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1. Sexual dysfunction in multiple sclerosis: the impact of different MSISQ-19 cut-offs on prevalence and associated risk factors

Author

Petracca, M, Carotenuto, A, Scandurra, C, Moccia, M, Rosa, L, Arena, S, Ianniello, A, Nozzolillo, A, Turrini, M, LM, Streito, Abbadessa, G, Cellerino, M, Bucello, S, Ferraro, E, Mattioli, M, Chiodi, A, Inglese, M, Bonavita, S, Clerico, M, Cordioli, C, Moiola, L, Patti, F, Lavorgna, L, Filippi, M, Borriello, G, D'Amico, E, Pozzilli, C, Brescia Morra, V, and Lanzillo, R

Published
2023
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8. Data monitoring roadmap. The experience of the Italian Multiple Sclerosis and Related Disorders Register

Author

Mosconi, P., Guerra, T., Paletta, P., D’Ettorre, A., Ponzio, M., Battaglia, M. A., Amato, M. P., Bergamaschi, R., Capobianco, M., Comi, G., Gasperini, C., Patti, F., Pugliatti, M., Ulivelli, M., Trojano, M., Lepore, V., Aguglia, U., Amato, M., Ancona, A., Ardito, B., Avolio, C., Balgera, R., Banfi, P., Barcella, V., Barone, P., Bellantonio, P., Berardinelli, A., Bertora, P., Bianchi, M., Bramanti, P., Brescia Morra, V., Brichetto, G., Brioschi, A., Buccafusca, M., Bucello, S., Busillo, V., Calchetti, B., Cantello, R., Capone, F., Capone, L., Cargnelutti, D., Carozzi, M., Cartechini, E., Cavaletti, G., Cavalla, P., Celani, M., Clerici, R., Clerico, M., Cocco, E., Torri Clerici, V., Coniglio, M., Conte, A., Corea, F., Cottone, S., Crociani, P., D’Andrea, F., Danni, M., De Luca, G., de Pascalis, D., De Riz, M., De Robertis, F., De Rosa, G., De Stefano, N., Della Corte, M., Di Sapio, A., Docimo, R., Falcini, M., Falcone, N., Fermi, S., Ferraro, E., Ferrò, M., Fortunato, M., Foschi, M., Gajofatto, A., Gallo, A., Gallo, P., Gatto, M., Gazzola, P., Giordano, A., Granella, F., Grasso, M., Grimaldi, L., Iaffaldano, P., Immovilli, P., Imperiale, D., Inglese, M., Iodice, R., Leva, S., Leuzzi, V., Lugaresi, A., Lus, G., Maimone, D., Mancinelli, L., Maniscalco, G., Marfia, G., Margari, L., Marinelli, F., Marini, B., Marson, A., Mascoli, N., Massacesi, L., Melani, F., Merello, M., Fioretti, C., Mirabella, Massimiliano, Montepietra, S., Nasuelli, D., Nicolao, P., Pasquali, L., Passantino, F., Pecori, C., Peresson, M., Pesci, I., Piantadosi, C., Piras, M. L., Pizzorno, M., Plewnia, K., Pozzilli, C., Protti, A., Quatrale, R., Realmuto, S., Ribizzi, G., Rinalduzzi, S., Rini, A., Romano, S., Filippi, M., Ronzoni, M., Rossi, P., Rovaris, M., Salemi, G., Santangelo, G., Santangelo, M., Leone, A., Sarchielli, P., Sinisi, L., Ferraro, D., Solaro, C., Spitaleri, D., Strumia, S., Tassinari, T., Santuccio, G., Tortorella, C., Totaro, R., Tozzo, A., Trivelli, G., Turano, G., Valentino, P., Venturi, S., Vianello, M., Zaffaroni, M., and Zarbo, R.

Subjects
Multiple sclerosis, Settore MED/26 - NEUROLOGIA, Real world data, Quality control, Quality indicators, Register
Published
2023

9. JC virus antibody index in natalizumab-treated patients: correlations with John Cunningham virus DNA and C-reactive protein level

Author

Lanzillo R, Liuzzi R, Vallefuoco L, Moccia M, Amato L, Vacca G, Vacchiano V, Portella G, and Brescia Morra V

Subjects
Therapeutics. Pharmacology, RM1-950
Abstract

Roberta Lanzillo,1 Raffaele Liuzzi,2 Luca Vallefuoco,3 Marcello Moccia,1 Luca Amato,1 Giovanni Vacca,1 Veria Vacchiano,1 Giuseppe Portella,3 Vincenzo Brescia Morra1 1Neurological Sciences Department, Federico II University, 2Institute of Biostructure and Bioimaging, National Research Council, 3Clinical Pathology Department, Federico II University, Naples, ItalyAbstract: Natalizumab-treated patients have a higher risk of developing progressive multifocal leukoencephalopathy. Exposure to John Cunningham virus (JCV) is a prerequisite for PML (progressive multifocal leukoencephalopathy). To assess JCV exposure in multiple sclerosis patients, we performed a serological examination, obtained the antibody index, performed real-time polymerase chain reaction (PCR) to detect JCV DNA in plasma and urine, and investigated the role of ultrasensitive C-reactive protein (usCRP) as a possible biological marker of JCV reactivation. We retrospectively analyzed consecutive natalizumab-treated multiple sclerosis patients who underwent a JCV antibody test through a two-step enzyme-linked immunosorbent assay (STRATIFY test) to the measure of serum usCRP levels, and to perform blood and urine JCV PCR. The studied cohort included 97 relapsing–remitting patients (60 women). Fifty-two patients (53.6%) tested positive for anti-JCV antibodies. PCR showed JCV DNA in the urine of 30 out of 83 (36.1%) patients and 28 out of 44 seropositive patients (63.6%), with a 6.7% false-negative rate for the STRATIFY test. Normalized optical density values were higher in urinary JCV DNA-positive patients (P

Published
2014

10. 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

11. 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

14. 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

15. 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

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

Author

Ghezzi, A., Grimaldi, L. M. E., Marrosu, M. G., Pozzilli, C., Comi, G., Bertolotto, A., Trojano, M., Gallo, P., Capra, R., Centonze, D., Millefiorini, E., Sotgiu, S., Brescia Morra, V., Amato, M. P., Lugaresi, A., Mancardi, G., Caputo, D., Montanari, E., Provinciali, L., Durelli, L., Bergamaschi, R., Bellantonio, P., Tola, M. R., Cottone, S., Savettieri, G., Tedeschi, G., and MS-SIN Study Group

Published
2011
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23. Retinal vascular density in multiple sclerosis: a one year follow up

Author

Lanzillo, R, Cennamo, G, Moccia, M, Criscuolo, C, Carotenuto, A, Frattaruolo, N, Sparnelli, F, MELENZANE, ANTONIETTA, Lamberti, A, Servillo, G, Tranfa, F, De Crecchio, G, Brescia Morra, V, Lanzillo, R, Cennamo, G, Moccia, M, Criscuolo, C, Carotenuto, A, Frattaruolo, N, Sparnelli, F, Melenzane, Antonietta, Lamberti, A, Servillo, G, Tranfa, F, De Crecchio, G, and Brescia Morra, V

Subjects
retina, optical coherence tomography, parafovea, multiple sclerosi, vascular density
Abstract

Vascular pathology is increasingly acknowledged as a risk factor of multiple sclerosis (MS). Vascular density (VD) is reduced in MS patients' eyes on optical coherence tomography (OCT) angiography (A).

Published
2019

30. 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

31. 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

33. 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

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

Author

Mantovani, Lorenzo G., Cozzolino, Paolo, Cortesi, Paolo A., Patti, Francesco, the SA.FE. study group, 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., and Francia, A.

Subjects
SPASTICITY, MULTIPLE sclerosis, COST effectiveness, TIME perspective, MEDICAL registries, NATALIZUMAB
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 ≤ 6 months. 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 1 month of treatment, 0.118 (0.073) after 3 months' treatment and 0.127 (0.080) after 6 months' 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. [ABSTRACT FROM AUTHOR]

Published
2020
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36. 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

37. Treatment of multiple sclerosis patients after 24 Natalizumab doses: a prospective observational study: the TY-STOP

Author

Clerico, Marinella, Schiavetti, I, DE MERCANTI, STEFANIA FEDERICA, Piazza, F, Gned, Dario, Brescia Morra, V, Lanzillo, Raffaella, Ghezzi, A, Bianchi, A, Salemi, G, Realmuto, S, Sola, P, Vitetta, F, Cavalla, Paola, Superti, G, Ferraro, D, Paolicelli, D, Trojano, M, Sormani, Mp, Durelli, Luca, Clerico, M, Schiavetti, I, De Mercanti, S, Piazza, F, Gned, D, Brescia Morra, V, Lanzillo, R, Ghezzi, A, Bianchi, A, Salemi, G, Realmuto, S, Sola, P, Vitetta, F, Cavalla, P, Superti, G, Ferraro, D, Paolicelli, D, Trojano, M, Sormani, MP, and Durelli, L

Subjects
Multiple Sclerosis, Natalizumab, Ty-STOP, Settore MED/26 - Neurologia
Published
2014

38. Predictors of definite Multiple Sclerosis in patients with pediatric onset first demyelinating clinical attack

Author

SALEMI, Giuseppe, Iaffaldano P, Lucisano G, Ghezzi A, Comi V, Brescia Morra V, Patti F, Lugaresi A, Pozzilli C, Amato M, Millefiorini E, Lus G, Zimatore G, Maimone D, Coniglio G, Bergamaschi R, Marrosu M, Tedeschi G, Ardito D, Giuliani G, Avolio C, Montanari E, Simone M, Margari L, Lepore V, Trojano M., Salemi, G, and Iaffaldano P, Lucisano G, Ghezzi A, Comi V, Brescia Morra V, Patti F, Lugaresi A, Pozzilli C, Amato M, Millefiorini E, Lus G, Zimatore G, Maimone D, Coniglio G, Bergamaschi R, Marrosu M, Tedeschi G, Ardito D, Giuliani G, Avolio C, Montanari E, Simone M, Margari L, Lepore V, Trojano M

Subjects
Multiple Sclerosis, pediatric onset, Settore MED/26 - Neurologia
Published
2014

39. 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

40. Discontinuation of treatment with Natalizumab after 24 courses. Report from spontaneous, observational, prospective study (TYSTOP)

Author

Clerico, M, De Mercanti, S, Piazza, F, Versino, E, Gned, D, Gibbin, M, Brescia Morra, V, Lanzillo, R, Amato, L, Quarantelli, M, Ghezzi, A, Bianchi, A, Baroncini, D, Ferrò, MT, Vitetta, F, D’Onghia, M, Paolicelli, D, Trojano, M, Durelli L., SALEMI, Giuseppe, REALMUTO, Sabrina, Clerico, M, De Mercanti, S, Piazza, F, Versino, E, Gned, D, Gibbin, M, Brescia Morra, V, Lanzillo, R, Amato, L, Quarantelli, M, Ghezzi, A, Bianchi, A, Baroncini, D, Salemi, G, Realmuto, S, Ferrò, MT, Vitetta, F, D’Onghia, M, Paolicelli, D, Trojano, M, and Durelli L

Subjects
Multiple Sclerosis, Natalizumab, TySTOP, Settore MED/26 - Neurologia
Published
2013

41. Retinal vascular density in multiple sclerosis: a 1‐year follow‐up.

Author

Lanzillo, R., Cennamo, G., Moccia, M., Criscuolo, C., Carotenuto, A., Frattaruolo, N., Sparnelli, F., Melenzane, A., Lamberti, A., Servillo, G., Tranfa, F., De Crecchio, G., and Brescia Morra, V.

Subjects
MULTIPLE sclerosis, OPTICAL coherence tomography, MULTIPLE sclerosis treatment, RETINA, ANGIOGRAPHY, HEALTH outcome assessment
Abstract

Background and purpose: Vascular pathology is increasingly acknowledged as a risk factor for multiple sclerosis (MS). Vascular density (VD) is reduced in the eyes of patients with MS on optical coherence tomography (OCT) angiography. We performed a 1‐year prospective study to estimate VD variations over time and possible clinical correlates. Methods: A total of 50 patients with MS underwent spectral domain‐OCT and OCT angiography at baseline and after 1‐year follow‐up. Mixed‐effect linear regression models were used to assess variations of each OCT measure and its relation to treatment and clinical outcomes. Results: We observed an increase in parafovea VD (coefficient, 1.147; 95% confidence interval, 0.081–2.214; P = 0.035). Reduction in parafovea VD was associated with increase in Expanded Disability Status Scale score (coefficient, −0.969; 95% confidence interval, −1.732/−0.207; P = 0.013). Conclusions: Retinal VD can improve over time in MS, particularly in patients experiencing disease stability. Longer follow‐up, inclusion of early MS cases and combination with conventional markers of MS severity (i.e. brain atrophy) are needed to better define VD as a potential new biomarker. [ABSTRACT FROM AUTHOR]

Published
2019
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42. 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

43. Natalizumab Therapy, How to Treat How to Stop: The TY-STOP Study

Author

Clerico, Marinella, DE MERCANTI, STEFANIA FEDERICA, Piazza, F., Virgilio, E., Gned, Dario, Brescia Morra, V., Lanzillo, Raffaella, Amato, Laura, Quarantelli, M., Ghezzi, A., Bianchi, A., Baroncini, D., Salemi, G., Realmuto, S., Ferrò, M. T., Vitetta, F., Superti, G., Cavalla, Paola, D'Onghia, M., Paolicelli, D., Schiavetti, I., Sormani, M. P., Pinessi, Lorenzo, Trojano, M., and Durelli, Luca

Published
2014

44. 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

45. Brain atrophy in Relapsing-remitting multiple sclerosis patients treated with interferon-beta and atorvastatin (The ARIANNA study)

Author

Lanzillo, R., Quarantelli, M., Veria, V., Orefice, G., Marrosu, M. G., Trojano, M., Amato, M. P., Francia, A. M., Florio, C., Tedeschi, G., Bellantonio, P., Annunziata, P., Comerci, M., Brunetti, A., Bonavita, V., Alfano, B., Marini, S., Pozzilli, C., Brescia Morra, V, Schiavone, V, Vacchiano, V., Vacca, G., Cocco, E., Sosso, L., Patti, F., Stecchi, Provinciali, Sinisi, L., Ardito, B., Maimone, D., Zorzon, M., Grimaldi, L. M., Carolei, A., Costantino, G., Protti, A., Bianconi, C., Bertolotto, A., Motti, L., Meola, G., Sacco, R., and Maniscalco, G.

Subjects
Multiple Sclerosis, MRI
Published
2014

46. 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, Lugaresi, A, Confalonieri, P, Granella, F, Radice, D, Trojano, M, Martinelli, V, Pucci E, Solari A., Messmer Uccelli, M, Ferrari, G, Martini, F, D'Annunzio, G, Farina, D, Travaglini, D, Pietrolongo, E, Onofrj, M, Torri Clerici, V, Bonanno, S, Brambilla, L, 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, Giuseppe, and Immovilli, P.

Subjects
Multiple sclerosis, complex health intervention, Multiple sclerosis, complex health intervention, information aid, disease knowledge, patient satisfaction, clinical practice, patient satisfaction, disease knowledge, information aid, clinical practice
Published
2014

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