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56 results on '"Brescia Morra, V."'

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. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. Cognitive impairment and its relation with disease measures in mildly disabled patients with relapsing-remitting multiple sclerosis: baseline results from the Cognitive Impairment in Multiple Sclerosis (COGIMUS) study

Author

Patti, F, Amato, Mp, Trojano, M, Bastianello, S, Tola, Mr, Goretti, B, Caniatti, L, DI MONTE, E, Ferrazza, P, BRESCIA MORRA, V, LO FERMO, S, Picconi, O, Luccichenti, G, Vecchio, R, Maimone, D, Messina, S, Gasperini, C, Orefice, V, Florio, C, Portaccio, E, Zipoli, V, Bertolotto, A, Bramant, P, Sessa, E, Centonze, D, Cottone, S, Salemi, G, Falcini, M, Gallo, P, Perini, P, Gigli, Gian Luigi, Giuliani, G, Grimald, Lm, Murri, L, Lugaresi, A, 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, Tartaglione, A., Patti, F, Amato, Mp, Trojano, M, Bastianello, S, Tola, Mr, Goretti, B, Caniatti, L, Di Monte, E, Ferrazza, P, BRESCIA MORRA, Vincenzo, Lo Fermo, S, Picconi, O, Luccichenti, G, COGIMUS Study, Group, Vecchio, R, Maimone, D, Messina, S, Gasperini, C, Orefice, V, Brescia Morra, V, Florio, C, Amato, MP, 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, 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, Tartaglione, A, DI MONTE, E, BRESCIA MORRA, V, LO FERMO, S, and Zorzon, Marino

Subjects
Male, Pediatrics, Intelligence, Relapsing-Remitting, Neuropsychological Tests, Severity of Illness Index, Disability Evaluation, Cognition, Risk Factors, Odds Ratio, Prevalence, Neuropsychological assessment, Prospective Studies, Neurologic Examination, medicine.diagnostic_test, Cognitive impairmet. Cognitive function. Multiple Sclerosis. Neuropsychological assessment, Cognitive disorder, Neuropsychology, Age Factors, Middle Aged, Magnetic Resonance Imaging, Cognitive test, Treatment Outcome, Neurology, Italy, Female, Settore MED/26 - Neurologia, Psychology, Adult, medicine.medical_specialty, Multiple Sclerosis, Adolescent, Neurological examination, Risk Assessment, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Predictive Value of Tests, Immunologic Factors, Humans, Interferon-beta, Cognition Disorders, Cross-Sectional Studies, medicine, Expanded Disability Status Scale, Multiple sclerosis, McDonald criteria, medicine.disease, Physical therapy, Neurology (clinical)
Abstract

Background Cognitive impairment is a common symptom of multiple sclerosis (MS), but the association between cognitive impairment and magnetic resonance imaging (MRI) disease measures in patients with relapsing–remitting (RR) MS is unclear. Objectives To study the prevalence of cognitive impairment and its relation with MRI disease measures in mildly disabled patients with RRMS. Methods Patients aged 18–50 years with RRMS (McDonald criteria) and an Expanded Disability Status Scale (EDSS) score ≤4.0, who were enrolled in the Cognitive Impairment in Multiple Sclerosis (COGIMUS) study, underwent baseline standardized MRI complete neurological examination and neuropsychological testing. Results A total of 550 patients were enrolled, 327 of whom underwent MRI assessments. Cognitive impairment (impaired performance in ≥3 cognitive tests) was present in approximately 20% of all patients and in the subgroup who underwent MRI. T2 hyperintense and T1 hypointense lesion volumes were significantly higher in patients with cognitive impairment (defined as impaired performance on at least three tests of the Rao’s battery) than those without. EDSS score was also significantly higher in cognitively impaired than in cognitively preserved patients. Disease duration, depression, and years in formal education did not differ significantly between cognitively impaired and cognitively preserved patients. T2 lesion volume, performance intelligence quotient, and age were significant predictors of cognitive impairment in this population. Weak correlations were found between performance on individual cognitive tests and specific MRI measures, with T1 and T2 lesion volumes correlating with performance on most cognitive tests. Conclusions Cognitive impairment occurs in approximately one-fifth of mildly disabled patients with MS and is associated with specific MRI disease measures. Assessment of cognitive function at diagnosis could facilitate the identification of patients who may benefit from therapeutic intervention with disease-modifying therapies to prevent further lesion development.

Published
2009

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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

31. 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

32. 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

33. 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

34. Signals of pseudo-starvation unveil the amino acid transporter SLC7A11 as key determinant in the control of Treg cell proliferative potential

Author

Maria Lepore, Dario Di Silvestre, Fabio Buttari, Claudia La Rocca, Antonio Uccelli, Paola de Candia, Giuseppe Matarese, Danila Vella, Alessandra Colamatteo, Giusy De Rosa, Pierluigi Mauri, Sarah Grossi, Claudia Russo, Roberta Lanzillo, Vincenzo Brescia Morra, Mario Galgani, Maria Mottola, Giorgia Teresa Maniscalco, Paola Campomenosi, Claudio Procaccini, Diego Centonze, Marco Salvetti, Silvia Garavelli, Deriggio Faicchia, Bruno Zuccarelli, Francesco Prattichizzo, Fortunata Carbone, Dario Greco, Procaccini, C., Garavelli, S., Carbone, F., Di Silvestre, D., La Rocca, C., Greco, D., Colamatteo, A., Lepore, M. T., Russo, C., De Rosa, G., Faicchia, D., Prattichizzo, F., Grossi, S., Campomenosi, P., Buttari, F., Mauri, P., Uccelli, A., Salvetti, M., Brescia Morra, V., Vella, D., Galgani, M., Mottola, M., Zuccarelli, B., Lanzillo, R., Maniscalco, G. T., Centonze, D., de Candia, P., and Matarese, G.

Subjects
0301 basic medicine, Male, Antiporter, T-Lymphocytes, SLC7A11, Relapsing-Remitting, medicine.disease_cause, T-Lymphocytes, Regulatory, Autoimmunity, 0302 clinical medicine, Immunology and Allergy, Homeostasis, Cells, Cultured, Cultured, dimethyl fumarate, biology, autoimmunity, Glutamate receptor, hemic and immune systems, Regulatory, Transmembrane protein, Cell biology, Infectious Diseases, 030220 oncology & carcinogenesis, multiple sclerosi, Female, Human, leptin, metabolism, multiple sclerosis, proliferation, starvation, Treg cells, xCT, Adult, Amino Acid Transport System y+, Cell Proliferation, Humans, Immune Tolerance, Multiple Sclerosis, Relapsing-Remitting, NF-E2-Related Factor 2, Multiple Sclerosis, Cells, Immunology, chemical and pharmacologic phenomena, Settore MED/26, 03 medical and health sciences, Homeostasi, medicine, Amino acid transporter, Treg cell, Solute carrier family, 030104 developmental biology, biology.protein
Abstract

Summary Human CD4+CD25hiFOXP3+ regulatory T (Treg) cells are key players in the control of immunological self-tolerance and homeostasis. Here, we report that signals of pseudo-starvation reversed human Treg cell in vitro anergy through an integrated transcriptional response, pertaining to proliferation, metabolism, and transmembrane solute carrier transport. At the molecular level, the Treg cell proliferative response was dependent on the induction of the cystine/glutamate antiporter solute carrier (SLC)7A11, whose expression was controlled by the nuclear factor erythroid 2-related factor 2 (NRF2). SLC7A11 induction in Treg cells was impaired in subjects with relapsing-remitting multiple sclerosis (RRMS), an autoimmune disorder associated with reduced Treg cell proliferative capacity. Treatment of RRMS subjects with dimethyl fumarate (DMF) rescued SLC7A11 induction and fully recovered Treg cell expansion. These results suggest a previously unrecognized mechanism that may account for the progressive loss of Treg cells in autoimmunity and unveil SLC7A11 as major target for the rescue of Treg cell proliferation.

Published
2021

35. 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

36. 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

37. 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

38. 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

39. 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

40. 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

41. Assessment of retinal vascular network in amnestic mild cognitive impairment by optical coherence tomography angiography

Author

Elena Salvatore, Gilda Cennamo, Roberta Lanzillo, Giovanni Cennamo, Fausto Tranfa, Chiara Criscuolo, Alfonso Strianese, Daniela Montorio, Vincenzo Brescia Morra, Antonio Carotenuto, Criscuolo, C., Cennamo, G., Montorio, D., Carotenuto, A., Strianese, A., Salvatore, E., Tranfa, F., Lanzillo, R., and Brescia Morra, V.

Subjects
Male, Fovea Centralis, Social Sciences, Cardiovascular Medicine, Alzheimer's Disease, Diagnostic Radiology, chemistry.chemical_compound, 0302 clinical medicine, Medicine and Health Sciences, Psychology, Cardiovascular Imaging, Fluorescein Angiography, Cognitive impairment, Tomography, Cognitive Impairment, Aged, 80 and over, Multidisciplinary, medicine.diagnostic_test, Cognitive Neurology, Radiology and Imaging, Angiography, Neuropsychology, Neurodegenerative Diseases, Healthy Volunteers, Neurology, Medicine, Female, Anatomy, Tomography, Optical Coherence, Research Article, medicine.medical_specialty, Imaging Techniques, Cognitive Neuroscience, Ocular Anatomy, Science, Research and Analysis Methods, behavioral disciplines and activities, 03 medical and health sciences, Ocular System, Diagnostic Medicine, Ophthalmology, Mental Health and Psychiatry, mental disorders, medicine, Humans, Cognitive Dysfunction, Neuropsychological Testing, Aged, Mini–Mental State Examination, Involvement patterns, business.industry, Biology and Life Sciences, Retinal Vessels, Retinal, Optical coherence tomography angiography, chemistry, Vascular network, Microvessels, Cardiovascular Anatomy, 030221 ophthalmology & optometry, Cognitive Science, Blood Vessels, Feasibility Studies, Dementia, business, 030217 neurology & neurosurgery, Neuroscience
Abstract

Objective To assess the presence of retinal vascular network abnormalities in amnestic mild cognitive impairment (aMCI) patients and healthy subjects (HS) through optical coherence tomography angiography (OCTA). Methods OCTA and SD-OCT were performed in aMCI patients and cognitive normal HS. A complete neuropsychological evaluation was performed. Differences in vessel density (VD) in each retinal vascular plexus and in foveal avascular zone (FAZ) were evaluated with linear mixed model after correction for age, sex and disease duration. Results Twenty-seven aMCI patients (10 Single domain aMCI, 17 Multidomain aMCI) and 29 HS were enrolled. aMCI patients showed a statistically significant reduced VD in superficial capillary plexus (SCP), deep capillary plexus (DCP) and an increased FAZ compared to controls. When aMCI patients were divided in single domain (SD) and multiple domains (MD) aMCI, SD aMCI showed no VD differences in SCP, DCP and Radial Peripapillary Capillary, while the FAZ area was significantly larger compared to controls. In MD aMCI, VD values were lower and FAZ was increased compared to controls. Comparing both aMCI groups, MD aMCI showed a significant reduction in VD values of SCP. No correlation was found between mini mental state examination (MMSE) scores and OCTA parameters. Conclusions OCTA is able to detect changes in retinal microvascular network in early cognitive deficits and, the most sensitive alteration seems to be the enlargement of the FAZ. This non-invasive tool provides useful information on retinal involvement patterns in MCI diagnosis and follow up. Vascular network impairment seems to be related to the number of domains affected and not to MMSE.

Published
2020

42. The impact of diagnostic criteria and treatments on the 20-year costs for treating relapsing-remitting multiple sclerosis

Author

Raffaele Palladino, Martina Petruzzo, Vincenzo Brescia Morra, Agostino Nozzolillo, Giuseppe Servillo, Valentina Orlando, Marcello De Angelis, Antonio Nardone, Roberta Lanzillo, Marcello Moccia, Petruzzo, M., Palladino, R., Nardone, A., Nozzolillo, A., Servillo, G., Orlando, V., De Angelis, M., Lanzillo, R., Brescia Morra, V., and Moccia, M.

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Cost, Economic, Disease, 03 medical and health sciences, Indirect costs, 0302 clinical medicine, Natalizumab, Multiple Sclerosis, Relapsing-Remitting, Health care, Medicine, Humans, Immunologic Factors, Multiple sclerosi, 030212 general & internal medicine, Medical prescription, business.industry, Multiple sclerosis, DMT, Interrupted Time Series Analysis, General Medicine, Health Care Costs, Middle Aged, medicine.disease, Treatment, Neurology, Relapsing remitting, Italy, Research centre, Practice Guidelines as Topic, Female, Neurology (clinical), business, 030217 neurology & neurosurgery, medicine.drug
Abstract

Objective: To assess whether the introduction of the new diagnostic criteria and disease modifying therapies (DMTs) is associated with higher cost for treating multiple sclerosis (MS). Methods: This is a regression-based quasi-experimental study employing interrupted time series analysis, including data from 2229 patients (age 42.1 ± 11.2 years; female 63.34%), with incident diagnosis of relapsing remitting MS (RRMS) and followed up from 1997 to 2017, extracted from the database of the MS Clinical Care and Research Centre of the Federico II University Hospital of Naples (Italy). Annual healthcare costs for DMT (e.g., prescription, staff involved in DMT administration) and management (e.g., neurological consultations, other consultations related to DMT safety, MRI, laboratory exams), were calculated and inflated to the most recent value. Results: Annual costs per patient for DMT prescription and management were not affected by the introduction of 2001 and 2005 criteria, but decreased by 0.4% after the introduction of 2011 criteria (PD= -0.4%; 95% C.I. -0.7%/-0.0%; p=0.023). Annual costs per patient increased by 11.2% after the introduction of Natalizumab in 2007 (PD= 11.2%; 95% C.I.= 9.4%/13.0%; p

Published
2019

43. 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

44. Glatiramer Acetate modulates ion channels expression and calcium homeostasis in B cell of patients with relapsing-remitting multiple sclerosis

Author

R. de Cegli, Agnese Secondo, V. Brescia Morra, Diego di Bernardo, Francesca Boscia, Diego Carrella, Giuseppe Matarese, P. de Candia, Tiziana Petrozziello, R Lanzillo, C. E. La Rocca, Annamaria Carissimo, Alessandra Cianflone, Farancesco Napolitano, Chiara Criscuolo, Criscuolo, C., Cianflone, A., Lanzillo, R., Carrella, D., Carissimo, A., Napolitano, F., de Cegli, R., de Candia, P., La Rocca, C., Petrozziello, T., Matarese, G., Boscia, F., Secondo, A., Di Bernardo, D., and Brescia Morra, V.

Subjects
Male, 0301 basic medicine, Multiple Sclerosis, Bioinformatics, lcsh:Medicine, Endoplasmic Reticulum, Ion Channels, Article, 03 medical and health sciences, Multiple Sclerosis, Relapsing-Remitting, 0302 clinical medicine, Immune system, In vivo, medicine, Homeostasis, Humans, Glatiramer acetate, lcsh:Science, B cell, B-Lymphocytes, Multidisciplinary, Chemistry, Multiple sclerosis, Endoplasmic reticulum, lcsh:R, Glatiramer Acetate, medicine.disease, 3. Good health, Cell biology, 030104 developmental biology, medicine.anatomical_structure, Gene Expression Regulation, Apoptosis, lcsh:Q, Calcium, Female, 030217 neurology & neurosurgery, medicine.drug
Abstract

To investigate the effects of Glatiramer Acetate (GA) on B cells by an integrated computational and experimental approach. GA is an immunomodulatory drug approved for the treatment of multiple sclerosis (MS). GA effect on B cells is yet to be fully elucidated. We compared transcriptional profiles of B cells from treatment-naïve relapsing remitting MS patients, treated or not with GA for 6 hours in vitro, and of B cells before and after six months of GA administration in vivo. Microarrays were analyzed with two different computational approaches, one for functional analysis of pathways (Gene Set Enrichment Analysis) and one for the identification of new drug targets (Mode-of-action by Network Analysis). GA modulates the expression of genes involved in immune response and apoptosis. A differential expression of genes encoding ion channels, mostly regulating Ca2+ homeostasis in endoplasmic reticulum (ER) was also observed. Microfluorimetric analysis confirmed this finding, showing a specific GA effect on ER Ca2+ concentration. Our findings unveils a GA regulatory effect on the immune response by influencing B cell phenotype and function. In particular, our results highlight a new functional role for GA in modulating Ca2+ homeostasis in these cells.

Published
2019

45. Therapeutic lag in reducing disability progression in relapsing-remitting multiple sclerosis: 8-year follow-up of two randomized add-on trials with atorvastatin

Author

Raffaele Palladino, Antonio Carotenuto, Agostino Nozzolillo, Martina Petruzzo, Roberta Lanzillo, Vincenzo Brescia Morra, Cinzia Valeria Russo, Jeremy Chataway, Marcello Moccia, Lanzillo, R., Moccia, M., Russo, C. V., Carotenuto, A., Nozzolillo, A., Petruzzo, M., Palladino, R., Chataway, J., and Brescia Morra, V.

Subjects
Adult, Male, medicine.medical_specialty, Time Factors, Atorvastatin, Placebo, Multiple sclerosis, Disability Evaluation, 03 medical and health sciences, symbols.namesake, Multiple Sclerosis, Relapsing-Remitting, 0302 clinical medicine, Extension, Internal medicine, medicine, Humans, Disability progression, 030212 general & internal medicine, Poisson regression, Retrospective Studies, business.industry, Proportional hazards model, Statin, Interferon-beta, General Medicine, medicine.disease, Clinical trial, Treatment, Neurology, Relapsing remitting, Disease Progression, symbols, Female, Neurology (clinical), Hydroxymethylglutaryl-CoA Reductase Inhibitors, business, 030217 neurology & neurosurgery, Follow-Up Studies, medicine.drug
Abstract

Background Current treatments for relapsing remitting multiple sclerosis (RRMS) reduce inflammation, but have a partial or modest effect on disability. This effect may require a much longer follow-up than standard trial design, in particular in RRMS with relatively-preserved functional reserve. We aimed to assess the long-term clinical evolution of RRMS patients exposed to atorvastatin in two trials (ACTIVE and ARIANNA). Methods We retrospectively looked at 69 participants randomized with atorvastatin or placebo as add-on therapy to interferon-beta for 24 months at a single MS centre. We recorded relapses, 1-point EDSS progression and progression to EDSS 4.0. Cox regression was performed for these three questions. A Poisson regression model was used to evaluate the association between atorvastatin treatment and annualized relapse rate (ARR). Results After 8.4 ± 2.3 (3.7–11.9) years from trial, the use of atorvastatin was associated with reduced risk of 1-point EDSS progression (HR = 0.440; 95%CI = 0.225–0.861; p = 0.017), and of EDSS 4.0 (HR = 0.310; 95%CI = 0.123–0.784; p = 0.013). We found no significant association between atorvastatin and relapses. Discussion These data suggest that a delayed treatment effect may be seen with atorvastatin added to interferon-beta, eight years after entering the clinical trials. Long-term follow-up of trial cohorts should be mandated.

Published
2019

46. Integrated Cognitive and Neuromotor Rehabilitation in Multiple Sclerosis: A Pragmatic Study

Author

Anna M. Barbarulo, Giacomo Lus, Elisabetta Signoriello, Luigi Trojano, Dario Grossi, Mariateresa Esposito, Teresa Costabile, Roberta Lanzillo, Francesco Saccà, Vincenzo Brescia Morra, Giovannina Conchiglia, Barbarulo, Anna M., Lus, Giacomo, Signoriello, Elisabetta, Trojano, Luigi, Grossi, Dario, Esposito, Mariateresa, Costabile, Teresa, Lanzillo, Roberta, Saccà, Francesco, Brescia Morra, Vincenzo, Conchiglia, Giovannina, Barbarulo, A. M., Lus, G., Signoriello, E., Trojano, L., Grossi, D., Esposito, M., Costabile, T., Lanzillo, R., Sacca, F., Brescia Morra, V., and Conchiglia, G.

Subjects
030506 rehabilitation, medicine.medical_specialty, Cognitive Neuroscience, medicine.medical_treatment, Cognitive motor interference, multiple sclerosis, Verbal learning, lcsh:RC321-571, 03 medical and health sciences, Behavioral Neuroscience, 0302 clinical medicine, Physical medicine and rehabilitation, Medicine, Multiple sclerosi, Cognitive rehabilitation therapy, lcsh:Neurosciences. Biological psychiatry. Neuropsychiatry, Brain plasticity, Rehabilitation, business.industry, Neuropsychology, Cognition, Cognitive rehabilitation, Executive functions, Cognitive training, Neuropsychology and Physiological Psychology, Anxiety, medicine.symptom, 0305 other medical science, business, 030217 neurology & neurosurgery, Neuromotor rehabilitation
Abstract

Background: Few studies examined the effects of combined motor and cognitive rehabilitation in patients with multiple sclerosis (MS). The present prospective, multicenter, observational study aimed to determine the efficacy of an integrated cognitive and neuromotor rehabilitation program versus a traditional neuromotor training on walking, balance, cognition and emotional functioning in MS patients. Methods: Sixty three MS patients were selected and assigned either to the Integrated Treatment Group (ITG; n = 32), receiving neuropsychological treatment (performed by ERICA software and paper–pencil tasks) complemented by conventional neuromotor rehabilitation, or to the Motor Treatment Group (n = 31) receiving neuromotor rehabilitation only. The intervention included two 60-min sessions per week for 24 weeks. At baseline and at end of the training all patients underwent a wide-range neuropsychological, psychological/emotional, and motor assessment. Results: At baseline the two groups did not differ for demographic, neuropsychological, psychological/emotional, and motor features significantly. After rehabilitation, only ITG group significantly (p-corrected for False Discovery Rate) improved on test tapping spatial memory, attention and cognitive flexibility, as well as on scales assessing depression and motor performance (balance and gait). A regression analysis showed that neuropsychological and motor improvement was not related to improvements in fatigue and depression. Conclusion: The present study demonstrated positive effects in emotional, motor, and cognitive aspects in MS patients who received an integrated cognitive and neuromotor training. Overall, results are supportive of interventions combining motor and cognitive training for MS.

Published
2018

47. Pregnancy decision-making in women with multiple sclerosis treated with natalizumab: I: Fetal risks

Author

Maria Giovanna Marrosu, Paola Cavalla, Claudio Solaro, Eleonora Cocco, Antonio Uccelli, Marta Giannini, Giancarlo Comi, Mauro Zaffaroni, Vittorio Martinelli, Lucia Moiola, Francesca Rinaldi, Vincenzo Brescia Morra, Roberta Lanzillo, Paolo Gallo, Francesco Patti, Alice Laroni, Pietro Annovazzi, Luisa Pastò, Laura De Giglio, Carla Tortorella, Carlo Pozzilli, Angelo Ghezzi, Maria Pia Amato, Maria Trojano, Paolo Bellantonio, Damiano Paolicelli, Emilio Portaccio, Portaccio, E, Annovazzi, P, Ghezzi, A, Zaffaroni, M, Moiola, L, Martinelli, V, Lanzillo, R, Brescia Morra, V, Rinaldi, F, Gallo, P, Tortorella, C, Paolicelli, D, Pozzilli, C, De Giglio, L, Cavalla, P, Cocco, E, Marrosu, Mg, Patti, F, Solaro, C, Bellantonio, P, Uccelli, A, Laroni, A, Pastò, L, Giannini, M, Trojano, M, Comi, G, Amato, Mp, MS Study Group of the Italian Neurological, Society, Radaelli, M, Portaccio, Emilio, Annovazzi, Pietro, Ghezzi, Angelo, Zaffaroni, Mauro, Moiola, Lucia, Martinelli, Vittorio, Lanzillo, Roberta, Brescia Morra, Vincenzo, Rinaldi, Francesca, Gallo, Paolo, Tortorella, Carla, Paolicelli, Damiano, Pozzilli, Carlo, De Giglio, Laura, Cavalla, Paola, Cocco, Eleonora, Marrosu, Maria Giovanna, Patti, Francesco, Solaro, Claudio, Bellantonio, Paolo, Uccelli, Antonio, Laroni, Alice, Pastò, Luisa, Giannini, Marta, Trojano, Maria, Comi, Giancarlo, and Amato, Maria Pia

Subjects
0301 basic medicine, Pregnancy, education.field_of_study, medicine.medical_specialty, business.industry, Obstetrics, Population, Odds ratio, Abortion, medicine.disease, Confidence interval, 03 medical and health sciences, 030104 developmental biology, Natalizumab, medicine, Gestation, Neurology (clinical), business, education, medicine.drug, Cohort study
Abstract

ObjectiveTo assess fetal risk after pregnancy exposure to natalizumab in women with multiple sclerosis (MS), with a specific focus on spontaneous abortion (SA) and congenital anomalies (CA).MethodsData of all pregnancies occurring between 2009 and 2015 in patients with MS treated with natalizumab and referring to 19 participating sites were collected and compared with those of pregnancies in untreated patients and patients treated with injectable immunomodulatory agents. Rates of SA and CA were also compared with those reported in the Italian population. Multivariable logistic and linear regression models were performed.ResultsA total of 92 pregnancies were tracked in 83 women. In the multivariable analysis, natalizumab exposure was associated with SA (odds ratio [OR] 3.9, 95% confidence interval [CI] 1.9–8.5, p < 0.001). However, the rate of SA (17.4%) was within the estimates for the general population, as well as the rate of major CA (3.7%). Moreover, exposure to natalizumab and interferon-β (IFN-β) was associated with lower length and weight of the babies (p < 0.001).ConclusionOur results showed that natalizumab exposure to up 12 weeks of gestation is associated with an increased risk of SA, although within the limits expected in the general population, whereas the risk of CA needs further investigation. Taking into account the high risk of disease reactivation after natalizumab suspension, pregnancy could be planned continuing natalizumab while strictly monitoring conception.Classification of evidenceThis study provides Class III evidence that in women with MS, natalizumab exposure increases the risk of spontaneous abortion as compared to IFN-β-exposed or untreated patients (OR 3.9, 95% CI 1.9–8.5).

Published
2018

48. No evidence of beneficial effects of plasmapheresis in natalizumab-associated PML

Author

Landi, Doriana, De Rossi, Nicola, Zagaglia, Sara, Scarpazza, Cristina, Prosperini, Luca, Albanese, Maria, Buttari, Fabio, Mori, Francesco, Marfia, Girolama Alessandra, Sormani, Maria Pia, Capra, Ruggero, Centonze, Diego, the Italian PML Study group Amato, Maria Pia, Bandini, F, Bertolotto, Antonio, Brescia-Morra, Vincenzo, Cavaletti, G, Cavalla, Paola, Capobianco, Marco, Clerico, Marinella, D'Aleo, G, De Riz, M, Deotto, L, Durelli, Luca, Falcini, M, Ferrari, E, Fusco, ML, Gasperini, C, Gerevini, S, Ghezzi, A, Grimaldi, L, Guidotti, M, Lugaresi, A, Naldi, P, Moiola, Lucia, Perrone, P, Pizzorno, M, Pozzilli, C, Rezzonico, M, Rovaris, M, Salemi, G, Salvetti, M, Santuccio, G, Scarpini, E, Sessa, E, Solaro, C, Tabiadon, G, Tortorella, C, Trojano M., Landi, Doriana, De Rossi, Nicola, Zagaglia, Sara, Scarpazza, Cristina, Prosperini, Luca, Albanese, Maria, Buttari, Fabio, Mori, Francesco, Marfia, Girolama Alessandra, Sormani, Maria Pia, Capra, Ruggero, Centonze, Diego, Brescia Morra, Vincenzo, the Italian PML Study group Amato, Maria Pia, Bandini, F, Bertolotto, Antonio, Brescia-Morra, Vincenzo, Cavaletti, G, Cavalla, Paola, Capobianco, Marco, Clerico, Marinella, D'Aleo, G, De Riz, M, Deotto, L, Durelli, Luca, Falcini, M, Ferrari, E, Fusco, ML, Gasperini, C, Gerevini, S, Ghezzi, A, Grimaldi, L, Guidotti, M, Lugaresi, A, Naldi, P, Moiola, Lucia, Perrone, P, Pizzorno, M, Pozzilli, C, Rezzonico, M, Rovaris, M, Salemi, G, Salvetti, M, Santuccio, G, Scarpini, E, Sessa, E, Solaro, C, Tabiadon, G, Tortorella, C, Trojano M., Landi, D, De Rossi, N, Zagaglia, S, Scarpazza, C, Prosperini, L, Albanese, M, Buttari, F, Mori, F, Marfia, G, Sormani, M, Capra, R, Centonze, D, Amato, M, Bertolotto, A, Brescia Morra, V, Cavalla, P, Capobianco, M, Clerico, M, de Riz, M, Durelli, L, Fusco, M, Moiola, L, and Trojano, M

Subjects
Oncology, Male, JC virus, 030204 cardiovascular system & hematology, medicine.disease_cause, Leukoencephalopathy, Disability Evaluation, neurology (clinical), progressive multifocal leukoencephalopathy, reconstitution inflammatory syndrome, multiple-sclerosis, 0302 clinical medicine, Natalizumab, Immunologic Factor, Retrospective Studie, Multiple Sclerosi, Medicine, Plasmapheresi, Adult, Female, Humans, Immunologic Factors, Leukoencephalopathy, Progressive Multifocal, Middle Aged, Multiple Sclerosis, Plasmapheresis, PubMed, Retrospective Studies, Statistics, Nonparametric, Treatment Outcome, Progressive multifocal leukoencephalopathy, Statistics, Settore MED/26 - Neurologia, medicine.drug, Human, medicine.medical_specialty, Progressive Multifocal, 03 medical and health sciences, Immune reconstitution inflammatory syndrome, Internal medicine, Nonparametric, progressive multifocal leukoencephalopathy, multiple sclerosis, side effect, Expanded Disability Status Scale, business.industry, Multiple sclerosis, Retrospective cohort study, medicine.disease, Immunology, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

Objective:To examine retrospectively the effects of plasmapheresis (PLEX) on the survival and clinical outcomes of patients with multiple sclerosis (MS) and natalizumab (NTZ)–associated progressive multifocal leukoencephalopathy (PML).Methods:The medical literature was searched for the terms natalizumab and progressive multifocal leukoencephalopathy. A total of 193 international and 34 Italian NTZ-PML cases were included. Clinical outcome was determined by comparing the patients' clinical status at PML diagnosis with status after PML resolution. The effects on survival and clinical outcome of PLEX, sex, age, country, pre-PML Expanded Disability Status Scale score, NTZ infusion number, prior immunosuppressant exposure, PML symptoms, PML lesion location at diagnosis, CSF JC virus status and copies, additional PML treatments and steroids, and PML immune reconstitution inflammatory syndrome (IRIS) development were investigated with both univariate and multivariate analyses.Results:A total of 219 NTZ-PML cases were analyzed, and 184 (84%) underwent PLEX, which did not reduce the mortality risk or the likelihood of poor vs favorable outcomes. Country was predictive of mortality and poor outcome, while PML-IRIS development was predictive of poor outcome.Conclusions:PLEX did not improve the survival or clinical outcomes of Italian or international patients with MS and NTZ-PML, suggesting that this treatment should be performed cautiously in the future.Classification of evidence:This study provides Class III evidence that for patients with NTZ-PML, PLEX does not improve survival. The study lacks the statistical precision to exclude an important benefit or harm of PLEX.

Published
2017

49. Sativex in resistant multiple sclerosis spasticity: Discontinuation study in a large population of Italian patients (SA.FE. study)

Author

Silvia Messina, Claudio Solaro, Isabella Righini, Roberto Bergamaschi, Simona Bonavita, Roberto Bruno Bossio, Vincenzo Brescia Morra, Gianfranco Costantino, Paola Cavalla, Diego Centonze, Giancarlo Comi, Salvatore Cottone, Maura Chiara Danni, Ada Francia, Alberto Gajofatto, Claudio Gasperini, Mauro Zaffaroni, Loredana Petrucci, Elisabetta Signoriello, Giorgia Teresa Maniscalco, Gabriella Spinicci, Manuela Matta, Massimiliano Mirabella, Graziella Pedà, Letizia Castelli, Marco Rovaris, Edoardo Sessa, Daniele Spitaleri, Damiano Paolicelli, Alfredo Granata, Mario Zappia, Francesco Patti, SA.FE. study group, Messina, S, Solaro, C, Righini, I, Bergamaschi, R, Bonavita, S, Bossio, Rb, Brescia Morra, V, Costantino, G, Cavalla, P, Centonze, D, Comi, G, Cottone, S, Danni, Mc, Francia, A, Gajofatto, A, Gasperini, C, Zaffaroni, M, Petrucci, L, Signoriello, E, Maniscalco, Gt, Spinicci, G, Matta, M, Mirabella, M, Pedà, G, Castelli, L, Rovaris, M, Sessa, E, Spitaleri, D, Paolicelli, D, Granata, A, Zappia, M, Patti, F., Messina, Silvia, Solaro, Claudio, Righini, Isabella, Bergamaschi, Roberto, Bonavita, Simona, Bossio, Roberto Bruno, Brescia Morra, Vincenzo, Costantino, Gianfranco, Cavalla, Paola, Centonze, Diego, Comi, Giancarlo, Cottone, Salvatore, Danni, Maura Chiara, Francia, Ada, Gajofatto, Alberto, Gasperini, Claudio, Zaffaroni, Mauro, Petrucci, Loredana, Signoriello, Elisabetta, Maniscalco, Giorgia Teresa, Spinicci, Gabriella, Matta, Manuela, Mirabella, Massimiliano, Pedà, Graziella, Castelli, Letizia, Rovaris, Marco, Sessa, Edoardo, Spitaleri, Daniele, Paolicelli, Damiano, Granata, Alfredo, Zappia, Mario, Patti, Francesco, Morra, Vincenzo Brescia, and Pedã , Graziella

Subjects
Registrie, Genetics and Molecular Biology (all), Male, Economics, Social Sciences, Drug research and development, Biochemistry, Severity of Illness Index, 0302 clinical medicine, Multiple Sclerosi, 80 and over, Ethnicities, Medicine, Dronabinol, lcsh:Science, Drug Approval, Aged, 80 and over, evaluation, Sativex, multiple sclerosis spasticity, discontinuation, effectiveness, Drug Combinations, Neurology, Italy, Regression Analysis, Human, medicine.medical_specialty, Multiple Sclerosis, Drug Industry, Immunology, Plant Extract, 03 medical and health sciences, Health Economics, Pharmacotherapy, Drug Therapy, Severity of illness, Humans, Spasticity, Adult, Aged, Cannabidiol, Cost Sharing, Drug Costs, Female, Kaplan-Meier Estimate, Middle Aged, Multivariate Analysis, Muscle Spasticity, Parasympatholytics, Plant Extracts, Proportional Hazards Models, Registries, Young Adult, Biochemistry, Genetics and Molecular Biology (all), Agricultural and Biological Sciences (all), Adverse effect, Demography, Pharmacology, Proportional hazards model, Parasympatholytic, lcsh:R, Biology and Life Sciences, Management of multiple sclerosis, medicine.disease, Discontinuation, Health Care, Proportional Hazards Model, Population Groupings, lcsh:Q, Clinical Medicine, 030217 neurology & neurosurgery, Multivariate analysis, lcsh:Medicine, Medicine (all), Geographical Locations, Clinical trials, Drug Combination, Medicine and Health Sciences, 030212 general & internal medicine, Multivariate Analysi, Drug Cost, Multidisciplinary, Pharmaceutics, Neurodegenerative Diseases, Italian People, Phase III clinical investigation, Europe, Settore MED/26 - NEUROLOGIA, Research Design, medicine.symptom, Research Article, Clinical Research Design, Research and Analysis Methods, Settore MED/26, Regression Analysi, Autoimmune Diseases, Internal medicine, business.industry, Demyelinating Disorders, People and Places, Physical therapy, Clinical Immunology, Adverse Events, business
Abstract

Background The approval of Sativex for the management of multiple sclerosis (MS) spasticity opened a new opportunity to many patients. In Italy, the healthcare payer can be fully reimbursed by the involved pharma company with the cost of treatment for patients not responding after a 4 week (28 days) trial period (Payment by Results, PbR), and 50% reimbursed with the cost of 6 weeks (42 days) treatment for other patients discontinuing (Cost Sharing, CS). The aim of our study was to describe the Sativex discontinuation profile from a large population of spasticity treated Italian MS patients. Methods We collected data of patients from 30 MS centres across the country starting Sativex between January 2014 and February 2015. Data were collected from the mandatory Italian Medicines Agency (AIFA) web-registry. Predictors of treatment discontinuation were assessed using a multivariate Cox proportional regression analysis. Results During the observation period 631 out of 1597 (39.5%) patients discontinued Sativex. The Kaplan-Meier estimates curve showed that 333 patients (20.8%) discontinued treatment at 4 weeks while 422 patients (26.4%) discontinued at 6 weeks. We found after adjusted modeling that a higher NRS score at T1 (adjHR 2.23, 95% 2.07–2.41, p

Published
2017

50. Lymphocytosis as a response biomarker of natalizumab therapeutic efficacy in multiple sclerosis

Author

Giacomo Lus, M. Fratta, Roberta Lanzillo, Elisabetta Signoriello, G. Di Iorio, Antonio Carotenuto, V. Brescia Morra, Signoriello, E., Lanzillo, Roberta, BRESCIA MORRA, Vincenzo, Di Iorio, G., Fratta, M., Carotenuto, Antonio, Lus, G., Signoriello, E, Lanzillo, R, Brescia Morra, V, DI IORIO, Giuseppe, Fratta, Mario, Carotenuto, A, and Lus, Giacomo

Subjects
Adult, Male, 0301 basic medicine, Time Factors, Lymphocytosis, Lymphocyte, multiple sclerosis, Leukocyte Count, Young Adult, 03 medical and health sciences, Multiple Sclerosis, Relapsing-Remitting, 0302 clinical medicine, Natalizumab, Predictive Value of Tests, Risk Factors, medicine, Humans, Retrospective Studies, business.industry, Multiple sclerosis, Biomarker, Multiple Sclerosis, Chronic Progressive, medicine.disease, Magnetic Resonance Imaging, Treatment Outcome, 030104 developmental biology, medicine.anatomical_structure, Neurology, multiple sclerosi, Immunology, Biomarker (medicine), Female, Neurology (clinical), medicine.symptom, business, Immunosuppressive Agents, 030217 neurology & neurosurgery, medicine.drug
Abstract

Background: Natalizumab is an effective therapy in relapsing–remitting multiple sclerosis (RRMS), as it reduces lymphocyte transmigration through the blood–brain barrier (BBB) and induces lymphocytosis. Objectives: To analyse natalizumab-induced lymphocytosis (NIL) as a biomarker of drug efficacy. Materials and methods: We enrolled 50 relapsing–remitting (RR) and progressive–relapsing (PR) natalizumab-treated patients who had received at least 16 infusions and had been tested for lymphocyte count 24 hours before each administration. Clinical, MRI and hematological data were collected. Patients were divided into responders and sub-optimal responders according to the experience of at least one clinical and/or instrumental relapse during the treatment. Results: In 15 (30%) patients, an instrumental/clinical (14) or only instrumental (one) relapse occurred. We found a statistically significant difference in the mean percentage of the lymphocytes between the two groups over the first ten administrations ( p=0.04). The comparison between the time-to-relapse in the groups with high and low levels of lymphocytes showed that the group with a low NIL had a greater risk of relapse ( p=0.03). Conclusions: We suggest that NIL could be a biomarker of therapeutic efficacy in patients with RRMS treated with natalizumab, and that the risk of relapse may be higher in patients with a lower-than-expected NIL.

Published
2016

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