tedeschi, Gioacchino, MS SIN STUDY, Group, Comi, Giancarlo, Brescia Morra, V, Tedeschi, G, MS SIN Study, Group, Ghezzi A, Grimaldi LM, Marrosu MG, Pozzilli C, Comi G, Bertolotto A, Trojano M, Gallo P, Capra R, Centonze D, Millefiorini E, Sotgiu S, Brescia Morra V, Amato MP, Lugaresi A, Mancardi G, Caputo D, Montanari E, Provinciali L, Durelli L, Bergamaschi R, Bellantonio P, Tola MR, Cottone S, Savettieri G, Tedeschi G, MS-SIN Study Group, BRESCIA MORRA, Vincenzo, Ghezzi,A, Grimaldi,LM, Marrosu,MG, Comi,G, Bertolotto,A, Centonze. D, Amato,MP, Tola, MR, and MS-SIN Study Group.
Subjects: medicine.medical_specialty, Pediatrics, pml, iris, multiple sclerosis, natalizumab, Multiple Sclerosis, Neurology, MEDLINE, Progressive Multifocal, Dermatology, Relapsing-Remitting, Antibodies, Monoclonal, Humanized, Antibodies, Leukoencephalopathy, Multiple Sclerosis, Relapsing-Remitting, Natalizumab, Monoclonal, medicine, Humans, Adverse effect, Humanized, Antibodies, therapeutic use, Humans, Leukoencephalopathy, chemically induced, Multiple Sclerosis, drug therapy, Humanized, Multiple sclerosis, Natalizumab, PML, IRIS, business.industry, Progressive multifocal leukoencephalopathy, Multiple sclerosis, Leukoencephalopathy, Progressive Multifocal, Antibodies, Monoclonal, General Medicine, medicine.disease, Psychiatry and Mental health, therapeutic use, chemically induced, natalizumab, multiple sclerosis, treatment, guidelines, Physical therapy, Settore MED/26 - Neurologia, Neurology (clinical), Neurosurgery, business, medicine.drug
Abstract: Three years after the introduction of natalizumab (NA) therapy for the second line treatment of relapsing-remitting multiple sclerosis (MS), Italian MS centers critically reviewed the scientific literature and their own clinical experience. Natalizumab was shown to be highly efficacious in the treatment of MS. However, the risk of progressive multifocal leukoencephalopathy was confirmed and defined better. This article summarizes the MS-SIN Study Group recommendations on the use of NA in MS, with particular reference to the appropriate selection and monitoring of patients as well as to the management of adverse events.
Published: 2011

12. Predictive factors of neutralizing antibodies development in relapsing-remitting multiple sclerosis patients on interferon Beta-1b therapy

Author: Lanzillo, R., Orefice, G., Prinster, A., Ventrella, G., Liuzzi, R., Scarano, V., Florio, C., Vacca, G., Brunetti, A., Alfano, B., Brescia Morra, V., Bonavita, V., Lanzillo, Roberta, Orefice, Giuseppe, Prinster, A, Ventrella, G, Liuzzi, R, Scarano, V, Florio, C, Vacca, G, Brunetti, A, Alfano, B, BRESCIA MORRA, Vincenzo, and Bonavita, V.
Subjects: Adult, Male, medicine.medical_specialty, Neurology, Adolescent, Dermatology, Neutralizing antibodies, Multiple sclerosis, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Adjuvants, Immunologic, Internal medicine, medicine, Humans, Young adult, Cognitive deficit, Retrospective Studies, Expanded Disability Status Scale, business.industry, Incidence (epidemiology), Interferon beta-1b, Retrospective cohort study, Interferon-beta, General Medicine, Middle Aged, Prognosis, medicine.disease, Antibodies, Neutralizing, Psychiatry and Mental health, Immunology, Disease Progression, Female, Neurology (clinical), medicine.symptom, Beta interferon, business, Predictive factors
Abstract: The identification of predictive factors of NAbs development might have a relevant impact on clinical practice. Our objective is to look after predictive factors of NAbs development in MS IFN Beta-1b-treated patients. Database was screened for patients on IFN Beta-1b treatment with an Expanded Disability Status Scale (EDSS) at a baseline between 1 and 3.5, disease duration shorter than 15 years, and NAbs analysis performed every 6 months. The NAbs positive status was analysed in relation to baseline clinical, neuropsychological and brain imaging measures. Forty-nine patients were included. Sixteen patients had become NAbs positive at some point on IFN therapy (35%). NAbs producers differed from not producers for higher incidence of cognitive deficit and higher lesion load (OR = 5.0 and 5.6, respectively). Our study suggests that NAbs development might be a marker of a more aggressive disease and that worse outcome in NAbs producers might be biased by baseline condition. © 2011 Springer-Verlag.
Published: 2011

13. Subcutaneous interferon β-1a may protect against cognitive impairment in patients with relapsing-remitting multiple sclerosis: 5-year follow-up of the COGIMUS study

Author: Patti, F, Lo, S, Messina, S, Vecchio, R, Maimone, D, Gasperini, C, Orefice, G, Brescia Morra, V, Florio, C, Amato, Mp, Goretti, B, Portaccio, E, Zipoli, V, Bertolotto, A, Bramanti, P, Sessa, E, Centonze, D, Cottone, S, Salemi, G, Falcini, M, Gallo, Paolo, Perini, Paola, Gigli, Gl, Giuliani, G, Grimaldi, Lm, Murri, L, Lugaresi, A, Monaco, F, Montanari, E, Motti, L, Neri, G, Paciello, M, Provinciali, L, Ragno, M, Rosati, G, Ruggieri, S, Tola, Mr, Caniatti, L, Tonali, P, Batocchi, Ap, Trojano, M, Di Monte, E, De Caro MF, Ghezzi, A, Zaffaroni, M, Zolo, P, Zorzon, M, Scarpini, E, Durelli, L, Carolei, A, Totaro, R, Spitaleri, D, Tartaglione, A., Patti, F, Lo, S, Messina, S, Vecchio, R, Maimone, D, Gasperini, C, Orefice, G, Brescia-Morra, V, Florio, C, Amato, MP, Goretti, B, Portaccio, E, Zipoli, V, Bertolotto, A, Bramanti, P, Sessa, E, Centonze, D, Cottone, S, Salemi, G, Falcini, M, Gallo, P, Perini, P, Gigli, GL, Giuliani, G, Grimaldi, LM, Murri, L, Lugaresi, A, Monaco, F, Montanari, E, Motti, L, Neri, G, Paciello, M, Provinciali, L, Ragno, M, Rosati, G, Ruggieri, S, Tola, MR, Caniatti, L, Tonali, P, Batocchi, AP, Trojano, M, Di Monte, E, De Caro, MF, Ghezzi, A, Zaffaroni, M, Zolo, P, Zorzon, M, Scarpini, E, Durelli, L, Carolei, A, Totaro, R, Spitaleri, D, Tartaglione, A, BRESCIA MORRA, Vincenzo, Amato, Mp, Bastianello, S, Tola, Mr, Plant, A, Orefice, Giuseppe, and G.
Subjects: Adult, Male, medicine.medical_specialty, 5 year follow up, Multiple Sclerosis, Adolescent, Science, Injections, Subcutaneous, Brain damage, Young Adult, Interferon, Recurrence, Internal medicine, medicine, Humans, In patient, Young adult, Cognitive impairment, Sex Characteristics, Multidisciplinary, medicine.diagnostic_test, business.industry, Multiple sclerosis, Multiple Sclerosis, Subcutaneous interferon β-1a, cognitive impairment, Magnetic resonance imaging, Interferon-beta, medicine.disease, Treatment Outcome, Immunology, Medicine, Female, Settore MED/26 - Neurologia, medicine.symptom, Safety, business, Cognition Disorders, Interferon beta-1a, medicine.drug, Research Article, Follow-Up Studies
Abstract: ObjectiveTo assess the effects of subcutaneous (sc) interferon (IFN) -1a on cognition over 5 years in mildly disabled patients with relapsing-remitting multiple sclerosis (RRMS).MethodsPatients aged 18-50 years with RRMS (Expanded Disability Status Scale score ≤4.0) who had completed the 3-year COGIMUS study underwent standardized magnetic resonance imaging, neurological examination, and neuropsychological testing at years 4 and 5. Predictors of cognitive impairment at year 5 were identified using multivariate analysis.ResultsOf 331 patients who completed the 3-year COGIMUS study, 265 participated in the 2-year extension study, 201 of whom (75.8%; sc IFN β-1a three times weekly: 44 µg, n = 108; 22 µg, n = 93) completed 5 years' follow-up. The proportion of patients with cognitive impairment in the study population overall remained stable between baseline (18.0%) and year 5 (22.6%). The proportion of patients with cognitive impairment also remained stable in both treatment groups between baseline and year 5, and between year 3 and year 5. However, a significantly higher proportion of men than women had cognitive impairment at year 5 (26.5% vs 14.4%, p = 0.046). Treatment with the 22 versus 44 µg dose was predictive of cognitive impairment at year 5 (hazard ratio 0.68; 95% confidence interval 0.48-0.97).ConclusionsThis study suggests that sc IFN β-1a dose-dependently stabilizes or delays cognitive impairment over a 5-year period in most patients with mild RRMS. Women seem to be more protected against developing cognitive impairment, which may indicate greater response to therapy or the inherently better prognosis associated with female sex in MS.
Published: 2013

14. Patient adherence to and tolerability of self-administered interferon β-1a using an electronic autoinjection device: a multicentre, open-label, phase IV study

Author: Lugaresi A, Florio C, Brescia-Morra V, Cottone S, Bellantonio P, Clerico M, Centonze D, Uccelli A, di Ioia M, De Luca G, Marcellusi A, Paolillo A, Bridge Study Group, Lugaresi A, Florio C, Brescia-Morra V, Cottone S, Bellantonio P, Clerico M, Centonze D, Uccelli A, di Ioia M, De Luca G, Marcellusi A, Paolillo A, Bridge Study Group, Lugaresi, A, Florio, C, BRESCIA MORRA, Vincenzo, Cottone, S, Bellantonio, P, Clerico, M, Centonze, D, Uccelli, A, di Ioia, M, De Luca, G, Marcellusi, A, Paolillo, A, and for the BRIDGE study, Group
Subjects: Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Injections, Subcutaneous, Population, Clinical Neurology, Self Administration, Hospital Anxiety and Depression Scale, lcsh:RC346-429, IFN beta, Disability Evaluation, Young Adult, Autoinjector, Internal medicine, medicine, Humans, Immunologic Factors, multiple sclerosis, autoinjector, device, electronic, adherence, tolerability, Adverse effect, education, Medication adherence, lcsh:Neurology. Diseases of the nervous system, Pain Measurement, education.field_of_study, Analysis of Variance, Expanded Disability Status Scale, business.industry, General Medicine, Interferon-beta, Middle Aged, Drug delivery systems, Clinical trial, Logistic Models, Treatment Outcome, Tolerability, Physical therapy, Anxiety, Patient Compliance, Relapsing-remitting multiple sclerosis, Female, Settore MED/26 - Neurologia, Neurology (clinical), medicine.symptom, business, Research Article, Follow-Up Studies
Abstract: Background Achieving good adherence to self-injected treatments for multiple sclerosis can be difficult. Injection devices may help to overcome some of the injection-related barriers to adherence that can be experienced by patients. We sought to assess short-term adherence to, and tolerability of, interferon (IFN) β-1a administered via electronic autoinjection device in patients with relapsing-remitting multiple sclerosis (RRMS). Methods BRIDGE (RebiSmart to self-inject Rebif serum-free formulation in a multidose cartridge) was a 12-week, multicentre, open-label, single-arm, observational, Phase IV study in which patients self-administered IFN β-1a (titrated to 44 μg), subcutaneously (sc), three times weekly, via electronic autoinjection device. Patients were assessed at baseline and 4-weekly intervals to Week 12 or early termination (ET) for: physical examinations; diary card completion (baseline, Weeks 4, 8 only); neurological examinations (baseline, Week 12/ET only); MS Treatment Concern Questionnaire (MSTCQ; Weeks 4, 8, 12 only); Convenience Questionnaire (Week 12 only); Hospital Anxiety and Depression Scale (HADS); and Paced Auditory Serial Addition Task (PASAT; baseline only). Adherence was defined as administration of ≥ 80% of scheduled injections, recorded by the autoinjection device. Results Overall, 88.2% (105/119; intent-to-treat population) of patients were adherent; 67.2% (80/119) administered all scheduled injections. Medical reasons accounted for 35.6% (31/87) of missed injections, forgetfulness for 20.6% (18/87). Adherence did not correlate with baseline Expanded Disability Status Scale (P = 0.821) or PASAT (P = 0.952) scores, or pre-study therapy (P = 0.303). No significant changes (baseline-Week 12) in mean HADS depression (P = 0.482) or anxiety (P = 0.156) scores were observed. 'Overall convenience' was the most important reported benefit of the autoinjection device. Device features associated with handling and ease of use were highly rated. Mean MSTCQ scores for 'flu-like' symptoms (P = 0.022) and global side effects (P = 0.002) significantly improved from Week 4-12. Mean MSTCQ scores for pain at injection site and injection pain increased from Week 4-12 (P < 0.001). Adverse events were mild/moderate. No new safety signals were identified. Conclusion Convenience and ease of use of the autoinjection device may improve adherence and, therefore, outcomes, in patients with RRMS receiving sc IFN β-1a. Trial registration EU Clinical Trials Register (EU-CTR; http://www.clinicaltrialsregister.eu): 2009-013333-24
Published: 2012

15. Changes in magnetic resonance imaging disease measures over 3 years in mildly disabled patients with relapsing-remitting multiple sclerosis receiving interferon β-1a in the COGnitive Impairment in MUltiple Sclerosis (COGIMUS) study

Author: Patti, F., Lo Fermo, S., Vecchio, R., Maimone, D., Messina, S., Gasperini, C., Orefice, V., Brecia Morra, V., Florio, C., Amato, M., Goretti, B., Portaccio, E., Zipoli, V., Bertolotto, A., Bramanti, P., Sessa, E., Centonze, D., Cottone, S., Salemi, G., Falcini, M., Gallo, P., Perini, P., Gigli, G., Giuliani, G., Grimaldi, L., Murri, L., Lugaresi, A., Monaco, F., Montanari, E., Motti, L., Neri, S., Paciello, M., Provinciali, L., Ragno, M., Rosati, G., Ruggieri, S., Tola, M., Caniatti, L., Tonali, P., Batocchi, A., Trojano, M., Di Monte, E., De Caro, M., Ghezzi, A., Zaffaroni, M., Zolo, P., Zorzon, M., Signorino, M., Scarpini, E., Durelli, L., Carolei, A., Totaro, R., Spitaleri, D., Tartaglione, A., Patti F, Lo Fermo S, Vecchio R, Maimone D, Messina S, Gasperini C, Orefice V, Brecia Morra V, Florio C, Amato MP, Goretti B, Portaccio E, Zipoli V, Bertolotto A, Bramanti P, Sessa E, Centonze, D, Cottone, S, Salemi, G, Falcini, M, Gallo, P, Perini, P, Gigli, GL, Giuliani, G, Grimaldi, LM, Murri, L, Lugaresi, A, Monaco, F, Montanari, E, Motti, L, Neri, S, Paciello, M, Provinciali, L, Ragno, M, Rosati, G, Ruggieri, S, Tola, MR, Caniatti, L, Tonali, P, Batocchi, AP, Trojano, M, Di Monte, E, De Caro, MF, Ghezzi, A, Zaffaroni, M, Zolo, P, Zorzon, M, Signorino, M, Scarpini, E, Durelli, L, Carolei, A, Totaro, R, Spitaleri, D, and Tartaglione, A
Subjects: Male, Pathology, Neurology, Disease, Relapsing-Remitting, Neuropsychological Tests, lcsh:RC346-429, 0302 clinical medicine, Relapsing-Remitting Multiple Sclerosi, 030212 general & internal medicine, 10. No inequality, medicine.diagnostic_test, Brain, General Medicine, Magnetic Resonance Imaging, 3. Good health, Female, Settore MED/26 - Neurologia, Radiology, Neurosurgery, Neuroimaging, Immunologic Factors, Dose-Response Relationship, Drug, Humans, Interferon-beta, Quality of Life, Multiple Sclerosis, Relapsing-Remitting, Cognition Disorders, Adult, Drug, Interferon beta-1a, Research Article, medicine.medical_specialty, Multiple Sclerosis, Clinical Neurology, Dose-Response Relationship, 03 medical and health sciences, medicine, Neurochemistry, lcsh:Neurology. Diseases of the nervous system, business.industry, Multiple sclerosis, Magnetic resonance imaging, Brain Magnetic Resonance Imaging, medicine.disease, Clinical trial, Relapsing-Remitting Multiple Sclerosis, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract: Background Conventional magnetic resonance imaging (MRI) has improved the diagnosis and monitoring of multiple sclerosis (MS). In clinical trials, MRI has been found to detect treatment effects with greater sensitivity than clinical measures; however, clinical and MRI outcomes tend to correlate poorly. Methods In this observational study, patients (n = 550; 18-50 years; relapsing-remitting MS [Expanded Disability Status Scale score ≤4.0]) receiving interferon (IFN) β-1a therapy (44 or 22 µg subcutaneously [sc] three times weekly [tiw]) underwent standardized MRI, neuropsychological and quality-of-life (QoL) assessments over 3 years. In this post hoc analysis, MRI outcomes and correlations between MRI parameters and clinical and functional outcomes were analysed. Results MRI data over 3 years were available for 164 patients. T2 lesion and T1 gadolinium-enhancing (Gd+) lesion volumes, but not black hole (BH) volumes, decreased significantly from baseline to Year 3 (P < 0.0001). Percentage decreases (baseline to Year 3) were greater with the 44 μg dose than with the 22 μg dose for T2 lesion volume (-10.2% vs -4.5%, P = 0.025) and T1 BH volumes (-7.8% vs +10.3%, P = 0.002). A decrease in T2 lesion volume over 3 years predicted stable QoL over the same time period. Treatment with IFN β-1a, 44 μg sc tiw, predicted an absence of cognitive impairment at Year 3. Conclusion Subcutaneous IFN β-1a significantly decreased MRI measures of disease, with a significant benefit shown for the 44 µg over the 22 µg dose; higher-dose treatment also predicted better cognitive outcomes over 3 years.
Published: 2011

16. Implementation of the 'Sapere Migliora' information aid for newly diagnosed people with multiple sclerosis in routine clinical practice: a late-phase controlled trial

Author: Giordano A, Martinelli V, Lugaresi A, Pucci E, Granella F, Trojano M, Solari A, Messmer Uccelli M, Ferrari G, Martini F, Radice D, D'Annunzio G, Farina D, Travaglini D, Pietrolongo E, Onofrj M, Torri Clerici V, Bonanno S, Brambilla L, Confalonieri P, Radaelli M, Messina J, Comi G, Tortorella C, Luciannatelli E, Senesi C, Tsantes E, Conti M, Rottoli M, Bellantonio P, Fischetti M, Fantozzi R, Pala A, Traccis S, Di Battista G, Bianchi M, Benedetti M, Gaetani L, Di Filippo M, Carolei A, Totaro R, Lanzillo R, Brescia Morra V, Coppola R, Cottone S, Chiavazza C, Cavalla P, Leonardi C, Aguglia U, Ziuliani C, Valla P, Sasanelli F, Valentino P, Quattrone A, Martino PG, Russo M, Vita G, Immovilli P., Giordano A, Lugaresi A, Confalonieri P, Granella F, Radice D, Trojano M, Martinelli V, Solari A, on behalf of the SIMS-Practice groupa, Giordano, A, Lugaresi, A, Confalonieri, P, Granella, F, Radice, D, Trojano, M, Comi, Giancarlo, on behalf of the SIMS Practice, Group, and Radaelli, Marta
Subjects: Adult, Male, medicine.medical_specialty, Health Knowledge, Attitudes, Practice, Multiple Sclerosis, Adolescent, patient satisfaction, Health literacy, Group B, law.invention, Interviews as Topic, Young Adult, Patient satisfaction, complex health intervention, Randomized controlled trial, Patient Education as Topic, law, Surveys and Questionnaires, Multiple Sclerosi, Clinical endpoint, Medicine, Humans, Prospective Studies, Young adult, Prospective cohort study, disease knowledge, information aid, Internet, business.industry, Multiple sclerosis, multiple sclerosis, clinical practice, Middle Aged, medicine.disease, Health Literacy, Treatment Outcome, Neurology, Italy, Physical therapy, Female, Pamphlets, Neurology (clinical), business, Comprehension
Abstract: Background: The SIMS-Trial showed that the ‘Sapere Migliora’ information aid (IA) for newly diagnosed people with multiple sclerosis (PwMS) effectively improved patient knowledge and satisfaction with care. Objectives: The objectives of this paper are to assess the effectiveness of the IA in clinical practice and to compare the whole IA with the take-home booklet/website component alone. Methods: After updating the IA and replacing the CD with a website, a prospective, open-label non-randomised controlled trial compared the whole IA (group A, five SIMS-Trial centres) to take-home (group B, 16 centres). One month after the intervention, participants completed the MS Knowledge Questionnaire (MSKQ), care satisfaction questionnaire (COSM-R) (primary study outcomes), Hospital and Anxiety Depression Scale, and ad hoc questionnaire appraising the IA. Results: We enrolled 159 newly diagnosed PwMS (May 2012–March 2013). Drop-outs were four of 77 (5%, group A) and 11/82 (13%, group B). Primary endpoint (highest tertile both for MSKQ and COSM-R section 2 scores) was achieved by 38/77 (49%) group A and 33/82 (40%) group B ( p = 0.25). Attainment of secondary outcomes was also similar between groups. Conclusions: This study shows that the entire IA is not superior to the booklet/website alone, and that both are comparable in efficacy to the intervention arm of the SIMS-Trial. Trial registration number: ISRCTN78940214.
Published: 2014

17. Supportive strategies to improve adherence to IFN β-1b in multiple sclerosis - Results of the βPlus observational cohort study

Author: Pozzilli, C, Schweikert, B, Ecari, U, Oentrich, W, Benesova, Y, Fiedler, J, Meluzinova, E, Novotna, A, Pikova, J, Albrecht, W, Altmann, N, Augspach-Hofmann, R, Berdermann-Welz, S, Blodau, A, Bode, L, Böer, A, Botzler, D, Burkhardtde Boor, E, Christopher, A, Dieler, J, Domke, S, Eckhardt, U, Eder, H, Faiss, J, Fegers, S, Franz, P, Freidel, M, Haas, J, Hackebeil, C, Helfrich, S, Herzog, S, Hofmann, W, Käfferlein, W, Kausch, U, Kaya, B, Korda, W, Krumpolt, H, Luber, G, Maier, I, Mamerow, U, Müllner, E, Niedhammer, M, Oschmann, P, Ossig, W, Peschel, S, Piepenbrock, N, Rauber, A, Rauch, G, Rohrer, G, Rosenthal, A, Rüther, K, Safavi, A, Schlote, M, Schnelzer, R, Seifert, E, Seybold, J, Siefjediers, V, Siever, A, Veit, B, Wietfeld, R, Abbasyonn, T, Abdoli, M, Abolfazli, R, Airemlou, H, Alikhani, K, Ashjazadeh, N, Ashtari, F, Azarangi, D, Azarians, S, Azimi, B, Azimian, M, Beladimoghadam, N, Chitsaz, A, Etemadyfar, M, Farhoudi, M, Fayaz Nekoo, M, Ghadiri, F, Ghazvinian, S, Ghelich Nia Emrani, H, Ghorbani, A, Harirchian, M. H, Homam, M, Ilkhani, M, Khosravi, K, Lotfi, J, Malekzadeh, G, Moshiri, Z, Motamadi, M, Motamed, M. M, Nabavi, S, Nafissi, S, Najlerahim, A, Nikanfar, M, Nikkhah, K, Nikseresht, A, Noorian, A, Oraki, Z, Pashapour, A, Pourmahmoudian, H, Saadatnia, M, Sadeghi, H, Sadreddini, S, Saeidi, M, Sahraian, M, Salarjan, B, Sasannezhad, P, Seifi, J, Shahbeigi, S, Shahidi, M, Shariat, A, Shaygannejad, V, Tabatabaei, M, Togha, M, Torabi, H, Vosooghi, R, Yousefi Azarfam, J, Yousefipour, G, Block, I, Karni, A, Karussis, D, Kirshner, I, Miller, A, Milo, R, Amato, M, Annunziata, P, Assetta, M, Batocchi, A, Brescia Morra, V, Carbonin, C, Carolei, A, Catalan, M, Cavallo, R, Comi, G, Coniglio, M, Constantino, F, Costantino, C, Cottone, S, Durelli, L, Ferraro, E, Ghezzi, A, Gometto, B, Grasso, M, Greco, L, Handouk, Y, Iudice, A, Koudriautseva, T, Lugaresi, A, Maimone, D, Mannu, L, Marchioretto, F, Marrosu, M, Meola, G, Millefiorini, E, Montanari, E, Patti, F, Pauri, F, Plewnia, K, Protti, A, Reggio, A, Rottoli, M, Sinisi, L, Spitaleri, D, Tola, M. R, Abdallah, H, Eid, H, Ezzeddine, F, Jbelly, S, Khamis, C, Koussa, S, Masri, W, Sawaya, R, Serhan, A, Shatila, A. R, Souklawi, K, Sukkari, R, Tfaily, H, Traboulsi, H, Wehbi, M, Yamout, B, Hadich, M. S, Baal, M. G, Dellemyn, P, Driesen, J. J. M, Timmerhues, T. P. J, Valente, I, Abduljabar, M, Cho, K. H, Kim, J. W, Sangdoe, Y, Batue, J, Ramio, L, Benrabah, R, Couur, B, D'Gal, O, Gras, P, Guinot, H, Lemarquis, P, Munoz-Lacoste, P, Nayef, A, Vaunaize, J, Visy, J. -M, Vongsouthi, C, Chang, W. N, Tain-Junn, C, Yeh, S. J, Celebi, A, Erdemoglu, A. K, Gedizlioglu, M, Uysal Tan, F, Pozzilli C, Schweikert B, Ecari U, Oentrich W, BetaPlus Study group, Lugaresi A, Pozzilli, C, Schweikert, B, Ecari, U, Oentrich, W, and BRESCIA MORRA, Vincenzo
Subjects: Adult, Male, medicine.medical_specialty, Coping (psychology), Health outcomes, Medication Adherence, Cohort Studies, Multiple sclerosis, Adjuvants, Immunologic, Autoinjector, medicine, Humans, Prospective Studies, nurses, adherence, interferon beta-1b, multiple sclerosis, coping styles, autoinjector devices, business.industry, Interferon beta-1b, Interferon-beta, interferon beta, adherence, injection device, Middle Aged, medicine.disease, Patient support, Settore MED/26 - NEUROLOGIA, Disease factors, Neurology, Physical therapy, Female, Neurology (clinical), business, Cohort study
Abstract: Background: Low adherence to treatment in Multiple Sclerosis (MS) has been shown to lead to poor health outcomes. Various strategies to improve adherence have been suggested including educative programs, injection devices and dedicated nurse assistance. Objective: To assess the impact of elements of the patient support program on adherence; to explore disease factors affecting adherence; and to determine whether these factors influence the choices of supportive elements. Methods: A prospective, observational cohort study was conducted. MS patients were eligible if they had switched to Interferon beta-1b (IFNB-1b) between 1 and 3 months prior to inclusion. Data were collected at months 6, 12, 18 and 24 after inclusion. Adherence was defined as completion of both study protocol and medication at 24 months. Patients underwent evaluations of disability, quality of life, depression, and coping styles. Results: A total of 1077 patients from 15 countries were included, of which 61.8% were adherent to IFNB-1b after 24-months. Depression, quality of life and autoinjector devices were baseline predictors of adherence at 24-months. Coping styles did not show to have substantial impact on adherence. Lower quality of life increased the probability of choosing supportive elements. Conclusion: The study showed that the usage of autoinjector devices chosen during the study was the strongest predictor of drug adherence of all the supportive elements tested in this study. (C) 2011 Elsevier B.V. All rights reserved.
Published: 2011

18. Effects of immunomodulatory treatment with subcutaneous interferon beta-1a on cognitive decline in mildly disabled patients with relapsing-remitting multiple sclerosis

Author: Patti, F., Lo Fermo, S., Vecchio, R., Maimone, D., Messina, S., Gasperini, C., Orefice, V., Morra, V., Florio, C., Amato, M., Goretti, B., Portaccio, E., Zipoli, V., Bertolotto, A., Bramanti, P., Sessa, E., Centonze, D., Cottone, S., Salemi, G., Falcini, M., Gallo, P., Perini, P., Gigli, G., Giuliani, G., Grimaldi, L., Murri, L., Lugaresi, A., Monaco, F., Montanari, E., Motti, L., Neri, S., Paciello, M., Provinciali, L., Ragno, M., Rosati, G., Ruggieri, S., Tola, M., Caniatti, L., Tonali, P., Batocchi, A., Trojano, M., Di Monte, E., De Caro MF, Ghezzi, A., Zaffaroni, M., Zolo, P., Zorzon, M., Signorino, M., Scarpini, E., Durelli, L., Carolei, A., Todaro, M., Spitaleri, D., Tartaglione, A., Patti F, Amato MP, Bastianello S, Caniatti L, Di Monte E, Ferrazza P, Goretti B, Gallo P, Morra VB, Lo Fermo S, Picconi O, Tola MR, Trojano M, COGIMUS Study Group, Lugaresi A, Vecchio R, Maimone D, Messina S, Gasperini C, Orefice V, Florio C, Portaccio E, Zipoli V, Bertolotto A, Bramanti P, Sessa E, Centonze D, Cottone S, Salemi G, Falcini M, Perini P, Gigli GL, Giuliani G, Grimaldi LM, Murri L, Monaco F, Montanari E, Motti L, Neri S, Paciello M, Provinciali L, Ragno M, Rosati G, Ruggieri S, Tonali P, Batocchi AP, De Caro MF, Ghezzi A, Zaffaroni M, Zolo P, Zorzon M, Signorino M, Scarpini E, Durelli L, Carolei A, Todaro M, Spitaleri D, and Tartaglione A
Subjects: Male, interferon beta-1a, Kaplan-Meier Estimate, Relapsing-Remitting, Neuropsychological Tests, Cohort Studies, Disability Evaluation, Medicine, Adolescent, Young Adult, Middle Aged, Cognition Disorders, Survival Analysis, Female, Dose-Response Relationship, Drug, Humans, Multiple Sclerosis, Relapsing-Remitting, Prospective Studies, Disease Progression, Interferon-beta, Injections, Subcutaneous, Adult, Immunologic Factors, Endpoint Determination, Prospective cohort study, interferon beta, multiple sclerosis, cognitive impairment, Subcutaneous, Cognitive disorder, Hazard ratio, Settore MED/26 - NEUROLOGIA, Neurology, Settore MED/26 - Neurologia, Drug, medicine.drug, medicine.medical_specialty, Multiple Sclerosis, Lower risk, Injections, Dose-Response Relationship, Internal medicine, cognitive function, cognitive impairment, Expanded Disability Status Scale, business.industry, Interferon beta-1a, McDonald criteria, Odds ratio, medicine.disease, Surgery, disability, Neurology (clinical), business, disease progression, multiple sclerosis
Abstract: The objective of this study was to assess the effects of subcutaneous (sc) interferon beta-1a (IFNβ-1a) on cognition in mildly disabled patients with relapsing—remitting multiple sclerosis (RRMS). Patients aged 18—50 years with RRMS (McDonald criteria; Expanded Disability Status Scale score ≤4.0) were assigned IFNβ therapy at the physician’s discretion and underwent standardized magnetic resonance imaging, neurological examination and neuropsychological testing at the baseline and regular intervals for up to three years. This analysis included 459 patients who received sc IFNβ-1a (44 mcg: n = 236; 22 mcg: n = 223; three-year follow up was available for 318 patients). The hazard ratio for cognitive impairment over three years (44 mcg versus 22 mcg) was 0.68 (95% confidence interval [CI]: 0.480—0.972), suggesting a 32% lower risk with the higher dose treatment. At year 3, the proportion of patients who were cognitively impaired increased slightly from 23.5% at the baseline to 24.8% in the IFNβ-1a 22 mcg treatment group, but remained stable at 15.2% in the IFNβ-1a 44 mcg treatment group. The proportion of patients with cognitive impairment at year 3 was significantly higher in the 22 mcg group than in the 44 mcg group (P = 0.03), although a trend was also seen at the baseline (P = 0.058). Multivariate logistic regression (corrected for baseline cognitive deficits) indicated that treatment with the higher dose of IFNβ-1a was predictive of lower cognitive impairment at three years (odds ratio: 0.51, 95% CI: 0.26—0.99) compared with the lower dose of IFNβ-1a. These findings suggest that sc IFNβ-1a may have dose-dependent cognitive benefits in mildly disabled patients with RRMS, and may support early initiation of high-dose IFNβ-1a treatment.
Published: 2010

19. The effect of air pollution on COVID‐19 severity in a sample of patients with multiple sclerosis

Author: Bergamaschi, Roberto, Ponzano, Marta, Schiavetti, Irene, Carmisciano, Luca, Cordioli, Cinzia, Filippi, Massimo, Radaelli, Marta, Immovilli, Paolo, Capobianco, Marco, De Rossi, Nicola, Brichetto, Giampaolo, Cocco, Eleonora, Scandellari, Cinzia, Cavalla, Paola, Pesci, Ilaria, Zito, Antonio, Confalonieri, Paolo, Marfia, Girolama Alessandra, Perini, Paola, Inglese, Matilde, Trojano, Maria, Brescia Morra, Vincenzo, Pisoni, Enrico, Tedeschi, Gioacchino, Comi, Giancarlo, Battaglia, Mario Alberto, Patti, Francesco, Salvetti, Marco, Sormani, Maria Pia, Gianmarco Abbadessa, Umberto Aguglia, Lia Allegorico, Rossi Beatrice Maria Allegri, Anastasia Alteno, Maria Pia Amato, Pietro Annovazzi, Carlo Antozzi, Lucia Appendino, Sebastiano Arena, Viola Baione, Roberto Balgera, Valeria Barcella, Damiano Baroncini, Caterina Barrilà, Mario A Battaglia, Alessandra Bellacosa, Gianmarco Bellucci, Roberto Bergamaschi, Valeria Bergamaschi, Daiana Bezzini, Beatrice Biolzi, Alvino Bisecco, Simona Bonavita, Giovanna Borriello, Chiara Bosa, Antonio Bosco, Francesca Bovis, Marco Bozzali, Laura Brambilla, Morra Vincenzo Brescia, Giampaolo Brichetto, Maria Buccafusca, Elisabetta Bucciantini, Sebastiano Bucello, Maria Chiara Buscarinu, Maria Paola Cabboi, Massimiliano Calabrese, Francesca Calabria, Francesca Caleri, Federico Camilli, Luisa Maria Caniatti, Roberto Cantello, Marco Capobianco, Ruggero Capra, Rocco Capuano, Luca Carmisciano, Patrizia Carta, Paola Cavalla, Maria Grazia Celani, Maria Cellerino, Raffaella Cerqua, Clara Chisari, Raffaella Clerici, Marinella Clerico, Eleonora Cocco, Gaia Cola, Giancarlo Comi, Paolo Confalonieri, Antonella Conte, Marta Zaffira Conti, Christian Cordano, Susanna Cordera, Cinzia Cordioli, Francesco Corea, Claudio Correale, Salvatore Cottone, Francesco Crescenzo, Erica Curti, Alessandro d'Ambrosio, Emanuele D'Amico, Maura Chiara Danni, Alessia d'Arma, Vincenzo Dattola, Stefano de Biase, Giovanna De Luca, Stefania Federica De Mercanti, Paolo De Mitri, Nicola De Rossi, Nicola De Stefano, Cava Marco Della, Mario di Napoli, Alessia Di Sapio, Renato Docimo, Anna Dutto, Luana Evangelista, Salvatore Fanara, Diana Ferraro, Maria Teresa Ferrò, Massimo Filippi, Cristina Fioretti, Mario Fratta, Jessica Frau, Marzia Fronza, Roberto Furlan, Alberto Gajofatto, Antonio Gallo, Paolo Gallo, Claudio Gasperini, Anna Ghazaryan, Bruno Giometto, Francesca Gobbin, Flora Govone, Franco Granella, Erica Grange, Maria Grazia Grasso, Angelica Guareschi, Clara Guaschino, Simone Guerrieri, Donata Guidetti, Pietro Iaffaldano, Antonio Ianniello, Luigi Iasevoli, Paolo Immovilli, Daniele Imperiale, Maria Teresa Infante, Matilde Inglese, Rosa Iodice, Aniello Iovino, Giovanna Konrad, Doriana Landi, Roberta Lanzillo, Caterina Lapucci, Luigi Lavorgna, Maria Rita L'Episcopo, Serena Leva, Giuseppe Liberatore, Re Marianna Lo, Marco Longoni, Leonardo Lopiano, Lorena Lorefice, Matteo Lucchini, Giacomo Lus, Davide Maimone, Maria Malentacchi, Giulia Mallucci, Simona Malucchi, Chiara Rosa Mancinelli, Luca Mancinelli, Paolo Manganotti, Giorgia Teresa Maniscalco, Vittorio Mantero, Sabrina Marangoni, Damiano Marastoni, Girolama Alessandra Marfia, Fabiana Marinelli, Alessandro Marti, Boneschi Filippo Martinelli, Zoli Federco Masserano, Francesca Matta, Laura Mendozzi, Giuseppe Meucci, Silvia Miante, Giuseppina Miele, Eva Milano, Massimiliano Mirabella, Rosanna Missione, Marcello Moccia, Lucia Moiola, Sara Montepietra, Margherita MontiBragadin, Federico Montini, Roberta Motta, Raffaele Nardone, Carolina Gabri Nicoletti, Eduardo Nobile-Orazio, Agostino Nozzolillo, Marco Onofrj, Riccardo Orlandi, Anna Palmieri, Damiano Paolicelli, Livia Pasquali, Luisa Pastò, Francesco Patti, Elisabetta Pedrazzoli, Paola Perini, Ilaria Pesci, Maria Petracca, Alfredo Petrone, Carlo Piantadosi, Anna M Pietroboni, Federica Pinardi, Marta Ponzano, Emilio Portaccio, Mattia Pozzato, Carlo Pozzilli, Luca Prosperini, Alessandra Protti, Marta Radaelli, Paolo Ragonese, Sarah Rasia, Sabrina Realmuto, Anna Repice, Eleonora Rigoni, Maria Teresa Rilla, Francesca Rinaldi, Calogero Marcello Romano, Marco Ronzoni, Marco Rovaris, Francesca Ruscica, Loredana Sabattini, Giuseppe Salemi, Marco Salvetti, Lorenzo Saraceno, Alessia Sartori, Arianna Sartori, Elvira Sbragia, Cinzia Scandellari, Giuditta Ilaria Scarano, Valentina Scarano, Irene Schiavetti, Maria Sessa, Caterina Sgarito, Grazia Sibilia, Gabriele Siciliano, Alessio Signori, Elisabetta Signoriello, Leonardo Sinisi, Francesca Sireci, Patrizia Sola, Claudio Solaro, Maria Pia Sormani, Stefano Sotgiu, Maddalena Sparaco, Maria Laura Stromillo, Silvia Strumia, Emanuela Laura Susani, Giulietta Tabiadon, Francesco Teatini, Gioacchino Tedeschi, Valentina Tomassini, Simone Tonietti, Clerici Valentina Torri, Carla Tortorella, Simona Toscano, Rocco Totaro, Maria Trojano, Maria Trotta, Gabriella Turano, Monica Ulivelli, Manzo Valentino, Giovanna Vaula, Domizia Vecchio, Marco Vercellino, Elena Pinuccia Verrengia, Marika Vianello, Eleonora Virgilio, Francesca Vitetta, Stefano Vollaro, Mauro Zaffaroni, Mauro Zampolini, Ignazio Roberto Zarbo, Antonio Zito, Luigi Zuliani, Bergamaschi, R, Ponzano, M, Schiavetti, I, Carmisciano, L, Cordioli, C, Filippi, M, Radaelli, M, Immovilli, P, Capobianco, M, De Rossi, N, Brichetto, G, Cocco, E, Scandellari, C, Cavalla, P, Pesci, I, Zito, A, Confalonieri, P, Marfia, Ga, Perini, P, Inglese, M, Trojano, M, Brescia Morra, V, Pisoni, E, Tedeschi, G, Comi, G, Battaglia, Ma, Patti, F, Salvetti, M, Sormani, Mp, Abbadessa, Gianmarco, Umberto, Aguglia, Lia, Allegorico, Rossi Beatrice Maria Allegri, Anastasia, Alteno, Maria Pia Amato, Pietro, Annovazzi, Carlo, Antozzi, Lucia, Appendino, Sebastiano, Arena, Viola, Baione, Roberto, Balgera, Valeria, Barcella, Damiano, Baroncini, Caterina, Barrilà, Mario, A Battaglia, Alessandra, Bellacosa, Gianmarco, Bellucci, Roberto, Bergamaschi, Valeria, Bergamaschi, Daiana, Bezzini, Beatrice, Biolzi, Bisecco, Alvino, Bonavita, Simona, Giovanna, Borriello, Chiara, Bosa, Bosco, Antonio, Francesca, Bovi, Marco, Bozzali, Laura, Brambilla, Morra Vincenzo Brescia, Giampaolo, Brichetto, Maria, Buccafusca, Elisabetta, Bucciantini, Sebastiano, Bucello, Maria Chiara Buscarinu, Maria Paola Cabboi, Massimiliano, Calabrese, Francesca, Calabria, Francesca, Caleri, Federico, Camilli, Luisa Maria Caniatti, Roberto, Cantello, Marco, Capobianco, Ruggero, Capra, Capuano, Rocco, Luca, Carmisciano, Patrizia, Carta, Paola, Cavalla, Maria Grazia Celani, Maria, Cellerino, Raffaella, Cerqua, Clara, Chisari, Raffaella, Clerici, Marinella, Clerico, Eleonora, Cocco, Gaia, Cola, Giancarlo, Comi, Paolo, Confalonieri, Antonella, Conte, Marta Zaffira Conti, Christian, Cordano, Susanna, Cordera, Cinzia, Cordioli, Corea, Francesco, Claudio, Correale, Salvatore, Cottone, Francesco, Crescenzo, Erica, Curti, Alessandro, D'Ambrosio, Emanuele, D'Amico, Maura Chiara Danni, Alessia, D'Arma, Vincenzo, Dattola, Stefano de Biase, Giovanna De Luca, Stefania Federica De Mercanti, Paolo De Mitri, Nicola De Rossi, Nicola De Stefano, Cava Marco Della, Mario di Napoli, Alessia Di Sapio, Docimo, Renato, Anna, Dutto, Luana, Evangelista, Salvatore, Fanara, Diana, Ferraro, Maria Teresa Ferrò, Massimo, Filippi, Cristina, Fioretti, Fratta, Mario, Jessica, Frau, Marzia, Fronza, Roberto, Furlan, Alberto, Gajofatto, Gallo, Antonio, Paolo, Gallo, Claudio, Gasperini, Anna, Ghazaryan, Bruno, Giometto, Francesca, Gobbin, Flora, Govone, Franco, Granella, Erica, Grange, Maria Grazia Grasso, Angelica, Guareschi, Clara, Guaschino, Simone, Guerrieri, Donata, Guidetti, Pietro, Iaffaldano, Antonio, Ianniello, Luigi, Iasevoli, Paolo, Immovilli, Daniele, Imperiale, Maria Teresa Infante, Matilde, Inglese, Rosa, Iodice, Aniello, Iovino, Giovanna, Konrad, Doriana, Landi, Roberta, Lanzillo, Caterina, Lapucci, Luigi, Lavorgna, Maria Rita L'Episcopo, Serena, Leva, Giuseppe, Liberatore, Re Marianna Lo, Marco, Longoni, Leonardo, Lopiano, Lorena, Lorefice, Matteo, Lucchini, Lus, Giacomo, Davide, Maimone, Maria, Malentacchi, Giulia, Mallucci, Simona, Malucchi, Chiara Rosa Mancinelli, Luca, Mancinelli, Paolo, Manganotti, Giorgia Teresa Maniscalco, Vittorio, Mantero, Sabrina, Marangoni, Damiano, Marastoni, Girolama Alessandra Marfia, Fabiana, Marinelli, Alessandro, Marti, Boneschi Filippo Martinelli, Zoli Federco Masserano, Francesca, Matta, Laura, Mendozzi, Giuseppe, Meucci, Silvia, Miante, Miele, Giuseppina, Eva, Milano, Massimiliano, Mirabella, Missione, Rosanna, Marcello, Moccia, Lucia, Moiola, Sara, Montepietra, Margherita, Montibragadin, Federico, Montini, Roberta, Motta, Raffaele, Nardone, Carolina Gabri Nicoletti, Eduardo, Nobile-Orazio, Agostino, Nozzolillo, Marco, Onofrj, Riccardo, Orlandi, Palmieri, Anna, Damiano, Paolicelli, Livia, Pasquali, Luisa, Pastò, Francesco, Patti, Elisabetta, Pedrazzoli, Paola, Perini, Ilaria, Pesci, Maria, Petracca, Alfredo, Petrone, Carlo, Piantadosi, Anna, M Pietroboni, Federica, Pinardi, Marta, Ponzano, Emilio, Portaccio, Mattia, Pozzato, Carlo, Pozzilli, Luca, Prosperini, Alessandra, Protti, Marta, Radaelli, Paolo, Ragonese, Sarah, Rasia, Sabrina, Realmuto, Anna, Repice, Eleonora, Rigoni, Maria Teresa Rilla, Francesca, Rinaldi, Calogero Marcello Romano, Marco, Ronzoni, Marco, Rovari, Francesca, Ruscica, Loredana, Sabattini, Giuseppe, Salemi, Marco, Salvetti, Lorenzo, Saraceno, Alessia, Sartori, Arianna, Sartori, Elvira, Sbragia, Cinzia, Scandellari, Giuditta Ilaria Scarano, Valentina, Scarano, Irene, Schiavetti, Maria, Sessa, Caterina, Sgarito, Grazia, Sibilia, Gabriele, Siciliano, Alessio, Signori, Signoriello, Elisabetta, Leonardo, Sinisi, Francesca, Sireci, Patrizia, Sola, Claudio, Solaro, Maria Pia Sormani, Stefano, Sotgiu, Sparaco, Maddalena, Maria Laura Stromillo, Silvia, Strumia, Emanuela Laura Susani, Giulietta, Tabiadon, Francesco, Teatini, Tedeschi, Gioacchino, Valentina, Tomassini, Simone, Tonietti, Clerici Valentina Torri, Carla, Tortorella, Simona, Toscano, Rocco, Totaro, Maria, Trojano, Trotta, Maria Consiglia, Gabriella, Turano, Monica, Ulivelli, Manzo, Valentino, Giovanna, Vaula, Domizia, Vecchio, Marco, Vercellino, Elena Pinuccia Verrengia, Marika, Vianello, Eleonora, Virgilio, Francesca, Vitetta, Stefano, Vollaro, Mauro, Zaffaroni, Mauro, Zampolini, Ignazio Roberto Zarbo, Zito, Guido Antonio, Bergamaschi, R., Ponzano, M., Schiavetti, I., Carmisciano, L., Cordioli, C., Filippi, M., Radaelli, M., Immovilli, P., Capobianco, M., De Rossi, N., Brichetto, G., Cocco, E., Scandellari, C., Cavalla, P., Pesci, I., Zito, A., Confalonieri, P., Marfia, G. A., Perini, P., Inglese, M., Trojano, M., Brescia Morra, V., Pisoni, E., Tedeschi, G., Comi, G., Battaglia, M. A., Patti, F., Salvetti, M., Sormani, M. P., Bergamaschi, Roberto, Ponzano, Marta, Schiavetti, Irene, Carmisciano, Luca, Cordioli, Cinzia, Filippi, Massimo, Radaelli, Marta, Immovilli, Paolo, Capobianco, Marco, De Rossi, Nicola, Brichetto, Giampaolo, Cocco, Eleonora, Scandellari, Cinzia, Cavalla, Paola, Pesci, Ilaria, Zito, Antonio, Confalonieri, Paolo, Marfia, Girolama Alessandra, Perini, Paola, Inglese, Matilde, Trojano, Maria, Brescia Morra, Vincenzo, Pisoni, Enrico, Comi, Giancarlo, Battaglia, Mario Alberto, Patti, Francesco, Salvetti, Marco, Sormani, Maria, Pia, Gianmarco, Abbadessa, Alvino, Bisecco, Simona, Bonavita, Antonio, Bosco, Rocco, Capuano, Francesco, Corea, Renato, Docimo, Mario, Fratta, Antonio, Gallo, Iodice, Rosa, Iovino, Aniello, Lanzillo, Roberta, Giacomo, Lu, Giuseppina, Miele, Rosanna, Missione, Moccia, Marcello, Anna, Palmieri, Elisabetta, Signoriello, Maddalena, Sparaco, Gioacchino, Tedeschi, Maria, Trotta, Antonio, Zito, and Luigi, Zuliani
Subjects: air pollution, coronavirus, multiple sclerosis, medicine.medical_specialty, Multivariate analysis, Coronavirus disease 2019 (COVID-19), Clinical Sciences, Air pollution, Sample (statistics), Neurodegenerative, Settore MED/26, medicine.disease_cause, Autoimmune Disease, law.invention, Sustainable Cities and Communities, Clinical Research, law, Humans, Medicine, Climate-Related Exposures and Conditions, Neurology & Neurosurgery, MuSC-19 study group, SARS-CoV-2, business.industry, Multiple sclerosis, Neurosciences, COVID-19, Retrospective cohort study, Original Articles, medicine.disease, Intensive care unit, Particulate Matter, Air Pollution, Multiple Sclerosis, Brain Disorders, coronaviru, Settore MED/26 - NEUROLOGIA, Good Health and Well Being, Neurology, multiple sclerosi, Emergency medicine, Original Article, Neurology (clinical), Ordered logit, business, Human
Abstract: Background and purpose Some studies have shown that air pollution, often assessed by thin particulate matter with diameter below 2.5 µg/m3 (PM2.5), may contribute to severe COVID‐19 courses, as well as play a role in the onset and evolution of multiple sclerosis (MS). However, the impact of air pollution on COVID‐19 has never been explored specifically amongst patients with MS (PwMS). This retrospective observational study aims to explore associations between PM2.5 and COVID‐19 severity amongst PwMS. Methods Data were retrieved from an Italian web‐based platform (MuSC‐19) which includes PwMS with COVID‐19. PM2.5 2016–2018 average concentrations were provided by the Copernicus Atmospheric Monitoring Service. Italian patients inserted in the platform from 15 January 2020 to 9 April 2021 with a COVID‐19 positive test were included. Ordered logistic regression models were used to study associations between PM2.5 and COVID‐19 severity. Results In all, 1087 patients, of whom 13% required hospitalization and 2% were admitted to an intensive care unit or died, were included. Based on the multivariate analysis, higher concentrations of PM2.5 increased the risk of worse COVID‐19 course (odds ratio 1.90; p = 0.009). Conclusions Even if several other factors explain the unfavourable course of COVID‐19 in PwMS, the role of air pollutants must be considered and further investigated., Air pollution, often assessed by particulate matter with diameter below 2.5 µg/m3, may contribute to severe COVID‐19 courses. 1087 patients were included, of whom 13% required hospitalization and 2% were admitted to an intensive care unit or died. Even if several other factors explain the unfavourable course of COVID‐19 in patients with multiple sclerosis, the role of air pollutants must be considered and further investigated.
Published: 2021

20. Transition to secondary progression in relapsing-onset multiple sclerosis: Definitions and risk factors

Author: Simonetta Galgani, Giuseppe Lucisano, Matilde Inglese, Giacomo Lus, M. Achille, V. Lovato, M. Zaffaroni, V. Brescia Morra, Giuseppe Salemi, Marco Salvetti, Carlo Pozzilli, G. T. Maniscalco, Maria Trojano, Francesco Patti, Diana Ferraro, Massimo Filippi, Maria Pia Amato, Pietro Iaffaldano, Alessandra Lugaresi, G. Marrazzo, Roberto Bergamaschi, G. De Luca, Antonella Conte, Marco Rovaris, F. O. Logullo, G. Comi, Damiano Paolicelli, Eleonora Cocco, Iaffaldano, Pietro, Lucisano, Giuseppe, Patti, Francesco, Brescia Morra, Vincenzo, De Luca, Giovanna, Lugaresi, Alessandra, Zaffaroni, Mauro, Inglese, Matilde, Salemi, Giuseppe, Cocco, Eleonora, Conte, Antonella, Ferraro, Diana, Galgani, Simonetta, Bergamaschi, Roberto, Pozzilli, Carlo, Salvetti, Marco, Lus, Giacomo, Rovaris, Marco, Maniscalco, Giorgia Teresa, Logullo, Francesco Ottavio, Paolicelli, Damiano, Achille, Mariaclara, Marrazzo, Giuseppina, Lovato, Valeria, Comi, Giancarlo, Filippi, Massimo, Amato, Maria Pia, Trojano, Maria, Iaffaldano P., Lucisano G., Patti F., Brescia Morra V., De Luca G., Lugaresi A., Zaffaroni M., Inglese M., Salemi G., Cocco E., Conte A., Ferraro D., Galgani S., Bergamaschi R., Pozzilli C., Salvetti M., Lus G., Rovaris M., Maniscalco G.T., Logullo F.O., Paolicelli D., Achille M., Marrazzo G., Lovato V., Comi G., Filippi M., Amato M.P., Trojano M., Iaffaldano, P., Lucisano, G., Patti, F., Brescia Morra, V., De Luca, G., Lugaresi, A., Zaffaroni, M., Inglese, M., Salemi, G., Cocco, E., Conte, A., Ferraro, D., Galgani, S., Bergamaschi, R., Pozzilli, C., Salvetti, M., Lus, G., Rovaris, M., Maniscalco, G. T., Logullo, F. O., Paolicelli, D., Achille, M., Marrazzo, G., Lovato, V., Comi, G., Filippi, M., Amato, M. P., and Trojano, M.
Subjects: Oncology, medicine.medical_specialty, Relapsing-Remitting, Multiple sclerosis, 03 medical and health sciences, Multiple Sclerosis, Relapsing-Remitting, 0302 clinical medicine, Disease registry, Recurrence, Risk Factors, big data, Internal medicine, medicine, Humans, data-driven algorithm, Multiple sclerosi, 030212 general & internal medicine, disease registry, prognosis, secondary progressive, Disease Progression, Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive, Secondary progressive, Transition (genetics), business.industry, medicine.disease, Chronic Progressive, Neurology, Settore MED/26 - Neurologia, Neurology (clinical), business, prognosi, 030217 neurology & neurosurgery
Abstract: Background: No uniform criteria for a sensitive identification of the transition from relapsing–remitting multiple sclerosis (MS) to secondary-progressive multiple sclerosis (SPMS) are available. Objective: To compare risk factors of SPMS using two definitions: one based on the neurologist judgment (ND) and an objective data-driven algorithm (DDA). Methods: Relapsing-onset MS patients ( n = 19,318) were extracted from the Italian MS Registry. Risk factors for SPMS and for reaching irreversible Expanded Disability Status Scale (EDSS) 6.0, after SP transition, were estimated using multivariable Cox regression models. Results: SPMS identified by the DDA ( n = 2343, 12.1%) were older, more disabled and with a faster progression to severe disability ( p 40 years, higher baseline EDSS score and a higher number of relapses; the most consistent protective factor was the disease-modifying therapy (DMT) exposure. DMT exposure during SP did not impact the risk of reaching irreversible EDSS 6.0. Conclusion: A DDA definition of SPMS identifies more aggressive progressive patients. DMT exposure reduces the risk of SPMS conversion, but it does not prevent the disability accumulation after the SP transition.
Published: 2021

21. Lifestyle and Mediterranean diet adherence in a cohort of Southern Italian patients with Multiple Sclerosis

Author: G. Tedeschi, Alessio Signori, Francesca Trojsi, Simona Bonavita, Luigi Lavorgna, V. Brescia Morra, Antonio Gallo, Simone Cepparulo, Luca Carmisciano, Camilla Russo, Maddalena Sparaco, Elisabetta Signoriello, G. T. Maniscalco, Sabrina Esposito, Giacomo Lus, Francesco Saccà, R Lanzillo, Esposito, S, Sparaco, M, Maniscalco, G T, Signoriello, E, Lanzillo, R, Russo, C, Carmisciano, L, Cepparulo, S, Lavorgna, L, Gallo, A, Trojsi, F, Brescia Morra, V, Lus, G, Tedeschi, G, Saccà, F, Signori, A, Bonavita, S, Esposito, S., Sparaco, M., Maniscalco, G. T., Signoriello, E., Lanzillo, R., Russo, C., Carmisciano, L., Cepparulo, S., Lavorgna, L., Gallo, A., Trojsi, F., Brescia Morra, V., Lus, G., Tedeschi, G., Sacca, F., Signori, A., and Bonavita, S.
Subjects: medicine.medical_specialty, Multiple Sclerosis, Mediterranean diet, Physical examination, Systemic inflammation, Diet, Mediterranean, 03 medical and health sciences, 0302 clinical medicine, Retrospective Studie, Internal medicine, medicine, Outpatient clinic, Humans, Multiple sclerosi, 030212 general & internal medicine, Life Style, Retrospective Studies, Cross-Sectional Studie, Expanded Disability Status Scale, medicine.diagnostic_test, business.industry, Multiple sclerosis, General Medicine, medicine.disease, Cardiovascular risk, Lifestyle, Cross-Sectional Studies, Neurology, Italy, Cohort, Neurology (clinical), medicine.symptom, business, Body mass index, 030217 neurology & neurosurgery, Human
Abstract: Background/objectives Several studies supported the beneficial effects of the Mediterranean diet (MeDi) on chronic diseases. In Multiple Sclerosis (MS), the MeDi might interfere with systemic inflammatory state, gut microbiota, and comorbidities. The Med Diet Score (MDS) estimates the adherence to the MeDi and the cardiovascular (CV) risk. Aims of our study were i) to photograph lifestyle and diet habits of a southern Italy cohort of people with MS (pwMS), and ii) to investigate the impact of the MeDi on MS clinical outcomes. Subjects/methods We conducted a multi-center, cross-sectional study, enrolling 435 consecutive consenting pwMS, attending the outpatient clinics for routine follow-up visits. Participants underwent a clinical examination and a 29-item self-administered questionnaire on life and dietary habits. Disease phenotype, Expanded Disability Status Scale (EDSS), MS Severity Score (MSSS), waist circumference (WC), Body Mass Index (BMI), therapies, and comorbidities, were updated. MDS was assessed and correlated with current and retrospective clinical data. Results 75.8% of respondents were interested in nutrition, 72.8% were non-smokers, 52.9% performed physical activity, and 45.6% used food supplements. MDS was higher in pwMS with normal WC (p = 0.031), and inversely correlated with MSSS (p = 0.013) and EDSS (p = 0.012) at survey time. MDS did not correlate with the total number of relapses (before and after diagnosis) (p = 0.372). Metabolic comorbidities were associated with an increased 10-year CV risk (r = 0.85, p = 0.002). Conclusion Our findings suggest a putative beneficial effect of the MeDi on WC, MS course and disability. Given the role of chronic systemic inflammation in maintenance of autoimmunity and secondary neurodegeneration, both involved in long-term disability, we may suppose a beneficial effect of the MeDi on MS long-term disability outcomes, probably mediated by a modulation of the gut microbiota and the low-grade chronic systemic inflammation.
Published: 2021

22. Risk of Persistent Disability in Patients With Pediatric-Onset Multiple Sclerosis

Author: Paolo Ragonese, Marta Simone, Vincenzo Brescia Morra, Lucia Margari, Giuseppe Salemi, Eleonora Cocco, Massimo Filippi, Mauro Zaffaroni, Damiano Baroncini, Giuseppe Fenu, Matilde Inglese, Francesco Patti, Marzia Romeo, Pietro Iaffaldano, Italian Ms registry, Clara Grazia Chisari, Angelo Ghezzi, Maria Cellerino, Giancarlo Comi, Roberta Lanzillo, Baroncini, Damiano, Simone, Marta, Iaffaldano, Pietro, Brescia Morra, Vincenzo, Lanzillo, Roberta, Filippi, Massimo, Romeo, Marzia, Patti, Francesco, Chisari, Clara Grazia, Cocco, Eleonora, Fenu, Giuseppe, Salemi, Giuseppe, Ragonese, Paolo, Inglese, Matilde, Cellerino, Maria, Margari, Lucia, Comi, Giancarlo, Zaffaroni, Mauro, Ghezzi, Angelo, Baroncini D., Simone M., Iaffaldano P., Brescia Morra V., Lanzillo R., Filippi M., Romeo M., Patti F., Chisari C.G., Cocco E., Fenu G., Salemi G., Ragonese P., Inglese M., Cellerino M., Margari L., Comi G., Zaffaroni M., Ghezzi A., Baroncini, D, Simone, M, Iaffaldano, P, Brescia Morra, V, Lanzillo, R, Filippi, M, Romeo, M, Patti, F, Chisari, C, Cocco, E, Fenu, G, Salemi, G, Ragonese, P, Inglese, M, Cellerino, M, Margari, L, Comi, G, Zaffaroni, M, Ghezzi, A, and Cavaletti, G
Subjects: Male, Registrie, Pediatrics, Adolescent, Adult, Age of Onset, Aged, Child, Child, Preschool, Female, Humans, Italy, Middle Aged, Multiple Sclerosis, Registries, Retrospective Studies, Risk Factors, Young Adult, Disabled Persons, Disease Progression, Risk of Disability, 0302 clinical medicine, Retrospective Studie, Multiple Sclerosi, 030212 general & internal medicine, Original Investigation, Hazard ratio, Confounding, pediatric-onset MS (POMS), therapeutic and managing standards, Settore MED/26 - Neurologia, Disabled Person, Human, medicine.medical_specialty, MEDLINE, Profile of mood states, 03 medical and health sciences, medicine, In patient, Preschool, pediatric-onset MS (POMS), therapeutic and managing standards, Expanded Disability Status Scale, business.industry, Pediatric-Onset Multiple Sclerosis, Multiple sclerosis, Risk Factor, medicine.disease, Observational study, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract: Importance Availability of new disease-modifying therapies (DMTs) and changes of therapeutic paradigms have led to a general improvement of multiple sclerosis (MS) prognosis in adults. It is still unclear whether this improvement also involves patients with pediatric-onset MS (POMS), whose early management is more challenging. Objective To evaluate changes in the prognosis of POMS over time in association with changes in therapeutic and managing standards. Design, Setting, and Participants Retrospective, multicenter, observational study. Data were extracted and collected in May 2019 from the Italian MS Registry, a digital database including more than 59 000 patients. Inclusion criteria were MS onset before age 18 years, diagnosis before January 2014, and disease duration of at least 3 years. Exclusion criteria were primary progressive MS, Expanded Disability Status Scale (EDSS) score of at least 8 one year after onset, unavailability of diagnosis date, and less than 2 EDSS score evaluations. Eligible patients were 4704 patients with POMS. According to these criteria, we enrolled 3198 patients, excluding 1506. Exposures We compared time to reach disability milestones by epoch of MS diagnosis (
Published: 2021

23. A snapshot on patient-reported outcome measures of people with multiple sclerosis on first-line therapies in a real world setting

Author: Luigi Lavorgna, Teresa Costabile, Luca Carmisciano, R Lanzillo, N. Frattaruolo, Giacomo Lus, Alvino Bisecco, Alessio Signori, Simona Bonavita, A. Strianese, G. T. Maniscalco, V. Brescia Morra, Maddalena Sparaco, Elisabetta Signoriello, Simone Cepparulo, Francesco Saccà, Camilla Russo, Lanzillo, R, Sparaco, M, Lavorgna, L, Carmisciano, L, Signoriello, E, Signori, A, Costabile, T, Maniscalco, G T, Saccà, F, Cepparulo, S, Russo, C V, Bisecco, A, Frattaruolo, N, Strianese, A, Lus, G, Brescia Morra, V, Bonavita, S, Lanzillo, R., Sparaco, M., Lavorgna, L., Carmisciano, L., Signoriello, E., Signori, A., Costabile, T., Maniscalco, G. T., Sacca, F., Cepparulo, S., Russo, C. V., Bisecco, A., Frattaruolo, N., Strianese, A., Lus, G., Brescia Morra, V., and Bonavita, S.
Subjects: medicine.medical_specialty, Neurology, Multiple Sclerosis, Disease-modifying therapies, First-line therapies, Multiple sclerosis, Patient-reported outcomes, Dermatology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Multiple Sclerosis, Relapsing-Remitting, Teriflunomide, medicine, Humans, Multiple sclerosi, Disease-modifying therapie, 030212 general & internal medicine, Effects of sleep deprivation on cognitive performance, Patient Reported Outcome Measures, Glatiramer acetate, First-line therapie, Aged, business.industry, Cognition, General Medicine, Glatiramer Acetate, medicine.disease, humanities, Psychiatry and Mental health, chemistry, Physical therapy, Quality of Life, Patient-reported outcome, Neurology (clinical), Analysis of variance, business, 030217 neurology & neurosurgery, medicine.drug
Abstract: Background: Patient-reported outcomes (PROs) may help patients and clinicians in selecting disease-modifying therapies (DMTs) for multiple sclerosis (MS). Objective: To evaluate PRO differences among first-line DMTs for relapsing-remitting (RR) people with MS (pwMS). Methods: Multicenter study. RR pwMS on first-line DMTs completed Fatigue Severity Scale (FSS), PROs Indices for MS (PRIMUS), 36-item Short-Form Health Survey (SF-36), treatment satisfaction questionnaire for medication (TSQM), Beck Depression Inventory-II (BDI-II), and Symbol Digit Modalities Test (SDMT). Differences among PROs across DMTs were tested by ANOVA. Multivariable linear regressions were used to investigate associations between PROs and the treatment group. Results: Two-hundred eighty pwMS were enrolled: 56% were on interferons (INF), 22% on dimethylfumarate (DMF), 13% on glatiramer acetate, and 9% on teriflunomide (Teri). Compared with INF, pwMS on Teri were the oldest, with higher disability, worst depression at BDI, worst cognitive performances at SDMT (p = 0.001), fatigue at FSS (p = 0.001), and activity limitation and quality of life respectively at PRIMUS (p = 0.005) and SF-36 Mental Composite Score (p < 0.001); pwMS on DMF reported highest side effects and, together with pwMS on Teri, better treatment satisfaction at TSQM. Conclusions: Compared with INF-treated patients, pwMS on DMF and Teri reported the best treatment satisfaction, although DMF-treated pwMS reported higher side effects and those on Teri the worst QoL and fatigue; however, the older age, higher disability and depression, and worse cognitive performance of pwMS on Teri suggest to be careful in evaluating these results.
Published: 2019

24. Clinical predictors of Dimethyl Fumarate response in multiple sclerosis: a real life multicentre study

Author: Antonio Carotenuto, Elisabetta Signoriello, Leonardo Sinisi, Giacomo Lus, Rosa Iodice, Luigi Lavorgna, V. Brescia Morra, Martina Petruzzo, B. Ronga, A. De Rosa, G. T. Maniscalco, Marcello Moccia, Camilla Russo, Raffaele Palladino, F. Romano, Simona Bonavita, Ciro Florio, M. De Angelis, Roberta Lanzillo, V. Orlando, Francesco Saccà, Lanzillo, R, Moccia, M, Palladino, R, Signoriello, E, Carotenuto, A, Maniscalco, G T, Saccà, F, Bonavita, S, Russo, C V, Iodice, R, Petruzzo, M, Sinisi, L, De Angelis, M, Lavorgna, L, De Rosa, A, Romano, F, Orlando, V, Ronga, B, Florio, C, Lus, G, Brescia Morra, V, Lanzillo, R., Moccia, M., Palladino, R., Signoriello, E., Carotenuto, A., Maniscalco, G. T., Sacca, F., Bonavita, S., Russo, C. V., Iodice, R., Petruzzo, M., Sinisi, L., De Angelis, M., Lavorgna, L., De Rosa, A., Romano, F., Orlando, V., Ronga, B., Florio, C., Lus, G., and Brescia Morra, V.
Subjects: Adult, Male, medicine.medical_specialty, Multivariate analysis, Time Factors, Efficacy, Dimethyl Fumarate, Real life, Disease, law.invention, Multiple sclerosis, Persistence, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Multiple Sclerosis, Relapsing-Remitting, Randomized controlled trial, law, Recurrence, Internal medicine, Outcome Assessment, Health Care, medicine, Humans, Immunologic Factors, Multiple sclerosi, 030212 general & internal medicine, Prospective Studies, Risk factor, Age of Onset, Retrospective Studies, Expanded Disability Status Scale, Dimethyl fumarate, business.industry, General Medicine, Middle Aged, Multiple Sclerosis, Chronic Progressive, medicine.disease, Dimethyl-fumarate, Neurology, Tolerability, chemistry, Disease Progression, Female, Neurology (clinical), business, 1109 Neurosciences, 030217 neurology & neurosurgery
Abstract: Background: Dimethyl-fumarate (DMF) was effective and safe in relapsing–remitting multiple sclerosis (MS) in randomized clinical trials. We aimed to evaluate the efficacy and safety of DMF and factors related to drug response in real-life setting. Methods: We analysed prospectively collected demographic and clinical data for patients treated with DMF in six multiple sclerosis (MS) centers from 2015 to 2017 in Campania region, Italy. We performed univariate and multivariate analyses to assess relationships between baseline parameters and DMF efficacy outcomes, Annualized Relapse Rate (ARR), Expanded Disability Status Scale (EDSS) progression and No Evidence of Disease Activity (NEDA-3) status. Results: we analyzed data of 456 patients (67% female subjects, mean age 40 ± 12 years, mean disease duration 9 ± 9 years, mean treatment duration 18 ± 11 months, median EDSS 2.5, 0–8). Proportion of Naïve versus pretreated with other DMTs patients was 149/307 (32.7%), with 122 patients switching to DMF for disease activity (26.7%) and 185 for safety and tolerability issues (40.6%). During treatment with DMF, the annualized relapse rate was reduced by 75% respect to the pre-treatment ARR [incidence-rate-ratio (IRR) = 0.25, p < 0.001, CI 0.18–0.33]. Factors influencing ARR rate while on DMF were relapsing remitting (RR) MS course (IRR = 2.0, p =
Published: 2019

25. Healthcare resource utilization and costs for multiple sclerosis management in the Campania region of Italy: Comparison between centre-based and local service healthcare delivery

Author: Francesca Pennino, Roberta Lanzillo, Primo Sergianni, Marcello Moccia, Raffaele Palladino, Guido Corbisiero, Vincenzo Brescia Morra, Antonio Capacchione, Giacomo Lus, Andrea Tajani, Adriano Vercellone, Maria Triassi, Rosa Acampora, Elisabetta Signoriello, Moccia, M., Tajani, Andrea, Acampora, R., Signoriello, E., Corbisiero, G., Vercellone, A., Sergianni, Primo, Pennino, F., Lanzillo, R., Palladino, R., Capacchione, A., Morra, V. B., Lus, G., Triassi, M., Moccia, M, Tajani, A, Acampora, R, Signoriello, E, Corbisiero, G, Vercellone, A, Sergianni, P, Pennino, F, Lanzillo, R, Palladino, R, Capacchione, A, Brescia Morra, V, and Lus, G
Subjects: Male, European People, Economics, Health Care Providers, Organizational model, Social Sciences, Geographical locations, Diagnostic Radiology, 0302 clinical medicine, Mathematical and Statistical Techniques, Multidisciplinary approach, Health care, Medicine and Health Sciences, Ethnicities, 030212 general & internal medicine, Allied Health Care Professionals, Multidisciplinary, Radiology and Imaging, Statistics, Neurodegenerative Diseases, Health Care Costs, Health Services, Middle Aged, Magnetic Resonance Imaging, Italian People, Medication possession ratio, Europe, Treatment Outcome, Italy, Neurology, Physical Sciences, Medicine, Regression Analysis, Female, Research Article, medicine.medical_specialty, Multiple Sclerosis, General Science & Technology, Imaging Techniques, Science, Immunology, Linear Regression Analysis, Research and Analysis Methods, Medication Adherence, Autoimmune Diseases, 03 medical and health sciences, Health Economics, Healthcare delivery, Diagnostic Medicine, medicine, Humans, Immunologic Factors, European Union, Statistical Methods, Retrospective Studies, Service (business), business.industry, Multiple sclerosis, Biology and Life Sciences, Patient Acceptance of Health Care, medicine.disease, Demyelinating Disorders, Health Care, Emergency medicine, People and Places, Linear Models, Clinical Immunology, Population Groupings, Clinical Medicine, business, Delivery of Health Care, 030217 neurology & neurosurgery, Resource utilization, Mathematics
Abstract: BackgroundMultiple sclerosis (MS) requires multidisciplinary management. We evaluated differences in healthcare resource utilization and costs between Federico II and Vanvitelli MS Centres of Naples (Italy), representative of centralised (i.e., MS Care Unit) and local service-based models of multidisciplinary care, respectively.MethodsWe included MS patients continuously seen at the same local healthcare services and MS Centre (Federico II = 187; Vanvitelli = 90) from 2015 to 2017. Healthcare resources for MS treatment and management were collected and costs were calculated. Adherence was estimated as the rate of medication possession ratio (MPR) during 3-years of follow-up. Mixed-effect linear regression models were used to estimate differences in all outcomes between Federico II and Vanvitelli.ResultsPatients at Federico II had more consultations within the MS centre (pDiscussionHealthcare services were more complete (and expensive) at the Federico II centralised MS Care Unit, compared with the Vanvitelli local service-based organizational model. Future research should evaluate whether better integration between MS Centres and local services can lead to improved MS management and lower costs.
Published: 2019

26. Corpus callosum involvement: a useful clue for differentiating Fabry Disease from Multiple Sclerosis

Author: Enrico Tedeschi, Lorenzo Ugga, Silvia Migliaccio, Antonino Tuttolomondo, Massimiliano Veroux, Dario De Rosa, Sirio Cocozza, Massimo Imbriaco, Aurelio Caronia, Yuri Battaglia, Cinzia Valeria Russo, Roberta Lanzillo, Arturo Brunetti, Giuseppe Pontillo, Gaia Olivo, Antonio Pisani, Daniela Concolino, Vincenzo Brescia Morra, Federico Pieruzzi, Camilla Russo, Eleonora Riccio, Sandro Feriozzi, Cocozza S, Olivo G, Riccio E, Russo C, Pontillo G, Ugga L, Migliaccio S, de Rosa D, Feriozzi S, Veroux M, Battaglia Y, Concolino D, Pieruzzi F, Tuttolomondo A, Caronia A, Russo CV, Lanzillo R, Brescia Morra V, Imbriaco M, Brunetti A, Tedeschi E, Pisani A, Cocozza, S, Olivo, G, Riccio, E, Russo, C, Pontillo, G, Ugga, L, Migliaccio, S, de Rosa, D, Feriozzi, S, Veroux, M, Battaglia, Y, Concolino, D, Pieruzzi, F, Tuttolomondo, A, Caronia, A, Lanzillo, R, Brescia Morra, V, Imbriaco, M, Brunetti, A, Tedeschi, E, Pisani, A, Cocozza, Sirio, Olivo, Gaia, Riccio, Eleonora, Russo, Camilla, Pontillo, Giuseppe, Ugga, Lorenzo, Migliaccio, Silvia, DE ROSA, Dario, Feriozzi, Sandro, Veroux, Massimiliano, Battaglia, Yuri, Concolino, Daniela, Pieruzzi, Federico, Tuttolomondo, Antonino, Caronia, Aurelio, Russo, CINZIA VALERIA, Lanzillo, Roberta, BRESCIA MORRA, Vincenzo, Imbriaco, Massimo, Brunetti, Arturo, Tedeschi, Enrico, and Pisani, Antonio
Subjects: Adult, Male, medicine.medical_specialty, Pathology, Neurology, Settore MED/09 - Medicina Interna, Adolescent, Corpus callosum, Fluid-attenuated inversion recovery, Fabry disease, MRI, Multiple sclerosis, 030218 nuclear medicine & medical imaging, Diagnosis, Differential, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, Radiology, Nuclear Medicine and imaging, Aged, Retrospective Studies, Neuroradiology, business.industry, Middle Aged, medicine.disease, Magnetic Resonance Imaging, Hyperintensity, Female, Neurology (clinical), Radiology, Differential diagnosis, Cardiology and Cardiovascular Medicine, business, 030217 neurology & neurosurgery
Abstract: PURPOSE: Multiple sclerosis (MS) has been proposed as a possible differential diagnosis for Fabry disease (FD). The aim of this work was to evaluate the involvement of corpus callosum (CC) on MR images and its possible role as a radiological sign to differentiate between FD and MS. METHODS: In this multicentric study, we retrospectively evaluated the presence of white matter lesions (WMLs) on the FLAIR images of 104 patients with FD and 117 patients with MS. The incidence of CC-WML was assessed in the two groups and also in a subgroup of 37 FD patients showing neurological symptoms. RESULTS: WMLs were detected in 50 of 104 FD patients (48.1%) and in all MS patients. However, a lesion in the CC was detected in only 3 FD patients (2.9%) and in 106 MS patients (90.6%). In the FD subgroup with neurological symptoms, WMLs were present in 26 of 37 patients (70.3%), with two subjects (5.4%) showing a definite callosal lesion. CONCLUSION: FD patients have a very low incidence of CC involvement on conventional MR images compared to MS, independently from the clinical presentation and the overall degree of WM involvement. Evaluating the presence of CC lesions on brain MR scans can be used as a radiological sign for a differential diagnosis between MS and FD, rapidly addressing the physician toward a correct diagnosis and subsequent treatment options.
Published: 2017

27. Natalizumab in pediatric multiple sclerosis: results of a cohort of 55 cases

Author: Ghezzi, A, Zaffaroni, M, Bianchi, A, Pozzilli, C, Prosperini, L, Borriello, G, Filippi, M, Moiola, L, Gerevini, S, Rocca, MA, Martinelli, V, Comi, G, Grimaldi, LM, Bucello, S, Lus, G, Rinaldi, F, Gallo, P, Trojano, M, Provinciali, L, Pucci, E, Bortolon, F, Capra, R, Coniglio, G, Gasperini, C, Lugaresi, A, Pietrolongo, E, Farina, D, Di Ioia, M, Milani, N, Rottoli, MR, Sarchielli, P., BRESCIA MORRA, VINCENZO, LANZILLO, ROBERTA, Ghezzi, A, Zaffaroni, M, Bianchi, A, Pozzilli, C, Prosperini, L, Borriello, G, Filippi, M, Moiola, L, Gerevini, S, Rocca, Ma, Martinelli, V, Comi, G, BRESCIA MORRA, Vincenzo, Lanzillo, Roberta, Grimaldi, Lm, Bucello, S, Lus, G, Rinaldi, F, Gallo, P, Trojano, M, Provinciali, L, Pucci, E, Bortolon, F, Capra, R, Coniglio, G, Gasperini, C, Lugaresi, A, Pietrolongo, E, Farina, D, Di Ioia, M, Milani, N, Rottoli, Mr, Sarchielli, P., Brescia Morra, V, Comi, Giancarlo, Filippi, Massimo, Italian MS Study, Group, Ghezzi A, Pozzilli C, Grimaldi L, Moiola L, Brescia-Morra V, Lugaresi A, Lus G, Rinaldi F, Rocca M, Trojano M, Bianchi A, Comi G, Filippi M, the Italian MS Study Group, and Lus, Giacomo
Subjects: Male, medicine.medical_specialty, Pediatrics, Adolescent, Antibodies, Monoclonal, Humanized, adolescence, childhood, Multiple sclerosis, natalizumab, Brain, Child, Cohort Studies, Female, Humans, Magnetic Resonance Imaging, Multiple Sclerosis, Relapsing-Remitting, Natalizumab, Neurology, Neurology (clinical), Female patient, Medicine, Multiple sclerosi, Cognitive skill, Expanded Disability Status Scale, medicine.diagnostic_test, business.industry, Magnetic resonance imaging, Mean age, medicine.disease, Surgery, Cohort, business, medicine.drug
Abstract: Background: Limited information is available on the use of natalizumab (NA) in pediatric multiple sclerosis (ped-MS) patients. Objective: The purpose of this study was to describe the long-term effects of NA in a large cohort of active ped-MS patients. Methods: Patients with definite ped-MS were treated with NA if in the previous year they had experienced at least two relapses or a severe relapse with incomplete recovery while on immunomodulating treatment, or at least two relapses and new magnetic resonance imaging (MRI) lesions regardless of any prior treatment. Results: The study included 55 patients (mean age: 14.4 years, mean number of relapses: 4.4, pre-treatment mean disease duration: 25.5 months). They received a median number of 26 infusions. Three relapses occurred during the follow-up, one female patient continued to deteriorate in cognitive functioning. Mean Expanded Disability Status Scale (EDSS) scores decreased from 2.7 to 1.9 at the last visit ( pConclusions: NA was well tolerated in all patients. A strong suppression of disease activity was observed in the majority of patients during the follow-up.
Published: 2013

28. Lesion load may predict long-term cognitive dysfunction in multiple sclerosis patients

Author: Gioacchino Tedeschi, Sabrina Realmuto, Damiano Paolicelli, Giovanni Savettieri, Vincenzo Brescia Morra, Alessandro d’Ambrosio, Silvia Messina, Veria Vacchiano, Mario Zappia, Maria Buccafusca, Bruno Alfano, Roberta Lanzillo, Domenico Ippolito, Paola Valentino, Antonio Gallo, Luigi Lavorgna, Manuela De Stefano, Francesco Patti, Rosa Gemma Viterbo, Patrizia Montella, Isabella Laura Simone, Clara Grazia Chisari, G. Coniglio, Simona Bonavita, Patti, F, De Stefano, M, Lavorgna, L, Messina, S, Chisari, C. G, Ippolito, D, Lanzillo, Roberta, Vacchiano, V, Realmuto, S, Valentino, P, Coniglio, G, Buccafusca, M, Paolicelli, D, D'Ambrosio, A, Montella, P, BRESCIA MORRA, Vincenzo, Savettieri, Giovanni, Alfano, B, Gallo, A, Simone, I, Viterbo, R, Zappia, M, Bonavita, S, Tedeschi, G., Chisari, Cg, Lanzillo, R, D'Ambrosio, Alessandro, Brescia Morra, V, Savettieri, G, Gallo, Antonio, Bonavita, Simona, Tedeschi, Gioacchino, Patti, F., De Stefano, M., Lavorgna, L., Messina, S., Chisari, C., Ippolito, D., Lanzillo, R., Vacchiano, V., Realmuto, S., Valentino, P., Coniglio, G., Buccafusca, M., Paolicelli, D., D'Ambrosio, A., Montella, P., Brescia Morra, V., Savettieri, G., Alfano, B., Gallo, A., Simone, I., Viterbo, R., Zappia, M., and Bonavita, S.
Subjects: EMTREE medical terms: Article, recall, lcsh:Medicine, Audiology, Neuropsychological Tests, Nerve Fibers, Myelinated, 030218 nuclear medicine & medical imaging, Cohort Studies, 0302 clinical medicine, cognitive defect, nuclear magnetic resonance imaging, lcsh:Science, Modified Card Sorting Test, Multidisciplinary, neuroimaging, Semantically Related Word List Test, Multiple Sclerosis, Cognitive Dysfunction, MRI, medicine.diagnostic_test, predictive value, Brain, Cognition, Neuropsychological test, gray matter, Middle Aged, Prognosis, Magnetic Resonance Imaging, Memory, Short-Term, female, brain size, multiple sclerosi, Cohort, Disease Progression, Settore MED/26 - Neurologia, white matter, Research Article, Adult, medicine.medical_specialty, Multiple Sclerosis, Paced Auditory Serial Addition Test, verbal memory, cerebrospinal fluid, working memory, 03 medical and health sciences, male, medicine, Humans, controlled study, human, Recall, business.industry, Multiple sclerosis, lcsh:R, Magnetic resonance imaging, medicine.disease, major clinical study, attention, executive function, Symbol Digit Modalities Test, neuropsychological test, lcsh:Q, Verbal memory, business, Cognition Disorders, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract: Background: Magnetic Resonance Imaging (MRI) techniques provided evidences into the understanding of cognitive impairment (CIm) in Multiple Sclerosis (MS). Objectives: To investigate the role of white matter (WM) and gray matter (GM) in predicting long-term CIm in a cohort of MS patients. Methods: 303 out of 597 patients participating in a previous multicenter clinical-MRI study were enrolled (49.4% were lost at follow-up). The following MRI parameters, expressed as fraction (f) of intracranial volume, were evaluated: cerebrospinal fluid (CSF-f), WM-f, GM-f and abnormal WM (AWM-f), a measure of lesion load. Nine years later, cognitive status was assessed in 241 patients using the Symbol Digit Modalities Test (SDMT), the Semantically Related Word List Test (SRWL), the Modified Card Sorting Test (MCST), and the Paced Auditory Serial Addition Test (PASAT). In particular, being SRWL a memory test, both immediate recall and delayed recall were evaluated. MCST scoring was calculated based on the number of categories, number of perseverative and non-perseverative errors. Results: AWM-f was predictive of an impaired performance 9 years ahead in SDMT (OR 1.49, CI 1.12-1.97 p = 0.006), PASAT (OR 1.43, CI 1.14-1.80 p = 0.002), SRWL-immediate recall (OR 1.72 CI 1.35-2.20 p
Published: 2015

29. Risk of invasive fungal infections among patients treated with disease modifying treatments for multiple sclerosis: a comprehensive review

Author: Antonio Reia, Riccardo Scotto, Emanuela Zappulo, Marcello Moccia, E. Pisano, Antonio Riccardo Buonomo, Ivan Gentile, Giulio Viceconte, V. Brescia Morra, Scotto, R., Reia, A., Buonomo, A. R., Moccia, M., Viceconte, G., Pisano, E., Zappulo, E., Brescia Morra, V., and Gentile, I.
Subjects: Risk, medicine.medical_specialty, Multiple Sclerosis, medicine.drug_class, Opportunistic Infection, Disease, Opportunistic Infections, Monoclonal antibody, Immunosuppressive Agent, Immunologic Factor, Disease modifying treatment, Internal medicine, parasitic diseases, Humans, Immunologic Factors, Medicine, Invasive Fungal Infection, Pharmacology (medical), monoclonal antibodie, business.industry, Multiple sclerosis, General Medicine, medicine.disease, infection, invasive fungal disease, multiple sclerosi, business, Immunosuppressive Agents, Invasive Fungal Infections, Human
Abstract: Introduction: Disease modifying treatments are commonly used in the treatment of multiple sclerosis. As different opportunistic infections have been reported, concerns are also raised regarding the risk of invasive fungal infections. Areas covered: Both clinical trials and observational studies on safety and efficacy of diseases modifying treatment for multiple sclerosis were reviewed and data regarding the occurrence of invasive fungal infections were reported. Papers evaluating the following drugs were reviewed: rituximab, ocrelizumab, alemtuzumab, fingolimod, natalizumab, dimethyl fumarate, interferon, glatiramer acetate, cladribine, teriflunomide. Expert opinion: Overall, the occurrence of invasive fungal infections was low, with most infective events reported among patients treated with monoclonal antibodies and fingolimod. Aspergillosis and cryptococcal meningitidis were the most representative fungal infections. Although not common, these infections may be difficult to diagnose and their fatality rate is often high. For this reason, screening protocols for fungal infections must be implemented in the clinical practice when managing patients with MS.
Published: 2021

30. Autosomal recessive progressive myoclonus epilepsy with ataxia and mental retardation

Author: V. Scarano, Giuseppe De Michele, Paolo Gasparini, Lucio Santoro, Giovanni Coppola, Anna Perretti, Filippo M. Santorelli, Alessandro Filla, Sandro Banfi, Adamo Pio d'Adamo, Francesco Saccà, Chiara Criscuolo, Pasquale Striano, Anna E. Lehesjoki, Salvatore Striano, Vincenzo Brescia Morra, Fabrizio Barbieri, G., Coppola, C., Criscuolo, Michele, G. D., Striano, Salvatore, F., Barbieri, P., Striano, A., Perretti, L., Santoro, V. B., Morra, Sacca', Francesco, V., Scarano, A. P., D'Adamo, S., Banfi, P., Gasparini, F. M., Santorelli, A. E., Lehesjoki, Filla, Alessandro, Coppola, G, Criscuolo, C, De Michele, G, Striano, S, Barbieri, F, Striano, P, Perretti, A, Santoro, L, Brescia Morra, V, Sacca, F, Scarano, V, D'Adamo, Ap, Banfi, Sandro, Gasparini, P, Santorelli, Fm, Lehesjoki, Ae, Filla, A., DE MICHELE, Giuseppe, Barbieri, Fabrizio, Perretti, ANNA CARMELA AGNESE, Santoro, Lucio, BRESCIA MORRA, Vincenzo, Banfi, S, DE MICHELE, G, BRESCIA MORRA, V, D'Adamo, ADAMO PIO, and Gasparini, Paolo
Subjects: Pediatrics, Neurology, Ataxia: pathology, DNA Mutational Analysis, Mental Retardation: complications, Neurological disorder, pathology [Ataxia], Progressive: genetics, Epilepsy, Mental Retardation, Ataxia: genetics, genetics, Age of Onset, Mitochondrial: genetics, genetic [Mitochondrial], Progressive: pathology, Adult, Ataxia, Ataxia: complications, DNA, Mitochondrial, Family Health, Female, Humans, Magnetic Resonance Imaging, Magnetic Resonance Imaging: methods, Mental Retardation: genetics, Mental Retardation: pathology, Myoclonic Epilepsies, Progressive, Progressive: complications, Point Mutation, pathology [Progressive], Adult, Age of Onset, Ataxia, complications/genetics/pathology, DNA Mutational Analysis, DNA, genetics, Family Health, Female, Humans, Intellectual Disability, complications/genetics/pathology, Magnetic Resonance Imaging, methods, Myoclonic Epilepsies, complications/genetics/pathology, Point Mutation, medicine.symptom, Human, congenital, hereditary, and neonatal diseases and abnormalities, medicine.medical_specialty, complication [Ataxia], Myoclonic Epilepsie, complication [Progressive], Progressive myoclonus epilepsy, DNA, Mitochondrial, methods, DNA Mutational Analysi, pathology [Mental Retardation], Intellectual Disability, medicine, Psychiatry, complication [Mental Retardation], genetic [Progressive], business.industry, complications/genetics/pathology, genetic [Ataxia], medicine.disease, Myoclonic Epilepsies, Progressive, Developmental disorder, method [Magnetic Resonance Imaging], Neurology (clinical), genetic [Mental Retardation], Age of onset, business, methods, Myoclonic Epilepsie, Myoclonus
Abstract: We describe two couples of sibs from a southern Italian family affected by epilepsy, myoclonus, mental retardation and slight ataxia. Onset was between 4 and 12 years and the course slowly progressive. The clinical picture suggested the diagnosis of Unverricht–Lundborg disease. Molecular study excluded linkage to EPM1. Other possible causes of progressive myoclonus epilepsy were also excluded.
Published: 2005

31. Peripapillary vascular density in resolved non-arteritic anterior ischemic optic neuropathy: colocalization between structural and vascular parameters

Author: Mariapaola Giordano, Gilda Cennamo, Daniela Montorio, Vincenzo Brescia Morra, Marina Concilio, Giordano, M., Montorio, D., Concilio, M., Morra, V. B., and Cennamo, G.
Subjects: Male, medicine.medical_specialty, genetic structures, Peripapillary vascular density, Fundus Oculi, Optic Disk, Nerve fiber layer, Dermatology, Fundus (eye), 03 medical and health sciences, 0302 clinical medicine, medicine.artery, Ophthalmology, medicine, Humans, Optic Neuropathy, Ischemic, 030212 general & internal medicine, Neuroradiology, business.industry, General Medicine, Middle Aged, medicine.disease, Optical coherence tomography angiography, eye diseases, Ciliary arteries, Visual field, Arteritic anterior ischemic optic neuropathy, Psychiatry and Mental health, medicine.anatomical_structure, Anterior ischemic optic neuropathy, sense organs, Neurology (clinical), business, Microvascular Density, Non-arteritic anterior ischemic optic neuropathy, Tomography, Optical Coherence, 030217 neurology & neurosurgery, Human, Optic disc
Abstract: Introduction/aims Non-arteritic anterior ischemic optic neuropathy (NAION) is an acute infarction of the prelaminar anterior optic disc, resulting from the occlusion of posterior ciliary arteries. Here, we evaluated the correlation between structural and vascular features in a case of resolved NAION. Methods Observational case report. Results A 50-year-old male patient was referred at an Eye clinic due to an altitudinal visual field defect in the left eye, occurred 9 months before. Fundus examination was unremarkable, while structural SD-OCT reveals retinal nerve fiber layer (RNFL), ganglion cell complex (GCC) thinning associated with reduction of peripapillary vascular density at OCT Angiography. Discussion We found a precise spatial correlation among RNFL and GCC thinning, peripapillary vascular reduction and visual field defects. This case demonstrates that OCTA represents a new, valid and non-invasive imaging technique in the diagnosis and follow-up of NAION, even after the resolution of the acute phase, in the absence of clinical signs at fundus examination.
Published: 2021

32. Persistence, adherence, healthcare resource utilisation and costs for interferon Beta in multiple sclerosis: a population-based study in the Campania region (southern Italy)

Author: Ilaria Loperto, Antonio Carotenuto, Marcello Moccia, Antonio Capacchione, Vincenzo Brescia Morra, Raffaele Palladino, Maria Triassi, Roberta Lanzillo, Moccia, M., Loperto, I., Lanzillo, R., Capacchione, A., Carotenuto, A., Triassi, M., Brescia Morra, V., and Palladino, R.
Subjects: Male, 1110 Nursing, Health administration, Persistence (computer science), 0302 clinical medicine, Pegylated interferon, Health care, 030212 general & internal medicine, PREDICTORS, GLATIRAMER ACETATE, RISK, education.field_of_study, Health Policy, lcsh:Public aspects of medicine, Middle Aged, INSIGHTS, Italy, DISEASE-MODIFYING THERAPIES, Health Policy & Services, Costs and Cost Analysis, Health Resources, Interferon, Female, BURDEN, Life Sciences & Biomedicine, medicine.drug, Research Article, Adult, medicine.medical_specialty, EUROPE, Cost, Population, 1117 Public Health and Health Services, Medication Adherence, Multiple sclerosis, 03 medical and health sciences, Internal medicine, Healthcare resource utilization, medicine, Humans, COHORT, Formulary, Medical prescription, education, Retrospective Studies, Science & Technology, business.industry, lcsh:RA1-1270, Interferon-beta, medicine.disease, EFFICACY, Costs, Health Care Sciences & Services, business, 030217 neurology & neurosurgery, 0807 Library and Information Studies
Abstract: Background To differentiate five formulations of Interferon Beta for the treatment of multiple sclerosis (MS) in clinical practice, by analysing persistence, adherence, healthcare resource utilisation and costs at population level. Methods In this population-based study, we included individuals with MS living in the Campania Region of Italy from 2015 to 2017, on treatment with intramuscular Interferon Beta-1a (Avonex® = 618), subcutaneous pegylated Interferon Beta-1a (Plegridy® = 259), subcutaneous Interferon Beta-1a (Rebif® = 1220), and subcutaneous Interferon Beta-1b (Betaferon® = 348; and Extavia® = 69). We recorded healthcare resource utilisation from administrative databases (hospital discharges, drug prescriptions, MS-related outpatients), and derived costs from the Regional formulary. We classified hospital admissions into MS-related and non-MS-related. Persistence (time to switch to other disease modifying treatments (DMTs)), and adherence (medication possession ratio (MPR) = medication supply obtained/medication supply expected during follow-up period) were calculated. Results Patients treated with Rebif® were younger, when compared with other Interferon Beta formulations (p p p p = 0.03), when compared with Rebif®. The probability of MS-related hospital admissions was 40% higher in Avonex® (p = 0.03), 400% higher in Betaferon® (p p = 0.04), resulting into higher non-DMT-related costs, when compared with Rebif®. Discussion Interferon Beta formulations presented with different prescription patterns, persistence, adherence, healthcare resource utilisation and costs, with Rebif® being used in younger patients and with less MS-related hospital admissions.
Published: 2020

33. ProspeCtive study to evaluate efficacy, safety and tOlerability of dietary supplemeNT of Curcumin (BCM95) in subjects with Active relapsing MultIple Sclerosis treated with subcutaNeous Interferon beta 1a 44 mcg TIW (CONTAIN): A randomized, controlled trial

Author: G. Vacca, Barbara Satelliti, Maria Petracca, Roberta Lanzillo, Francesco Assogna, Gianluigi D'Ambrosio, Antonio Capacchione, Monica Ragucci, Mario Quarantelli, Marcello Moccia, Antonio Carotenuto, Vincenzo Brescia Morra, Petracca, M., Quarantelli, M., Moccia, M., Vacca, G., Satelliti, B., D'Ambrosio, G., Carotenuto, A., Ragucci, M., Assogna, F., Capacchione, A., Lanzillo, R., and Morra, V. B.
Subjects: medicine.medical_specialty, Curcumin, Multiple Sclerosis, Combination therapy, Placebo, Gastroenterology, law.invention, Interferon β-1a, Multiple Sclerosis, Relapsing-Remitting, Randomized controlled trial, Adjuvants, Immunologic, law, Recurrence, Internal medicine, medicine, Clinical endpoint, Humans, Multiple sclerosi, Prospective Studies, Neurodegeneration, Prospective cohort study, Inflammation, business.industry, Multiple sclerosis, Interferon beta-1a, General Medicine, medicine.disease, Magnetic Resonance Imaging, Treatment Outcome, Neurology, Tolerability, Dietary Supplements, Neurology (clinical), business, medicine.drug
Abstract: Background multiple sclerosis (MS) is a complex disease sustained by several pathogenic mechanisms. As such, combination therapy strategies, targeting a range of disease mechanisms, might represent the ideal therapeutic approach. Here we investigated the efficacy of curcumin, a naturally occurring poly-phenolic phytochemical with potent anti-inflammatory and antioxidant properties, in subjects under treatment with IFN β-1a, to test the effects of this combination therapy on clinical and MRI parameters of inflammation and neurodegeneration in relapsing MS (RMS). Methods eighty active RMS were prospectively enrolled, randomized (1:1) to either the IFN-curcumin or the IFN-placebo group and followed up longitudinally with clinical and MRI assessments for 24 months. Primary endpoint was the efficacy of curcumin versus placebo as add-on therapy on new/enlarging T2 lesions in RMS subjects under treatment with subcutaneous IFN β-1a 44 mcg TIW. Efficacy on clinical parameters (relapses and disability progression), other MRI parameters of inflammation (T1 Gd-enhancing lesions, combined unique active-CUA lesions) and neurodegeneration (T1-hypointense lesions, grey matter loss and white matter microstructural damage) as well as safety and tolerability of curcumin were explored as secondary endpoints. Results ten subjects dropped out from the study by month 12 (6 in the IFN-curcumin group and 4 in the IFN-placebo group), and 27 by month 24 (11 in the IFN-curcumin group and 16 in the IFN-placebo group). Although no between-group difference was present in terms of proportion of subjects free from new/enlarging T2 lesions, a lower proportion of patients with CUA lesions was noted at month 12 in the IFN-curcumin group in comparison with the IFN-placebo group (7.5% vs 17.5%, χ² test p= 0.0167). This result was not confirmed at month 24. The statistical analysis failed to reveal any difference between the two treatment groups – IFN-curcumin and IFN-placebo – in terms of relapses, disability progression, other MRI metrics of inflammation and MRI changes suggestive of ongoing neurodegeneration. No difference in the rate and nature of adverse events was observed between the two treatment groups. Conclusion Although the study drop-out rate was too high to allow definite conclusions, our findings suggest that curcumin might add to IFN β-1a efficacy on radiological signs of inflammation in MS, while it did not seem to exert any neuroprotective effect as assessed by clinical and MRI parameters. (NCT01514370)
Published: 2021

34. Correlation between the optic nerve pial diameter and radial peripapillary vascular changes in primary open-angle glaucoma

Author: Michele Reibaldi, Giovanni Cennamo, Vincenzo Brescia Morra, Maria Angelica Breve, Feliciana Menna, Daniela Montorio, Gilda Cennamo, Montorio, D., Cennamo, G., Breve, M. A., Menna, F., Reibaldi, M., and Morra, V. B.
Subjects: medicine.medical_specialty, genetic structures, Open angle glaucoma, Optic Disk, Nerve fiber layer, Glaucoma, A-scan ultrasound, Optic nerve pial diameter, Optical coherence tomography angiography, Primary open angle glaucoma, Optic neuropathy, Cellular and Molecular Neuroscience, Ophthalmology, medicine, Humans, Prospective Studies, Intraocular Pressure, business.industry, Ultrasound, Reproducibility of Results, Retinal Vessels, medicine.disease, eye diseases, Sensory Systems, Visual field, Ganglion, medicine.anatomical_structure, Optic nerve, sense organs, business, Glaucoma, Open-Angle, Tomography, Optical Coherence
Abstract: Purpose To assess the optic nerve pial diameter (ONPD) in patients with primary open-angle glaucoma (POAG) using standardized A-scan ultrasound and to evaluate the correlation between the ONPD and structural, vascular optic nerve head features and visual field parameters in glaucomatous eyes. Methods In this prospective study, we enrolled 126 eyes of 63 POAG patients and 124 eyes of 62 healthy controls. In all subjects, the ONPD was evaluated by means of A-scan ultrasound. Spectral domain (SD)-OCT was used to assess ganglion cell complex (GCC), retinal nerve fiber layer (RNFL), thicknesses, and the optic nerve head (ONH) morphology. OCTA measured the vessel density (VD) of radial peripapillary capillary (RPC) plexus. Results The ONPD showed a statistically significant reduction in POAG group with respect to controls (p p p = 0.009) and an increased cup-to-disc area ratio (p = 0.013) and cup volume (p p = 0.006). Moreover, significant correlation was also found between ONPD and structural SD-OCT parameters (p = 0.001) and between ONPD and visual field parameters (p = 0.001). Conclusions The standardized A-scan ultrasound measurements of the ONPD showed a significant correlation with structural and vascular glaucomatous changes measured by means of SD-OCT and OCTA. These results confirm the diagnostic reliability of the ultrasound evaluation in glaucoma optic neuropathy.
Published: 2021

35. Optical coherence tomography angiography in contractile morning glory syndrome

Author: Giovanni Cennamo, Gilda Cennamo, Vincenzo Brescia Morra, Maria Angelica Breve, Daniela Montorio, Cennamo, Gilda., Montorio, D., Breve, M. A., Morra, V. B., and Cennamo, G.
Subjects: Male, Adolescent, genetic structures, Optic Disk, Optic disk, optical coherence tomography angiography, Peripapillary retina, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Optical coherence tomography, Vascular plexus, Humans, Medicine, Eye Abnormalities, Fluorescein Angiography, Morning, Morning glory syndrome, medicine.diagnostic_test, business.industry, Retinal Vessels, Syndrome, General Medicine, Anatomy, Optical coherence tomography angiography, eye diseases, Ophthalmology, spectral domain optical coherence tomography, Microvascular Network, 030221 ophthalmology & optometry, Optic nerve, Female, sense organs, business, Tomography, Optical Coherence, 030217 neurology & neurosurgery
Abstract: This study describes the optical coherence tomography and optical coherence tomography angiography features of three eyes of three patients affected by contractile morning glory syndrome. Optical coherence tomography angiography scans of the peripapillary retina revealed a dense microvascular network without any vascular difference between the superficial vascular plexus and the deep vascular plexus around the optic nerve. These optical coherence tomography angiography findings confirm that the contractile movement could be due to the presence of an autonomic cholinergic muscular mechanism in the posterior part of the globe. In fact in our cases, the contractile movement seemed to be induced by massage of the eyeball. Optical coherence tomography angiography is a valid, non-invasive, dyeless, and reliable method that could shed light on the pathogenesis of this rare disease of the optic disk.
Published: 2019

36. A Retrospective Exploratory Analysis on Cardiovascular Risk and Cognitive Dysfunction in Multiple Sclerosis

Author: Teresa Costabile, Vincenzo Brescia Morra, Fabrizia Falco, Marcello Moccia, Antonio Reia, Matteo Conenna, Roberta Lanzillo, Giuseppe Servillo, Martina Petruzzo, Maria Petracca, Antonio Carotenuto, Reia, A., Petruzzo, M., Falco, F., Costabile, T., Conenna, M., Carotenuto, A., Petracca, M., Servillo, G., Lanzillo, R., Brescia Morra, V., and Moccia, M.
Subjects: medicine.medical_specialty, Population, Neurosciences. Biological psychiatry. Neuropsychiatry, 030204 cardiovascular system & hematology, Verbal learning, multiple sclerosis, Article, cognitive, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Medicine, Multiple sclerosi, Cognitive decline, education, education.field_of_study, Framingham Risk Score, California Verbal Learning Test, business.industry, General Neuroscience, cardiovascular, Neuropsychology, Retrospective cohort study, Cognition, Cardiovascular, Cognitive, Multiple sclerosis, verbal learning, business, 030217 neurology & neurosurgery, RC321-571
Abstract: Background. Cardiovascular comorbidities have been associated with cognitive decline in the general population. Objectives. To evaluate the associations between cardiovascular risk and neuropsychological performances in MS. Methods. This is a retrospective study, including 69 MS patients. For all patients, we calculated the Framingham risk score, which provides the 10-year probability of developing macrovascular disease, using age, sex, diabetes, smoking, systolic blood pressure, and cholesterol levels as input variables. Cognitive function was examined with the Brief International Cognitive Assessment for MS (BICAMS), including the Symbol Digit Modalities Test (SDMT), the California Verbal Learning Test-II (CVLT-II), and the Brief Visuospatial Memory Test-Revised (BVMT-R). Results. Each point increase of the Framingham risk score corresponded to 0.21 lower CVLT-II score. Looking at Framingham risk score components, male sex and higher total cholesterol levels corresponded to lower CVLT scores (Coeff = −8.54, 95%CI = −15.51, −1.57, and Coeff = −0.11, 95%CI = −0.20, −0.02, respectively). No associations were found between cardiovascular risk and SDMT or BVMT-R. Conclusions. In our exploratory analyses, cardiovascular risk was associated with verbal learning dysfunction in MS. Lifestyle and pharmacological interventions on cardiovascular risk factors should be considered carefully in the management of MS, given the possible effects on cognitive function.
Published: 2021

37. Neuroimaging Correlates of Cognitive Dysfunction in Adults with Multiple Sclerosis

Author: Maria Petracca, Sirio Cocozza, Vincenzo Brescia Morra, Giuseppe Pontillo, Arturo Brunetti, Marcello Moccia, Antonio Carotenuto, Roberta Lanzillo, Petracca, M., Pontillo, G., Moccia, M., Carotenuto, A., Cocozza, S., Lanzillo, R., Brunetti, A., and Brescia Morra, V.
Subjects: positron emission tomography, Review, multiple sclerosis, 030218 nuclear medicine & medical imaging, lcsh:RC321-571, 03 medical and health sciences, 0302 clinical medicine, Atrophy, Neuroimaging, cognitive dysfunction, medicine, magnetic resonance imaging, Multiple sclerosi, Cognitive decline, Cognitive impairment, sodium, lcsh:Neurosciences. Biological psychiatry. Neuropsychiatry, neuroimaging, medicine.diagnostic_test, business.industry, General Neuroscience, Multiple sclerosis, food and beverages, Magnetic resonance imaging, Cognition, medicine.disease, Cognitive dysfunction, Positron emission tomography, Sodium, business, Neuroscience, 030217 neurology & neurosurgery
Abstract: Cognitive impairment is a frequent and meaningful symptom in multiple sclerosis (MS), caused by the accrual of brain structural damage only partially counteracted by effective functional reorganization. As both these aspects can be successfully investigated through the application of advanced neuroimaging, here, we offer an up-to-date overview of the latest findings on structural, functional and metabolic correlates of cognitive impairment in adults with MS, focusing on the mechanisms sustaining damage accrual and on the identification of useful imaging markers of cognitive decline.
Published: 2021

38. Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register

Author: Marco Onofrj, Giacomo Lus, Damiano Paolicelli, Matilde Inglese, Giorgia Teresa Maniscalco, Massimo Filippi, Emanuele D'Amico, M. Vianello, Simonetta Galgani, Vincenzo Brescia Morra, Francesco Patti, Antonio Gallo, Aurora Zanghì, Paolo Confalonieri, Giuseppe Salemi, Giovanna De Luca, Maria Trojano, Carlo Avolio, Maria Pia Amato, Eleonora Cocco, Marzia Romeo, D'Amico, E., Zanghi, A., Romeo, M., Cocco, E., Maniscalco, G. T., Brescia Morra, V., Paolicelli, D., De Luca, G., Galgani, S., Amato, M. P., Salemi, G., Inglese, M., Confalonieri, P. A., Lus, G., Avolio, C., Gallo, A., Vianello, M., Onofrj, M., Filippi, M., Trojano, M., Patti, F., D'Amico, Emanuele, Zanghì, Aurora, Romeo, Marzia, Cocco, Eleonora, Maniscalco, Giorgia Teresa, Brescia Morra, Vincenzo, Paolicelli, Damiano, De Luca, Giovanna, Galgani, Simonetta, Amato, Maria Pia, Salemi, Giuseppe, Inglese, Matilde, Confalonieri, Paolo Agostino, Lus, Giacomo, Avolio, Carlo, Gallo, Antonio, Vianello, Marika, Onofrj, Marco, Filippi, Massimo, Trojano, Maria, and Patti, Francesco
Subjects: Male, oral DMTs, oral DMT, Administration, Oral, Disease, Relapsing-Remitting, Cohort Studies, 0302 clinical medicine, Immunologic, injectable DMT, Pharmacology (medical), 030212 general & internal medicine, Registries, Subcutaneous, Middle Aged, Italy, EDSS score, injectable DMTs, Multiple sclerosis, real-world setting, Adjuvants, Immunologic, Adult, Female, Follow-Up Studies, Glatiramer Acetate, Humans, Immunologic Factors, Injections, Subcutaneous, Interferon-beta, Multiple Sclerosis, Relapsing-Remitting, Retrospective Studies, Administration, Cohort, Settore MED/26 - Neurologia, Original Article, Neurosurgery, Cohort study, Oral, medicine.medical_specialty, Lower risk, Injections, 03 medical and health sciences, Internal medicine, medicine, Multiple sclerosi, Adjuvants, Pharmacology, business.industry, medicine.disease, Discontinuation, Observational study, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract: The current study aims to compare injectable and oral first-line disease-modifying therapies (DMTs) for time to first relapse, time to confirmed disability progression (CDP), and time to discontinuation using a cohort of relapsing remitting multiple sclerosis (RRMS) patients, with data extracted from the Italian MS Register. This multicenter, observational, retrospectively acquired, and propensity-adjusted cohort study utilized RRMS-naïve patients from the Italian MS Register who started either injectable or oral first-line DMTs between January 1, 2010, and December 31, 2017, to evaluate the impact on disability outcomes in patients. Enrolled patients were divided into two groups, namely the injectable group (IG) and the oral group (OG). Of a cohort of 11,416 patients, 4602 were enrolled (3919 in the IG and 683 in the OG). The IG had a higher rate of women (67.3% vs 63.4%, p p p p = 0.941), while a lower risk of DMT was found in the OG (HR = 0.72; CI 95% 0.58–0.88, p = 0.002) for the event time to discontinuation. Real-world data from the Italian MS Register suggests that first-line oral DMTs are associated with a lower risk of experiencing a new relapse and of therapy discontinuation compared to injectable DMTs.
Published: 2021

39. SARS-CoV-2 serology after COVID-19 in multiple sclerosis: An international cohort study

Author: Maria Pia Sormani, Irene Schiavetti, Doriana Landi, Luca Carmisciano, Nicola De Rossi, Cinzia Cordioli, Lucia Moiola, Marta Radaelli, Paolo Immovilli, Marco Capobianco, Vincenzo Brescia Morra, Maria Trojano, Gioacchino Tedeschi, Giancarlo Comi, Mario Alberto Battaglia, Francesco Patti, Yara Dadalti Fragoso, Sedat Sen, Aksel Siva, Roberto Furlan, Marco Salvetti, Gianmarco Abbadessa, Umberto Aguglia, Lia Allegorico, Rossi Beatrice Maria Allegri, Maria Pia Amato, Pietro Annovazzi, Carlo Antozzi, Lucia Appendino, Sebastiano Arena, Viola Baione, Roberto Balgera, Valeria Barcella, Damiano Baroncini, Caterina Barrilà, Mario A. Battaglia, Alessandra Bellacosa, Gianmarco Bellucci, Roberto Bergamaschi, Valeria Bergamaschi, Daiana Bezzini, Beatrice Biolzi, Alvino Bisecco, Simona Bonavita, Giovanna Borriello, Chiara Bosa, Antonio Bosco, Francesca Bovis, Marco Bozzali, Laura Brambilla, Morra Vincenzo Brescia, Giampaolo Brichetto, Maria Buccafusca, Elisabetta Bucciantini, Sebastiano Bucello, Maria Chiara Buscarinu, Maria Paola Cabboi, Massimiliano Calabrese, Francesca Calabria, Francesca Caleri, Federico Camilli, Luisa Maria Caniatti, Roberto Cantello, Ruggero Capra, Rocco Capuano, Patrizia Carta, Paola Cavalla, Maria Grazia Celani, Maria Cellerino, Raffaella Cerqua, Clara Chisari, Raffaella Clerici, Marinella Clerico, Eleonora Cocco, Gaia Cola, Paolo Confalonieri, Antonella Conte, Marta Zaffira Conti, Christian Cordano, Susanna Cordera, Francesco Corea, Claudio Correale, Salvatore Cottone, Francesco Crescenzo, Erica Curti, Alessandro d’Ambrosio, Emanuele D’Amico, Maura Chiara Danni, Alessia d’Arma, Vincenzo Dattola, Stefano de Biase, Giovanna De Luca, Stefania Federica De Mercanti, Paolo De Mitri, Nicola De Stefano, Marco Della Cava, Mario di Napoli, Alessia Di Sapio, Renato Docimo, Anna Dutto, Luana Evangelista, Salvatore Fanara, Diana Ferraro, Maria Teresa Ferrò, Massimo Filippi, Cristina Fioretti, Mario Fratta, Jessica Frau, Marzia Fronza, Alberto Gajofatto, Antonio Gallo, Paolo Gallo, Claudio Gasperini, Anna Ghazaryan, Bruno Giometto, Francesca Gobbin, Flora Govone, Franco Granella, Erica Grange, Maria Grazia Grasso, Angelica Guareschi, Clara Guaschino, Simone Guerrieri, Donata Guidetti, Pietro Iaffaldano, Antonio Ianniello, Luigi Iasevoli, Daniele Imperiale, Maria Teresa Infante, Matilde Inglese, Rosa Iodice, Aniello Iovino, Giovanna Konrad, Roberta Lanzillo, Caterina Lapucci, Luigi Lavorgna, Rita L’Episcopo Maria, Serena Leva, Giuseppe Liberatore, Marianna Lo Re, Marco Longoni, Leonardo Lopiano, Lorena Lorefice, Matteo Lucchini, Giacomo Lus, Davide Maimone, Maria Malentacchi, Giulia Mallucci, Simona Malucchi, Chiara Rosa Mancinelli, Luca Mancinelli, Paolo Manganotti, Teresa Giorgia Maniscalco, Vittorio Mantero, Sabrina Marangoni, Damiano Marastoni, Alessandra Girolama Marfia, Fabiana Marinelli, Alessandro Marti, Filippo Martinelli Boneschi, Federco Masserano Zoli, Francesca Matta, Laura Mendozzi, Giuseppe Meucci, Silvia Miante, Giuseppina Miele, Eva Milano, Massimiliano Mirabella, Rosanna Missione, Marcello Moccia, Sara Montepietra, Margherita Monti Bragadin, Federico Montini, Roberta Motta, Raffaele Nardone, Carolina Gabri Nicoletti, Eduardo Nobile-Orazio, Agostino Nozzolillo, Marco Onofrj, Riccardo Orlandi, Anna Palmieri, Damiano Paolicelli, Livia Pasquali, Luisa Pastò, Elisabetta Pedrazzoli, Paola Perini, Ilaria Pesci, Maria Petracca, Alfredo Petrone, Carlo Piantadosi, Anna M. Pietroboni, Federica Pinardi, Marta Ponzano, Emilio Portaccio, Mattia Pozzato, Carlo Pozzilli, Luca Prosperini, Alessandra Protti, Paolo Ragonese, Sarah Rasia, Sabrina Realmuto, Anna Repice, Eleonora Rigoni, Maria Teresa Rilla, Francesca Rinaldi, Calogero Marcello Romano, Marco Ronzoni, Marco Rovaris, Francesca Ruscica, Loredana Sabattini, Giuseppe Salemi, Lorenzo Saraceno, Alessia Sartori, Arianna Sartori, Elvira Sbragia, Cinzia Scandellari, Ilaria Scarano Giuditta, Valentina Scarano, Valentina Schillaci, Maria Sessa, Caterina Sgarito, Grazia Sibilia, Gabriele Siciliano, Alessio Signori, Elisabetta Signoriello, Leonardo Sinisi, Francesca Sireci, Patrizia Sola, Claudio Solaro, Stefano Sotgiu, Maddalena Sparaco, Maria Laura Stromillo, Silvia Strumia, Laura Emanuela Susani, Giulietta Tabiadon, Francesco Teatini, Valentina Tomassini, Simone Tonietti, Clerici Valentina Torri, Carla Tortorella, Simona Toscano, Rocco Totaro, Maria Trotta, Gabriella Turano, Monica Ulivelli, Manzo Valentino, Giovanna Vaula, Domizia Vecchio, Marco Vercellino, Elena Pinuccia Verrengia, Marika Vianello, Eleonora Virgilio, Francesca Vitetta, Stefano Vollaro, Mauro Zaffaroni, Mauro Zampolini, Ignazio Roberto Zarbo, Antonio Zito, Luigi Zuliani, Sormani, M. P., Schiavetti, I., Landi, D., Carmisciano, L., De Rossi, N., Cordioli, C., Moiola, L., Radaelli, M., Immovilli, P., Capobianco, M., Brescia Morra, V., Trojano, M., Tedeschi, G., Comi, G., Battaglia, M. A., Patti, F., Fragoso, Y. D., Sen, S., Siva, A., Furlan, R., Salvetti, M., Bisecco, Alvino, Pia Sormani, Maria, Schiavetti, Irene, Landi, Doriana, Carmisciano, Luca, De Rossi, Nicola, Cordioli, Cinzia, Moiola, Lucia, Radaelli, Marta, Immovilli, Paolo, Capobianco, Marco, Brescia Morra, Vincenzo, Trojano, Maria, Tedeschi, Gioacchino, Comi, Giancarlo, Alberto Battaglia, Mario, Patti, Francesco, Dadalti Fragoso, Yara, Sen, Sedat, Siva, Aksel, Furlan, Roberto, Salvetti, Marco, Study Group Gianmarco Abbadessa, MuSC-19, Aguglia, Umberto, Allegorico, Lia, Beatrice Maria Allegri, Rossi, Pia Amato, Maria, Annovazzi, Pietro, Antozzi, Carlo, Appendino, Lucia, Arena, Sebastiano, Baione, Viola, Balgera, Roberto, Barcella, Valeria, Baroncini, Damiano, Barrilà, Caterina, A Battaglia, Mario, Bellacosa, Alessandra, Bellucci, Gianmarco, Bergamaschi, Roberto, Bergamaschi, Valeria, Bezzini, Daiana, Biolzi, Beatrice, Bonavita, Simona, Borriello, Giovanna, Bosa, Chiara, Bosco, Antonio, Bovis, Francesca, Bozzali, Marco, Brambilla, Laura, Vincenzo Brescia, Morra, Brichetto, Giampaolo, Buccafusca, Maria, Bucciantini, Elisabetta, Bucello, Sebastiano, Chiara Buscarinu, Maria, Paola Cabboi, Maria, Calabrese, Massimiliano, Calabria, Francesca, Caleri, Francesca, Camilli, Federico, Maria Caniatti, Luisa, Cantello, Roberto, Capra, Ruggero, Capuano, Rocco, Carta, Patrizia, Cavalla, Paola, Grazia Celani, Maria, Cellerino, Maria, Cerqua, Raffaella, Chisari, Clara, Clerici, Raffaella, Clerico, Marinella, Cocco, Eleonora, Cola, Gaia, Confalonieri, Paolo, Conte, Antonella, Zaffira Conti, Marta, Cordano, Christian, Cordera, Susanna, Corea, Francesco, Correale, Claudio, Cottone, Salvatore, Crescenzo, Francesco, Curti, Erica, D'Ambrosio, Alessandro, D'Amico, Emanuele, Chiara Danni, Maura, D'Arma, Alessia, Dattola, Vincenzo, de Biase, Stefano, De Luca, Giovanna, Federica De Mercanti, Stefania, De Mitri, Paolo, De Stefano, Nicola, Della Cava, Marco, di Napoli, Mario, Di Sapio, Alessia, Docimo, Renato, Dutto, Anna, Evangelista, Luana, Fanara, Salvatore, Ferraro, Diana, Teresa Ferrò, Maria, Filippi, Massimo, Fioretti, Cristina, Fratta, Mario, Frau, Jessica, Fronza, Marzia, Gajofatto, Alberto, Gallo, Antonio, Gallo, Paolo, Gasperini, Claudio, Ghazaryan, Anna, Giometto, Bruno, Gobbin, Francesca, Govone, Flora, Granella, Franco, Grange, Erica, Grazia Grasso, Maria, Guareschi, Angelica, Guaschino, Clara, Guerrieri, Simone, Guidetti, Donata, Iaffaldano, Pietro, Ianniello, Antonio, Iasevoli, Luigi, Imperiale, Daniele, Teresa Infante, Maria, Inglese, Matilde, Iodice, Rosa, Iovino, Aniello, Konrad, Giovanna, Lanzillo, Roberta, Lapucci, Caterina, Lavorgna, Luigi, L'Episcopo Maria, Rita, Leva, Serena, Liberatore, Giuseppe, Lo Re, Marianna, Longoni, Marco, Lopiano, Leonardo, Lorefice, Lorena, Lucchini, Matteo, Lus, Giacomo, Maimone, Davide, Malentacchi, Maria, Mallucci, Giulia, Malucchi, Simona, Rosa Mancinelli, Chiara, Mancinelli, Luca, Manganotti, Paolo, Giorgia Maniscalco, Teresa, Mantero, Vittorio, Marangoni, Sabrina, Marastoni, Damiano, Girolama Marfia, Alessandra, Marinelli, Fabiana, Marti, Alessandro, Martinelli Boneschi, Filippo, Masserano Zoli, Federco, Matta, Francesca, Mendozzi, Laura, Meucci, Giuseppe, Miante, Silvia, Miele, Giuseppina, Milano, Eva, Mirabella, Massimiliano, Missione, Rosanna, Moccia, Marcello, Montepietra, Sara, Monti Bragadin, Margherita, Montini, Federico, Motta, Roberta, Nardone, Raffaele, Gabri Nicoletti, Carolina, Nobile-Orazio, Eduardo, Nozzolillo, Agostino, Onofrj, Marco, Orlandi, Riccardo, Palmieri, Anna, Paolicelli, Damiano, Pasquali, Livia, Pastò, Luisa, Pedrazzoli, Elisabetta, Perini, Paola, Pesci, Ilaria, Petracca, Maria, Petrone, Alfredo, Piantadosi, Carlo, M Pietroboni, Anna, Pinardi, Federica, Ponzano, Marta, Portaccio, Emilio, Pozzato, Mattia, Pozzilli, Carlo, Prosperini, Luca, Protti, Alessandra, Ragonese, Paolo, Rasia, Sarah, Realmuto, Sabrina, Repice, Anna, Rigoni, Eleonora, Teresa Rilla, Maria, Rinaldi, Francesca, Marcello Romano, Calogero, Ronzoni, Marco, Rovaris, Marco, Ruscica, Francesca, Sabattini, Loredana, Salemi, Giuseppe, Saraceno, Lorenzo, Sartori, Alessia, Sartori, Arianna, Sbragia, Elvira, Scandellari, Cinzia, Scarano Giuditta, Ilaria, Scarano, Valentina, Schillaci, Valentina, Sessa, Maria, Sgarito, Caterina, Sibilia, Grazia, Siciliano, Gabriele, Signori, Alessio, Signoriello, Elisabetta, Sinisi, Leonardo, Sireci, Francesca, Sola, Patrizia, Solaro, Claudio, Sotgiu, Stefano, Sparaco, Maddalena, Laura Stromillo, Maria, Strumia, Silvia, Emanuela Susani, Laura, Tabiadon, Giulietta, Teatini, Francesco, Tomassini, Valentina, Tonietti, Simone, Valentina Torri, Clerici, Tortorella, Carla, Toscano, Simona, Totaro, Rocco, Trotta, Maria, Turano, Gabriella, Ulivelli, Monica, Valentino, Manzo, Vaula, Giovanna, Vecchio, Domizia, Vercellino, Marco, Pinuccia Verrengia, Elena, Vianello, Marika, Virgilio, Eleonora, Vitetta, Francesca, Vollaro, Stefano, Zaffaroni, Mauro, Zampolini, Mauro, Roberto Zarbo, Ignazio, Zito, Antonio, Zuliani, Luigi, Abbadessa, Gianmarco, Trotta, Maria Consiglia, and Zito, Guido Antonio
Subjects: 0301 basic medicine, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), immunosuppressive therapie, coronavirus, Settore MED/26, medicine.disease_cause, Antibodies, Viral, immunosuppressive therapies, Antibodies, Serology, Cohort Studies, Multiple sclerosis, 03 medical and health sciences, 0302 clinical medicine, Seroepidemiologic Studies, Pandemic, Medicine, Humans, Multiple sclerosi, Viral, Coronavirus, business.industry, immunomodulatory therapie, immunomodulatory therapies, COVID-19, medicine.disease, Virology, coronaviru, Settore MED/26 - NEUROLOGIA, Sars-COV-2, 030104 developmental biology, Neurology, Neurology (clinical), business, SARS-CoV-2, Multiple Sclerosis, 030217 neurology & neurosurgery, Cohort study
Abstract: Background: The MuSC-19 project is an Italian cohort study open to international partners that collects data on multiple sclerosis (MS) patients with COVID-19. During the second wave of the pandemic, serological tests became routinely available. Objective: To evaluate the seroprevalence of anti-SARS-CoV-2 antibodies according to the use of disease-modifying therapy (DMT) in a subset of patients included in the MuSC-19 data set who had undergone a serological test. Methods: We evaluated the association between positive serological test results and time elapsed since infection onset, age, sex, Expanded Disability Status Scale score, comorbidities and DMT exposure using a multivariable logistic model. Results: Data were collected from 423 patients (345 from Italy, 61 from Turkey and 17 from Brazil) with a serological test performed during follow-up. Overall, 325 out of 423 tested patients (76.8%) had a positive serological test. At multivariate analysis, therapy with anti-CD20 was significantly associated with a reduced probability of developing antibodies after COVID-19 (odds ratio (OR) = 0.20, p = 0.002). Conclusion: Patients with MS maintain the capacity to develop humoral immune response against SARS-COV-2, although to a lesser extent when treated with anti-CD20 drugs. Overall, our results are reassuring with respect to the possibility to achieve sufficient immunization with vaccination.
Published: 2021

40. COVID-19 Severity in Multiple Sclerosis: Putting Data Into Context

Author: Maria Pia Sormani, Irene Schiavetti, Luca Carmisciano, Cinzia Cordioli, Massimo Filippi, Marta Radaelli, Paolo Immovilli, Marco Capobianco, Nicola De Rossi, Giampaolo Brichetto, Eleonora Cocco, Cinzia Scandellari, Paola Cavalla, Ilaria Pesci, Antonio Zito, Paolo Confalonieri, Girolama Alessandra Marfia, Paola Perini, Matilde Inglese, Maria Trojano, Vincenzo Brescia Morra, Gioacchino Tedeschi, Giancarlo Comi, Mario Alberto Battaglia, Francesco Patti, Marco Salvetti, Gianmarco Abbadessa, Umberto Aguglia, Lia Allegorico, Beatrice Maria Allegri Rossi, Maria Pia Amato, Pietro Annovazzi, Carlo Antozzi, Lucia Appendino, Sebastiano Arena, Viola Baione, Roberto Balgera, Valeria Barcella, Damiano Baroncini, Caterina Barrilà, Alessandra Bellacosa, Gianmarco Bellucci, Roberto Bergamaschi, Valeria Bergamaschi, Daiana Bezzini, Beatrice Biolzi, Alvino Bisecco, Simona Bonavita, Giovanna Borriello, Chiara Bosa, Antonio Bosco, Francesca Bovis, Marco Bozzali, Laura Brambilla, Maria Buccafusca, Elisabetta Bucciantini, Sebastiano Bucello, Maria Chiara Buscarinu, Maria Paola Cabboi, Massimiliano Calabrese, Francesca Calabria, Francesca Caleri, Federico Camilli, Luisa Maria Caniatti, Roberto Cantello, Ruggero Capra, Rocco Capuano, Patrizia Carta, Maria Grazia Celani, Maria Cellerino, Raffaella Cerqua, Clara Chisari, Raffaella Clerici, Marinella Clerico, Gaia Cola, Antonella Conte, Marta Zaffira Conti, Christian Cordano, Susanna Cordera, Francesco Corea, Claudio Correale, Salvatore Cottone, Francesco Crescenzo, Erica Curti, Alessandro d'Ambrosio, Emanuele D'Amico, Maura Chiara Danni, Alessia d'Arma, Vincenzo Dattola, Stefano de Biase, Giovanna De Luca, Stefania Federica De Mercanti, Paolo De Mitri, Nicola De Stefano, Marco Della Cava, Mario di Napoli, Alessia Di Sapio, Renato Docimo, Anna Dutto, Luana Evangelista, Salvatore Fanara, Ferraro Diana, Maria Teresa Ferrò, Cristina Fioretti, Mario Fratta, Jessica Frau, Marzia Fronza, Roberto Furlan, Alberto Gajofatto, Antonio Gallo, Paolo Gallo, Claudio Gasperini, Anna Ghazaryan, Bruno Giometto, Francesca Gobbin, Flora Govone, Franco Granella, Erica Grange, Maria Grazia Grasso, Angelica Guareschi, Clara Guaschino, Simone Guerrieri, Donata Guidetti, Pietro Iaffaldano, Antonio Ianniello, Luigi Iasevoli, Daniele Imperiale, Maria Teresa Infante, Rosa Iodice, Aniello Iovino, Giovanna Konrad, Doriana Landi, Roberta Lanzillo, Caterina Lapucci, Luigi Lavorgna, Maria Rita L'Episcopo, Serena Leva, Giuseppe Liberatore, Marianna Lo Re, Marco Longoni, Leonardo Lopiano, Lorena Lorefice, Matteo Lucchini, Giacomo Lus, Davide Maimone, Maria Malentacchi, Giulia Mallucci, Simona Malucchi, Chiara Rosa Mancinelli, Luca Mancinelli, Paolo Manganotti, Giorgia Teresa Maniscalco, Vittorio Mantero, Sabrina Marangoni, Damiano Marastoni, Fabiana Marinelli, Alessandro Marti, Filippo Martinelli Boneschi, Federco Masserano Zoli, Francesca Matta, Laura Mendozzi, Giuseppe Meucci, Silvia Miante, Giuseppina Miele, Eva Milano, Massimiliano Mirabella, Rosanna Missione, Marcello Moccia, Lucia Moiola, Sara Montepietra, Margherita MontiBragadin, Federico Montini, Roberta Motta, Raffaele Nardone, Carolina Gabri Nicoletti, Eduardo Nobile-Orazio, Agostino Nozzolillo, Marco Onofrj, Riccardo Orlandi, Anna Palmieri, Damiano Paolicelli, Livia Pasquali, Luisa Pastò, Elisabetta Pedrazzoli, Maria Petracca, Alfredo Petrone, Carlo Piantadosi, Anna M Pietroboni, Federica Pinardi, Marta Ponzano, Emilio Portaccio, Mattia Pozzato, Carlo Pozzilli, Luca Prosperini, Alessandra Protti, Paolo Ragonese, Sarah Rasia, Sabrina Realmuto, Anna Repice, Eleonora Rigoni, Maria Teresa Rilla, Francesca Rinaldi, Calogero Marcello Romano, Marco Ronzoni, Marco Rovaris, Francesca Ruscica, Loredana Sabattini, Giuseppe Salemi, Lorenzo Saraceno, Alessia Sartori, Arianna Sartori, Elvira Sbragia, Giuditta Ilaria Scarano, Valentina Scarano, Valentina Schillaci, Maria Sessa, Caterina Sgarito, Grazia Sibilia, Gabriele Siciliano, Alessio Signori, Elisabetta Signoriello, Leonardo Sinisi, Francesca Sireci, Patrizia Sola, Claudio Solaro, Stefano Sotgiu, Maddalena Sparaco, Maria Laura Stromillo, Silvia Strumia, Emanuela Laura Susani, Giulietta Tabiadon, Francesco Teatini, Valentina Tomassini, Simone Tonietti, Clerici Valentina Torri, Carla Tortorella, Simona Toscano, Rocco Totaro, Maria Trotta, Gabriella Turano, Monica Ulivelli, Manzo Valentino, Giovanna Vaula, Domizia Vecchio, Marco Vercellino, Elena Pinuccia Verrengia, Marika Vianello, Eleonora Virgilio, Francesca Vitetta, Stefano Vollaro, Mauro Zaffaroni, Mauro Zampolini, Ignazio Roberto Zarbo, Luigi Zuliani, Pia Sormani, Maria, Schiavetti, Irene, Carmisciano, Luca, Cordioli, Cinzia, Filippi, Massimo, Radaelli, Marta, Immovilli, Paolo, Capobianco, Marco, De Rossi, Nicola, Brichetto, Giampaolo, Cocco, Eleonora, Scandellari, Cinzia, Cavalla, Paola, Pesci, Ilaria, Zito, Guido Antonio, Confalonieri, Paolo, Alessandra Marfia, Girolama, Perini, Paola, Inglese, Matilde, Trojano, Maria, Brescia Morra, Vincenzo, Tedeschi, Gioacchino, Comi, Giancarlo, Alberto Battaglia, Mario, Patti, Francesco, Salvetti, Marco, Abbadessa, Gianmarco, Aguglia, Umberto, Allegorico, Lia, Maria Allegri Rossi, Beatrice, Pia Amato, Maria, Annovazzi, Pietro, Antozzi, Carlo, Appendino, Lucia, Arena, Sebastiano, Baione, Viola, Balgera, Roberto, Barcella, Valeria, Baroncini, Damiano, Barrilà, Caterina, Bellacosa, Alessandra, Bellucci, Gianmarco, Bergamaschi, Roberto, Bergamaschi, Valeria, Bezzini, Daiana, Biolzi, Beatrice, Bisecco, Alvino, Bonavita, Simona, Borriello, Giovanna, Bosa, Chiara, Bosco, Antonio, Bovis, Francesca, Bozzali, Marco, Brambilla, Laura, Buccafusca, Maria, Bucciantini, Elisabetta, Bucello, Sebastiano, Chiara Buscarinu, Maria, Paola Cabboi, Maria, Calabrese, Massimiliano, Calabria, Francesca, Caleri, Francesca, Camilli, Federico, Maria Caniatti, Luisa, Cantello, Roberto, Capra, Ruggero, Capuano, Rocco, Carta, Patrizia, Grazia Celani, Maria, Cellerino, Maria, Cerqua, Raffaella, Chisari, Clara, Clerici, Raffaella, Clerico, Marinella, Cola, Gaia, Conte, Antonella, Zaffira Conti, Marta, Cordano, Christian, Cordera, Susanna, Corea, Francesco, Correale, Claudio, Cottone, Salvatore, Crescenzo, Francesco, Curti, Erica, D'Ambrosio, Alessandro, D'Amico, Emanuele, Chiara Danni, Maura, D'Arma, Alessia, Dattola, Vincenzo, de Biase, Stefano, De Luca, Giovanna, Federica De Mercanti, Stefania, De Mitri, Paolo, De Stefano, Nicola, Della Cava, Marco, di Napoli, Mario, Di Sapio, Alessia, Docimo, Renato, Dutto, Anna, Evangelista, Luana, Fanara, Salvatore, Diana, Ferraro, Teresa Ferrò, Maria, Fioretti, Cristina, Fratta, Mario, Frau, Jessica, Fronza, Marzia, Furlan, Roberto, Gajofatto, Alberto, Gallo, Antonio, Gallo, Paolo, Gasperini, Claudio, Ghazaryan, Anna, Giometto, Bruno, Gobbin, Francesca, Govone, Flora, Granella, Franco, Grange, Erica, Grazia Grasso, Maria, Guareschi, Angelica, Guaschino, Clara, Guerrieri, Simone, Guidetti, Donata, Iaffaldano, Pietro, Ianniello, Antonio, Iasevoli, Luigi, Imperiale, Daniele, Teresa Infante, Maria, Iodice, Rosa, Iovino, Aniello, Konrad, Giovanna, Landi, Doriana, Lanzillo, Roberta, Lapucci, Caterina, Lavorgna, Luigi, Rita L'Episcopo, Maria, Leva, Serena, Liberatore, Giuseppe, Lo Re, Marianna, Longoni, Marco, Lopiano, Leonardo, Lorefice, Lorena, Lucchini, Matteo, Lus, Giacomo, Maimone, Davide, Malentacchi, Maria, Mallucci, Giulia, Malucchi, Simona, Rosa Mancinelli, Chiara, Mancinelli, Luca, Manganotti, Paolo, Teresa Maniscalco, Giorgia, Mantero, Vittorio, Marangoni, Sabrina, Marastoni, Damiano, Marinelli, Fabiana, Marti, Alessandro, Martinelli Boneschi, Filippo, Masserano Zoli, Federco, Matta, Francesca, Mendozzi, Laura, Meucci, Giuseppe, Miante, Silvia, Miele, Giuseppina, Milano, Eva, Mirabella, Massimiliano, Missione, Rosanna, Moccia, Marcello, Moiola, Lucia, Montepietra, Sara, Montibragadin, Margherita, Montini, Federico, Motta, Roberta, Nardone, Raffaele, Gabri Nicoletti, Carolina, Nobile-Orazio, Eduardo, Nozzolillo, Agostino, Onofrj, Marco, Orlandi, Riccardo, Palmieri, Anna, Paolicelli, Damiano, Pasquali, Livia, Pastò, Luisa, Pedrazzoli, Elisabetta, Petracca, Maria, Petrone, Alfredo, Piantadosi, Carlo, M Pietroboni, Anna, Pinardi, Federica, Ponzano, Marta, Portaccio, Emilio, Pozzato, Mattia, Pozzilli, Carlo, Prosperini, Luca, Protti, Alessandra, Ragonese, Paolo, Rasia, Sarah, Realmuto, Sabrina, Repice, Anna, Rigoni, Eleonora, Teresa Rilla, Maria, Rinaldi, Francesca, Marcello Romano, Calogero, Ronzoni, Marco, Rovaris, Marco, Ruscica, Francesca, Sabattini, Loredana, Salemi, Giuseppe, Saraceno, Lorenzo, Sartori, Alessia, Sartori, Arianna, Sbragia, Elvira, Ilaria Scarano, Giuditta, Scarano, Valentina, Schillaci, Valentina, Sessa, Maria, Sgarito, Caterina, Sibilia, Grazia, Siciliano, Gabriele, Signori, Alessio, Signoriello, Elisabetta, Sinisi, Leonardo, Sireci, Francesca, Sola, Patrizia, Solaro, Claudio, Sotgiu, Stefano, Sparaco, Maddalena, Laura Stromillo, Maria, Strumia, Silvia, Laura Susani, Emanuela, Tabiadon, Giulietta, Teatini, Francesco, Tomassini, Valentina, Tonietti, Simone, Valentina Torri, Clerici, Tortorella, Carla, Toscano, Simona, Totaro, Rocco, Trotta, Maria Consiglia, Turano, Gabriella, Ulivelli, Monica, Valentino, Manzo, Vaula, Giovanna, Vecchio, Domizia, Vercellino, Marco, Pinuccia Verrengia, Elena, Vianello, Marika, Virgilio, Eleonora, Vitetta, Francesca, Vollaro, Stefano, Zaffaroni, Mauro, Zampolini, Mauro, Roberto Zarbo, Ignazio, Zuliani, Luigi, Sormani, M. P., Schiavetti, I., Carmisciano, L., Cordioli, C., Filippi, M., Radaelli, M., Immovilli, P., Capobianco, M., De Rossi, N., Brichetto, G., Cocco, E., Scandellari, C., Cavalla, P., Pesci, I., Zito, A., Confalonieri, P., Marfia, G. A., Perini, P., Inglese, M., Trojano, M., Brescia Morra, V., Tedeschi, G., Comi, G., Battaglia, M. A., Patti, F., Salvetti, M., Zito, Antonio, BRESCIA MORRA, Vincenzo, Trotta, Maria, Sormani, Maria Pia, Marfia, Girolama Alessandra, and Battaglia, Mario Alberto
Subjects: Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Coronavirus disease 2019 (COVID-19), Population, Intensive Care Unit, COVID-19, Cohort Studies, Comorbidity, Female, Hospitalization, Humans, Intensive Care Units, Italy, Middle Aged, Retrospective Studies, Risk Factors, Severity of Illness Index, Context (language use), Settore MED/26, Lower risk, Retrospective Studie, Internal medicine, Multiple Sclerosi, Medicine, In patient, National level, education, education.field_of_study, Expanded Disability Status Scale, business.industry, Risk Factor, Ethics committee, medicine.disease, Icu admission, Settore MED/26 - NEUROLOGIA, Neurology, Relative risk, Family medicine, Cohort, Honorarium, Observational study, Neurology (clinical), Cohort Studie, business, Human
Abstract: Background: It is unclear how multiple sclerosis (MS) affects the severity of Covid-19. Methods: Hospitalization, Intensive Care Unit (ICU) admission and death after Covid-19 diagnosis of 1362 MS patients were compared to the age and sex-matched Italian population in a retrospective observational case-cohort study with population-based control. The observed vs the expected events were compared in the whole MS cohort and in different subgroups (higher-risk: EDSS>3 or at least one comorbidity, lower-risk: EDSS
Published: 2021

41. Cognitive trajectories in multiple sclerosis: a long-term follow-up study

Author: Roberta Lanzillo, Maria Brunella Cipullo, Moccia Moccia, Teresa Costabile, Giuseppe Pontillo, Cinzia Valeria Russo, Elena Augusta Vola, Sirio Cocozza, Fabrizia Falco, Teresa Perillo, Antonio Carotenuto, Martina Di Stasi, Chiara Paolella, Francesco Saccà, Martina Petruzzo, Vincenzo Brescia Morra, Maria Petracca, Carotenuto, A., Costabile, T., Pontillo, G., Moccia, M., Falco, F., Petracca, M., Petruzzo, M., Russo, C. V., Di Stasi, M., Paolella, C., Perillo, T., Vola, E. A., Cipullo, M. B., Cocozza, S., Lanzillo, R., Brescia Morra, V., and Saccà, Francesco
Subjects: Male, 0301 basic medicine, medicine.medical_specialty, Multiple Sclerosis, Physical disability, Neurology, Dermatology, Neuropsychological Tests, Disability predictors, Hippocampus, Disability predictor, 03 medical and health sciences, Cognition, Multiple Sclerosis, Relapsing-Remitting, Hippocampu, 0302 clinical medicine, Physical medicine and rehabilitation, Magnetic resonance imaging, Cognitive dysfunction, medicine, Humans, Cognitive rehabilitation therapy, Neuroradiology, medicine.diagnostic_test, business.industry, Multiple sclerosis, Infant, Biomarkers, Longitudinal data analysis, Biomarker, General Medicine, medicine.disease, Psychiatry and Mental health, 030104 developmental biology, Longitudinal data analysi, Female, Original Article, Neurology (clinical), Neurosurgery, Atrophy, business, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract: Background Cognitive impairment occurs in multiple sclerosis (MS) and undergoes a progressive worsening over disease course. However, clinicians still struggle to predict the course of cognitive function. To evaluate baseline clinical and imaging predictors of cognitive abilities worsening over time, we performed a latent trajectory analysis for cognitive performances in MS patients, up to 15 years from disease onset. Methods We collected age, sex, education, dominant and non-dominant 9-hole peg test (9HP) and timed 25-foot walk (T25-FW) as well as MRI measures (grey matter volume and lesion load) within 6 months from disease diagnosis for relapsing–remitting MS (RR-MS) patients. At diagnosis and over the follow-up, we also assessed cognitive status through the symbol digit modalities test (SDMT). Cognitive impairment was defined by applying age-, gender- and education-adjusted normative values. Group-based trajectory analysis was performed to determine trajectories, and the predictive value of clinical and imaging variables at baseline was assessed through multinomial logistic regression. Results We included 148 RR-MS (98 females and 50 males). Over 11 ± 4 year follow-up, 51.4% remained cognitively stable whereas 48.6% cognitively worsened. Cognitively worsening patients had a higher T25FW time (p = 0.004) and a reduced hippocampal volume at baseline (p = 0.04). Conclusion Physical disability as well as hippocampal atrophy might depict patients at risk of cognitive worsening over the disease course. Therefore, using such predictors, clinicians may select patients to carefully evaluate for cognitive impairment as to eventually introduce cognitive rehabilitation treatments.
Published: 2021

42. Disease-Modifying Therapies and Coronavirus Disease 2019 Severity in Multiple Sclerosis

Author: Sormani, Maria P., Nicola De Rossi, Irene, Schiavetti, Luca, Carmisciano, Cinzia, Cordioli, Lucia, Moiola, Marta, Radaelli, Paolo, Immovilli, Marco, Capobianco, Maria, Trojano, Paola, Zaratin, Gioacchino, Tedeschi, Giancarlo, Comi, Battaglia, Mario A., Francesco, Patti, Marco, Salvetti, Agostino, Nozzolillo, Alessandra, Bellacosa, Alessandra, Protti, Alessia Di Sapio, Alessio, Signori, Alfredo, Petrone, Alvino, Bisecco, Aniello, Iovino, Anna, Dutto, Anna Maria Repice, Antonella, Conte, Antonio, Bertolotto, Antonio, Bosco, Antonio, Gallo, Antonio, Zito, Arianna, Sartori, Bruno, Giometto, Carla, Tortorella, Carlo, Antozzi, Carlo, Pozzilli, Chiara Rosa Mancinelli, Chiara, Zanetta, Christian, Cordano, Cinzia, Scandellari, Clara, Guaschino, Claudio, Gasperini, Claudio, Solaro, Cristina, Fioretti, Daiana, Bezzini, Damiano, Marastoni, Damiano, Paolicelli, Domizia, Vecchio, Doriana, Landi, Elisabetta, Bucciantini, Elisabetta, Pedrazzoli, Elisabetta, Signoriello, Elvira, Sbragia, Emanuela Laura Susani, Erica, Curti, Eva, Milano, Fabiana, Marinelli, Federico, Camilli, Filippo Martinelli Boneschi, Flora, Govone, Francesca, Bovis, Francesca, Calabria, Francesca, Caleri, Francesca, Rinaldi, Francesca, Vitetta, Francesco, Corea, Francesco, Crescenzo, Francesco, Teatini, Giulietta, Tabiadon, Franco, Granella, Giacomo, Boffa, Giacomo, Lus, Giampaolo, Brichetto, Giorgia Teresa Maniscalco, Giovanna, Borriello, Giovanna De Luca, Giovanna, Konrad, Giovanna, Vaula, Girolama Alessandra Marfia, Giulia, Mallucci, Giuseppe, Liberatore, Giuseppe, Salemi, Giuseppina, Miele, Grazia, Sibilia, Ilaria, Pesci, Laura, Brambilla, Leonardo, Lopiano, Leonardo, Sinisi, Pasquali, Livia, Lorenzo, Saraceno, Luca, Chiveri, Luca, Mancinelli, Grimaldi, Luigi M. E., Luisa Maria Caniatti, Marco Della Cava, Marco, Onofrj, Marco, Rovaris, Marco, Vercellino, Margherita Monti Bragadin, Maria, Buccafusca, Maria Chiara Buscarinu, Maria Grazia Celani, Maria Grazia Grasso, Maria Laura Stromillo, Maria, Petracca, Maria Pia Amato, Maria Pia Sormani, Maria Rita L'Episcopo, Maria, Sessa, Maria Teresa Ferrò, Maria Vittoria Ercolani, Mariangela, Bianco, Marianna Lo Re, Marika, Vianello, Marinella, Clerico, Mario Alberto Battaglia, Mario di Napoli, Marta, Ponzano, Marta Zaffira Conti, Massimiliano, Calabrese, Massimiliano, Mirabella, Massimo, Filippi, Matilde, Inglese, Matteo, Lucchini, Matteo, Pozzato, Maura Chiara Danni, Mauro, Zaffaroni, Mauro, Zampolini, Michela, Ponzio, Milena De Riz, Nicola De Stefano, Paola, Cavalla, Paola De Mitri, Paola, Grossi, Paolo, Confalonieri, Paolo, Gallo, Paolo, Ragonese, Patrizia, Sola, Pietro, Annovazzi, Pietro, Iaffaldano, Raffaele, Nardone, Raffaella, Cerqua, Raffaella, Clerici, Roberta, Lanzillo, Roberta, Motta, Roberto, Balgera, Roberto, Bergamaschi, Rocco, Totaro, Rosa, Iodice, Ruggero, Capra, Sabrina, Marangoni, Sabrina, Realmuto, Salvatore, Cottone, Sara, Montepietra, Sarah, Rasia, Sebastiano, Arena, Sebastiano, Bucello, Silvia, Banfi, Simona, Bonavita, Simona, Malucchi, Simone, Tonietti, Stefano, Vollaro, Susanna, Cordera, Umberto, Aguglia, Valentina Torri Clerici, Valeria, Barcella, Valeria, Bergamaschi, Vincenzo Brescia Morra, Vincenzo, Dattola, and Vittorio Mantero, Sormani, M. P., De Rossi, N., Schiavetti, I., Carmisciano, L., Cordioli, C., Moiola, L., Radaelli, M., Immovilli, P., Capobianco, M., Trojano, M., Zaratin, P., Tedeschi, G., Comi, G., Battaglia, M. A., Patti, F., Salvetti, M., P Sormani, Maria, De Rossi, Nicola, Schiavetti, Irene, Carmisciano, Luca, Cordioli, Cinzia, Moiola, Lucia, Radaelli, Marta, Immovilli, Paolo, Capobianco, Marco, Trojano, Maria, Zaratin, Paola, Tedeschi, Gioacchino, Comi, Giancarlo, A Battaglia, Mario, Patti, Francesco, Salvetti, Marco, Nozzolillo, Agostino, Bellacosa, Alessandra, Protti, Alessandra, Di Sapio, Alessia, Signori, Alessio, Petrone, Alfredo, Bisecco, Alvino, Iovino, Aniello, Dutto, Anna, Maria Repice, Anna, Conte, Antonella, Bertolotto, Antonio, Bosco, Antonio, Gallo, Antonio, Zito, Antonio, Sartori, Arianna, Giometto, Bruno, Tortorella, Carla, Antozzi, Carlo, Pozzilli, Carlo, Rosa Mancinelli, Chiara, Zanetta, Chiara, Cordano, Christian, Scandellari, Cinzia, Guaschino, Clara, Gasperini, Claudio, Solaro, Claudio, Fioretti, Cristina, Bezzini, Daiana, Marastoni, Damiano, Paolicelli, Damiano, Vecchio, Domizia, Landi, Doriana, Bucciantini, Elisabetta, Pedrazzoli, Elisabetta, Signoriello, Elisabetta, Sbragia, Elvira, Laura Susani, Emanuela, Curti, Erica, Milano, Eva, Marinelli, Fabiana, Camilli, Federico, Martinelli Boneschi, Filippo, Govone, Flora, Bovis, Francesca, Calabria, Francesca, Caleri, Francesca, Rinaldi, Francesca, Vitetta, Francesca, Corea, Francesco, Crescenzo, Francesco, Teatini, Francesco, Tabiadon, Giulietta, Granella, Franco, Boffa, Giacomo, Lus, Giacomo, Brichetto, Giampaolo, Teresa Maniscalco, Giorgia, Borriello, Giovanna, De Luca, Giovanna, Konrad, Giovanna, Vaula, Giovanna, Alessandra Marfia, Girolama, Mallucci, Giulia, Liberatore, Giuseppe, Salemi, Giuseppe, Miele, Giuseppina, Sibilia, Grazia, Pesci, Ilaria, Brambilla, Laura, Lopiano, Leonardo, Sinisi, Leonardo, Pasquali, Livia, Saraceno, Lorenzo, Chiveri, Luca, Mancinelli, Luca, E Grimaldi, Luigi M, Maria Caniatti, Luisa, Della Cava, Marco, Onofrj, Marco, Rovaris, Marco, Vercellino, Marco, Monti Bragadin, Margherita, Buccafusca, Maria, Chiara Buscarinu, Maria, Grazia Celani, Maria, Grazia Grasso, Maria, Laura Stromillo, Maria, Petracca, Maria, Pia Amato, Maria, Pia Sormani, Maria, Rita L'Episcopo, Maria, Sessa, Maria, Teresa Ferrò, Maria, Vittoria Ercolani, Maria, Bianco, Mariangela, Lo Re, Marianna, Vianello, Marika, Clerico, Marinella, Alberto Battaglia, Mario, di Napoli, Mario, Ponzano, Marta, Zaffira Conti, Marta, Calabrese, Massimiliano, Mirabella, Massimiliano, Filippi, Massimo, Inglese, Matilde, Lucchini, Matteo, Pozzato, Matteo, Chiara Danni, Maura, Zaffaroni, Mauro, Zampolini, Mauro, Ponzio, Michela, De Riz, Milena, De Stefano, Nicola, Cavalla, Paola, De Mitri, Paola, Grossi, Paola, Confalonieri, Paolo, Gallo, Paolo, Ragonese, Paolo, Sola, Patrizia, Annovazzi, Pietro, Iaffaldano, Pietro, Nardone, Raffaele, Cerqua, Raffaella, Clerici, Raffaella, Lanzillo, Roberta, Motta, Roberta, Balgera, Roberto, Bergamaschi, Roberto, Totaro, Rocco, Iodice, Rosa, Capra, Ruggero, Marangoni, Sabrina, Realmuto, Sabrina, Cottone, Salvatore, Montepietra, Sara, Rasia, Sarah, Arena, Sebastiano, Bucello, Sebastiano, Banfi, Silvia, Bonavita, Simona, Malucchi, Simona, Tonietti, Simone, Vollaro, Stefano, Cordera, Susanna, Aguglia, Umberto, Torri Clerici, Valentina, Barcella, Valeria, Bergamaschi, Valeria, Brescia Morra, Vincenzo, Dattola, Vincenzo, Mantero, Vittorio, Mp, Sormani, N, De Rossi, I, Schiavetti, L, Carmisciano, C, Cordioli, L, Moiola, M, Radaelli, P, Immovilli, M, Capobianco, M, Trojano, P, Zaratin, G, Tedeschi, G, Comi, Ma, Battaglia, F, Patti, M, Salvetti, Study Group Agostino Nozzolillo, Musc-19, Grimaldi, Luigi M. E., Vittorio Mantero, And, Nozzolillo, A., Bellacosa, A., Protti, A., Di Sapio, A., Signori, A., Petrone, A., Bisecco, A., Iovino, A., Dutto, A., Repice, A. M., Conte, A., Bertolotto, A., Bosco, A., Gallo, A., Zito, A., Sartori, A., Giometto, B., Tortorella, C., Antozzi, C., Pozzilli, C., Mancinelli, C. R., Zanetta, C., Cordano, C., Scandellari, C., Guaschino, C., Gasperini, C., Solaro, C., Fioretti, C., Bezzini, D., Marastoni, D., Paolicelli, D., Vecchio, D., Landi, D., Bucciantini, E., Pedrazzoli, E., Signoriello, E., Sbragia, E., Susani, E. L., Curti, E., Milano, E., Marinelli, F., Camilli, F., Boneschi, F. M., Govone, F., Bovis, F., Calabria, F., Caleri, F., Rinaldi, F., Vitetta, F., Corea, F., Crescenzo, F., Teatini, F., Tabiadon, G., Granella, F., Boffa, G., Lus, G., Brichetto, G., Maniscalco, G. T., Borriello, G., De Luca, G., Konrad, G., Vaula, G., Marfia, G. A., Mallucci, G., Liberatore, G., Salemi, G., Miele, G., Sibilia, G., Pesci, I., Brambilla, L., Lopiano, L., Sinisi, L., Pasquali, L., Saraceno, L., Chiveri, L., Mancinelli, L., Grimaldi, L. M. E., Caniatti, L. M., Cava, M. D., Onofrj, M., Rovaris, M., Vercellino, M., Bragadin, M. M., Buccafusca, M., Buscarinu, M. C., Celani, M. G., Grasso, M. G., Stromillo, M. L., Petracca, M., Amato, M. P., L'Episcopo, M. R., Sessa, M., Ferro, M. T., Ercolani, M. V., Bianco, M., Re, M. L., Vianello, M., Clerico, M., di Napoli, M., Ponzano, M., Conti, M. Z., Calabrese, M., Mirabella, M., Filippi, M., Inglese, M., Lucchini, M., Pozzato, M., Danni, M. C., Zaffaroni, M., Zampolini, M., Ponzio, M., De Riz, M., De Stefano, N., Cavalla, P., De Mitri, P., Grossi, P., Confalonieri, P., Gallo, P., Ragonese, P., Sola, P., Annovazzi, P., Iaffaldano, P., Nardone, R., Cerqua, R., Clerici, R., Lanzillo, R., Motta, R., Balgera, R., Bergamaschi, R., Totaro, R., Iodice, R., Capra, R., Marangoni, S., Realmuto, S., Cottone, S., Montepietra, S., Rasia, S., Arena, S., Bucello, S., Banfi, S., Bonavita, S., Malucchi, S., Tonietti, S., Vollaro, S., Cordera, S., Aguglia, U., Clerici, V. T., Barcella, V., Bergamaschi, V., Morra, V. B., Dattola, V., Mantero, V., Sormani M.P., De Rossi N., Schiavetti I., Carmisciano L., Cordioli C., Moiola L., Radaelli M., Immovilli P., Capobianco M., Trojano M., Zaratin P., Tedeschi G., Comi G., Battaglia M.A., Patti F., Salvetti M., Nozzolillo A., Bellacosa A., Protti A., Di Sapio A., Signori A., Petrone A., Bisecco A., Iovino A., Dutto A., Repice A.M., Conte A., Bertolotto A., Bosco A., Gallo A., Zito A., Sartori A., Giometto B., Tortorella C., Antozzi C., Pozzilli C., Mancinelli C.R., Zanetta C., Cordano C., Scandellari C., Guaschino C., Gasperini C., Solaro C., Fioretti C., Bezzini D., Marastoni D., Paolicelli D., Vecchio D., Landi D., Bucciantini E., Pedrazzoli E., Signoriello E., Sbragia E., Susani E.L., Curti E., Milano E., Marinelli F., Camilli F., Boneschi F.M., Govone F., Bovis F., Calabria F., Caleri F., Rinaldi F., Vitetta F., Corea F., Crescenzo F., Teatini F., Tabiadon G., Granella F., Boffa G., Lus G., Brichetto G., Maniscalco G.T., Borriello G., De Luca G., Konrad G., Vaula G., Marfia G.A., Mallucci G., Liberatore G., Salemi G., Miele G., Sibilia G., Pesci I., Brambilla L., Lopiano L., Sinisi L., Pasquali L., Saraceno L., Chiveri L., Mancinelli L., Grimaldi L.M.E., Caniatti L.M., Cava M.D., Onofrj M., Rovaris M., Vercellino M., Bragadin M.M., Buccafusca M., Buscarinu M.C., Celani M.G., Grasso M.G., Stromillo M.L., Petracca M., Amato M.P., L'Episcopo M.R., Sessa M., Ferro M.T., Ercolani M.V., Bianco M., Re M.L., Vianello M., Clerico M., di Napoli M., Ponzano M., Conti M.Z., Calabrese M., Mirabella M., Filippi M., Inglese M., Lucchini M., Pozzato M., Danni M.C., Zaffaroni M., Zampolini M., Ponzio M., De Riz M., De Stefano N., Cavalla P., De Mitri P., Grossi P., Confalonieri P., Gallo P., Ragonese P., Sola P., Annovazzi P., Iaffaldano P., Nardone R., Cerqua R., Clerici R., Lanzillo R., Motta R., Balgera R., Bergamaschi R., Totaro R., Iodice R., Capra R., Marangoni S., Realmuto S., Cottone S., Montepietra S., Rasia S., Arena S., Bucello S., Banfi S., Bonavita S., Malucchi S., Tonietti S., Vollaro S., Cordera S., Aguglia U., Clerici V.T., Barcella V., Bergamaschi V., Morra V.B., Dattola V., and Mantero V.
Subjects: Male, 0301 basic medicine, Dimethyl Fumarate, Neurodegenerative, multiple sclerosis, coronavirus, pneumonia, Severity of Illness Index, law.invention, Immunosuppressive Agent, Immunologic Factor, 0302 clinical medicine, Natalizumab, law, Monoclonal, Multiple Sclerosi, 80 and over, Lung, Humanized, Research Articles, Aged, 80 and over, Middle Aged, Intensive care unit, Hospitalization, Settore MED/26 - NEUROLOGIA, Intensive Care Units, Neurology, Methylprednisolone, Neurological, Pneumonia & Influenza, Interferon, Female, Immunosuppressive Agents, Research Article, Human, medicine.drug, Adult, medicine.medical_specialty, Musc-19 Study Group, Multiple Sclerosis, Adolescent, Clinical Sciences, Intensive Care Unit, Clinical Neurology, Settore MED/26, Antibodies, Monoclonal, Humanized, Autoimmune Disease, Antibodies, Young Adult, 03 medical and health sciences, Clinical Research, Internal medicine, Severity of illness, medicine, Humans, Immunologic Factors, Mortality, Aged, COVID-19, Fingolimod Hydrochloride, Interferons, SARS-CoV-2, Neurology & Neurosurgery, Expanded Disability Status Scale, business.industry, Multiple sclerosis, Neurosciences, Pneumonia, Odds ratio, medicine.disease, Brain Disorders, Good Health and Well Being, 030104 developmental biology, Ocrelizumab, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract: Objective: This study was undertaken to assess the impact of immunosuppressive and immunomodulatory therapies on the severity of coronavirus disease 2019 (COVID-19) in people with multiple sclerosis (PwMS). Methods: We retrospectively collected data of PwMS with suspected or confirmed COVID-19. All the patients had complete follow-up to death or recovery. Severe COVID-19 was defined by a 3-level variable: mild disease not requiring hospitalization versus pneumonia or hospitalization versus intensive care unit (ICU) admission or death. We evaluated baseline characteristics and MS therapies associated with severe COVID-19 by multivariate and propensity score (PS)-weighted ordinal logistic models. Sensitivity analyses were run to confirm the results. Results: Of 844 PwMS with suspected (n = 565) or confirmed (n = 279) COVID-19, 13 (1.54%) died; 11 of them were in a progressive MS phase, and 8 were without any therapy. Thirty-eight (4.5%) were admitted to an ICU; 99 (11.7%) had radiologically documented pneumonia; 96 (11.4%) were hospitalized. After adjusting for region, age, sex, progressive MS course, Expanded Disability Status Scale, disease duration, body mass index, comorbidities, and recent methylprednisolone use, therapy with an anti-CD20 agent (ocrelizumab or rituximab) was significantly associated (odds ratio [OR] = 2.37, 95% confidence interval [CI] = 1.18–4.74, p = 0.015) with increased risk of severe COVID-19. Recent use (
Published: 2021

43. Ocrelizumab depletes T-lymphocytes more than rituximab in multiple sclerosis

Author: Antonio Carotenuto, Roberta Lanzillo, Marcello Moccia, Cinzia Valeria Russo, Agostino Nozzolillo, Francesco Saccà, Nicola Capasso, Giulia Scalia, Marcello De Angelis, Martina Petruzzo, Vincenzo Brescia Morra, Capasso, N., Nozzolillo, A., Scalia, G., Lanzillo, R., Carotenuto, A., De Angelis, M., Petruzzo, M., Saccà, Francesco, Russo, C. V., Brescia Morra, V., and Moccia, M.
Subjects: Multiple Sclerosis, Lymphocyte, Antibodies, Monoclonal, Humanized, CD19, 03 medical and health sciences, 0302 clinical medicine, immune system diseases, Retrospective Studie, hemic and lymphatic diseases, medicine, Humans, Multiple sclerosi, 030212 general & internal medicine, Ocrelizumab, Lymphocyte Count, Retrospective Studies, CD20, biology, business.industry, Multiple sclerosis, General Medicine, medicine.disease, medicine.anatomical_structure, Neurology, Immunology, biology.protein, Rituximab, Neurology (clinical), Antibody, business, 030217 neurology & neurosurgery, CD8, medicine.drug, Human
Abstract: Background: We aim to directly compare changes in lymphocyte subpopulations between chimeric (rituximab) and humanised (ocrelizumab) anti-CD20 antibodies in multiple sclerosis (MS). Methods: In this retrospective analysis of prospectively collected data, we included 88 patients with MS, treated with rituximab (n=50) or ocrelizumab (n=38). We used flow cytometry in the peripheral blood to count total lymphocytes and lymphocytes expressing different phenotypic markers (CD4, CD8, CD19, CD20, CD4/CD8 ratio), before treatment and after 1, 3 and 6 months. Results: On linear mixed effect regression models, after 1, 3 and 6 months, patients treated with rituximab and with ocrelizumab were similar in total lymphocyte count, CD19 lymphocytes, CD20 lymphocytes and CD4/CD8 ratio. However, patients treated with ocrelizumab presented with lower CD4 T lymphocytes and CD8 T lymphocytes after 1, 3 and 6 months (all p
Published: 2021

44. Interferon beta for the treatment of multiple sclerosis in the Campania Region of Italy: Merging the real-life to routinely collected healthcare data

Author: Antonio Capacchione, Raffaele Palladino, Roberta Lanzillo, Maria Triassi, Vincenzo Brescia Morra, Emma Montella, Marcello Moccia, Antonio Carotenuto, Giuseppina Affinito, Moccia, M., Affinito, G., Capacchione, A., Lanzillo, R., Carotenuto, A., Montella, E., Triassi, M., Morra, V. B., and Palladino, R.
Subjects: Male, Registrie, Epidemiology, Biochemistry, Geographical locations, Persistence (computer science), Medical Conditions, Mathematical and Statistical Techniques, Immunologic Factor, Retrospective Studie, Outpatients, Multiple Sclerosi, Medicine and Health Sciences, Registries, Healthcare data, education.field_of_study, Multidisciplinary, Statistics, Neurodegenerative Diseases, Middle Aged, Hospitals, Multidisciplinary Sciences, Europe, Treatment Outcome, Neurology, Italy, Physical Sciences, symbols, Science & Technology - Other Topics, Regression Analysis, Medicine, Female, Research Article, Human, Adult, medicine.medical_specialty, Multiple Sclerosis, Patients, General Science & Technology, Science, Population, Immunology, MEDLINE, Linear Regression Analysis, Research and Analysis Methods, Autoimmune Diseases, symbols.namesake, Internal medicine, Linear regression, medicine, Humans, Immunologic Factors, Poisson regression, European Union, Statistical Methods, education, Retrospective Studies, Hospitalizations, Science & Technology, business.industry, Multiple sclerosis, Biology and Life Sciences, Proteins, Interferon-beta, medicine.disease, Demyelinating Disorders, Discontinuation, Health Care, Health Care Facilities, Medical Risk Factors, Clinical Immunology, Interferons, Clinical Medicine, People and places, business, Mathematics
Abstract: Background We aim to overcome limitations of previous clinical and population-based studies by merging a clinical registry to routinely-collected healthcare data, and to specifically describe differences in clinical outcomes, healthcare resource utilization and costs between interferon beta formulations for multiple sclerosis (MS). Methods We included 850 patients with MS treated with interferon beta formulations, from 2015 to 2019, seen at the MS Clinical Care and Research Centre (Federico II University of Naples, Italy) and with linkage to routinely-collected healthcare data (prescription data, hospital admissions, outpatient services). We extracted and computed clinical outcomes (relapses, 6-month EDSS progression using a roving EDSS as reference), persistence (time spent on a specific interferon beta formulation), adherence (medication possession ratio (MPR)), healthcare resource utilization and costs (annualized hospitalization rate (AHR), costs for hospital admissions and DMTs). To evaluate differences between interferon beta formulations, we used linear regression (adherence), Poisson regression (AHR), mixed-effect regression (costs), and Cox-regression models (time varying variables); covariates were age, sex, treatment duration, baseline EDSS and adherence. Results Looking at clinical outcomes, rates of relapses and EDSS progression were lower than studies run on previous cohorts; there was no differences in relapse risk between interferon beta formulations. Risk of discontinuation was higher for Betaferon®/Extavia® (HR = 3.28; 95%CI = 2.11, 5.12; p Conclusions We have showed the feasibility of merging routinely-collected healthcare data to a clinical registry for future MS research, and have confirmed interferon beta formulations play an important role in the management of MS, with positive clinical outcomes. Differences between interferon beta formulations are mostly driven by adherence and healthcare resource utilization.
Published: 2021

45. A Combined Radiomics and Machine Learning Approach to Overcome the Clinicoradiologic Paradox in Multiple Sclerosis

Author: R Lanzillo, Rosa Iodice, Antonio Carotenuto, Nikolaos Petsas, Patrizia Pantano, Silvia Tommasin, Renato Cuocolo, V. Brescia Morra, S. Cocozza, Mario Quarantelli, Maria Petracca, Carlo Pozzilli, Enrico Tedeschi, Lorenzo Ugga, Giuseppe Pontillo, Pontillo, G., Tommasin, S., Cuocolo, R., Petracca, M., Petsas, N., Ugga, L., Carotenuto, A., Pozzilli, C., Iodice, R., Lanzillo, R., Quarantelli, M., Brescia Morra, V., Tedeschi, E., Pantano, P., and Cocozza, S.
Subjects: Multiple Sclerosis, Feature selection, Fluid-attenuated inversion recovery, Machine learning, computer.software_genre, multiple sclerosis, radiomics, machine learning, clinical disability, volumetric MRI, Machine Learning, Medicine, Humans, Radiology, Nuclear Medicine and imaging, Generalizability theory, Retrospective Studies, Multidimensional analysis, Expanded Disability Status Scale, business.industry, Multiple sclerosis, Adult Brain, medicine.disease, Magnetic Resonance Imaging, Cross-Sectional Studies, Test set, Cohort, NA, Neurology (clinical), Artificial intelligence, business, computer
Abstract: BACKGROUND AND PURPOSE: Conventional MR imaging explains only a fraction of the clinical outcome variance in multiple sclerosis. We aimed to evaluate machine learning models for disability prediction on the basis of radiomic, volumetric, and connectivity features derived from routine brain MR images. MATERIALS AND METHODS: In this retrospective cross-sectional study, 3T brain MR imaging studies of patients with multiple sclerosis, including 3D T1-weighted and T2-weighted FLAIR sequences, were selected from 2 institutions. T1-weighted images were processed to obtain volume, connectivity score (inferred from the T2 lesion location), and texture features for an atlas-based set of GM regions. The site 1 cohort was randomly split into training (n = 400) and test (n = 100) sets, while the site 2 cohort (n = 104) constituted the external test set. After feature selection of clinicodemographic and MR imaging–derived variables, different machine learning algorithms predicting disability as measured with the Expanded Disability Status Scale were trained and cross-validated on the training cohort and evaluated on the test sets. The effect of different algorithms on model performance was tested using the 1-way repeated-measures ANOVA. RESULTS: The selection procedure identified the 9 most informative variables, including age and secondary-progressive course and a subset of radiomic features extracted from the prefrontal cortex, subcortical GM, and cerebellum. The machine learning models predicted disability with high accuracy (r approaching 0.80) and excellent intra- and intersite generalizability (r ≥ 0.73). The machine learning algorithm had no relevant effect on the performance. CONCLUSIONS: The multidimensional analysis of brain MR images, including radiomic features and clinicodemographic data, is highly informative of the clinical status of patients with multiple sclerosis, representing a promising approach to bridge the gap between conventional imaging and disability.
Published: 2020

46. Single-Center 8-Years Clinical Follow-Up of Cladribine-Treated Patients From Phase 2 and 3 Trials

Author: Marcello Moccia, Roberta Lanzillo, Martina Petruzzo, Agostino Nozzolillo, Marcello De Angelis, Antonio Carotenuto, Raffaele Palladino, Vincenzo Brescia Morra, Moccia, M., Lanzillo, R., Petruzzo, M., Nozzolillo, A., De Angelis, M., Carotenuto, A., Palladino, R., and Brescia Morra, V.
Subjects: Reduced risk, medicine.medical_specialty, real-world, cladribine, Placebo, Single Center, multiple sclerosis, lcsh:RC346-429, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Disability progression, 030212 general & internal medicine, Cladribine, lcsh:Neurology. Diseases of the nervous system, relapse, treatment, business.industry, Multiple sclerosis, Disease progression, 1103 Clinical Sciences, Brief Research Report, medicine.disease, Clinical trial, Neurology, disability, 1701 Psychology, multiple sclerosi, Neurology (clinical), 1109 Neurosciences, business, 030217 neurology & neurosurgery, medicine.drug
Abstract: Background: Cladribine is approved for the treatment of highly-active relapsing multiple sclerosis (MS), where it is also effective on disability progression. In the present single-center study, we aim to report on the 8-years clinical follow-up of 27 patients included in phase 2 and 3 clinical trials for cladribine. Methods: We included patients exposed to cladribine (n = 13) or placebo (n = 14) in ONWARD, CLARITY, and ORACLE-MS trials, and followed-up at the same center after trial termination. Outcomes of long-term disease progression were recorded. Results: During 8-year follow-up, patients treated with cladribine presented with reduced risk of EDSS progression (HR = 0.148; 95%CI = 0.031, 0.709; p = 0.017), of reaching EDSS 6.0 (HR = 0.115; 95%CI = 0.015, 0.872; p = 0.036), and of SP conversion (HR = 0.010; 95%CI = 0.001, 0.329; p = 0.010), when compared with placebo. Conclusions: Our exploratory study provides additional evidence that cladribine may be useful to prevent or, at least, mitigate the risk of disability progression after 8 years.
Published: 2020

47. Assessing disability and relapses in multiple sclerosis on tele-neurology

Author: Letizia Leocani, Gioacchino Tedeschi, Simona Bonavita, Luigi Lavorgna, Roberta Lanzillo, Marcello Moccia, Vincenzo Brescia Morra, Moccia, Marcello, Lanzillo, Roberta, Brescia Morra, Vincenzo, Bonavita, Simona, Tedeschi, Gioacchino, Leocani, Letizia, Lavorgna, Luigi, Moccia, M., Lanzillo, R., Brescia Morra, V., Bonavita, S., Tedeschi, G., Leocani, L., and Lavorgna, L.
Subjects: medicine.medical_specialty, Multiple Sclerosis, Neurology, Coronavirus disease 2019 (COVID-19), Pneumonia, Viral, Clinical Neurology, Neurological examination, Dermatology, Brief Communication, Betacoronavirus, Disability Evaluation, 03 medical and health sciences, Multiple Sclerosis, Relapsing-Remitting, 0302 clinical medicine, medicine, Humans, Multiple sclerosi, 030212 general & internal medicine, Pandemics, Neuroradiology, COVID, medicine.diagnostic_test, SARS-CoV-2, business.industry, Multiple sclerosis, COVID-19, General Medicine, Tele-medicine, medicine.disease, Telemedicine, Cognitive test, Psychiatry and Mental health, Physical therapy, Chronic disability, Neurology (clinical), Neurosurgery, Tele-neurology, Coronavirus Infections, business, 030217 neurology & neurosurgery
Abstract: Background: As a consequence of the coronavirus disease 2019 (COVID-19) pandemic, a large amount of consultations will be delivered through tele-medicine, especially for diseases causing chronic disability and requiring immunomodulatory treatments, such as multiple sclerosis (MS). Methods: We have hereby reviewed available tools for tele-neurology examination in MS, including components of neurological examination that can be assessed through video, patient-reported outcome measures (PROMs), and digital technology. Results: Overall, we have suggested a battery for assessing MS disability and relapses on tele-medicine, which brings together conventional examination, PROMs (e.g., Patient Determined Disease Steps, MS Impact Scale), and cognitive tests (Symbol Digit Modalities Test) that can be delivered remotely and in multiple languages. Discussion: The use of common tools for neurological examination could improve tele-neurology practice for both general neurologists and MS specialists, and quality of care for people with MS.
Published: 2020

48. Prevalence of GLA gene mutations and polymorphisms in patients with multiple sclerosis: A cross-sectional study

Author: Sergio Cocozza, Letizia Spinelli, Camilla Russo, Alberto Cuocolo, Giuseppe Pontillo, Eleonora Riccio, Luigi Annicchiarico Petruzzelli, Roberta Lanzillo, Antonio Pisani, Giulia De Riso, Sirio Cocozza, Vincenzo Brescia Morra, Giovanni Duro, Arturo Brunetti, Enrico Tedeschi, Massimo Imbriaco, Cinzia Valeria Russo, Paolo Colomba, Teodolinda Di Risi, Russo, C., Cocozza, S., Riccio, E., Pontillo, G., Petruzzelli, L. A., Lanzillo, R., Spinelli, L., Sapio, Colomba, Duro, G., Imbriaco, M., Russo, C. V., De Riso, G., Di Risi, T., Tedeschi, E., Cuocolo, A., Brunetti, A., Morra, V. B., and Pisani, A.
Subjects: medicine.medical_specialty, Cross-sectional study, Epidemiology, Population, Multiple sclerosis, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Prevalence, medicine, Humans, 030212 general & internal medicine, Allele, education, Genotyping, Exome, GLA gene, education.field_of_study, Fabry disease, business.industry, medicine.disease, Cross-Sectional Studies, Neurology, alpha-Galactosidase, Mutation, Neurology (clinical), Differential diagnosis, business, 030217 neurology & neurosurgery
Abstract: Purpose Fabry Disease (FD) has been frequently proposed as possible underestimated differential diagnosis of Multiple Sclerosis (MS), but no study has been performed to test prevalence of GLA gene mutations in a population fulfilling diagnostic criteria of MS. Aim of this study is to determine the prevalence of GLA gene mutations in a large and representative population diagnosed with MS, simultaneously providing a critical revision of current literature reports of coexistence or misdiagnosis between these two conditions. Methods In this mono-centric cross-sectional study, 927 patients fulfilling McDonald diagnostic criteria and encompassing all MS phenotypes were enrolled. Patients underwent evaluation of α-GalA activity and genotyping. Both genetic variants annotated as pathogenic and GVUS were considered. Estimated alleles frequencies were then compared to the ones reported in the gnomAD database. Results GLA gene variants were found in seven individuals. Five patients carried variants previously described having controversial impact on FD phenotype, and the analysis of exome database revealed that they are not rare among healthy individuals. One patient showed a new variant never described before, and another one carried a late-onset FD cardiac variant. Conclusions The overall prevalence of GLA gene variants in MS patients is comparable to the one estimated in healthy population. This result is further supported by critical revision of current literature evidences of misdiagnosis between MS and FD, arguing in favour of independence between these disorders.
Published: 2020

49. Treatment of multiple sclerosis with rituximab: A multicentric Italian–Swiss experience

Author: Antonio Gallo, Gianmarco Abbadessa, Chiara Zecca, Giancarlo Coghe, Giuseppe Salemi, Antonio Uccelli, Marco Capobianco, Stefania Barone, Rosaria Sacco, Lorena Lorefice, Claudia Mechi, Giorgia Mataluni, Elio Prestipino, Jessica Frau, Claudio Gobbi, Alessandro Barilaro, Giorgia Teresa Maniscalco, Erica Curti, E. Magnani, Bahia Hakiki, Maria Malentacchi, Simona Bonavita, Alessia Di Sapio, Francesca Bovis, Maria Cellerino, Franco Granella, Roberta Lanzillo, Anna Maria Repice, Marcello De Angelis, Isabella Maraffi, Laura Brambilla, Giuseppe Fenu, Elisabetta Signoriello, Alessio Signori, Paola Cavalla, Maria Pia Sormani, Agostino Nozzolillo, Giacomo Boffa, Simona Malucchi, Maria Pia Amato, Giovanni Novi, Sabrina Realmuto, Francesca Sperli, Ilaria Maietta, Vincenzo Brescia Morra, Zecca, C., Bovis, F., Novi, G., Capobianco, M., Lanzillo, R., Frau, J., Repice, A. M., Hakiki, B., Realmuto, S., Bonavita, S., Curti, E., Brambilla, L., Mataluni, G., Cavalla, P., Di Sapio, A., Signoriello, E., Barone, S., Maniscalco, G. T., Maietta, I., Maraffi, I., Boffa, G., Malucchi, S., Nozzolillo, A., Coghe, G., Mechi, C., Salemi, G., Gallo, A., Sacco, R., Cellerino, M., Malentacchi, M., De Angelis, M., Lorefice, L., Magnani, E., Prestipino, E., Sperli, F., Brescia Morra, V., Fenu, G., Barilaro, A., Abbadessa, G., Signori, A., Granella, F., Amato, M. P., Uccelli, A., Gobbi, C., Sormani, M. P., Zecca, Chiara, Bovis, Francesca, Novi, Giovanni, Capobianco, Marco, Lanzillo, Roberta, Frau, Jessica, Repice, Anna Maria, Hakiki, Bahia, Realmuto, Sabrina, Bonavita, Simona, Curti, Erica, Brambilla, Laura, Mataluni, Giorgia, Cavalla, Paola, Di Sapio, Alessia, Signoriello, Elisabetta, Barone, Stefania, Maniscalco, Giorgia T, Maietta, Ilaria, Maraffi, Isabella, Boffa, Giacomo, Malucchi, Simona, Nozzolillo, Agostino, Coghe, Giancarlo, Mechi, Claudia, Salemi, Giuseppe, Gallo, Antonio, Sacco, Rosaria, Cellerino, Maria, Malentacchi, Maria, De Angelis, Marcello, Lorefice, Lorena, Magnani, Eliana, Prestipino, Elio, Sperli, Francesca, Brescia Morra, Vincenzo, Fenu, Giuseppe, Barilaro, Alessandro, Abbadessa, Gianmarco, Signori, Alessio, Granella, Franco, Amato, Maria Pia, Uccelli, Antonio, Gobbi, Claudio, and Sormani, Maria Pia
Subjects: Multiple Sclerosis, medicine.drug_class, Lymphocyte depletion, relapsing–remitting, Monoclonal antibody, Primary progressive, 03 medical and health sciences, 0302 clinical medicine, Multiple Sclerosis, Relapsing-Remitting, real life, medicine, Humans, Immunologic Factors, 030212 general & internal medicine, Secondary progressive, Retrospective Studies, primary progressive, business.industry, Multiple sclerosis, Rituximab, multiple sclerosis, secondary progressive, Treatment options, medicine.disease, Neurology, Relapsing remitting, Italy, multiple sclerosi, Immunology, Settore MED/26 - Neurologia, Neurology (clinical), business, 030217 neurology & neurosurgery, Switzerland, medicine.drug
Abstract: Background: Rituximab, an anti-CD20 monoclonal antibody leading to B lymphocyte depletion, is increasingly used as an off-label treatment option for multiple sclerosis (MS). Objective: To investigate the effectiveness and safety of rituximab in relapsing–remitting (RR) and progressive MS. Methods: This is a multicenter, retrospective study on consecutive MS patients treated off-label with rituximab in 22 Italian and 1 Swiss MS centers. Relapse rate, time to first relapse, Expanded Disability Status Scale (EDSS) progression, incidence of adverse events, and radiological outcomes from 2009 to 2019 were analyzed. Results: A total of 355/451 enrolled subjects had at least one follow-up visit and were included in the outcome analysis. Annualized relapse rate significantly decreases after rituximab initiation versus the pre-rituximab start year in RRMS (from 0.86 to 0.09, p Conclusion: Consistently with other observational studies, our data show effectiveness of rituximab in reducing disease activity in patients with MS.
Published: 2020

50. Validation of the Italian version of the Multiple Sclerosis Intimacy and Sexuality Questionnaire-19

Author: Roberta Lanzillo, Francesca Di Lauro, Laura De Giglio, Alessandro Chiodi, L. Rosa, Antonio Carotenuto, Ilaria Ferrante, Carlo Pozzilli, Maurizio Bianchi, Maria Petracca, Antonio Ianniello, Marcello Moccia, Vincenzo Brescia Morra, Carotenuto, A., De Giglio, L., Chiodi, A., Petracca, M., Rosa, L., Bianchi, M., Ferrante, I., Lauro, F., Moccia, M., Ianniello, A., Pozzilli, C., Brescia Morra, V., and Lanzillo, R.
Subjects: Male, Psychometrics, Italian, Reproducibility of Result, Human sexuality, Dermatology, Disability, MSISQ-19, Multiple sclerosis, Sexuality, Validation, External validity, 03 medical and health sciences, Disability Evaluation, 0302 clinical medicine, Cronbach's alpha, Surveys and Questionnaires, medicine, Surveys and Questionnaire, Humans, Multiple sclerosi, 030212 general & internal medicine, business.industry, Construct validity, Reproducibility of Results, General Medicine, medicine.disease, Exploratory factor analysis, Psychiatry and Mental health, Sexual dysfunction, Italy, Female, Neurology (clinical), medicine.symptom, business, 030217 neurology & neurosurgery, Psychometric, Clinical psychology, Human
Abstract: Background: People with multiple sclerosis (MS) may experience sexual dysfunction throughout the disease course. Validated scales to assess sexual dysfunction in MS for Italian patients are lacking. Hence, we aimed at validating Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) for Italian MS patients. Methods: We included both male and female MS patients. Each patient completed the Italian translation of the MSISQ-19. Construct validity was explored by the exploratory factor analysis and the Cronbach’s alpha coefficient. Test-retest stability and concurrent internal and external validity were examined by Pearson’ correlation coefficients. Results: We enrolled 369 MS patients (323 female and 46 male). Italian MSISQ-19 showed a Cronbach’s alpha of 0.92. MSISQ-19 test and retest total scores correlated between each other (r = 0.48, p = 0.01). MSISQ-19 total score also correlated with primary, secondary and tertiary subscales (p < 0.001). Conclusion: The Italian Version of the MSISQ-19 showed satisfactory internal consistency and reliability with moderately adequate test-retest reproducibility, suggesting that it may be used as a valuable measure of sexual dysfunction in the Italian population.
Published: 2020

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