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1. Disease-modifying therapies in managing disability worsening in paediatric-onset multiple sclerosis: a longitudinal analysis of global and national registries

Author: Sharmin, S, Roos, I, Malpas, CB, Iaffaldano, P, Simone, M, Filippi, M, Havrdova, EK, Ozakbas, S, Morra, VB, Alroughani, R, Zaffaroni, M, Patti, F, Eichau, S, Salemi, G, Di Sapio, A, Inglese, M, Portaccio, E, Trojano, M, Amato, MP, Kalincik, T, Sharmin, S, Roos, I, Malpas, CB, Iaffaldano, P, Simone, M, Filippi, M, Havrdova, EK, Ozakbas, S, Morra, VB, Alroughani, R, Zaffaroni, M, Patti, F, Eichau, S, Salemi, G, Di Sapio, A, Inglese, M, Portaccio, E, Trojano, M, Amato, MP, and Kalincik, T
Abstract: BACKGROUND: High-efficacy disease-modifying therapies have been proven to slow disability accrual in adults with relapsing-remitting multiple sclerosis. However, their impact on disability worsening in paediatric-onset multiple sclerosis, particularly during the early phases, is not well understood. We evaluated how high-efficacy therapies influence transitions across five disability states, ranging from minimal disability to gait impairment and secondary progressive multiple sclerosis, in people with paediatric-onset multiple sclerosis. METHODS: Longitudinal data were obtained from the international MSBase registry, containing data from people with multiple sclerosis from 151 centres across 41 countries, and the Italian Multiple Sclerosis and Related Disorders Register, containing data from people with multiple sclerosis from 178 Italian multiple sclerosis centres. People younger than 18 years at the onset of multiple sclerosis symptoms were included, provided they had a confirmed diagnosis of relapsing-remitting multiple sclerosis and at least four Expanded Disability Status Scale (EDSS) scores recorded within 12-month intervals. The primary outcome was the time to change in disability state: minimal disability (EDSS scores 0, 1·0, and 1·5), mild disability (EDSS scores 2·0 and 2·5), moderate disability (EDSS scores 3·0 and 3·5), gait impairment (EDSS scores ≥4·0), and clinician diagnosed secondary progressive multiple sclerosis. A multi-state model was constructed to simulate the natural course of multiple sclerosis, modelling the probabilities of both disability worsening and improvement simultaneously. The impact of high-efficacy disease-modifying therapies (alemtuzumab, cladribine, daclizumab, fingolimod, mitoxantrone, natalizumab, ocrelizumab, rituximab, or autologous haematopoietic stem cell transplantation) and low-efficacy disease-modifying therapies (dimethyl fumarate, glatiramer acetate, interferon beta, or teriflunomide), compared with no treatment, on
Published: 2024

2. Evaluation of drivers of treatment switch in relapsing multiple sclerosis: a study from the Italian MS Registry

Author: Iaffaldano, P, Lucisano, G, Guerra, T, Patti, F, Cocco, E, De Luca, G, Brescia Morra, V, Pozzilli, C, Zaffaroni, M, Ferraro, D, Gasperini, C, Salemi, G, Bergamaschi, R, Lus, G, Inglese, M, Romano, S, Bellantonio, P, Di Monte, E, Maniscalco, G, Conte, A, Lugaresi, A, Vianello, M, Torri Clerici, V, Di Sapio, A, Pesci, I, Granella, F, Totaro, R, Marfia, G, Danni, M, Cavalla, P, Valentino, P, Aguglia, U, Montepietra, S, Ferraro, E, Protti, A, Spitaleri, D, Avolio, C, De Riz, M, Maimone, D, Cavaletti, G, Gazzola, P, Tedeschi, G, Sessa, M, Rovaris, M, Di Palma, F, Gatto, M, Cargnelutti, D, De Robertis̄, F, Logullo, F, Rini, A, Meucci, G, Ardito, B, Banfi, P, Nasuelli, D, Paolicelli, D, Rocca, M, Portaccio, E, Chisari, C, Fenu, G, Onofrj, M, Carotenuto, A, Ruggieri, S, Tortorella, C, Ragonese, P, Nica, M, Amato, M, Filippi, M, Trojano, M, Iaffaldano P., Lucisano G., Guerra T., Patti F., Cocco E., De Luca G., Brescia Morra V., Pozzilli C., Zaffaroni M., Ferraro D., Gasperini C., Salemi G., Bergamaschi R., Lus G., Inglese M., Romano S., Bellantonio P., Di Monte E., Maniscalco G. T., Conte A., Lugaresi A., Vianello M., Torri Clerici V. L. A., Di Sapio A., Pesci I., Granella F., Totaro R., Marfia G. A., Danni M. C., Cavalla P., Valentino P., Aguglia U., Montepietra S., Ferraro E., Protti A., Spitaleri D., Avolio C., De Riz M., Maimone D., Cavaletti G., Gazzola P., Tedeschi G., Sessa M., Rovaris M., Di Palma F., Gatto M., Cargnelutti D., De Robertis̄ F., Logullo F. O., Rini A., Meucci G., Ardito B., Banfi P., Nasuelli D., Paolicelli D., Rocca M. A., Portaccio E., Chisari C. G., Fenu G., Onofrj M., Carotenuto A., Ruggieri S., Tortorella C., Ragonese P., Nica M., Amato M. P., Filippi M., Trojano M., Iaffaldano, P, Lucisano, G, Guerra, T, Patti, F, Cocco, E, De Luca, G, Brescia Morra, V, Pozzilli, C, Zaffaroni, M, Ferraro, D, Gasperini, C, Salemi, G, Bergamaschi, R, Lus, G, Inglese, M, Romano, S, Bellantonio, P, Di Monte, E, Maniscalco, G, Conte, A, Lugaresi, A, Vianello, M, Torri Clerici, V, Di Sapio, A, Pesci, I, Granella, F, Totaro, R, Marfia, G, Danni, M, Cavalla, P, Valentino, P, Aguglia, U, Montepietra, S, Ferraro, E, Protti, A, Spitaleri, D, Avolio, C, De Riz, M, Maimone, D, Cavaletti, G, Gazzola, P, Tedeschi, G, Sessa, M, Rovaris, M, Di Palma, F, Gatto, M, Cargnelutti, D, De Robertis̄, F, Logullo, F, Rini, A, Meucci, G, Ardito, B, Banfi, P, Nasuelli, D, Paolicelli, D, Rocca, M, Portaccio, E, Chisari, C, Fenu, G, Onofrj, M, Carotenuto, A, Ruggieri, S, Tortorella, C, Ragonese, P, Nica, M, Amato, M, Filippi, M, Trojano, M, Iaffaldano P., Lucisano G., Guerra T., Patti F., Cocco E., De Luca G., Brescia Morra V., Pozzilli C., Zaffaroni M., Ferraro D., Gasperini C., Salemi G., Bergamaschi R., Lus G., Inglese M., Romano S., Bellantonio P., Di Monte E., Maniscalco G. T., Conte A., Lugaresi A., Vianello M., Torri Clerici V. L. A., Di Sapio A., Pesci I., Granella F., Totaro R., Marfia G. A., Danni M. C., Cavalla P., Valentino P., Aguglia U., Montepietra S., Ferraro E., Protti A., Spitaleri D., Avolio C., De Riz M., Maimone D., Cavaletti G., Gazzola P., Tedeschi G., Sessa M., Rovaris M., Di Palma F., Gatto M., Cargnelutti D., De Robertis̄ F., Logullo F. O., Rini A., Meucci G., Ardito B., Banfi P., Nasuelli D., Paolicelli D., Rocca M. A., Portaccio E., Chisari C. G., Fenu G., Onofrj M., Carotenuto A., Ruggieri S., Tortorella C., Ragonese P., Nica M., Amato M. P., Filippi M., and Trojano M.
Abstract: Background: Active relapsing–remitting (RR) and secondary progressive (SP) multiple sclerosis (MS) are currently defined as “relapsing MS” (RMS). The aim of this cross-sectional study was to assess drivers of treatment switches due to clinical relapses in a population of RMS patients collected in the Italian MS and Related Disorders Register (I-MS&RD). Methods: RRMS and SPMS patients with at least one relapse in a time window of 2 years before of data extraction were defined as RMS. Factors associated with disease-modifying therapy (DMT) switching due to clinical activity were assessed through multivariable logistic regression models in which treatment exposure was included as the last recorded DMT and the last DMT’s class [moderate-efficacy (ME), high-efficacy (HE) DMTs and anti-CD20 drugs]. Results: A cohort of 4739 RMS patients (4161 RRMS, 578 SPMS) was extracted from the I-MS&RD. A total of 2694 patients switching DMTs due to relapses were identified. Switchers were significantly (p < 0.0001) younger, less disabled, more frequently affected by an RR disease course in comparison to non-switcher patients. The multivariable logistic regression models showed that Alemtuzumab (OR 0.08, 95% CI 0.02–0.37), Natalizumab (0.48, 0.30–0.76), Ocrelizumab (0.1, 0.02–0.45) and Rituximab (0.23, 0.06–0.82) exposure was a protective factor against treatment switch due to relapses. Moreover, the use of HE DMTs (0.43, 0.31–0.59), especially anti-CD20 drugs (0.14, 0.05–0.37), resulted to be a protective factor against treatment switch due to relapses in comparison with ME DMTs. Conclusions: More than 50% of RMS switched therapy due to disease activity. HE DMTs, especially anti-CD20 drugs, significantly reduce the risk of treatment switch.
Published: 2023

3. Data monitoring roadmap. The experience of the Italian Multiple Sclerosis and Related Disorders Register

Author: Mosconi, P, Guerra, T, Paletta, P, D'Ettorre, A, Ponzio, M, Battaglia, M, Amato, M, Bergamaschi, R, Capobianco, M, Comi, G, Gasperini, C, Patti, F, Pugliatti, M, Ulivelli, M, Trojano, M, Lepore, V, Aguglia, U, Ancona, A, Ardito, B, Avolio, C, Balgera, R, Banfi, P, Barcella, V, Barone, P, Bellantonio, P, Berardinelli, A, Bertora, P, Bianchi, M, Bramanti, P, Brescia Morra, V, Brichetto, G, Brioschi, A, Buccafusca, M, Bucello, S, Busillo, V, Calchetti, B, Cantello, R, Capone, F, Capone, L, Cargnelutti, D, Carozzi, M, Cartechini, E, Cavaletti, G, Cavalla, P, Celani, M, Clerici, R, Clerico, M, Cocco, E, Torri Clerici, V, Coniglio, M, Conte, A, Corea, F, Cottone, S, Crociani, P, D'Andrea, F, Danni, M, De Luca, G, de Pascalis, D, De Riz, M, De Robertis, F, De Rosa, G, De Stefano, N, Della Corte, M, Di Sapio, A, Docimo, R, Falcini, M, Falcone, N, Fermi, S, Ferraro, E, Ferro, M, Fortunato, M, Foschi, M, Gajofatto, A, Gallo, A, Gallo, P, Gatto, M, Gazzola, P, Giordano, A, Granella, F, Grasso, M, Grimaldi, L, Iaffaldano, P, Immovilli, P, Imperiale, D, Inglese, M, Iodice, R, Leva, S, Leuzzi, V, Lugaresi, A, Lus, G, Maimone, D, Mancinelli, L, Maniscalco, G, Marfia, G, Margari, L, Marinelli, F, Marini, B, Marson, A, Mascoli, N, Massacesi, L, Melani, F, Merello, M, Fioretti, C, Mirabella, M, Montepietra, S, Nasuelli, D, Nicolao, P, Pasquali, L, Passantino, F, Pecori, C, Peresson, M, Pesci, I, Piantadosi, C, Piras, M, Pizzorno, M, Plewnia, K, Pozzilli, C, Protti, A, Quatrale, R, Realmuto, S, Ribizzi, G, Rinalduzzi, S, Rini, A, Romano, S, Filippi, M, Ronzoni, M, Rossi, P, Rovaris, M, Salemi, G, Santangelo, G, Santangelo, M, Leone, A, Sarchielli, P, Sinisi, L, Ferraro, D, Solaro, C, Spitaleri, D, Strumia, S, Tassinari, T, Santuccio, G, Tortorella, C, Totaro, R, Tozzo, A, Trivelli, G, Turano, G, Valentino, P, Venturi, S, Vianello, M, Zaffaroni, M, Zarbo, R, Mosconi P., Guerra T., Paletta P., D'Ettorre A., Ponzio M., Battaglia M. A., Amato M. P., Bergamaschi R., Capobianco M., Comi G., Gasperini C., Patti F., Pugliatti M., Ulivelli M., Trojano M., Lepore V., Aguglia U., Amato M., Ancona A., Ardito B., Avolio C., Balgera R., Banfi P., Barcella V., Barone P., Bellantonio P., Berardinelli A., Bertora P., Bianchi M., Bramanti P., Brescia Morra V., Brichetto G., Brioschi A., Buccafusca M., Bucello S., Busillo V., Calchetti B., Cantello R., Capone F., Capone L., Cargnelutti D., Carozzi M., Cartechini E., Cavaletti G., Cavalla P., Celani M., Clerici R., Clerico M., Cocco E., Torri Clerici V., Coniglio M., Conte A., Corea F., Cottone S., Crociani P., D'Andrea F., Danni M., De Luca G., de Pascalis D., De Riz M., De Robertis F., De Rosa G., De Stefano N., Della Corte M., Di Sapio A., Docimo R., Falcini M., Falcone N., Fermi S., Ferraro E., Ferro M., Fortunato M., Foschi M., Gajofatto A., Gallo A., Gallo P., Gatto M., Gazzola P., Giordano A., Granella F., Grasso M., Grimaldi L., Iaffaldano P., Immovilli P., Imperiale D., Inglese M., Iodice R., Leva S., Leuzzi V., Lugaresi A., Lus G., Maimone D., Mancinelli L., Maniscalco G., Marfia G., Margari L., Marinelli F., Marini B., Marson A., Mascoli N., Massacesi L., Melani F., Merello M., Fioretti C., Mirabella M., Montepietra S., Nasuelli D., Nicolao P., Pasquali L., Passantino F., Pecori C., Peresson M., Pesci I., Piantadosi C., Piras M., Pizzorno M., Plewnia K., Pozzilli C., Protti A., Quatrale R., Realmuto S., Ribizzi G., Rinalduzzi S., Rini A., Romano S., Filippi M., Ronzoni M., Rossi P., Rovaris M., Salemi G., Santangelo G., Santangelo M., Leone A., Sarchielli P., Sinisi L., Ferraro D., Solaro C., Spitaleri D., Strumia S., Tassinari T., Santuccio G., Tortorella C., Totaro R., Tozzo A., Trivelli G., Turano G., Valentino P., Venturi S., Vianello M., Zaffaroni M., Zarbo R., Mosconi, P, Guerra, T, Paletta, P, D'Ettorre, A, Ponzio, M, Battaglia, M, Amato, M, Bergamaschi, R, Capobianco, M, Comi, G, Gasperini, C, Patti, F, Pugliatti, M, Ulivelli, M, Trojano, M, Lepore, V, Aguglia, U, Ancona, A, Ardito, B, Avolio, C, Balgera, R, Banfi, P, Barcella, V, Barone, P, Bellantonio, P, Berardinelli, A, Bertora, P, Bianchi, M, Bramanti, P, Brescia Morra, V, Brichetto, G, Brioschi, A, Buccafusca, M, Bucello, S, Busillo, V, Calchetti, B, Cantello, R, Capone, F, Capone, L, Cargnelutti, D, Carozzi, M, Cartechini, E, Cavaletti, G, Cavalla, P, Celani, M, Clerici, R, Clerico, M, Cocco, E, Torri Clerici, V, Coniglio, M, Conte, A, Corea, F, Cottone, S, Crociani, P, D'Andrea, F, Danni, M, De Luca, G, de Pascalis, D, De Riz, M, De Robertis, F, De Rosa, G, De Stefano, N, Della Corte, M, Di Sapio, A, Docimo, R, Falcini, M, Falcone, N, Fermi, S, Ferraro, E, Ferro, M, Fortunato, M, Foschi, M, Gajofatto, A, Gallo, A, Gallo, P, Gatto, M, Gazzola, P, Giordano, A, Granella, F, Grasso, M, Grimaldi, L, Iaffaldano, P, Immovilli, P, Imperiale, D, Inglese, M, Iodice, R, Leva, S, Leuzzi, V, Lugaresi, A, Lus, G, Maimone, D, Mancinelli, L, Maniscalco, G, Marfia, G, Margari, L, Marinelli, F, Marini, B, Marson, A, Mascoli, N, Massacesi, L, Melani, F, Merello, M, Fioretti, C, Mirabella, M, Montepietra, S, Nasuelli, D, Nicolao, P, Pasquali, L, Passantino, F, Pecori, C, Peresson, M, Pesci, I, Piantadosi, C, Piras, M, Pizzorno, M, Plewnia, K, Pozzilli, C, Protti, A, Quatrale, R, Realmuto, S, Ribizzi, G, Rinalduzzi, S, Rini, A, Romano, S, Filippi, M, Ronzoni, M, Rossi, P, Rovaris, M, Salemi, G, Santangelo, G, Santangelo, M, Leone, A, Sarchielli, P, Sinisi, L, Ferraro, D, Solaro, C, Spitaleri, D, Strumia, S, Tassinari, T, Santuccio, G, Tortorella, C, Totaro, R, Tozzo, A, Trivelli, G, Turano, G, Valentino, P, Venturi, S, Vianello, M, Zaffaroni, M, Zarbo, R, Mosconi P., Guerra T., Paletta P., D'Ettorre A., Ponzio M., Battaglia M. A., Amato M. P., Bergamaschi R., Capobianco M., Comi G., Gasperini C., Patti F., Pugliatti M., Ulivelli M., Trojano M., Lepore V., Aguglia U., Amato M., Ancona A., Ardito B., Avolio C., Balgera R., Banfi P., Barcella V., Barone P., Bellantonio P., Berardinelli A., Bertora P., Bianchi M., Bramanti P., Brescia Morra V., Brichetto G., Brioschi A., Buccafusca M., Bucello S., Busillo V., Calchetti B., Cantello R., Capone F., Capone L., Cargnelutti D., Carozzi M., Cartechini E., Cavaletti G., Cavalla P., Celani M., Clerici R., Clerico M., Cocco E., Torri Clerici V., Coniglio M., Conte A., Corea F., Cottone S., Crociani P., D'Andrea F., Danni M., De Luca G., de Pascalis D., De Riz M., De Robertis F., De Rosa G., De Stefano N., Della Corte M., Di Sapio A., Docimo R., Falcini M., Falcone N., Fermi S., Ferraro E., Ferro M., Fortunato M., Foschi M., Gajofatto A., Gallo A., Gallo P., Gatto M., Gazzola P., Giordano A., Granella F., Grasso M., Grimaldi L., Iaffaldano P., Immovilli P., Imperiale D., Inglese M., Iodice R., Leva S., Leuzzi V., Lugaresi A., Lus G., Maimone D., Mancinelli L., Maniscalco G., Marfia G., Margari L., Marinelli F., Marini B., Marson A., Mascoli N., Massacesi L., Melani F., Merello M., Fioretti C., Mirabella M., Montepietra S., Nasuelli D., Nicolao P., Pasquali L., Passantino F., Pecori C., Peresson M., Pesci I., Piantadosi C., Piras M., Pizzorno M., Plewnia K., Pozzilli C., Protti A., Quatrale R., Realmuto S., Ribizzi G., Rinalduzzi S., Rini A., Romano S., Filippi M., Ronzoni M., Rossi P., Rovaris M., Salemi G., Santangelo G., Santangelo M., Leone A., Sarchielli P., Sinisi L., Ferraro D., Solaro C., Spitaleri D., Strumia S., Tassinari T., Santuccio G., Tortorella C., Totaro R., Tozzo A., Trivelli G., Turano G., Valentino P., Venturi S., Vianello M., Zaffaroni M., and Zarbo R.
Abstract: Introduction: Over the years, disease registers have been increasingly considered a source of reliable and valuable population studies. However, the validity and reliability of data from registers may be limited by missing data, selection bias or data quality not adequately evaluated or checked. This study reports the analysis of the consistency and completeness of the data in the Italian Multiple Sclerosis and Related Disorders Register. Methods: The Register collects, through a standardized Web-based Application, unique patients. Data are exported bimonthly and evaluated to assess the updating and completeness, and to check the quality and consistency. Eight clinical indicators are evaluated. Results: The Register counts 77,628 patients registered by 126 centres. The number of centres has increased over time, as their capacity to collect patients. The percentages of updated patients (with at least one visit in the last 24 months) have increased from 33% (enrolment period 2000–2015) to 60% (enrolment period 2016–2022). In the cohort of patients registered after 2016, there were ≥ 75% updated patients in 30% of the small centres (33), in 9% of the medium centres (11), and in all the large centres (2). Clinical indicators show significant improvement for the active patients, expanded disability status scale every 6 months or once every 12 months, visits every 6 months, first visit within 1 year and MRI every 12 months. Conclusions: Data from disease registers provide guidance for evidence-based health policies and research, so methods and strategies ensuring their quality and reliability are crucial and have several potential applications.
Published: 2023

4. Disease-Modifying Treatments and Time to Loss of Ambulatory Function in Patients with Primary Progressive Multiple Sclerosis

Author: Portaccio, E, Fonderico, M, Iaffaldano, P, Pasto, L, Razzolini, L, Bellinvia, A, De Luca, G, Ragonese, P, Patti, F, Brescia Morra, V, Cocco, E, Sola, P, Inglese, M, Lus, G, Pozzilli, C, Maimone, D, Lugaresi, A, Gazzola, P, Comi, G, Pesci, I, Spitaleri, D, Rezzonico, M, Vianello, M, Avolio, C, Logullo, F, Granella, F, Salvetti, M, Zaffaroni, M, Lucisano, G, Filippi, M, Trojano, M, Amato, M, Cavaletti, G, Portaccio E., Fonderico M., Iaffaldano P., Pasto L., Razzolini L., Bellinvia A., De Luca G., Ragonese P., Patti F., Brescia Morra V., Cocco E., Sola P., Inglese M., Lus G., Pozzilli C., Maimone D., Lugaresi A., Gazzola P., Comi G., Pesci I., Spitaleri D., Rezzonico M., Vianello M., Avolio C., Logullo F. O., Granella F., Salvetti M., Zaffaroni M., Lucisano G., Filippi M., Trojano M., Amato M. P., Cavaletti G., Portaccio, E, Fonderico, M, Iaffaldano, P, Pasto, L, Razzolini, L, Bellinvia, A, De Luca, G, Ragonese, P, Patti, F, Brescia Morra, V, Cocco, E, Sola, P, Inglese, M, Lus, G, Pozzilli, C, Maimone, D, Lugaresi, A, Gazzola, P, Comi, G, Pesci, I, Spitaleri, D, Rezzonico, M, Vianello, M, Avolio, C, Logullo, F, Granella, F, Salvetti, M, Zaffaroni, M, Lucisano, G, Filippi, M, Trojano, M, Amato, M, Cavaletti, G, Portaccio E., Fonderico M., Iaffaldano P., Pasto L., Razzolini L., Bellinvia A., De Luca G., Ragonese P., Patti F., Brescia Morra V., Cocco E., Sola P., Inglese M., Lus G., Pozzilli C., Maimone D., Lugaresi A., Gazzola P., Comi G., Pesci I., Spitaleri D., Rezzonico M., Vianello M., Avolio C., Logullo F. O., Granella F., Salvetti M., Zaffaroni M., Lucisano G., Filippi M., Trojano M., Amato M. P., and Cavaletti G.
Abstract: Importance: Except for ocrelizumab, treatment options in primary progressive multiple sclerosis (PPMS) are lacking. Objective: To investigate the effectiveness of DMTs on the risk of becoming wheelchair dependent in a real-world population of patients with PPMS. Design, Setting, and Participants: This was a multicenter, observational, retrospective, comparative effectiveness research study. Data were extracted on November 28, 2018, from the Italian multiple sclerosis register and analyzed from June to December 2021. Mean study follow-up was 11 years. Included in the study cohort were patients with a diagnosis of PPMS and at least 3 years of Expanded Disability Status Scale (EDSS) evaluations and 3 years of follow-up. Main Outcomes and Measures: The risk of reaching an EDSS score of 7.0 was assessed through multivariable Cox regression models. Exposures: Patients who received DMT before the outcome were considered treated. DMT was assessed as a time-dependent variable and by class of DMT (moderately and highly effective). Results: From a total of 3298 patients with PPMS, 2633 were excluded because they did not meet the entry criteria for the phase 3, multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of ocrelizumab in adults with PPMS (ORATORIO) trial. Among the remaining 665 patients (mean [SD] age, 43.0 [10.7] years; 366 female patients [55.0%]), 409 were further selected for propensity score matching (288 treated and 121 untreated patients). In the matched cohort, during the study follow-up, 37% of patients (152 of 409) reached an EDSS score of 7.0 after a mean (SD) follow-up of 10.6 (5.6) years. A higher EDSS score at baseline (adjusted hazard ratio [aHR], 1.32; 95% CI, 1.13-1.55; P <.001), superimposed relapses (aHR, 2.37; 95% CI, 1.24-4.54; P =.009), and DMT exposure (aHR, 1.75; 95% CI, 1.04-2.94; P =.03) were associated with a higher risk of an EDSS score of 7.0, whereas the interaction term b
Published: 2022

5. Predictors of treatment switching in the Big Multiple Sclerosis Data Network.

Author: Spelman, T, Magyari, M, Butzkueven, H, Van Der Walt, A, Vukusic, S, Trojano, M, Iaffaldano, P, Horáková, D, Drahota, J, Pellegrini, F, Hyde, R, Duquette, P, Lechner-Scott, J, Sajedi, SA, Lalive, P, Shaygannejad, V, Ozakbas, S, Eichau, S, Alroughani, R, Terzi, M, Girard, M, Kalincik, T, Grand'Maison, F, Skibina, O, Khoury, SJ, Yamout, B, Sa, MJ, Gerlach, O, Blanco, Y, Karabudak, R, Oreja-Guevara, C, Altintas, A, Hughes, S, McCombe, P, Ampapa, R, de Gans, K, McGuigan, C, Soysal, A, Prevost, J, John, N, Inshasi, J, Stawiarz, L, Manouchehrinia, A, Forsberg, L, Sellebjerg, F, Glaser, A, Pontieri, L, Joensen, H, Rasmussen, PV, Sejbaek, T, Poulsen, MB, Christensen, JR, Kant, M, Stilund, M, Mathiesen, H, Hillert, J, Big MS Data Network: a collaboration of the Czech MS Registry, the Danish MS Registry, Italian MS Registry, Swedish MS Registry, MSBase Study Group, and OFSEP, Spelman, T, Magyari, M, Butzkueven, H, Van Der Walt, A, Vukusic, S, Trojano, M, Iaffaldano, P, Horáková, D, Drahota, J, Pellegrini, F, Hyde, R, Duquette, P, Lechner-Scott, J, Sajedi, SA, Lalive, P, Shaygannejad, V, Ozakbas, S, Eichau, S, Alroughani, R, Terzi, M, Girard, M, Kalincik, T, Grand'Maison, F, Skibina, O, Khoury, SJ, Yamout, B, Sa, MJ, Gerlach, O, Blanco, Y, Karabudak, R, Oreja-Guevara, C, Altintas, A, Hughes, S, McCombe, P, Ampapa, R, de Gans, K, McGuigan, C, Soysal, A, Prevost, J, John, N, Inshasi, J, Stawiarz, L, Manouchehrinia, A, Forsberg, L, Sellebjerg, F, Glaser, A, Pontieri, L, Joensen, H, Rasmussen, PV, Sejbaek, T, Poulsen, MB, Christensen, JR, Kant, M, Stilund, M, Mathiesen, H, Hillert, J, and Big MS Data Network: a collaboration of the Czech MS Registry, the Danish MS Registry, Italian MS Registry, Swedish MS Registry, MSBase Study Group, and OFSEP
Abstract: BACKGROUND: Treatment switching is a common challenge and opportunity in real-world clinical practice. Increasing diversity in disease-modifying treatments (DMTs) has generated interest in the identification of reliable and robust predictors of treatment switching across different countries, DMTs, and time periods. OBJECTIVE: The objective of this retrospective, observational study was to identify independent predictors of treatment switching in a population of relapsing-remitting MS (RRMS) patients in the Big Multiple Sclerosis Data Network of national clinical registries, including the Italian MS registry, the OFSEP of France, the Danish MS registry, the Swedish national MS registry, and the international MSBase Registry. METHODS: In this cohort study, we merged information on 269,822 treatment episodes in 110,326 patients from 1997 to 2018 from five clinical registries. Patients were included in the final pooled analysis set if they had initiated at least one DMT during the relapsing-remitting MS (RRMS) stage. Patients not diagnosed with RRMS or RRMS patients not initiating DMT therapy during the RRMS phase were excluded from the analysis. The primary study outcome was treatment switching. A multilevel mixed-effects shared frailty time-to-event model was used to identify independent predictors of treatment switching. The contributing MS registry was included in the pooled analysis as a random effect. RESULTS: Every one-point increase in the Expanded Disability Status Scale (EDSS) score at treatment start was associated with 1.08 times the rate of subsequent switching, adjusting for age, sex, and calendar year (adjusted hazard ratio [aHR] 1.08; 95% CI 1.07-1.08). Women were associated with 1.11 times the rate of switching relative to men (95% CI 1.08-1.14), whilst older age was also associated with an increased rate of treatment switching. DMTs started between 2007 and 2012 were associated with 2.48 times the rate of switching relative to DMTs that began between 1
Published: 2023

6. Data monitoring roadmap. The experience of the Italian Multiple Sclerosis and Related Disorders Register

Author: Mosconi, P., Guerra, T., Paletta, P., D’Ettorre, A., Ponzio, M., Battaglia, M. A., Amato, M. P., Bergamaschi, R., Capobianco, M., Comi, G., Gasperini, C., Patti, F., Pugliatti, M., Ulivelli, M., Trojano, M., Lepore, V., Aguglia, U., Amato, M., Ancona, A., Ardito, B., Avolio, C., Balgera, R., Banfi, P., Barcella, V., Barone, P., Bellantonio, P., Berardinelli, A., Bertora, P., Bianchi, M., Bramanti, P., Brescia Morra, V., Brichetto, G., Brioschi, A., Buccafusca, M., Bucello, S., Busillo, V., Calchetti, B., Cantello, R., Capone, F., Capone, L., Cargnelutti, D., Carozzi, M., Cartechini, E., Cavaletti, G., Cavalla, P., Celani, M., Clerici, R., Clerico, M., Cocco, E., Torri Clerici, V., Coniglio, M., Conte, A., Corea, F., Cottone, S., Crociani, P., D’Andrea, F., Danni, M., De Luca, G., de Pascalis, D., De Riz, M., De Robertis, F., De Rosa, G., De Stefano, N., Della Corte, M., Di Sapio, A., Docimo, R., Falcini, M., Falcone, N., Fermi, S., Ferraro, E., Ferrò, M., Fortunato, M., Foschi, M., Gajofatto, A., Gallo, A., Gallo, P., Gatto, M., Gazzola, P., Giordano, A., Granella, F., Grasso, M., Grimaldi, L., Iaffaldano, P., Immovilli, P., Imperiale, D., Inglese, M., Iodice, R., Leva, S., Leuzzi, V., Lugaresi, A., Lus, G., Maimone, D., Mancinelli, L., Maniscalco, G., Marfia, G., Margari, L., Marinelli, F., Marini, B., Marson, A., Mascoli, N., Massacesi, L., Melani, F., Merello, M., Fioretti, C., Mirabella, Massimiliano, Montepietra, S., Nasuelli, D., Nicolao, P., Pasquali, L., Passantino, F., Pecori, C., Peresson, M., Pesci, I., Piantadosi, C., Piras, M. L., Pizzorno, M., Plewnia, K., Pozzilli, C., Protti, A., Quatrale, R., Realmuto, S., Ribizzi, G., Rinalduzzi, S., Rini, A., Romano, S., Filippi, M., Ronzoni, M., Rossi, P., Rovaris, M., Salemi, G., Santangelo, G., Santangelo, M., Leone, A., Sarchielli, P., Sinisi, L., Ferraro, D., Solaro, C., Spitaleri, D., Strumia, S., Tassinari, T., Santuccio, G., Tortorella, C., Totaro, R., Tozzo, A., Trivelli, G., Turano, G., Valentino, P., Venturi, S., Vianello, M., Zaffaroni, M., Zarbo, R., Mirabella M. (ORCID:0000-0002-7783-114X), Mosconi, P., Guerra, T., Paletta, P., D’Ettorre, A., Ponzio, M., Battaglia, M. A., Amato, M. P., Bergamaschi, R., Capobianco, M., Comi, G., Gasperini, C., Patti, F., Pugliatti, M., Ulivelli, M., Trojano, M., Lepore, V., Aguglia, U., Amato, M., Ancona, A., Ardito, B., Avolio, C., Balgera, R., Banfi, P., Barcella, V., Barone, P., Bellantonio, P., Berardinelli, A., Bertora, P., Bianchi, M., Bramanti, P., Brescia Morra, V., Brichetto, G., Brioschi, A., Buccafusca, M., Bucello, S., Busillo, V., Calchetti, B., Cantello, R., Capone, F., Capone, L., Cargnelutti, D., Carozzi, M., Cartechini, E., Cavaletti, G., Cavalla, P., Celani, M., Clerici, R., Clerico, M., Cocco, E., Torri Clerici, V., Coniglio, M., Conte, A., Corea, F., Cottone, S., Crociani, P., D’Andrea, F., Danni, M., De Luca, G., de Pascalis, D., De Riz, M., De Robertis, F., De Rosa, G., De Stefano, N., Della Corte, M., Di Sapio, A., Docimo, R., Falcini, M., Falcone, N., Fermi, S., Ferraro, E., Ferrò, M., Fortunato, M., Foschi, M., Gajofatto, A., Gallo, A., Gallo, P., Gatto, M., Gazzola, P., Giordano, A., Granella, F., Grasso, M., Grimaldi, L., Iaffaldano, P., Immovilli, P., Imperiale, D., Inglese, M., Iodice, R., Leva, S., Leuzzi, V., Lugaresi, A., Lus, G., Maimone, D., Mancinelli, L., Maniscalco, G., Marfia, G., Margari, L., Marinelli, F., Marini, B., Marson, A., Mascoli, N., Massacesi, L., Melani, F., Merello, M., Fioretti, C., Mirabella, Massimiliano, Montepietra, S., Nasuelli, D., Nicolao, P., Pasquali, L., Passantino, F., Pecori, C., Peresson, M., Pesci, I., Piantadosi, C., Piras, M. L., Pizzorno, M., Plewnia, K., Pozzilli, C., Protti, A., Quatrale, R., Realmuto, S., Ribizzi, G., Rinalduzzi, S., Rini, A., Romano, S., Filippi, M., Ronzoni, M., Rossi, P., Rovaris, M., Salemi, G., Santangelo, G., Santangelo, M., Leone, A., Sarchielli, P., Sinisi, L., Ferraro, D., Solaro, C., Spitaleri, D., Strumia, S., Tassinari, T., Santuccio, G., Tortorella, C., Totaro, R., Tozzo, A., Trivelli, G., Turano, G., Valentino, P., Venturi, S., Vianello, M., Zaffaroni, M., Zarbo, R., and Mirabella M. (ORCID:0000-0002-7783-114X)
Abstract: IntroductionOver the years, disease registers have been increasingly considered a source of reliable and valuable population studies. However, the validity and reliability of data from registers may be limited by missing data, selection bias or data quality not adequately evaluated or checked.This study reports the analysis of the consistency and completeness of the data in the Italian Multiple Sclerosis and Related Disorders Register.MethodsThe Register collects, through a standardized Web-based Application, unique patients.Data are exported bimonthly and evaluated to assess the updating and completeness, and to check the quality and consistency. Eight clinical indicators are evaluated.ResultsThe Register counts 77,628 patients registered by 126 centres. The number of centres has increased over time, as their capacity to collect patients.The percentages of updated patients (with at least one visit in the last 24 months) have increased from 33% (enrolment period 2000-2015) to 60% (enrolment period 2016-2022). In the cohort of patients registered after 2016, there were >= 75% updated patients in 30% of the small centres (33), in 9% of the medium centres (11), and in all the large centres (2).Clinical indicators show significant improvement for the active patients, expanded disability status scale every 6 months or once every 12 months, visits every 6 months, first visit within 1 year and MRI every 12 months.ConclusionsData from disease registers provide guidance for evidence-based health policies and research, so methods and strategies ensuring their quality and reliability are crucial and have several potential applications.
Published: 2023

7. Detection of disability worsening in relapsing-remitting multiple sclerosis patients: a real-world roving Expanded Disability Status Scale reference analysis from the Italian Multiple Sclerosis Register

Author: Lepore, V, Bosetti, C, Santucci, C, Iaffaldano, P, Trojano, M, Mosconi, P, Totaro, R, Coniglio, M, Bossio, R, Valentino, P, Gatto, M, Paolicelli, D, Ardito, B, Barcella, V, Capone, L, Nicolao, P, Lugaresi, A, Rini, A, Bianchi, M, Plasmati, I, Cocco, E, Docimo, R, De Luca, G, Mondino, F, Di Sapio, A, Clerici, R, Mascoli, N, Ferro, M, Chisari, C, Maimone, D, Strumia, S, Pugliatti, M, Cargnelutti, D, Caniatti, L, Avolio, C, Crociani, P, Amato, M, Massacesi, L, Malagu, S, Ribizzi, G, Inglese, M, Venturi, S, Gazzola, P, Pizio, N, Brichetto, G, Plewnia, K, Bellantonio, P, Balgera, R, De Robertis, F, Fermi, S, Fausto, F, Mazzoni, M, Meucci, G, Cartechini, E, Cavaletti, G, Buccafusca, M, Bramanti, P, Romeo, M, Rovaris, M, Ronzoni, M, Confalonieri, P, Chiveri, L, Bertora, P, Tonietti, S, De Riz, M, Protti, A, Sola, P, Maremmani, C, Lus, G, Gallo, A, Maniscalco, G, Morra, V, Cacchio, G, Iodice, R, Ragno, M, Sinisi, L, Cantello, R, Piras, M, Salemi, G, Cottone, S, Grimaldi, L, Corea, F, Santangelo, G, Immovili, P, Gallo, P, D'Andrea, F, Frittelli, C, Pasquali, L, Falcini, M, Granella, F, Pesci, I, Ancona, A, Bergamaschi, R, Giordano, A, Di Napoli, M, Romano, S, Pozzilli, C, Mirabella, M, Conte, A, Galgani, S, Peresson, M, Grasso, M, Ferraro, E, Capone, F, Marfia, G, de Pascalis, D, Piantadosi, C, Valeriani, M, Busillo, V, Barone, P, De Stefano, N, Ulivelli, M, Santuccio, G, Parodi, S, Bucello, S, Traccis, S, Zarbo, R, Tassinari, T, Bandini, F, Cavalla, P, Clerico, M, De Rosa, G, Bertolotto, A, Imperiale, D, Sarchielli, P, Celani, M, Vianello, M, Marini, B, Fortunato, M, Zaffaroni, M, Nasuelli, D, Banfi, P, Brioschi, A, Solaro, C, Quatrale, R, Rossi, P, Gajofatto, A, Battaglia, M, Capobianco, M, Patti, F, Comi, G, Lepore V., Bosetti C., Santucci C., Iaffaldano P., Trojano M., Mosconi P., Totaro R., Coniglio M. G., Bossio R. B., Valentino P., Gatto M., Paolicelli D., Ardito B., Barcella V., Capone L., Nicolao P., Lugaresi A., Rini A., Bianchi M., Plasmati I., Cocco E., Docimo R., De Luca G., Mondino F., Di Sapio A., Clerici R., Mascoli N., Ferro M. T., Chisari C. G., Maimone D., Strumia S., Pugliatti M., Cargnelutti D., Caniatti L. M., Avolio C., Crociani P., Amato M. P., Massacesi L., Malagu S., Ribizzi G., Inglese M., Venturi S., Gazzola P., Pizio N. R., Brichetto G., Plewnia K., Bellantonio P., Balgera R., De Robertis F., Fermi S., Fausto F., Mazzoni M., Meucci G., Cartechini E., Cavaletti G., Buccafusca M., Bramanti P., Romeo M., Rovaris M., Ronzoni M., Confalonieri P., Chiveri L., Bertora P., Tonietti S., De Riz M., Protti A., Sola P., Maremmani C., Lus G., Gallo A., Maniscalco G. T., Morra V. B., Cacchio G., Iodice R., Ragno M., Sinisi L., Cantello R., Piras M. L., Salemi G., Cottone S., Grimaldi L. M. E., Corea F., Santangelo G., Immovili P., Gallo P., D'Andrea F., Frittelli C., Pasquali L., Falcini M., Granella F., Pesci I., Ancona A. L., Bergamaschi R., Giordano A., Di Napoli M., Romano S., Pozzilli C., Mirabella M., Conte A., Galgani S., Peresson M., Grasso M. G., Ferraro E., Capone F., Marfia G. A., de Pascalis D., Piantadosi C., Valeriani M., Busillo V., Barone P., De Stefano N., Ulivelli M., Santuccio G., Parodi S., Bucello S., Traccis S., Zarbo R., Tassinari T., Bandini F., Cavalla P., Clerico M., De Rosa G., Bertolotto A., Imperiale D., Sarchielli P., Celani M. G., Vianello M., Marini B., Fortunato M., Zaffaroni M., Nasuelli D., Banfi P., Brioschi A. M., Solaro C., Quatrale R., Rossi P., Gajofatto A., Battaglia M. A., Capobianco M., Patti F., Comi G., Lepore, V, Bosetti, C, Santucci, C, Iaffaldano, P, Trojano, M, Mosconi, P, Totaro, R, Coniglio, M, Bossio, R, Valentino, P, Gatto, M, Paolicelli, D, Ardito, B, Barcella, V, Capone, L, Nicolao, P, Lugaresi, A, Rini, A, Bianchi, M, Plasmati, I, Cocco, E, Docimo, R, De Luca, G, Mondino, F, Di Sapio, A, Clerici, R, Mascoli, N, Ferro, M, Chisari, C, Maimone, D, Strumia, S, Pugliatti, M, Cargnelutti, D, Caniatti, L, Avolio, C, Crociani, P, Amato, M, Massacesi, L, Malagu, S, Ribizzi, G, Inglese, M, Venturi, S, Gazzola, P, Pizio, N, Brichetto, G, Plewnia, K, Bellantonio, P, Balgera, R, De Robertis, F, Fermi, S, Fausto, F, Mazzoni, M, Meucci, G, Cartechini, E, Cavaletti, G, Buccafusca, M, Bramanti, P, Romeo, M, Rovaris, M, Ronzoni, M, Confalonieri, P, Chiveri, L, Bertora, P, Tonietti, S, De Riz, M, Protti, A, Sola, P, Maremmani, C, Lus, G, Gallo, A, Maniscalco, G, Morra, V, Cacchio, G, Iodice, R, Ragno, M, Sinisi, L, Cantello, R, Piras, M, Salemi, G, Cottone, S, Grimaldi, L, Corea, F, Santangelo, G, Immovili, P, Gallo, P, D'Andrea, F, Frittelli, C, Pasquali, L, Falcini, M, Granella, F, Pesci, I, Ancona, A, Bergamaschi, R, Giordano, A, Di Napoli, M, Romano, S, Pozzilli, C, Mirabella, M, Conte, A, Galgani, S, Peresson, M, Grasso, M, Ferraro, E, Capone, F, Marfia, G, de Pascalis, D, Piantadosi, C, Valeriani, M, Busillo, V, Barone, P, De Stefano, N, Ulivelli, M, Santuccio, G, Parodi, S, Bucello, S, Traccis, S, Zarbo, R, Tassinari, T, Bandini, F, Cavalla, P, Clerico, M, De Rosa, G, Bertolotto, A, Imperiale, D, Sarchielli, P, Celani, M, Vianello, M, Marini, B, Fortunato, M, Zaffaroni, M, Nasuelli, D, Banfi, P, Brioschi, A, Solaro, C, Quatrale, R, Rossi, P, Gajofatto, A, Battaglia, M, Capobianco, M, Patti, F, Comi, G, Lepore V., Bosetti C., Santucci C., Iaffaldano P., Trojano M., Mosconi P., Totaro R., Coniglio M. G., Bossio R. B., Valentino P., Gatto M., Paolicelli D., Ardito B., Barcella V., Capone L., Nicolao P., Lugaresi A., Rini A., Bianchi M., Plasmati I., Cocco E., Docimo R., De Luca G., Mondino F., Di Sapio A., Clerici R., Mascoli N., Ferro M. T., Chisari C. G., Maimone D., Strumia S., Pugliatti M., Cargnelutti D., Caniatti L. M., Avolio C., Crociani P., Amato M. P., Massacesi L., Malagu S., Ribizzi G., Inglese M., Venturi S., Gazzola P., Pizio N. R., Brichetto G., Plewnia K., Bellantonio P., Balgera R., De Robertis F., Fermi S., Fausto F., Mazzoni M., Meucci G., Cartechini E., Cavaletti G., Buccafusca M., Bramanti P., Romeo M., Rovaris M., Ronzoni M., Confalonieri P., Chiveri L., Bertora P., Tonietti S., De Riz M., Protti A., Sola P., Maremmani C., Lus G., Gallo A., Maniscalco G. T., Morra V. B., Cacchio G., Iodice R., Ragno M., Sinisi L., Cantello R., Piras M. L., Salemi G., Cottone S., Grimaldi L. M. E., Corea F., Santangelo G., Immovili P., Gallo P., D'Andrea F., Frittelli C., Pasquali L., Falcini M., Granella F., Pesci I., Ancona A. L., Bergamaschi R., Giordano A., Di Napoli M., Romano S., Pozzilli C., Mirabella M., Conte A., Galgani S., Peresson M., Grasso M. G., Ferraro E., Capone F., Marfia G. A., de Pascalis D., Piantadosi C., Valeriani M., Busillo V., Barone P., De Stefano N., Ulivelli M., Santuccio G., Parodi S., Bucello S., Traccis S., Zarbo R., Tassinari T., Bandini F., Cavalla P., Clerico M., De Rosa G., Bertolotto A., Imperiale D., Sarchielli P., Celani M. G., Vianello M., Marini B., Fortunato M., Zaffaroni M., Nasuelli D., Banfi P., Brioschi A. M., Solaro C., Quatrale R., Rossi P., Gajofatto A., Battaglia M. A., Capobianco M., Patti F., and Comi G.
Abstract: Background and purpose: In relapsing-remitting multiple sclerosis patients (RRMS) disability progressively accumulates over time. To compare the cumulative probability of 6-month confirmed disability-worsening events using a fixed baseline or a roving Expanded Disability Status Scale (EDSS) reference, in a real-world setting. Methods: A cohort of 7964 RRMS patients followed for 2 or more years, with EDSS scores recorded every 6 months, was selected from the Italian Multiple Sclerosis Register. The overall probability of confirmed disability-worsening events and of confirmed disability-worsening events unrelated to relapse was evaluated using as reference a fixed baseline EDSS score or a roving EDSS score in which the increase had to be separated from the last EDSS assessment by at least 6 or 12 months. Results: Using a fixed baseline EDSS reference, the cumulative probability of 6-year overall confirmed disability-worsening events was 33.2%, and that of events unrelated to relapse was 10.9% (33% of overall confirmed disability-worsening events). Using a roving EDSS, the proportions were respectively 35.2% and 21.3% (61% of overall confirmed disability-worsening events). Conclusions: In a real-world setting, roving EDSS reference scores appear to be more sensitive for detecting confirmed disability-worsening events unrelated to relapse in RRMS patients.
Published: 2021

8. Risk of Persistent Disability in Patients with Pediatric-Onset Multiple Sclerosis

Author: 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, Cavaletti, G, 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., Cavaletti G., 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, Cavaletti, G, 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., and Cavaletti G.
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 59000 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 (<1993, 1993-1999, 2000-2006, and 2007-2013), adjusting for possible confounders linked to EDSS evaluations and clinical disease activity. We then analyzed the difference among the 4 diagnosis epochs regarding demographic characteristics, clinical disease activity at onset, and DMTs management. Main Outcomes and Measures: Disability milestones were EDSS score 4.0 and 6.0, confirmed in the following clinical evaluation and in the last available visit. Results: We enrolled 3198 patients with POMS (mean age at onset, 15.2 years; 69% female; median time to diagnosis, 3.2 years; annualized relapse rate in first 1 and 3 years, 1.3 and 0.6, respectively), with a mean (SD) follow-up of 21.8 (11.7) years. Median survival times to reach EDSS score of 4.0 and 6.0 were 31.7 and 40.5 ye
Published: 2021

9. Do patients' and referral centers' characteristics influence multiple sclerosis phenotypes? Results from the Italian multiple sclerosis and related disorders register

Author: Bergamaschi, R, Beghi, E, Bosetti, C, Ponzio, M, Santucci, C, Lepore, V, Mosconi, P, Aguglia, U, Amato, M, Ancona, A, Ardito, B, Avolio, C, Balgera, R, Banfi, P, Barcella, V, Barone, P, Bellantonio, P, Berardinelli, A, Bertora, P, Bianchi, M, Bramanti, P, Morra, V, Brichetto, G, Brioschi, A, Buccafusca, M, Bucello, S, Busillo, V, Calchetti, B, Cantello, R, Capobianco, M, Capone, F, Capone, L, Cargnelutti, D, Carrozzi, M, Cartechini, E, Cavaletti, G, Cavalla, P, Celani, M, Clerici, R, Clerico, M, Cocco, E, Confalonieri, P, Coniglio, M, Conte, A, Corea, F, Cottone, S, Crociani, P, D'Andrea, F, Danni, M, De Luca, G, de Pascalis, D, De Riz, M, De Robertis, F, De Rosa, G, De Stefano, N, Corte, M, Di Sapio, A, Docimo, R, Falcini, M, Falcone, N, Fermi, S, Ferraro, E, Ferrò, M, Fortunato, M, Foschi, M, Gajofatto, A, Gallo, A, Gallo, P, Gatto, M, Gazzola, P, Giordano, A, Granella, F, Grasso, M, Grimaldi, L, Iaffaldano, P, Imperiale, D, Inglese, M, Iodice, R, Leva, S, Luezzi, V, Lugaresi, A, Lus, G, Maimone, D, Mancinelli, L, Maniscalco, G, Marfia, G, Marini, B, Marson, A, Mascoli, N, Massacesi, L, Melani, F, Merello, M, Meucci, G, Mirabella, M, Montepietra, S, Nasuelli, D, Nicolao, P, Passantino, F, Patti, F, Peresson, M, Pesci, I, Piantadosi, C, Piras, M, Pizzorno, M, Plewnia, K, Pozzilli, C, Protti, A, Quatrale, R, Realmuto, S, Ribizzi, G, Rinalduzzi, S, Rini, A, Romano, S, Romeo, M, Ronzoni, M, Rossi, P, Rovaris, M, Salemi, G, Santangelo, G, Santangelo, M, Santuccio, G, Sarchielli, P, Sinisi, L, Sola, P, Solaro, C, Spitaleri, D, Strumia, S, Tassinari, T, Tonietti, S, Tortorella, C, Totaro, R, Tozzo, A, Trivelli, G, Ulivelli, M, Valentino, P, Venturi, S, Vianello, M, Zaffaroni, M, Zarbo, R, Trojano, M, Battaglia, M, Pugliatti, M, Gasperini, C, Comi, G, Bergamaschi, Roberto, Beghi, Ettore, Bosetti, Cristina, Ponzio, Michela, Santucci, Claudia, Lepore, Vito, Mosconi, Paola, Amato, M P, Ancona, A L, Morra, V Brescia, Brioschi, A M, Celani, M G, Coniglio, M G, Danni, M C, Corte, M Della, Ferrò, M T, Grasso, M F, Grasso, M G, Grimaldi, L M E, Maniscalco, G T, Marfia, G A, Piras, M L, Trojano, Maria, Battaglia, Mario Alberto, Capobianco, Marco, Pugliatti, Maura, Ulivelli, Monica, Gasperini, Claudio, Patti, Francesco, Amato, Maria Pia, Comi, Giancarlo, Bergamaschi, R, Beghi, E, Bosetti, C, Ponzio, M, Santucci, C, Lepore, V, Mosconi, P, Aguglia, U, Amato, M, Ancona, A, Ardito, B, Avolio, C, Balgera, R, Banfi, P, Barcella, V, Barone, P, Bellantonio, P, Berardinelli, A, Bertora, P, Bianchi, M, Bramanti, P, Morra, V, Brichetto, G, Brioschi, A, Buccafusca, M, Bucello, S, Busillo, V, Calchetti, B, Cantello, R, Capobianco, M, Capone, F, Capone, L, Cargnelutti, D, Carrozzi, M, Cartechini, E, Cavaletti, G, Cavalla, P, Celani, M, Clerici, R, Clerico, M, Cocco, E, Confalonieri, P, Coniglio, M, Conte, A, Corea, F, Cottone, S, Crociani, P, D'Andrea, F, Danni, M, De Luca, G, de Pascalis, D, De Riz, M, De Robertis, F, De Rosa, G, De Stefano, N, Corte, M, Di Sapio, A, Docimo, R, Falcini, M, Falcone, N, Fermi, S, Ferraro, E, Ferrò, M, Fortunato, M, Foschi, M, Gajofatto, A, Gallo, A, Gallo, P, Gatto, M, Gazzola, P, Giordano, A, Granella, F, Grasso, M, Grimaldi, L, Iaffaldano, P, Imperiale, D, Inglese, M, Iodice, R, Leva, S, Luezzi, V, Lugaresi, A, Lus, G, Maimone, D, Mancinelli, L, Maniscalco, G, Marfia, G, Marini, B, Marson, A, Mascoli, N, Massacesi, L, Melani, F, Merello, M, Meucci, G, Mirabella, M, Montepietra, S, Nasuelli, D, Nicolao, P, Passantino, F, Patti, F, Peresson, M, Pesci, I, Piantadosi, C, Piras, M, Pizzorno, M, Plewnia, K, Pozzilli, C, Protti, A, Quatrale, R, Realmuto, S, Ribizzi, G, Rinalduzzi, S, Rini, A, Romano, S, Romeo, M, Ronzoni, M, Rossi, P, Rovaris, M, Salemi, G, Santangelo, G, Santangelo, M, Santuccio, G, Sarchielli, P, Sinisi, L, Sola, P, Solaro, C, Spitaleri, D, Strumia, S, Tassinari, T, Tonietti, S, Tortorella, C, Totaro, R, Tozzo, A, Trivelli, G, Ulivelli, M, Valentino, P, Venturi, S, Vianello, M, Zaffaroni, M, Zarbo, R, Trojano, M, Battaglia, M, Pugliatti, M, Gasperini, C, Comi, G, Bergamaschi, Roberto, Beghi, Ettore, Bosetti, Cristina, Ponzio, Michela, Santucci, Claudia, Lepore, Vito, Mosconi, Paola, Amato, M P, Ancona, A L, Morra, V Brescia, Brioschi, A M, Celani, M G, Coniglio, M G, Danni, M C, Corte, M Della, Ferrò, M T, Grasso, M F, Grasso, M G, Grimaldi, L M E, Maniscalco, G T, Marfia, G A, Piras, M L, Trojano, Maria, Battaglia, Mario Alberto, Capobianco, Marco, Pugliatti, Maura, Ulivelli, Monica, Gasperini, Claudio, Patti, Francesco, Amato, Maria Pia, and Comi, Giancarlo
Abstract: Background: Multiple sclerosis (MS) is characterized by phenotypical heterogeneity, partly resulting from demographic and environmental risk factors. Socio-economic factors and the characteristics of local MS facilities might also play a part. Methods: This study included patients with a confirmed MS diagnosis enrolled in the Italian MS and Related Disorders Register in 2000–2021. Patients at first visit were classified as having a clinically isolated syndrome (CIS), relapsing–remitting (RR), primary progressive (PP), progressive-relapsing (PR), or secondary progressive MS (SP). Demographic and clinical characteristics were analyzed, with centers’ characteristics, geographic macro-areas, and Deprivation Index. We computed the odds ratios (OR) for CIS, PP/PR, and SP phenotypes, compared to the RR, using multivariate, multinomial, mixed effects logistic regression models. Results: In all 35,243 patients from 106 centers were included. The OR of presenting more advanced MS phenotypes than the RR phenotype at first visit significantly diminished in relation to calendar period. Females were at a significantly lower risk of a PP/PR or SP phenotype. Older age was associated with CIS, PP/PR, and SP. The risk of a longer interval between disease onset and first visit was lower for the CIS phenotype, but higher for PP/PR and SP. The probability of SP at first visit was greater in the South of Italy. Discussion: Differences in the phenotype of MS patients first seen in Italian centers can be only partly explained by differences in the centers’ characteristics. The demographic and socio-economic characteristics of MS patients seem to be the main determinants of the phenotypes at first referral.
Published: 2022

10. Signs and symptoms of COVID-19 in patients with multiple sclerosis

Author: Schiavetti, I., Carmisciano, L., Ponzano, M., Cordioli, C., Cocco, E., Marfia, G. A., Inglese, M., Filippi, M., Radaelli, M., Bergamaschi, R., Immovilli, P., Capobianco, M., De Rossi, N., Brichetto, G., Scandellari, C., Cavalla, P., Pesci, I., Confalonieri, P., Perini, P., Trojano, M., Lanzillo, R., Tedeschi, G., Comi, G., Battaglia, M. A., Patti, F., Salvetti, M., Sormani, M. P., Abbadessa, G., Aguglia, U., Allegorico, L., Rossi Allegri, B. M., Alteno, A., Amato, M. P., Annovazzi, P., Antozzi, C., Appendino, L., Arena, S., Baione, V., Balgera, R., Barcella, V., Baroncini, D., Barrila, C., Bellacosa, A., Bellucci, G., Bergamaschi, V., Bezzini, D., Biolzi, B., Bisecco, A., Bonavita, S., Borriello, G., Bosa, C., Bosco, A., Bovis, F., Bozzali, M., Brambilla, L., Brescia Morra, V., Buccafusca, M., Bucciantini, E., Bucello, S., Buscarinu, M. C., Cabboi, M. P., Calabrese, M., Calabria, F., Caleri, F., Camilli, F., Caniatti, L. M., Cantello, R., Capra, R., Capuano, R., Carta, P., Celani, M. G., Cellerino, M., Cerqua, R., Chisari, C., Clerici, R., Clerico, M., Cola, G., Conte, A., Conti, M. Z., Cordano, C., Cordera, S., Corea, F., Correale, C., Cottone, S., Crescenzo, F., Curti, E., D'Ambrosio, A., D'Amico, E., Danni, M. C., D'Arma, A., Dattola, V., de Biase, S., De Luca, G., De Mercanti, S. F., De Mitri, P., De Stefano, N., Della Cava, F. M., Cava, M. D., Di Lemme, S., di Napoli, M., Di Sapio, A., Docimo, R., Dutto, A., Evangelista, L., Fanara, S., Fantozzi, R., Ferraro, D., Ferro, M. T., Fioretti, C., Fratta, M., Frau, J., Fronza, M., Furlan, R., Gajofatto, A., Gallo, A., Gallo, P., Gasperini, C., Ghazaryan, A., Giometto, B., Gobbin, F., Govone, F., Granella, F., Grange, E., Grasso, M. G., Grimaldi, L. M. E., Guareschi, A., Guaschino, C., Guerrieri, S., Guidetti, D., Juergenson, I. B., Iaffaldano, P., Ianniello, A., Iasevoli, L., Imperiale, D., Infante, M. T., Iodice, R., Iovino, A., Konrad, G., Landi, D., Lapucci, C., Lavorgna, L., L'Episcopo, M. R., Leva, S., Liberatore, G., Lo Re, M., Longoni, M., Lopiano, L., Lorefice, L., Lucchini, Matteo, Lus, G., Maimone, D., Malentacchi, M., Mallucci, G., Malucchi, S., Mancinelli, C. R., Mancinelli, L., Manganotti, P., Maniscalco, G. T., Mantero, V., Marangoni, S., Marastoni, D., Marinelli, F., Marti, A., Boneschi Martinelli, F., Masserano, Z. F., Matta, F., Mendozzi, L., Meucci, G., Miante, S., Miele, G., Milano, E., Mirabella, Massimiliano, Missione, R., Moccia, M., Moiola, L., Montepietra, S., Montibragadin, M., Montini, F., Motta, R., Nardone, R., Gabri Nicoletti, C., Nobile-Orazio, E., Nozzolillo, A., Onofrj, M., Orlandi, R., Palmieri, A., Paolicelli, D., Pasquali, L., Pasto, L., Pedrazzoli, E., Petracca, M., Petrone, A., Piantadosi, C., Pietroboni, A. M., Pinardi, F., Portaccio, E., Pozzato, M., Pozzilli, C., Prosperini, L., Protti, A., Ragonese, P., Rasia, S., Realmuto, S., Repice, A., Rigoni, E., Rilla, M. T., Rinaldi, F., Romano, C. M., Ronzoni, M., Rovaris, M., Ruscica, F., Sabattini, L., Salemi, G., Saraceno, L., Sartori, A., Sbragia, E., Scarano, G. I., Scarano, V., Sessa, M., Sgarito, C., Sibilia, G., Siciliano, G., Signori, A., Signoriello, E., Sinisi, L., Sireci, F., Sola, P., Solaro, C., Sotgiu, S., Sparaco, M., Stromillo, M. L., Strumia, S., Susani, E. L., Tabiadon, G., Teatini, F., Tomassini, V., Tonietti, S., Torri, V., Tortorella, C., Toscano, S., Totaro, R., Trotta, M., Turano, G., Ulivelli, M., Valentino, M., Vaula, G., Vecchio, D., Vercellino, M., Verrengia, E. P., Vianello, M., Virgilio, E., Vitetta, F., Vollaro, S., Zaffaroni, M., Zampolini, M., Zarbo, I. R., Zito, A., Zuliani, L., Lucchini M. (ORCID:0000-0002-0447-2297), Mirabella M. (ORCID:0000-0002-7783-114X), Schiavetti, I., Carmisciano, L., Ponzano, M., Cordioli, C., Cocco, E., Marfia, G. A., Inglese, M., Filippi, M., Radaelli, M., Bergamaschi, R., Immovilli, P., Capobianco, M., De Rossi, N., Brichetto, G., Scandellari, C., Cavalla, P., Pesci, I., Confalonieri, P., Perini, P., Trojano, M., Lanzillo, R., Tedeschi, G., Comi, G., Battaglia, M. A., Patti, F., Salvetti, M., Sormani, M. P., Abbadessa, G., Aguglia, U., Allegorico, L., Rossi Allegri, B. M., Alteno, A., Amato, M. P., Annovazzi, P., Antozzi, C., Appendino, L., Arena, S., Baione, V., Balgera, R., Barcella, V., Baroncini, D., Barrila, C., Bellacosa, A., Bellucci, G., Bergamaschi, V., Bezzini, D., Biolzi, B., Bisecco, A., Bonavita, S., Borriello, G., Bosa, C., Bosco, A., Bovis, F., Bozzali, M., Brambilla, L., Brescia Morra, V., Buccafusca, M., Bucciantini, E., Bucello, S., Buscarinu, M. C., Cabboi, M. P., Calabrese, M., Calabria, F., Caleri, F., Camilli, F., Caniatti, L. M., Cantello, R., Capra, R., Capuano, R., Carta, P., Celani, M. G., Cellerino, M., Cerqua, R., Chisari, C., Clerici, R., Clerico, M., Cola, G., Conte, A., Conti, M. Z., Cordano, C., Cordera, S., Corea, F., Correale, C., Cottone, S., Crescenzo, F., Curti, E., D'Ambrosio, A., D'Amico, E., Danni, M. C., D'Arma, A., Dattola, V., de Biase, S., De Luca, G., De Mercanti, S. F., De Mitri, P., De Stefano, N., Della Cava, F. M., Cava, M. D., Di Lemme, S., di Napoli, M., Di Sapio, A., Docimo, R., Dutto, A., Evangelista, L., Fanara, S., Fantozzi, R., Ferraro, D., Ferro, M. T., Fioretti, C., Fratta, M., Frau, J., Fronza, M., Furlan, R., Gajofatto, A., Gallo, A., Gallo, P., Gasperini, C., Ghazaryan, A., Giometto, B., Gobbin, F., Govone, F., Granella, F., Grange, E., Grasso, M. G., Grimaldi, L. M. E., Guareschi, A., Guaschino, C., Guerrieri, S., Guidetti, D., Juergenson, I. B., Iaffaldano, P., Ianniello, A., Iasevoli, L., Imperiale, D., Infante, M. T., Iodice, R., Iovino, A., Konrad, G., Landi, D., Lapucci, C., Lavorgna, L., L'Episcopo, M. R., Leva, S., Liberatore, G., Lo Re, M., Longoni, M., Lopiano, L., Lorefice, L., Lucchini, Matteo, Lus, G., Maimone, D., Malentacchi, M., Mallucci, G., Malucchi, S., Mancinelli, C. R., Mancinelli, L., Manganotti, P., Maniscalco, G. T., Mantero, V., Marangoni, S., Marastoni, D., Marinelli, F., Marti, A., Boneschi Martinelli, F., Masserano, Z. F., Matta, F., Mendozzi, L., Meucci, G., Miante, S., Miele, G., Milano, E., Mirabella, Massimiliano, Missione, R., Moccia, M., Moiola, L., Montepietra, S., Montibragadin, M., Montini, F., Motta, R., Nardone, R., Gabri Nicoletti, C., Nobile-Orazio, E., Nozzolillo, A., Onofrj, M., Orlandi, R., Palmieri, A., Paolicelli, D., Pasquali, L., Pasto, L., Pedrazzoli, E., Petracca, M., Petrone, A., Piantadosi, C., Pietroboni, A. M., Pinardi, F., Portaccio, E., Pozzato, M., Pozzilli, C., Prosperini, L., Protti, A., Ragonese, P., Rasia, S., Realmuto, S., Repice, A., Rigoni, E., Rilla, M. T., Rinaldi, F., Romano, C. M., Ronzoni, M., Rovaris, M., Ruscica, F., Sabattini, L., Salemi, G., Saraceno, L., Sartori, A., Sbragia, E., Scarano, G. I., Scarano, V., Sessa, M., Sgarito, C., Sibilia, G., Siciliano, G., Signori, A., Signoriello, E., Sinisi, L., Sireci, F., Sola, P., Solaro, C., Sotgiu, S., Sparaco, M., Stromillo, M. L., Strumia, S., Susani, E. L., Tabiadon, G., Teatini, F., Tomassini, V., Tonietti, S., Torri, V., Tortorella, C., Toscano, S., Totaro, R., Trotta, M., Turano, G., Ulivelli, M., Valentino, M., Vaula, G., Vecchio, D., Vercellino, M., Verrengia, E. P., Vianello, M., Virgilio, E., Vitetta, F., Vollaro, S., Zaffaroni, M., Zampolini, M., Zarbo, I. R., Zito, A., Zuliani, L., Lucchini M. (ORCID:0000-0002-0447-2297), and Mirabella M. (ORCID:0000-0002-7783-114X)
Abstract: Background and purpose Clinical outcomes of multiple sclerosis (MS) patients affected by coronavirus disease 2019 (COVID-19) have been thoroughly investigated, but a further analysis on main signs and symptoms and their risk factors still needs attention. The objective of this study was to group together and describe based on similarity the most common signs and symptoms of COVID-19 in MS patients and identify all factors associated with their manifestation. Method Logistic and linear regression models were run to recognize factors associated with each pooled group of symptoms and their total number. Results From March 2020 to November 2021, data were collected from 1354 MS patients with confirmed infection of COVID-19. Ageusia and anosmia was less frequent in older people (odds ratio [OR] 0.98; p = 0.005) and more in smoker patients (OR 1.39; p = 0.049). Smoke was also associated with an incremental number of symptoms (OR 1.24; p = 0.031), substance abuse (drugs or alcohol), conjunctivitis and rash (OR 5.20; p = 0.042) and the presence of at least one comorbidity with shortness of breath, tachycardia or chest pain (OR 1.24; p = 0.008). Some disease-modifying therapies were associated with greater frequencies of certain COVID-19 symptoms (association between anti-CD20 therapies and increment in the number of concomitant symptoms: OR 1.29; p = 0.05). Differences in frequencies between the three waves were found for flu-like symptoms (G1, p = 0.024), joint or muscle pain (G2, p = 0.013) and ageusia and anosmia (G5, p < 0.001). All cases should be referred to variants up to Delta. Conclusion Several factors along with the choice of specific therapeutic approaches might have a different impact on the occurrence of some COVID-19 symptoms.
Published: 2022

11. Do patients' and referral centers' characteristics influence multiple sclerosis phenotypes? Results from the Italian multiple sclerosis and related disorders register

Author: Bergamaschi, Roberto, Beghi, Ettore, Bosetti, Cristina, Ponzio, Michela, Santucci, Claudia, Lepore, Vito, Mosconi, Paola, Aguglia, U, Amato, M P, Ancona, A L, Ardito, B, Avolio, C, Balgera, R, Banfi, P, Barcella, V, Barone, P, Bellantonio, P, Berardinelli, A, Bergamaschi, R, Bertora, P, Bianchi, M, Bramanti, P, Morra, V Brescia, Brichetto, G, Brioschi, A M, Buccafusca, M, Bucello, S, Busillo, V, Calchetti, B, Cantello, R, Capobianco, M, Capone, F, Capone, L, Cargnelutti, D, Carrozzi, M, Cartechini, E, Cavaletti, G, Cavalla, P, Celani, M G, Clerici, R, Clerico, M, Cocco, E, Confalonieri, P, Coniglio, M G, Conte, A, Corea, F, Cottone, S, Crociani, P, D'Andrea, F, Danni, M C, De Luca, G, de Pascalis, D, De Riz, M, De Robertis, F, De Rosa, G, De Stefano, N, Corte, M Della, Di Sapio, A, Docimo, R, Falcini, M, Falcone, N, Fermi, S, Ferraro, E, Ferrò, M T, Fortunato, M, Foschi, M, Gajofatto, A, Gallo, A, Gallo, P, Gatto, M, Gazzola, P, Giordano, A, Granella, F, Grasso, M F, Grasso, M G, Grimaldi, L M E, Iaffaldano, P, Imperiale, D, Inglese, M, Iodice, R, Leva, S, Luezzi, V, Lugaresi, A, Lus, G, Maimone, D, Mancinelli, L, Maniscalco, G T, Marfia, G A, Marini, B, Marson, A, Mascoli, N, Massacesi, L, Melani, F, Merello, M, Meucci, G, Mirabella, Massimiliano, Montepietra, S, Nasuelli, D, Nicolao, P, Passantino, F, Patti, F, Peresson, M, Pesci, I, Piantadosi, C, Piras, M L, Pizzorno, M, Plewnia, K, Pozzilli, C, Protti, A, Quatrale, R, Realmuto, S, Ribizzi, G, Rinalduzzi, S, Rini, A, Romano, S, Romeo, M, Ronzoni, M, Rossi, P, Rovaris, M, Salemi, G, Santangelo, G, Santangelo, M, Santuccio, G, Sarchielli, P, Sinisi, L, Sola, P, Solaro, C, Spitaleri, D, Strumia, S, Tassinari, T, Tonietti, S, Tortorella, C, Totaro, R, Tozzo, A, Trivelli, G, Ulivelli, M, Valentino, P, Venturi, S, Vianello, M, Zaffaroni, M, Zarbo, R, Trojano, Maria, Battaglia, Mario Alberto, Capobianco, Marco, Pugliatti, Maura, Ulivelli, Monica, Gasperini, Claudio, Patti, Francesco, Amato, Maria Pia, Comi, Giancarlo, Mirabella, M (ORCID:0000-0002-7783-114X), Bergamaschi, Roberto, Beghi, Ettore, Bosetti, Cristina, Ponzio, Michela, Santucci, Claudia, Lepore, Vito, Mosconi, Paola, Aguglia, U, Amato, M P, Ancona, A L, Ardito, B, Avolio, C, Balgera, R, Banfi, P, Barcella, V, Barone, P, Bellantonio, P, Berardinelli, A, Bergamaschi, R, Bertora, P, Bianchi, M, Bramanti, P, Morra, V Brescia, Brichetto, G, Brioschi, A M, Buccafusca, M, Bucello, S, Busillo, V, Calchetti, B, Cantello, R, Capobianco, M, Capone, F, Capone, L, Cargnelutti, D, Carrozzi, M, Cartechini, E, Cavaletti, G, Cavalla, P, Celani, M G, Clerici, R, Clerico, M, Cocco, E, Confalonieri, P, Coniglio, M G, Conte, A, Corea, F, Cottone, S, Crociani, P, D'Andrea, F, Danni, M C, De Luca, G, de Pascalis, D, De Riz, M, De Robertis, F, De Rosa, G, De Stefano, N, Corte, M Della, Di Sapio, A, Docimo, R, Falcini, M, Falcone, N, Fermi, S, Ferraro, E, Ferrò, M T, Fortunato, M, Foschi, M, Gajofatto, A, Gallo, A, Gallo, P, Gatto, M, Gazzola, P, Giordano, A, Granella, F, Grasso, M F, Grasso, M G, Grimaldi, L M E, Iaffaldano, P, Imperiale, D, Inglese, M, Iodice, R, Leva, S, Luezzi, V, Lugaresi, A, Lus, G, Maimone, D, Mancinelli, L, Maniscalco, G T, Marfia, G A, Marini, B, Marson, A, Mascoli, N, Massacesi, L, Melani, F, Merello, M, Meucci, G, Mirabella, Massimiliano, Montepietra, S, Nasuelli, D, Nicolao, P, Passantino, F, Patti, F, Peresson, M, Pesci, I, Piantadosi, C, Piras, M L, Pizzorno, M, Plewnia, K, Pozzilli, C, Protti, A, Quatrale, R, Realmuto, S, Ribizzi, G, Rinalduzzi, S, Rini, A, Romano, S, Romeo, M, Ronzoni, M, Rossi, P, Rovaris, M, Salemi, G, Santangelo, G, Santangelo, M, Santuccio, G, Sarchielli, P, Sinisi, L, Sola, P, Solaro, C, Spitaleri, D, Strumia, S, Tassinari, T, Tonietti, S, Tortorella, C, Totaro, R, Tozzo, A, Trivelli, G, Ulivelli, M, Valentino, P, Venturi, S, Vianello, M, Zaffaroni, M, Zarbo, R, Trojano, Maria, Battaglia, Mario Alberto, Capobianco, Marco, Pugliatti, Maura, Ulivelli, Monica, Gasperini, Claudio, Patti, Francesco, Amato, Maria Pia, Comi, Giancarlo, and Mirabella, M (ORCID:0000-0002-7783-114X)
Abstract: Background Multiple sclerosis (MS) is characterized by phenotypical heterogeneity, partly resulting from demographic and environmental risk factors. Socio-economic factors and the characteristics of local MS facilities might also play a part.Methods This study included patients with a confirmed MS diagnosis enrolled in the Italian MS and Related Disorders Register in 2000-2021. Patients at first visit were classified as having a clinically isolated syndrome (CIS), relapsing-remitting (RR), primary progressive (PP), progressive-relapsing (PR), or secondary progressive MS (SP). Demographic and clinical characteristics were analyzed, with centers' characteristics, geographic macro-areas, and Deprivation Index. We computed the odds ratios (OR) for CIS, PP/PR, and SP phenotypes, compared to the RR, using multivariate, multinomial, mixed effects logistic regression models.Results In all 35,243 patients from 106 centers were included. The OR of presenting more advanced MS phenotypes than the RR phenotype at first visit significantly diminished in relation to calendar period. Females were at a significantly lower risk of a PP/PR or SP phenotype. Older age was associated with CIS, PP/PR, and SP. The risk of a longer interval between disease onset and first visit was lower for the CIS phenotype, but higher for PP/PR and SP. The probability of SP at first visit was greater in the South of Italy.Discussion Differences in the phenotype of MS patients first seen in Italian centers can be only partly explained by differences in the centers' characteristics. The demographic and socio-economic characteristics of MS patients seem to be the main determinants of the phenotypes at first referral.
Published: 2022

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

Author: 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., Abbadessa, G., Aguglia, U., Allegorico, L., Allegri, R. B. M., Amato, M. P., Annovazzi, P., Antozzi, C., Appendino, L., Arena, S., Baione, V., Balgera, R., Barcella, V., Baroncini, D., Barrila, C., Bellacosa, A., Bellucci, G., Bergamaschi, R., Bergamaschi, V., Bezzini, D., Biolzi, B., Bisecco, A., Bonavita, S., Borriello, G., Bosa, C., Bosco, A., Bovis, F., Bozzali, M., Brambilla, L., Brescia, M. V., Brichetto, G., Buccafusca, M., Bucciantini, E., Bucello, S., Buscarinu, M. C., Cabboi, M. P., Calabrese, M., Calabria, F., Caleri, F., Camilli, F., Caniatti, L. M., Cantello, R., Capra, R., Capuano, R., Carta, P., Cavalla, P., Celani, M. G., Cellerino, M., Cerqua, R., Chisari, C., Clerici, R., Clerico, M., Cocco, E., Cola, G., Confalonieri, P., Conte, A., Conti, M. Z., Cordano, C., Cordera, S., Corea, F., Correale, C., Cottone, S., Crescenzo, F., Curti, E., D'Ambrosio, A., D'Amico, E., Danni, M. C., D'Arma, A., Dattola, V., de Biase, S., De Luca, G., De Mercanti, S. F., De Mitri, P., De Stefano, N., Della Cava, M., di Napoli, M., Di Sapio, A., Docimo, R., Dutto, A., Evangelista, L., Fanara, S., Ferraro, D., Ferro, M. T., Filippi, M., Fioretti, C., Fratta, M., Frau, J., Fronza, M., Gajofatto, A., Gallo, A., Gallo, P., Gasperini, C., Ghazaryan, A., Giometto, B., Gobbin, F., Govone, F., Granella, F., Grange, E., Grasso, M. G., Guareschi, A., Guaschino, C., Guerrieri, S., Guidetti, D., Iaffaldano, P., Ianniello, A., Iasevoli, L., Imperiale, D., Infante, M. T., Inglese, M., Iodice, R., Iovino, A., Konrad, G., Lanzillo, R., Lapucci, C., Lavorgna, L., L'Episcopo Maria, R., Leva, S., Liberatore, G., Lo Re, M., Longoni, M., Lopiano, L., Lorefice, L., Lucchini, Matteo, Lus, G., Maimone, D., Malentacchi, M., Mallucci, G., Malucchi, S., Mancinelli, C. R., Mancinelli, L., Manganotti, P., Maniscalco, T. G., Mantero, V., Marangoni, S., Marastoni, D., Marfia, A. G., Marinelli, F., Marti, A., Martinelli Boneschi, F., Masserano Zoli, F., Matta, F., Mendozzi, L., Meucci, G., Miante, S., Miele, G., Milano, E., Mirabella, Massimiliano, Missione, R., Moccia, M., Montepietra, S., Monti Bragadin, M., Montini, F., Motta, R., Nardone, R., Nicoletti, C. G., Nobile-Orazio, E., Nozzolillo, A., Onofrj, M., Orlandi, R., Palmieri, A., Paolicelli, D., Pasquali, L., Pasto, L., Pedrazzoli, E., Perini, P., Pesci, I., Petracca, M., Petrone, A., Piantadosi, C., Pietroboni, A. M., Pinardi, F., Ponzano, M., Portaccio, E., Pozzato, M., Pozzilli, C., Prosperini, L., Protti, A., Ragonese, P., Rasia, S., Realmuto, S., Repice, A., Rigoni, E., Rilla, M. T., Rinaldi, F., Romano, C. M., Ronzoni, M., Rovaris, M., Ruscica, F., Sabattini, L., Salemi, G., Saraceno, L., Sartori, A., Sbragia, E., Scandellari, C., Scarano Giuditta, I., Scarano, V., Schillaci, V., Sessa, M., Sgarito, C., Sibilia, G., Siciliano, G., Signori, A., Signoriello, E., Sinisi, L., Sireci, F., Sola, P., Solaro, C., Sotgiu, S., Sparaco, M., Stromillo, M. L., Strumia, S., Susani, L. E., Tabiadon, G., Teatini, F., Tomassini, V., Tonietti, S., Torri, C. V., Tortorella, C., Toscano, S., Totaro, R., Trotta, M., Turano, G., Ulivelli, M., Valentino, M., Vaula, G., Vecchio, D., Vercellino, M., Verrengia, E. P., Vianello, M., Virgilio, E., Vitetta, F., Vollaro, S., Zaffaroni, M., Zampolini, M., Zarbo, I. R., Zito, A., Zuliani, L., Lucchini M. (ORCID:0000-0002-0447-2297), Mirabella M. (ORCID:0000-0002-7783-114X), 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., Abbadessa, G., Aguglia, U., Allegorico, L., Allegri, R. B. M., Amato, M. P., Annovazzi, P., Antozzi, C., Appendino, L., Arena, S., Baione, V., Balgera, R., Barcella, V., Baroncini, D., Barrila, C., Bellacosa, A., Bellucci, G., Bergamaschi, R., Bergamaschi, V., Bezzini, D., Biolzi, B., Bisecco, A., Bonavita, S., Borriello, G., Bosa, C., Bosco, A., Bovis, F., Bozzali, M., Brambilla, L., Brescia, M. V., Brichetto, G., Buccafusca, M., Bucciantini, E., Bucello, S., Buscarinu, M. C., Cabboi, M. P., Calabrese, M., Calabria, F., Caleri, F., Camilli, F., Caniatti, L. M., Cantello, R., Capra, R., Capuano, R., Carta, P., Cavalla, P., Celani, M. G., Cellerino, M., Cerqua, R., Chisari, C., Clerici, R., Clerico, M., Cocco, E., Cola, G., Confalonieri, P., Conte, A., Conti, M. Z., Cordano, C., Cordera, S., Corea, F., Correale, C., Cottone, S., Crescenzo, F., Curti, E., D'Ambrosio, A., D'Amico, E., Danni, M. C., D'Arma, A., Dattola, V., de Biase, S., De Luca, G., De Mercanti, S. F., De Mitri, P., De Stefano, N., Della Cava, M., di Napoli, M., Di Sapio, A., Docimo, R., Dutto, A., Evangelista, L., Fanara, S., Ferraro, D., Ferro, M. T., Filippi, M., Fioretti, C., Fratta, M., Frau, J., Fronza, M., Gajofatto, A., Gallo, A., Gallo, P., Gasperini, C., Ghazaryan, A., Giometto, B., Gobbin, F., Govone, F., Granella, F., Grange, E., Grasso, M. G., Guareschi, A., Guaschino, C., Guerrieri, S., Guidetti, D., Iaffaldano, P., Ianniello, A., Iasevoli, L., Imperiale, D., Infante, M. T., Inglese, M., Iodice, R., Iovino, A., Konrad, G., Lanzillo, R., Lapucci, C., Lavorgna, L., L'Episcopo Maria, R., Leva, S., Liberatore, G., Lo Re, M., Longoni, M., Lopiano, L., Lorefice, L., Lucchini, Matteo, Lus, G., Maimone, D., Malentacchi, M., Mallucci, G., Malucchi, S., Mancinelli, C. R., Mancinelli, L., Manganotti, P., Maniscalco, T. G., Mantero, V., Marangoni, S., Marastoni, D., Marfia, A. G., Marinelli, F., Marti, A., Martinelli Boneschi, F., Masserano Zoli, F., Matta, F., Mendozzi, L., Meucci, G., Miante, S., Miele, G., Milano, E., Mirabella, Massimiliano, Missione, R., Moccia, M., Montepietra, S., Monti Bragadin, M., Montini, F., Motta, R., Nardone, R., Nicoletti, C. G., Nobile-Orazio, E., Nozzolillo, A., Onofrj, M., Orlandi, R., Palmieri, A., Paolicelli, D., Pasquali, L., Pasto, L., Pedrazzoli, E., Perini, P., Pesci, I., Petracca, M., Petrone, A., Piantadosi, C., Pietroboni, A. M., Pinardi, F., Ponzano, M., Portaccio, E., Pozzato, M., Pozzilli, C., Prosperini, L., Protti, A., Ragonese, P., Rasia, S., Realmuto, S., Repice, A., Rigoni, E., Rilla, M. T., Rinaldi, F., Romano, C. M., Ronzoni, M., Rovaris, M., Ruscica, F., Sabattini, L., Salemi, G., Saraceno, L., Sartori, A., Sbragia, E., Scandellari, C., Scarano Giuditta, I., Scarano, V., Schillaci, V., Sessa, M., Sgarito, C., Sibilia, G., Siciliano, G., Signori, A., Signoriello, E., Sinisi, L., Sireci, F., Sola, P., Solaro, C., Sotgiu, S., Sparaco, M., Stromillo, M. L., Strumia, S., Susani, L. E., Tabiadon, G., Teatini, F., Tomassini, V., Tonietti, S., Torri, C. V., Tortorella, C., Toscano, S., Totaro, R., Trotta, M., Turano, G., Ulivelli, M., Valentino, M., Vaula, G., Vecchio, D., Vercellino, M., Verrengia, E. P., Vianello, M., Virgilio, E., Vitetta, F., Vollaro, S., Zaffaroni, M., Zampolini, M., Zarbo, I. R., Zito, A., Zuliani, L., Lucchini M. (ORCID:0000-0002-0447-2297), and Mirabella M. (ORCID:0000-0002-7783-114X)
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: 2022

13. 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, Massimiliano, Lus, G, Patti, F, Cavalla, P, Cellerino, M, Malucchi, S, Pisano, E, Vitetta, F, Paolicelli, D, Sola, P, Trojano, M, Mirabella, M (ORCID:0000-0002-7783-114X), Ferraro, D, Iaffaldano, P, Guerra, T, Inglese, M, Capobianco, M, Brescia Morra, V, Zaffaroni, M, Mirabella, Massimiliano, Lus, G, Patti, F, Cavalla, P, Cellerino, M, Malucchi, S, Pisano, E, Vitetta, F, Paolicelli, D, Sola, P, Trojano, M, and Mirabella, M (ORCID:0000-0002-7783-114X)
Abstract: Background: Fingolimod (FTY) induces sequestration of lymphocytes in secondary lymphoid organs and the average lymphocyte recovery following discontinuation takes 1-2 months. 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 > / = 18 weeks) in patients starting alemtuzumab, rituximab, ocrelizumab or cladribine following FTY discontinuation. Results: We included 329 patients in the analysis (226F, 103 M; mean age 41 ± 10 years). 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 > / = 18 weeks compared to the reference period (< 6 weeks). 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. Keywords: Alemtuzumab; Cladribine; Fingolimod; Multiple sclerosis; Ocrelizumab; Rituximab.
Published: 2021

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

Author: Sormani, M. P., De Rossi, N., Schiavetti, I., Carmisciano, L., Cordioli, C., Moiola, L., Radaelli, M., Immovilli, P., Capobianco, M., Trojano, M., Zaratin, P., Tedeschi, G., Comi, G., Battaglia, M. A., Patti, F., Salvetti, M., Nozzolillo, A., Bellacosa, A., Protti, A., Di Sapio, A., Signori, A., Petrone, A., Bisecco, A., Iovino, A., Dutto, A., Repice, A. M., Conte, A., Bertolotto, A., Bosco, A., Gallo, A., Zito, A., Sartori, A., Giometto, B., Tortorella, C., Antozzi, C., Pozzilli, C., Mancinelli, C. R., Zanetta, C., Cordano, C., Scandellari, C., Guaschino, C., Gasperini, C., Solaro, C., Fioretti, C., Bezzini, D., Marastoni, D., Paolicelli, D., Vecchio, D., Landi, D., Bucciantini, E., Pedrazzoli, E., Signoriello, E., Sbragia, E., Susani, E. L., Curti, E., Milano, E., Marinelli, F., Camilli, F., Boneschi, F. M., Govone, F., Bovis, F., Calabria, F., Caleri, F., Rinaldi, F., Vitetta, F., Corea, F., Crescenzo, F., Teatini, F., Tabiadon, G., Granella, F., Boffa, G., Lus, G., Brichetto, G., Maniscalco, G. T., Borriello, G., De Luca, G., Konrad, G., Vaula, G., Marfia, G. A., Mallucci, G., Liberatore, G., Salemi, G., Miele, G., Sibilia, G., Pesci, I., Brambilla, L., Lopiano, L., Sinisi, L., Pasquali, L., Saraceno, L., Chiveri, L., Mancinelli, L., Grimaldi, L. M. E., Caniatti, L. M., Cava, M. D., Onofrj, M., Rovaris, M., Vercellino, M., Bragadin, M. M., Buccafusca, M., Buscarinu, M. C., Celani, M. G., Grasso, M. G., Stromillo, M. L., Petracca, M., Amato, M. P., L'Episcopo, M. R., Sessa, M., Ferro, M. T., Ercolani, M. V., Bianco, M., Re, M. L., Vianello, M., Clerico, M., Ponzano, M., Conti, M. Z., Calabrese, M., Mirabella, Massimiliano, Filippi, M., Inglese, M., Lucchini, Matteo, Pozzato, M., Danni, M. C., Zaffaroni, M., Zampolini, M., Ponzio, M., De Riz, M., De Stefano, N., Cavalla, P., De Mitri, P., Grossi, P., Confalonieri, P., Gallo, P., Ragonese, P., Sola, P., Annovazzi, P., Iaffaldano, P., Nardone, R., Cerqua, R., Clerici, R., Lanzillo, R., Motta, R., Balgera, R., Bergamaschi, R., Totaro, R., Iodice, R., Capra, R., Marangoni, S., Realmuto, S., Cottone, S., Montepietra, S., Rasia, S., Arena, S., Bucello, S., Banfi, S., Bonavita, S., Malucchi, S., Tonietti, S., Vollaro, S., Cordera, S., Aguglia, U., Clerici, V. T., Barcella, V., Bergamaschi, V., Morra, V. B., Dattola, V., Mantero, V., di Napoli, M., Mirabella M. (ORCID:0000-0002-7783-114X), Lucchini M. (ORCID:0000-0002-0447-2297), Sormani, M. P., De Rossi, N., Schiavetti, I., Carmisciano, L., Cordioli, C., Moiola, L., Radaelli, M., Immovilli, P., Capobianco, M., Trojano, M., Zaratin, P., Tedeschi, G., Comi, G., Battaglia, M. A., Patti, F., Salvetti, M., Nozzolillo, A., Bellacosa, A., Protti, A., Di Sapio, A., Signori, A., Petrone, A., Bisecco, A., Iovino, A., Dutto, A., Repice, A. M., Conte, A., Bertolotto, A., Bosco, A., Gallo, A., Zito, A., Sartori, A., Giometto, B., Tortorella, C., Antozzi, C., Pozzilli, C., Mancinelli, C. R., Zanetta, C., Cordano, C., Scandellari, C., Guaschino, C., Gasperini, C., Solaro, C., Fioretti, C., Bezzini, D., Marastoni, D., Paolicelli, D., Vecchio, D., Landi, D., Bucciantini, E., Pedrazzoli, E., Signoriello, E., Sbragia, E., Susani, E. L., Curti, E., Milano, E., Marinelli, F., Camilli, F., Boneschi, F. M., Govone, F., Bovis, F., Calabria, F., Caleri, F., Rinaldi, F., Vitetta, F., Corea, F., Crescenzo, F., Teatini, F., Tabiadon, G., Granella, F., Boffa, G., Lus, G., Brichetto, G., Maniscalco, G. T., Borriello, G., De Luca, G., Konrad, G., Vaula, G., Marfia, G. A., Mallucci, G., Liberatore, G., Salemi, G., Miele, G., Sibilia, G., Pesci, I., Brambilla, L., Lopiano, L., Sinisi, L., Pasquali, L., Saraceno, L., Chiveri, L., Mancinelli, L., Grimaldi, L. M. E., Caniatti, L. M., Cava, M. D., Onofrj, M., Rovaris, M., Vercellino, M., Bragadin, M. M., Buccafusca, M., Buscarinu, M. C., Celani, M. G., Grasso, M. G., Stromillo, M. L., Petracca, M., Amato, M. P., L'Episcopo, M. R., Sessa, M., Ferro, M. T., Ercolani, M. V., Bianco, M., Re, M. L., Vianello, M., Clerico, M., Ponzano, M., Conti, M. Z., Calabrese, M., Mirabella, Massimiliano, Filippi, M., Inglese, M., Lucchini, Matteo, Pozzato, M., Danni, M. C., Zaffaroni, M., Zampolini, M., Ponzio, M., De Riz, M., De Stefano, N., Cavalla, P., De Mitri, P., Grossi, P., Confalonieri, P., Gallo, P., Ragonese, P., Sola, P., Annovazzi, P., Iaffaldano, P., Nardone, R., Cerqua, R., Clerici, R., Lanzillo, R., Motta, R., Balgera, R., Bergamaschi, R., Totaro, R., Iodice, R., Capra, R., Marangoni, S., Realmuto, S., Cottone, S., Montepietra, S., Rasia, S., Arena, S., Bucello, S., Banfi, S., Bonavita, S., Malucchi, S., Tonietti, S., Vollaro, S., Cordera, S., Aguglia, U., Clerici, V. T., Barcella, V., Bergamaschi, V., Morra, V. B., Dattola, V., Mantero, V., di Napoli, M., Mirabella M. (ORCID:0000-0002-7783-114X), and Lucchini M. (ORCID:0000-0002-0447-2297)
Abstract: Objective: This study was undertaken to assess the impact of immunosuppressive and immunomodulatory therapies on the severity of coronavirus disease 2019 (COVID-19) in people with multiple sclerosis (PwMS). Methods: We retrospectively collected data of PwMS with suspected or confirmed COVID-19. All the patients had complete follow-up to death or recovery. Severe COVID-19 was defined by a 3-level variable: mild disease not requiring hospitalization versus pneumonia or hospitalization versus intensive care unit (ICU) admission or death. We evaluated baseline characteristics and MS therapies associated with severe COVID-19 by multivariate and propensity score (PS)-weighted ordinal logistic models. Sensitivity analyses were run to confirm the results. Results: Of 844 PwMS with suspected (n = 565) or confirmed (n = 279) COVID-19, 13 (1.54%) died; 11 of them were in a progressive MS phase, and 8 were without any therapy. Thirty-eight (4.5%) were admitted to an ICU; 99 (11.7%) had radiologically documented pneumonia; 96 (11.4%) were hospitalized. After adjusting for region, age, sex, progressive MS course, Expanded Disability Status Scale, disease duration, body mass index, comorbidities, and recent methylprednisolone use, therapy with an anti-CD20 agent (ocrelizumab or rituximab) was significantly associated (odds ratio [OR] = 2.37, 95% confidence interval [CI] = 1.18–4.74, p = 0.015) with increased risk of severe COVID-19. Recent use (<1 month) of methylprednisolone was also associated with a worse outcome (OR = 5.24, 95% CI = 2.20–12.53, p = 0.001). Results were confirmed by the PS-weighted analysis and by all the sensitivity analyses. Interpretation: This study showed an acceptable level of safety of therapies with a broad array of mechanisms of action. However, some specific elements of risk emerged. These will need to be considered while the COVID-19 pandemic persists. ANN NEUROL 2021;89:780–789.
Published: 2021

15. Detection of disability worsening in relapsing-remitting multiple sclerosis patients: a real-world roving Expanded Disability Status Scale reference analysis from the Italian Multiple Sclerosis Register

Author: Lepore, V., Bosetti, C., Santucci, C., Iaffaldano, P., Trojano, M., Mosconi, P., Totaro, R., Coniglio, M. G., Bossio, R. B., Valentino, P., Gatto, M., Paolicelli, D., Ardito, B., Barcella, V., Capone, L., Nicolao, P., Lugaresi, A., Rini, A., Bianchi, M., Plasmati, I., Cocco, E., Docimo, R., De Luca, G., Mondino, F., Di Sapio, A., Clerici, R., Mascoli, N., Ferro, M. T., Chisari, C. G., Maimone, D., Strumia, S., Pugliatti, M., Cargnelutti, D., Caniatti, L. M., Avolio, C., Crociani, P., Amato, M. P., Massacesi, L., Malagu, S., Ribizzi, G., Inglese, M., Venturi, S., Gazzola, P., Pizio, N. R., Brichetto, G., Plewnia, K., Bellantonio, P., Balgera, R., De Robertis, F., Fermi, S., Fausto, F., Mazzoni, M., Meucci, G., Cartechini, E., Cavaletti, G., Buccafusca, M., Bramanti, P., Romeo, M., Rovaris, M., Ronzoni, M., Confalonieri, P., Chiveri, L., Bertora, P., Tonietti, S., De Riz, M., Protti, A., Sola, P., Maremmani, C., Lus, G., Gallo, A., Maniscalco, G. T., Morra, V. B., Cacchio, G., Iodice, R., Ragno, M., Sinisi, L., Cantello, R., Piras, M. L., Salemi, G., Cottone, S., Grimaldi, L. M. E., Corea, F., Santangelo, G., Immovili, P., Gallo, P., D'Andrea, F., Frittelli, C., Pasquali, L., Falcini, M., Granella, F., Pesci, I., Ancona, A. L., Bergamaschi, R., Di Napoli, M., Romano, S., Pozzilli, C., Mirabella, Massimiliano, Conte, A., Galgani, S., Peresson, M., Grasso, M. G., Ferraro, E., Capone, F., Marfia, G. A., de Pascalis, D., Piantadosi, C., Valeriani, M., Busillo, V., Barone, P., De Stefano, N., Ulivelli, M., Santuccio, G., Parodi, S., Bucello, S., Traccis, S., Zarbo, R., Tassinari, T., Bandini, F., Cavalla, P., Clerico, M., De Rosa, G., Bertolotto, A., Imperiale, D., Sarchielli, P., Celani, M. G., Vianello, M., Marini, B., Fortunato, M., Zaffaroni, M., Nasuelli, D., Banfi, P., Brioschi, A. M., Solaro, C., Quatrale, R., Rossi, P., Gajofatto, A., Battaglia, M. A., Capobianco, M., Patti, F., Comi, G., Giordano, A., Mirabella M. (ORCID:0000-0002-7783-114X), Lepore, V., Bosetti, C., Santucci, C., Iaffaldano, P., Trojano, M., Mosconi, P., Totaro, R., Coniglio, M. G., Bossio, R. B., Valentino, P., Gatto, M., Paolicelli, D., Ardito, B., Barcella, V., Capone, L., Nicolao, P., Lugaresi, A., Rini, A., Bianchi, M., Plasmati, I., Cocco, E., Docimo, R., De Luca, G., Mondino, F., Di Sapio, A., Clerici, R., Mascoli, N., Ferro, M. T., Chisari, C. G., Maimone, D., Strumia, S., Pugliatti, M., Cargnelutti, D., Caniatti, L. M., Avolio, C., Crociani, P., Amato, M. P., Massacesi, L., Malagu, S., Ribizzi, G., Inglese, M., Venturi, S., Gazzola, P., Pizio, N. R., Brichetto, G., Plewnia, K., Bellantonio, P., Balgera, R., De Robertis, F., Fermi, S., Fausto, F., Mazzoni, M., Meucci, G., Cartechini, E., Cavaletti, G., Buccafusca, M., Bramanti, P., Romeo, M., Rovaris, M., Ronzoni, M., Confalonieri, P., Chiveri, L., Bertora, P., Tonietti, S., De Riz, M., Protti, A., Sola, P., Maremmani, C., Lus, G., Gallo, A., Maniscalco, G. T., Morra, V. B., Cacchio, G., Iodice, R., Ragno, M., Sinisi, L., Cantello, R., Piras, M. L., Salemi, G., Cottone, S., Grimaldi, L. M. E., Corea, F., Santangelo, G., Immovili, P., Gallo, P., D'Andrea, F., Frittelli, C., Pasquali, L., Falcini, M., Granella, F., Pesci, I., Ancona, A. L., Bergamaschi, R., Di Napoli, M., Romano, S., Pozzilli, C., Mirabella, Massimiliano, Conte, A., Galgani, S., Peresson, M., Grasso, M. G., Ferraro, E., Capone, F., Marfia, G. A., de Pascalis, D., Piantadosi, C., Valeriani, M., Busillo, V., Barone, P., De Stefano, N., Ulivelli, M., Santuccio, G., Parodi, S., Bucello, S., Traccis, S., Zarbo, R., Tassinari, T., Bandini, F., Cavalla, P., Clerico, M., De Rosa, G., Bertolotto, A., Imperiale, D., Sarchielli, P., Celani, M. G., Vianello, M., Marini, B., Fortunato, M., Zaffaroni, M., Nasuelli, D., Banfi, P., Brioschi, A. M., Solaro, C., Quatrale, R., Rossi, P., Gajofatto, A., Battaglia, M. A., Capobianco, M., Patti, F., Comi, G., Giordano, A., and Mirabella M. (ORCID:0000-0002-7783-114X)
Abstract: Background and purpose: In relapsing-remitting multiple sclerosis patients (RRMS) disability progressively accumulates over time. To compare the cumulative probability of 6-month confirmed disability-worsening events using a fixed baseline or a roving Expanded Disability Status Scale (EDSS) reference, in a real-world setting. Methods: A cohort of 7964 RRMS patients followed for 2 or more years, with EDSS scores recorded every 6 months, was selected from the Italian Multiple Sclerosis Register. The overall probability of confirmed disability-worsening events and of confirmed disability-worsening events unrelated to relapse was evaluated using as reference a fixed baseline EDSS score or a roving EDSS score in which the increase had to be separated from the last EDSS assessment by at least 6 or 12 months. Results: Using a fixed baseline EDSS reference, the cumulative probability of 6-year overall confirmed disability-worsening events was 33.2%, and that of events unrelated to relapse was 10.9% (33% of overall confirmed disability-worsening events). Using a roving EDSS, the proportions were respectively 35.2% and 21.3% (61% of overall confirmed disability-worsening events). Conclusions: In a real-world setting, roving EDSS reference scores appear to be more sensitive for detecting confirmed disability-worsening events unrelated to relapse in RRMS patients.
Published: 2020

16. Multiple sclerosis registries in Europe – An updated mapping survey

Author: Glaser, A., Stahmann, A., Meissner, T., Flachenecker, P., Horáková, D., Zaratin, P., Brichetto, G., Pugliatti, M., Rienhoff, O., Vukusic, S., de Giacomoni, A. C., Battaglia, M. A., Brola, W., Butzkueven, H., Casey, R., Drulovic, J., Eichstädt, K., Hellwig, K., Iaffaldano, P., Ioannidou, E., Kuhle, J., Lycke, K., Magyari, M., Malbaša, T., Middleton, R., Myhr, K. M., Notas, K., Orologas, A., Otero-Romero, S., Pekmezovic, T., Sastre-Garriga, J., Seeldrayers, P., Soilu-Hänninen, M., Stawiarz, L., Trojano, M., Ziemssen, T., Hillert, J., Thalheim, C., Glaser, A., Stahmann, A., Meissner, T., Flachenecker, P., Horáková, D., Zaratin, P., Brichetto, G., Pugliatti, M., Rienhoff, O., Vukusic, S., de Giacomoni, A. C., Battaglia, M. A., Brola, W., Butzkueven, H., Casey, R., Drulovic, J., Eichstädt, K., Hellwig, K., Iaffaldano, P., Ioannidou, E., Kuhle, J., Lycke, K., Magyari, M., Malbaša, T., Middleton, R., Myhr, K. M., Notas, K., Orologas, A., Otero-Romero, S., Pekmezovic, T., Sastre-Garriga, J., Seeldrayers, P., Soilu-Hänninen, M., Stawiarz, L., Trojano, M., Ziemssen, T., Hillert, J., and Thalheim, C.
Published: 2019

17. Multiple sclerosis registries in Europe – An updated mapping survey

Author: Glaser, A., Stahmann, A., Meissner, T., Flachenecker, P., Horáková, D., Zaratin, P., Brichetto, G., Pugliatti, M., Rienhoff, O., Vukusic, S., de Giacomoni, A. C., Battaglia, M. A., Brola, W., Butzkueven, H., Casey, R., Drulovic, J., Eichstädt, K., Hellwig, K., Iaffaldano, P., Ioannidou, E., Kuhle, J., Lycke, K., Magyari, M., Malbaša, T., Middleton, R., Myhr, K. M., Notas, K., Orologas, A., Otero-Romero, S., Pekmezovic, T., Sastre-Garriga, J., Seeldrayers, P., Soilu-Hänninen, M., Stawiarz, L., Trojano, M., Ziemssen, T., Hillert, J., Thalheim, C., Glaser, A., Stahmann, A., Meissner, T., Flachenecker, P., Horáková, D., Zaratin, P., Brichetto, G., Pugliatti, M., Rienhoff, O., Vukusic, S., de Giacomoni, A. C., Battaglia, M. A., Brola, W., Butzkueven, H., Casey, R., Drulovic, J., Eichstädt, K., Hellwig, K., Iaffaldano, P., Ioannidou, E., Kuhle, J., Lycke, K., Magyari, M., Malbaša, T., Middleton, R., Myhr, K. M., Notas, K., Orologas, A., Otero-Romero, S., Pekmezovic, T., Sastre-Garriga, J., Seeldrayers, P., Soilu-Hänninen, M., Stawiarz, L., Trojano, M., Ziemssen, T., Hillert, J., and Thalheim, C.
Published: 2019

18. Multiple sclerosis registries in Europe – An updated mapping survey

Author: Glaser, A., Stahmann, A., Meissner, T., Flachenecker, P., Horáková, D., Zaratin, P., Brichetto, G., Pugliatti, M., Rienhoff, O., Vukusic, S., de Giacomoni, A. C., Battaglia, M. A., Brola, W., Butzkueven, H., Casey, R., Drulovic, J., Eichstädt, K., Hellwig, K., Iaffaldano, P., Ioannidou, E., Kuhle, J., Lycke, K., Magyari, M., Malbaša, T., Middleton, R., Myhr, K. M., Notas, K., Orologas, A., Otero-Romero, S., Pekmezovic, T., Sastre-Garriga, J., Seeldrayers, P., Soilu-Hänninen, M., Stawiarz, L., Trojano, M., Ziemssen, T., Hillert, J., Thalheim, C., Glaser, A., Stahmann, A., Meissner, T., Flachenecker, P., Horáková, D., Zaratin, P., Brichetto, G., Pugliatti, M., Rienhoff, O., Vukusic, S., de Giacomoni, A. C., Battaglia, M. A., Brola, W., Butzkueven, H., Casey, R., Drulovic, J., Eichstädt, K., Hellwig, K., Iaffaldano, P., Ioannidou, E., Kuhle, J., Lycke, K., Magyari, M., Malbaša, T., Middleton, R., Myhr, K. M., Notas, K., Orologas, A., Otero-Romero, S., Pekmezovic, T., Sastre-Garriga, J., Seeldrayers, P., Soilu-Hänninen, M., Stawiarz, L., Trojano, M., Ziemssen, T., Hillert, J., and Thalheim, C.
Published: 2019

19. Prognostic Indicators in Pediatric Clinically Isolated Syndrome

Author: Iaffaldano, P, Simone, M, Lucisano, G, Ghezzi, A, Coniglio, G, Morra, VB, Salemi, G, Patti, F, Lugaresi, A, Izquierdo, G, Bergamaschi, R, Cabrera-Gomez, JA, Pozzilli, C, Millefiorini, E, Alroughani, R, Boz, C, Pucci, E, Zimatore, GB, Sola, P, Lus, G, Maimone, D, Avolio, C, Cocco, E, Sajedi, SA, Costantino, G, Duquette, P, Shaygannejad, V, Petersen, T, Fernandez Bolanos, R, Paolicelli, D, Tortorella, C, Spelman, T, Margari, L, Amato, MP, Comi, G, Butzkueven, H, Trojano, M, Iaffaldano, P, Simone, M, Lucisano, G, Ghezzi, A, Coniglio, G, Morra, VB, Salemi, G, Patti, F, Lugaresi, A, Izquierdo, G, Bergamaschi, R, Cabrera-Gomez, JA, Pozzilli, C, Millefiorini, E, Alroughani, R, Boz, C, Pucci, E, Zimatore, GB, Sola, P, Lus, G, Maimone, D, Avolio, C, Cocco, E, Sajedi, SA, Costantino, G, Duquette, P, Shaygannejad, V, Petersen, T, Fernandez Bolanos, R, Paolicelli, D, Tortorella, C, Spelman, T, Margari, L, Amato, MP, Comi, G, Butzkueven, H, and Trojano, M
Abstract: OBJECTIVE: To assess prognostic factors for a second clinical attack and a first disability-worsening event in pediatric clinically isolated syndrome (pCIS) suggestive of multiple sclerosis (MS) patients. METHODS: A cohort of 770 pCIS patients was followed up for at least 10 years. Cox proportional hazard models and Recursive Partitioning and Amalgamation (RECPAM) tree-regression were used to analyze data. RESULTS: In pCIS, female sex and a multifocal onset were risk factors for a second clinical attack (hazard ratio [HR], 95% confidence interval [CI] = 1.28, 1.06-1.55; 1.42, 1.10-1.84, respectively), whereas disease-modifying drug (DMD) exposure reduced this risk (HR, 95% CI = 0.75, 0.60-0.95). After pediatric onset MS (POMS) diagnosis, age at onset younger than 15 years and DMD exposure decreased the risk of a first Expanded Disability Status Scale (EDSS)-worsening event (HR, 95% CI = 0.59, 0.42-0.83; 0.75, 0.71-0.80, respectively), whereas the occurrence of relapse increased this risk (HR, 95% CI = 5.08, 3.46-7.46). An exploratory RECPAM analysis highlighted a significantly higher incidence of a first EDSS-worsening event in patients with multifocal or isolated spinal cord or optic neuritis involvement at onset in comparison to those with an isolated supratentorial or brainstem syndrome. A Cox regression model including RECPAM classes confirmed DMD exposure as the most protective factor against EDSS-worsening events and relapses as the most important risk factor for attaining EDSS worsening. INTERPRETATION: This work represents a step forward in identifying predictors of unfavorable course in pCIS and POMS and supports a protective effect of early DMD treatment in preventing MS development and disability accumulation in this population. Ann Neurol 2017;81:729-739.
Published: 2017

20. Predictors of Long-Term Disability Accrual in Relapse-Onset Multiple Sclerosis

Author: Jokubaitis, VG, Spelman, T, Kalincik, T, Lorscheider, J, Havrdova, E, Horakova, D, Duquette, P, Girard, M, Prat, A, Izquierdo, G, Grammond, P, Van Pesch, V, Pucci, E, Grand'Maison, F, Hupperts, R, Granella, F, Sola, P, Bergamaschi, R, Iuliano, G, Spitaleri, D, Boz, C, Hodgkinson, S, Olascoaga, J, Verheul, F, McCombe, P, Petersen, T, Rozsa, C, Lechner-Scott, J, Laura Saladino, M, Farina, D, Iaffaldano, P, Paolicelli, D, Butzkueven, H, Lugaresi, A, Trojano, M, Jokubaitis, VG, Spelman, T, Kalincik, T, Lorscheider, J, Havrdova, E, Horakova, D, Duquette, P, Girard, M, Prat, A, Izquierdo, G, Grammond, P, Van Pesch, V, Pucci, E, Grand'Maison, F, Hupperts, R, Granella, F, Sola, P, Bergamaschi, R, Iuliano, G, Spitaleri, D, Boz, C, Hodgkinson, S, Olascoaga, J, Verheul, F, McCombe, P, Petersen, T, Rozsa, C, Lechner-Scott, J, Laura Saladino, M, Farina, D, Iaffaldano, P, Paolicelli, D, Butzkueven, H, Lugaresi, A, and Trojano, M
Abstract: OBJECTIVE: To identify predictors of 10-year Expanded Disability Status Scale (EDSS) change after treatment initiation in patients with relapse-onset multiple sclerosis. METHODS: Using data obtained from MSBase, we defined baseline as the date of first injectable therapy initiation. Patients need only have remained on injectable therapy for 1 day and were monitored on any approved disease-modifying therapy, or no therapy thereafter. Median EDSS score changes over a 10-year period were determined. Predictors of EDSS change were then assessed using median quantile regression analysis. Sensitivity analyses were further performed. RESULTS: We identified 2,466 patients followed up for at least 10 years reporting post-baseline disability scores. Patients were treated an average 83% of their follow-up time. EDSS scores increased by a median 1 point (interquartile range = 0-2) at 10 years post-baseline. Annualized relapse rate was highly predictive of increases in median EDSS over 10 years (coeff = 1.14, p = 1.9 × 10(-22) ). On-therapy relapses carried greater burden than off-therapy relapses. Cumulative treatment exposure was independently associated with lower EDSS at 10 years (coeff = -0.86, p = 1.3 × 10(-9) ). Furthermore, pregnancies were also independently associated with lower EDSS scores over the 10-year observation period (coeff = -0.36, p = 0.009). INTERPRETATION: We provide evidence of long-term treatment benefit in a large registry cohort, and provide evidence of long-term protective effects of pregnancy against disability accrual. We demonstrate that high annualized relapse rate, particularly on-treatment relapse, is an indicator of poor prognosis. Ann Neurol 2016;80:89-100.
Published: 2016

21. Conversion from clinically isolated syndrome to multiple sclerosis:A large multicentre study

Author: Kuhle, J, Disanto, G, Dobson, R, Adiutori, R, Bianchi, L, Topping, J, Bestwick, J P, Meier, U-C, Marta, M, Dalla Costa, G, Runia, T, Evdoshenko, E, Lazareva, N, Thouvenot, E, Iaffaldano, P, Direnzo, V, Khademi, M, Piehl, F, Comabella, M, Sombekke, M, Killestein, J, Hegen, H, Rauch, S, D'Alfonso, S, Alvarez-Cermeño, J C, Kleinová, P, Horáková, D, Roesler, R, Lauda, F, Llufriu, S, Avsar, T, Uygunoglu, U, Altintas, A, Saip, S, Menge, T, Rajda, C, Bergamaschi, R, Moll, N, Khalil, M, Marignier, R, Dujmovic, I, Larsson, H, Malmestrom, C, Scarpini, E, Fenoglio, C, Wergeland, S, Laroni, A, Annibali, V, Romano, S, Martínez, A D, Carra, A, Salvetti, M, Uccelli, A, Torkildsen, Ø, Myhr, K M, Galimberti, D, Rejdak, K, Lycke, J, Fredriksen, Jette Lautrup, Drulovic, J, Confavreux, C, Brassat, D, Enzinger, C, Fuchs, S, Bosca, I, Pelletier, J, Picard, C, Colombo, E, Franciotta, D, Derfuss, T, Lindberg, Rlp, Yaldizli, Ö, Vécsei, L, Kieseier, B C, Hartung, H P, Villoslada, P, Siva, A, Saiz, A, Tumani, H, Havrdová, E, Villar, L M, Leone, M, Barizzone, N, Deisenhammer, F, Teunissen, C, Montalban, X, Tintoré, M, Olsson, T, Trojano, M, Lehmann, S, Castelnovo, G, Lapin, S, Hintzen, R, Kappos, L, Furlan, R, Martinelli, V, Comi, G, Ramagopalan, S V, Giovannoni, G, Kuhle, J, Disanto, G, Dobson, R, Adiutori, R, Bianchi, L, Topping, J, Bestwick, J P, Meier, U-C, Marta, M, Dalla Costa, G, Runia, T, Evdoshenko, E, Lazareva, N, Thouvenot, E, Iaffaldano, P, Direnzo, V, Khademi, M, Piehl, F, Comabella, M, Sombekke, M, Killestein, J, Hegen, H, Rauch, S, D'Alfonso, S, Alvarez-Cermeño, J C, Kleinová, P, Horáková, D, Roesler, R, Lauda, F, Llufriu, S, Avsar, T, Uygunoglu, U, Altintas, A, Saip, S, Menge, T, Rajda, C, Bergamaschi, R, Moll, N, Khalil, M, Marignier, R, Dujmovic, I, Larsson, H, Malmestrom, C, Scarpini, E, Fenoglio, C, Wergeland, S, Laroni, A, Annibali, V, Romano, S, Martínez, A D, Carra, A, Salvetti, M, Uccelli, A, Torkildsen, Ø, Myhr, K M, Galimberti, D, Rejdak, K, Lycke, J, Fredriksen, Jette Lautrup, Drulovic, J, Confavreux, C, Brassat, D, Enzinger, C, Fuchs, S, Bosca, I, Pelletier, J, Picard, C, Colombo, E, Franciotta, D, Derfuss, T, Lindberg, Rlp, Yaldizli, Ö, Vécsei, L, Kieseier, B C, Hartung, H P, Villoslada, P, Siva, A, Saiz, A, Tumani, H, Havrdová, E, Villar, L M, Leone, M, Barizzone, N, Deisenhammer, F, Teunissen, C, Montalban, X, Tintoré, M, Olsson, T, Trojano, M, Lehmann, S, Castelnovo, G, Lapin, S, Hintzen, R, Kappos, L, Furlan, R, Martinelli, V, Comi, G, Ramagopalan, S V, and Giovannoni, G
Abstract: BACKGROUND AND OBJECTIVE: We explored which clinical and biochemical variables predict conversion from clinically isolated syndrome (CIS) to clinically definite multiple sclerosis (CDMS) in a large international cohort.METHODS: Thirty-three centres provided serum samples from 1047 CIS cases with at least two years' follow-up. Age, sex, clinical presentation, T2-hyperintense lesions, cerebrospinal fluid (CSF) oligoclonal bands (OCBs), CSF IgG index, CSF cell count, serum 25-hydroxyvitamin D3 (25-OH-D), cotinine and IgG titres against Epstein-Barr nuclear antigen 1 (EBNA-1) and cytomegalovirus were tested for association with risk of CDMS.RESULTS: At median follow-up of 4.31 years, 623 CIS cases converted to CDMS. Predictors of conversion in multivariable analyses were OCB (HR = 2.18, 95% CI = 1.71-2.77, p < 0.001), number of T2 lesions (two to nine lesions vs 0/1 lesions: HR = 1.97, 95% CI = 1.52-2.55, p < 0.001; >9 lesions vs 0/1 lesions: HR = 2.74, 95% CI = 2.04-3.68, p < 0.001) and age at CIS (HR per year inversely increase = 0.98, 95% CI = 0.98-0.99, p < 0.001). Lower 25-OH-D levels were associated with CDMS in univariable analysis, but this was attenuated in the multivariable model. OCB positivity was associated with higher EBNA-1 IgG titres.CONCLUSIONS: We validated MRI lesion load, OCB and age at CIS as the strongest independent predictors of conversion to CDMS in this multicentre setting. A role for vitamin D is suggested but requires further investigation.
Published: 2015

22. Geographical Variations in Sex Ratio Trends over Time in Multiple Sclerosis

Author: Paul, F, Trojano, M, Lucchese, G, Graziano, G, Taylor, BV, Simpson, S, Lepore, V, Grand'Maison, F, Duquette, P, Izquierdo, G, Grammond, P, Amato, MP, Bergamaschi, R, Giuliani, G, Boz, C, Hupperts, R, Van Pesch, V, Lechner-Scott, J, Cristiano, E, Fiol, M, Oreja-Guevara, C, Laura Saladino, M, Verheul, F, Slee, M, Paolicelli, D, Tortorella, C, D'Onghia, M, Iaffaldano, P, Direnzo, V, Butzkueven, H, Paul, F, Trojano, M, Lucchese, G, Graziano, G, Taylor, BV, Simpson, S, Lepore, V, Grand'Maison, F, Duquette, P, Izquierdo, G, Grammond, P, Amato, MP, Bergamaschi, R, Giuliani, G, Boz, C, Hupperts, R, Van Pesch, V, Lechner-Scott, J, Cristiano, E, Fiol, M, Oreja-Guevara, C, Laura Saladino, M, Verheul, F, Slee, M, Paolicelli, D, Tortorella, C, D'Onghia, M, Iaffaldano, P, Direnzo, V, and Butzkueven, H
Abstract: BACKGROUND: A female/male (F/M) ratio increase over time in multiple sclerosis (MS) patients was demonstrated in many countries around the world. So far, a direct comparison of sex ratio time-trends among MS populations from different geographical areas was not carried out. OBJECTIVE: In this paper we assessed and compared sex ratio trends, over a 60-year span, in MS populations belonging to different latitudinal areas. METHODS: Data of a cohort of 15,996 (F = 11,290; M = 4,706) definite MS with birth years ranging from 1930 to 1989 were extracted from the international MSBase registry and the New Zealand MS database. Gender ratios were calculated by six decades based on year of birth and were adjusted for the F/M born-alive ratio derived from the respective national registries of births. RESULTS: Adjusted sex ratios showed a significant increase from the first to the last decade in the whole MS sample (from 2.35 to 2.73; p = 0.03) and in the subgroups belonging to the areas between 83° N and 45° N (from 1.93 to 4.55; p<0.0001) and between 45° N to 35° N (from 1.46 to 2.30; p<0.05) latitude, while a sex ratio stability over time was found in the subgroup from areas between 12° S and 55° S latitude. The sex ratio increase mainly affected relapsing-remitting (RR) MS. CONCLUSIONS: Our results confirm a general sex ratio increase over time in RRMS and also demonstrate a latitudinal gradient of this increase. These findings add useful information for planning case-control studies aimed to explore sex-related factors responsible for MS development.
Published: 2012

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22 results on '"Iaffaldano P"'

1. Disease-modifying therapies in managing disability worsening in paediatric-onset multiple sclerosis: a longitudinal analysis of global and national registries

2. Evaluation of drivers of treatment switch in relapsing multiple sclerosis: a study from the Italian MS Registry

3. Data monitoring roadmap. The experience of the Italian Multiple Sclerosis and Related Disorders Register

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

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19. Prognostic Indicators in Pediatric Clinically Isolated Syndrome

20. Predictors of Long-Term Disability Accrual in Relapse-Onset Multiple Sclerosis

21. Conversion from clinically isolated syndrome to multiple sclerosis:A large multicentre study

22. Geographical Variations in Sex Ratio Trends over Time in Multiple Sclerosis

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