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3. 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

4. Incidence and Long-term Functional Outcome of Neurologic Disorders in Hospitalized Patients with COVID-19 Infected with Pre-Omicron Variants

Author

Beretta, S, Cristillo, V, Camera, G, Morotti Colleoni, C, Pellitteri, G, Viti, B, Bianchi, E, Gipponi, S, Grimoldi, M, Valente, M, Guttmann, S, Cotelli, M, Palumbo, P, Gelosa, G, Meletti, S, Schenone, C, Ottaviani, D, Filippi, M, Zini, A, Basilico, P, Tancredi, L, Cortelli, P, Braga, M, De Giuli, V, Servidei, S, Paolicelli, D, Verde, F, Caproni, S, Pisani, A, Lo Re, V, Massacesi, L, Roccatagliata, D, Manganotti, P, Spitaleri, D, Formenti, A, Piccoli, M, Marino, S, Polverino, P, Aguglia, U, Ornello, R, Perego, E, Siciliano, G, Merlo, P, Capobianco, M, Pantoni, L, Lugaresi, A, Angelocola, S, De Rosa, A, Sessa, M, Beghi, E, Agostoni, E, Monaco, S, Padovani, A, Priori, A, Silani, V, Tedeschi, G, Ferrarese, C, Beretta S., Cristillo V., Camera G., Morotti Colleoni C., Pellitteri G., Viti B., Bianchi E., Gipponi S., Grimoldi M., Valente M., Guttmann S., Cotelli M. S., Palumbo P., Gelosa G., Meletti S., Schenone C., Ottaviani D., Filippi M., Zini A., Basilico P., Tancredi L., Cortelli P., Braga M., De Giuli V., Servidei S., Paolicelli D., Verde F., Caproni S., Pisani A., Lo Re V., Massacesi L., Roccatagliata D. V., Manganotti P., Spitaleri D., Formenti A., Piccoli M., Marino S., Polverino P., Aguglia U., Ornello R., Perego E., Siciliano G., Merlo P., Capobianco M., Pantoni L., Lugaresi A., Angelocola S., De Rosa A., Sessa M., Beghi E., Agostoni E. C., Monaco S., Padovani A., Priori A., Silani V., Tedeschi G., Ferrarese C., Beretta, S, Cristillo, V, Camera, G, Morotti Colleoni, C, Pellitteri, G, Viti, B, Bianchi, E, Gipponi, S, Grimoldi, M, Valente, M, Guttmann, S, Cotelli, M, Palumbo, P, Gelosa, G, Meletti, S, Schenone, C, Ottaviani, D, Filippi, M, Zini, A, Basilico, P, Tancredi, L, Cortelli, P, Braga, M, De Giuli, V, Servidei, S, Paolicelli, D, Verde, F, Caproni, S, Pisani, A, Lo Re, V, Massacesi, L, Roccatagliata, D, Manganotti, P, Spitaleri, D, Formenti, A, Piccoli, M, Marino, S, Polverino, P, Aguglia, U, Ornello, R, Perego, E, Siciliano, G, Merlo, P, Capobianco, M, Pantoni, L, Lugaresi, A, Angelocola, S, De Rosa, A, Sessa, M, Beghi, E, Agostoni, E, Monaco, S, Padovani, A, Priori, A, Silani, V, Tedeschi, G, Ferrarese, C, Beretta S., Cristillo V., Camera G., Morotti Colleoni C., Pellitteri G., Viti B., Bianchi E., Gipponi S., Grimoldi M., Valente M., Guttmann S., Cotelli M. S., Palumbo P., Gelosa G., Meletti S., Schenone C., Ottaviani D., Filippi M., Zini A., Basilico P., Tancredi L., Cortelli P., Braga M., De Giuli V., Servidei S., Paolicelli D., Verde F., Caproni S., Pisani A., Lo Re V., Massacesi L., Roccatagliata D. V., Manganotti P., Spitaleri D., Formenti A., Piccoli M., Marino S., Polverino P., Aguglia U., Ornello R., Perego E., Siciliano G., Merlo P., Capobianco M., Pantoni L., Lugaresi A., Angelocola S., De Rosa A., Sessa M., Beghi E., Agostoni E. C., Monaco S., Padovani A., Priori A., Silani V., Tedeschi G., and Ferrarese C.

Abstract

Background and ObjectivesA variety of neurologic disorders have been reported as presentations or complications of coronavirus disease 2019 (COVID-19) infection. The objective of this study was to determine their incidence dynamics and long-term functional outcome.MethodsThe Neuro-COVID Italy study was a multicenter, observational, cohort study with ambispective recruitment and prospective follow-up. Consecutive hospitalized patients presenting new neurologic disorders associated with COVID-19 infection (neuro-COVID), independently from respiratory severity, were systematically screened and actively recruited by neurology specialists in 38 centers in Italy and the Republic of San Marino. The primary outcomes were incidence of neuro-COVID cases during the first 70 weeks of the pandemic (March 2020-June 2021) and long-term functional outcome at 6 months, categorized as full recovery, mild symptoms, disabling symptoms, or death.ResultsAmong 52,759 hospitalized patients with COVID-19, 1,865 patients presenting 2,881 new neurologic disorders associated with COVID-19 infection (neuro-COVID) were recruited. The incidence of neuro-COVID cases significantly declined over time, comparing the first 3 pandemic waves (8.4%, 95% CI 7.9-8.9; 5.0%, 95% CI 4.7-5.3; 3.3%, 95% CI 3.0-3.6, respectively; p = 0.027). The most frequent neurologic disorders were acute encephalopathy (25.2%), hyposmia-hypogeusia (20.2%), acute ischemic stroke (18.4%), and cognitive impairment (13.7%). The onset of neurologic disorders was more common in the prodromic phase (44.3%) or during the acute respiratory illness (40.9%), except for cognitive impairment whose onset prevailed during recovery (48.4%). A good functional outcome was achieved by most patients with neuro-COVID (64.6%) during follow-up (median 6.7 months), and the proportion of good outcome increased throughout the study period (r = 0.29, 95% CI 0.05-0.50; p = 0.019). Mild residual symptoms were frequently reported (28.1%) while disabling s

Published
2023

6. 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 M., 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 M., 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., Schiavetti, Irene, Carmisciano, Luca, Ponzano, Marta, Cordioli, Cinzia, Cocco, Eleonora, Marfia, Girolama Alessandra, Inglese, Matilde, Filippi, Massimo, Radaelli, Marta, Bergamaschi, Roberto, Immovilli, Paolo, Capobianco, Marco, De Rossi, Nicola, Brichetto, Giampaolo, Scandellari, Cinzia, Cavalla, Paola, Pesci, Ilaria, Confalonieri, Paolo, Perini, Paola, Trojano, Maria, Lanzillo, Roberta, Tedeschi, Gioacchino, Comi, Giancarlo, Battaglia, Mario Alberto, Patti, Francesco, Salvetti, Marco, Sormani, Maria Pia, Gianmarco, Abbadessa, Umberto, Aguglia, Allegorico, Lia, Beatrice Maria Rossi Allegri, Anastasia, Alteno, Amato, MARIA PIA, Pietro, Annovazzi, Carlo, Antozzi, Lucia, Appendino, Sebastiano, Arena, Viola, Baione, Roberto, Balgera, Valeria, Barcella, Damiano, Baroncini, Caterina, Barrilà, Alessandra, Bellacosa, Gianmarco, Bellucci, Valeria, Bergamaschi, Daiana, Bezzini, Beatrice, Biolzi, Bisecco, Alvino, Simona, Bonavita, Giovanna, Borriello, Chiara, Bosa, Antonio, Bosco, Francesca, Bovi, Marco, Bozzali, Laura, Brambilla, BRESCIA MORRA, Vincenzo, Maria, Buccafusca, Elisabetta, Bucciantini, Sebastiano, Bucello, Maria Chiara Buscarinu, Maria Paola Cabboi, Massimiliano, Calabrese, Francesca, Calabria, Francesca, Caleri, Federico, Camilli, Luisa Maria Caniatti, Roberto, Cantello, Ruggero, Capra, Rocco, Capuano, Patrizia, Carta, Maria Grazia Celani, Maria, Cellerino, Raffaella, Cerqua, Clara, Chisari, Raffaella, Clerici, Marinella, Clerico, Gaia, Cola, Antonella, Conte, Marta Zaffira Conti, Christian, Cordano, Susanna, Cordera, Francesco, Corea, Claudio, Correale, Salvatore, Cottone, Francesco, Crescenzo, Erica, Curti, Alessandro, D’Ambrosio, Emanuele, D’Amico, Maura Chiara Danni, Alessia, D’Arma, Vincenzo, Dattola, Stefano de Biase, Giovanna De Luca, Stefania Federica De Mercanti, Paolo De Mitri, Nicola De Stefano, Fabio Maria Della Cava, Marco Della Cava, Sonia Di Lemme, Mario di Napoli, Alessia Di Sapio, Renato, Docimo, Anna, Dutto, Luana, Evangelista, Salvatore, Fanara, Roberta, Fantozzi, Diana, Ferraro, Maria Teresa Ferrò, Cristina, Fioretti, Mario, Fratta, Jessica, Frau, Marzia, Fronza, Roberto, Furlan, Alberto, Gajofatto, Gallo, Antonio, Paolo, Gallo, Claudio, Gasperini, Anna, Ghazaryan, Bruno, Giometto, Francesca, Gobbin, Flora, Govone, Franco, Granella, Erica, Grange, Grasso, MARIA GRAZIA, Grimaldi, Luigi M. E., Angelica, Guareschi, Clara, Guaschino, Simone, Guerrieri, Donata, Guidetti, Ina Barbara Juergenson, Pietro, Iaffaldano, Ianniello, Antonio, Luigi, Iasevoli, Daniele, Imperiale, Maria Teresa Infante, Iodice, Rosa, Iovino, Aniello, Giovanna, Konrad, Doriana, Landi, Caterina, Lapucci, Luigi, Lavorgna, Maria Rita L’Episcopo, Serena, Leva, Giuseppe, Liberatore, Marianna Lo Re, Marco, Longoni, Leonardo, Lopiano, Lorena, Lorefice, Matteo, Lucchini, Lus, Giacomo, Maimone, Davide, Maria, Malentacchi, Giulia, Mallucci, Simona, Malucchi, Chiara Rosa Mancinelli, Luca, Mancinelli, Paolo, Manganotti, Giorgia Teresa Maniscalco, Vittorio, Mantero, Sabrina, Marangoni, Damiano, Marastoni, Fabiana, Marinelli, Marti, NICOLA ALESSANDRO, Filippo Boneschi Martinelli, Zoli Federco Masserano, Francesca, Matta, Laura, Mendozzi, Giuseppe, Meucci, Silvia, Miante, Giuseppina, Miele, Eva, Milano, Massimiliano, Mirabella, Rosanna, Missione, Moccia, Marcello, Lucia, Moiola, Sara, Montepietra, Margherita, Montibragadin, Federico, Montini, Roberta, Motta, Raffaele, Nardone, Carolina Gabri Nicoletti, Eduardo, Nobile‐orazio, Nozzolillo, Agostino, Marco, Onofrj, Riccardo, Orlandi, Anna, Palmieri, Damiano, Paolicelli, Livia, Pasquali, Luisa, Pastò, Elisabetta, Pedrazzoli, Petracca, Maria, Alfredo, Petrone, Carlo, Piantadosi, Pietroboni, Anna M., Federica, Pinardi, Emilio, Portaccio, Mattia, Pozzato, Pozzilli, Carlo, Luca, Prosperini, Alessandra, Protti, Paolo, Ragonese, Sarah, Rasia, Sabrina, Realmuto, Anna, Repice, Eleonora, Rigoni, Maria Teresa Rilla, DELLA RATTA RINALDI, Francesca, Calogero Marcello Romano, Marco, Ronzoni, Marco, Rovari, Francesca, Ruscica, Loredana, Sabattini, Giuseppe, Salemi, Lorenzo, Saraceno, Alessia, Sartori, Arianna, Sartori, Elvira, Sbragia, Giuditta Ilaria Scarano, Valentina, Scarano, Maria, Sessa, Caterina, Sgarito, Sibilia, Grazia, Gabriele, Siciliano, Alessio, Signori, Signoriello, Elisabetta, Sinisi, Leonardo, Francesca, Sireci, Patrizia, Sola, Claudio, Solaro, Stefano, Sotgiu, Maddalena, Sparaco, Maria Laura Stromillo, Silvia, Strumia, Emanuela Laura Susani, Giulietta, Tabiadon, Francesco, Teatini, Valentina, Tomassini, Simone, Tonietti, Valentina, Torri, Tortorella, Carla, Simona, Toscano, Rocco, Totaro, Maria, Trotta, Gabriella, Turano, Monica, Ulivelli, Manzo, Valentino, Giovanna, Vaula, Domizia, Vecchio, Marco, Vercellino, Elena Pinuccia Verrengia, Marika, Vianello, Eleonora, Virgilio, Francesca, Vitetta, Vollaro, Stefano, Mauro, Zaffaroni, Mauro, Zampolini, Ignazio Roberto Zarbo, Antonio, Zito, and Luigi Zuliani, 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, M., 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, M., 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., and Zuliani, L.

Subjects
Multiple Sclerosis, Anosmia, Clinical Sciences, neurological disorders, Neurodegenerative, Settore MED/26, demyelinating disease, COVID-19, demyelinating diseases, disease-modifying treatment, multiple sclerosis, Humans, neurological disorder, Aged, Neurology & Neurosurgery, SARS-CoV-2, Pain Research, Neurosciences, Brain Disorders, Settore MED/26 - NEUROLOGIA, Good Health and Well Being, Neurology, multiple sclerosi, Neurology (clinical), MuSC-19 Study Group, Ageusia, Human
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

8. 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

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

Author

Mantovani, L, Cozzolino, P, Cortesi, P, Patti, F, Messina, S, Solaro, C, Amato, M, Bergamaschi, R, Bonavita, S, Bruno Bossio, R, Brescia Morra, V, Costantino, G, Cavalla, P, Centonze, D, Comi, G, Cottone, S, Danni, M, Francia, A, Gajofatto, A, Gasperini, C, Ghezzi, A, Iudice, A, Lus, G, Maniscalco, G, Marrosu, M, Matta, M, Mirabella, M, Montanari, E, Pozzilli, C, Rovaris, M, Sessa, E, Spitaleri, D, Trojano, M, Valentino, P, Zappia, M, Benedetti, M, Bertolotto, A, Berra, E, Bianco, A, Buttari, F, Cerqua, R, Florio, C, Fuiani, A, Guareschi, A, Ippolito, D, Nuara, A, Palmieri, V, Paolicelli, D, Petrucci, L, Pontecorvo, S, Sacca, F, Salomone, G, Signoriello, E, Spinicci, G, Russo, M, Tavazzi, E, Trabucco, E, Trotta, M, Zaffaroni, M, Mantovani L. G., Cozzolino P., Cortesi P. A., Patti F., Messina S., Solaro C., Amato M. P., Bergamaschi R., Bonavita S., Bruno Bossio R., Brescia Morra V., Costantino G. F., Cavalla P., Centonze D., Comi G., Cottone S., Danni M., Francia A., Gajofatto A., Gasperini C., Ghezzi A., Iudice A., Lus G., Maniscalco G. T., Marrosu M. G., Matta M., Mirabella M., Montanari E., Pozzilli C., Rovaris M., Sessa E., Spitaleri D., Trojano M., Valentino P., Zappia M., Benedetti M. D., Bertolotto A., Berra E., Bianco A., Buttari F., Cerqua R., Florio C., Fuiani A., Guareschi A., Ippolito D., Nuara A., Palmieri V., Paolicelli D., Petrucci L., Pontecorvo S., Sacca F., Salomone G., Signoriello E., Spinicci G., Russo M., Tavazzi E., Trabucco E., Trotta M., Zaffaroni M., Mantovani, L, Cozzolino, P, Cortesi, P, Patti, F, Messina, S, Solaro, C, Amato, M, Bergamaschi, R, Bonavita, S, Bruno Bossio, R, Brescia Morra, V, Costantino, G, Cavalla, P, Centonze, D, Comi, G, Cottone, S, Danni, M, Francia, A, Gajofatto, A, Gasperini, C, Ghezzi, A, Iudice, A, Lus, G, Maniscalco, G, Marrosu, M, Matta, M, Mirabella, M, Montanari, E, Pozzilli, C, Rovaris, M, Sessa, E, Spitaleri, D, Trojano, M, Valentino, P, Zappia, M, Benedetti, M, Bertolotto, A, Berra, E, Bianco, A, Buttari, F, Cerqua, R, Florio, C, Fuiani, A, Guareschi, A, Ippolito, D, Nuara, A, Palmieri, V, Paolicelli, D, Petrucci, L, Pontecorvo, S, Sacca, F, Salomone, G, Signoriello, E, Spinicci, G, Russo, M, Tavazzi, E, Trabucco, E, Trotta, M, Zaffaroni, M, Mantovani L. G., Cozzolino P., Cortesi P. A., Patti F., Messina S., Solaro C., Amato M. P., Bergamaschi R., Bonavita S., Bruno Bossio R., Brescia Morra V., Costantino G. F., Cavalla P., Centonze D., Comi G., Cottone S., Danni M., Francia A., Gajofatto A., Gasperini C., Ghezzi A., Iudice A., Lus G., Maniscalco G. T., Marrosu M. G., Matta M., Mirabella M., Montanari E., Pozzilli C., Rovaris M., Sessa E., Spitaleri D., Trojano M., Valentino P., Zappia M., Benedetti M. D., Bertolotto A., Berra E., Bianco A., Buttari F., Cerqua R., Florio C., Fuiani A., Guareschi A., Ippolito D., Nuara A., Palmieri V., Paolicelli D., Petrucci L., Pontecorvo S., Sacca F., Salomone G., Signoriello E., Spinicci G., Russo M., Tavazzi E., Trabucco E., Trotta M., and Zaffaroni M.

Abstract

Introduction: Multiple sclerosis (MS) is a highly symptomatic disease, with a wide range of disabilities affecting many bodily functions, even in younger persons with a short disease history. The availability of a cannabinoid oromucosal spray (Sativex) for the management of treatment-resistant MS spasticity has provided a new opportunity for many patients. Objective: Our study aimed to assess the cost effectiveness of Sativex in Italian patients with treatment-resistant MS spasticity. The analysis was based on the real-world data of a large registry of Italian patients. Methods: A cost-utility analysis was conducted using data collected prospectively from an electronic registry of all patients who began to use Sativex for MS-resistant spasticity between January 2014 and February 2015 in 30 specialized MS units across Italy and were followed up for ≤ 6 months. Data on drug consumption and spasticity/utility were used to estimate the incremental cost-effectiveness ratio (ICER) of Sativex, as compared with no intervention. No costs or spasticity/utility changes were assumed for no treatment intervention. The ICER was expressed as quality-adjusted life-years (QALYs) gained, using the Italian NHS perspective and a 6-month time horizon. Results: Sativex effectiveness and consumption was estimated analyzing data of 1350 patients from the registry. These patients reported a mean (SD) utility increment of 0.087 (0.069) after 1 month of treatment, 0.118 (0.073) after 3 months’ treatment and 0.127 (0.080) after 6 months’ treatment. The 6-month cost of treating the entire population with Sativex was €1,361,266, with a €1008 cost and 0.0284 QALYs gained per patient. The estimated ICER was €35,516 per QALY gained, with little variability around the central estimate of cost-effectiveness, as shown by the cost-effectiveness acceptability curve. Conclusion: The use of Sativex could improve the quality of life of patients with a reasonable incremental cost resulti

Published
2020

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

Author

Ferraro, D., Iaffaldano, P., Guerra, T., Inglese, M., Capobianco, M., Brescia Morra, V., Zaffaroni, M., Mirabella, M., Lus, G., Patti, F., Cavalla, P., Cellerino, M., Malucchi, S., Pisano, E., Vitetta, F., Paolicelli, D., Sola, P., Trojano, M., Aguglia, U., Amato, M. P., Avolio, C., Balgera, R., Banfi, P., Bellantonio, P., Bergamaschi, R., Cargnelutti, D., Cartechini, E., Chiveri, L., Clerici, R., Cocco, E., Conte, A., Corea, F., Danni, M. C., De Luca, G., Di Sapio, A., Ferraro, E., Galgani, S., Gallo, A., Gatto, M., Gazzola, P., Granella, F., Lugaresi, A., Maimone, D., Maniscalco, G. T., Marfia, G. A., Montepietra, S., Paolo, C., Pesci, I., Pozzilli, C., Carlo, P., Protti, A., Quatrale, R., Realmuto, S., Romano, S., Romeo, M., Salemi, G., Leonardo, S., Rocco, T., Paola, V., Marika, V., Ferraro, D., Iaffaldano, P., Guerra, T., Inglese, M., Capobianco, M., Brescia Morra, V., Zaffaroni, M., Mirabella, M., Lus, G., Patti, F., Cavalla, P., Cellerino, M., Malucchi, S., Pisano, E., Vitetta, F., Paolicelli, D., Sola, P., Trojano, M., Aguglia, U., Amato, M. P., Avolio, C., Balgera, R., Banfi, P., Bellantonio, P., Bergamaschi, R., Cargnelutti, D., Cartechini, E., Chiveri, L., Clerici, R., Cocco, E., Conte, A., Corea, F., Danni, M. C., De Luca, G., Di Sapio, A., Ferraro, E., Galgani, S., Gallo, A., Gatto, M., Gazzola, P., Granella, F., Lugaresi, A., Maimone, D., Maniscalco, G. T., Marfia, G. A., Montepietra, S., Paolo, C., Pesci, I., Pozzilli, C., Carlo, P., Protti, A., Quatrale, R., Realmuto, S., Romano, S., Romeo, M., Salemi, G., Leonardo, S., Rocco, T., Paola, V., and Marika, V.

Subjects
Adult, medicine.medical_specialty, Relapsing-Remitting, Settore MED/26, Gastroenterology, Multiple sclerosis, Immunosuppressive Agent, Multiple Sclerosis, Relapsing-Remitting, Recurrence, Internal medicine, Multiple Sclerosi, medicine, Humans, Ocrelizumab, Cladribine, Alemtuzumab, Fingolimod, Rituximab, Fingolimod Hydrochloride, Immunosuppressive Agents, Middle Aged, Multiple Sclerosis, business.industry, Hazard ratio, Washout, Discontinuation, Settore MED/26 - NEUROLOGIA, Neurology, Neurology (clinical), business, medicine.drug, Human
Abstract

Background: Fingolimod (FTY) induces sequestration of lymphocytes in secondary lymphoid organs and the average lymphocyte recovery following discontinuation takes 1–2months. It has been hypothesized that the therapeutic effects of subsequent cell-depleting agents may be compromised if initiated before lymphocyte recovery has occurred. Objective: To assess the risk of relapses following FTY discontinuation and the initiation of a B/T cell-depleting agent in relation to washout duration using data from the Italian MS Register. Methods: The risk of relapses was assessed in relation to different washout durations (< 6, 6–11, 12–17 and > / = 18weeks) in patients starting alemtuzumab, rituximab, ocrelizumab or cladribine following FTY discontinuation. Results: We included 329 patients in the analysis (226F, 103M; mean age 41 ± 10years). During the cell-depleting treatment, the incidence rate ratio for a relapse was significantly greater in patients with a washout period of 12–17 and > / = 18weeks compared to the reference period (< 6weeks). The risk of a relapse was significantly influenced by the occurrence of relapses during FTY treatment and by washout length, with hazard ratios markedly increasing with the washout duration. Conclusion: The risk of relapses increases with the washout duration when switching from FTY to lymphocyte-depleting agents.

Published
2021

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

Author

Mantovani, Lg, Cozzolino, P, Cortesi, Pa, Patti, F, Messina, S, Solaro, C, Amato, Mp, Bergamaschi, R, Bonavita, S, Bruno Bossio, R, Brescia Morra, V, Costantino, Gf, Cavalla, P, Centonze, D, Comi, G, Cottone, S, Danni, M, Francia, A, Gajofatto, A, Gasperini, C, Ghezzi, A, Iudice, A, Lus, G, Maniscalco, Gt, Marrosu, Mg, Matta, M, Mirabella, M, Montanari, E, Pozzilli, C, Rovaris, M, Sessa, E, Spitaleri, D, Trojano, M, Valentino, P, Zappia, M, Benedetti, Md, Bertolotto, A, Berra, E, Bianco, A, Buttari, F, Cerqua, R, Florio, C, Fuiani, A, Guareschi, A, Ippolito, D, Nuara, A, Palmieri, V, Paolicelli, D, Petrucci, L, Pontecorvo, S, Sacca, F, Salomone, G, Signoriello, E, Spinicci, G, Russo, M, Tavazzi, E, Trabucco, E, Trotta, M, Zaffaroni, M, Mantovani, L, Cozzolino, P, Cortesi, P, Patti, F, Messina, S, Solaro, C, Amato, M, Bergamaschi, R, Bonavita, S, Bruno Bossio, R, Brescia Morra, V, Costantino, G, Cavalla, P, Centonze, D, Comi, G, Cottone, S, Danni, M, Francia, A, Gajofatto, A, Gasperini, C, Ghezzi, A, Iudice, A, Lus, G, Maniscalco, G, Marrosu, M, Matta, M, Mirabella, M, Montanari, E, Pozzilli, C, Rovaris, M, Sessa, E, Spitaleri, D, Trojano, M, Valentino, P, Zappia, M, Benedetti, M, Bertolotto, A, Berra, E, Bianco, A, Buttari, F, Cerqua, R, Florio, C, Fuiani, A, Guareschi, A, Ippolito, D, Nuara, A, Palmieri, V, Paolicelli, D, Petrucci, L, Pontecorvo, S, Sacca, F, Salomone, G, Signoriello, E, Spinicci, G, Russo, M, Tavazzi, E, Trabucco, E, Trotta, M, Zaffaroni, M, Mantovani, Lorenzo G, Cozzolino, Paolo, Cortesi, Paolo A, Patti, Francesco, Amato, Mp, Costantino, Gf, Maniscalco, Gt, Marrosu, Mg, Benedetti, Md, Saccà, F, Zaffaroni, M., Mantovani, L. G., Cozzolino, P., Cortesi, P. A., Patti, F., Messina, S., Solaro, C., Amato, M. P., Bergamaschi, R., Bonavita, S., Bruno Bossio, R., Brescia Morra, V., Costantino, G. F., Cavalla, P., Centonze, D., Comi, G., Cottone, S., Danni, M., Francia, A., Gajofatto, A., Gasperini, C., Ghezzi, A., Iudice, A., Lus, G., Maniscalco, G. T., Marrosu, M. G., Matta, M., Mirabella, M., Montanari, E., Pozzilli, C., Rovaris, M., Sessa, E., Spitaleri, D., Trojano, M., Valentino, P., Zappia, M., Benedetti, M. D., Bertolotto, A., Berra, E., Bianco, A., Buttari, F., Cerqua, R., Florio, C., Fuiani, A., Guareschi, A., Ippolito, D., Nuara, A., Palmieri, V., Paolicelli, D., Petrucci, L., Pontecorvo, S., Sacca, F., Salomone, G., Signoriello, E., Spinicci, G., Russo, M., Tavazzi, E., Trabucco, E., and Trotta, M.

Subjects
Adult, Male, medicine.medical_specialty, Cost effectiveness, Cost-Benefit Analysis, MEDLINE, 030204 cardiovascular system & hematology, Settore MED/26, multiple sclerosis, 030226 pharmacology & pharmacy, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Cannabidiol, Dronabinol, Drug Combinations, Female, Humans, Italy, Middle Aged, Multiple Sclerosis, Muscle Spasticity, Quality of Life, Quality-Adjusted Life Years, Medicine, Pharmacology (medical), Spasticity, spasticity, multiple sclerosis, cannabinoid, health care economics and organizations, Cost-Effectiveness Analysis, Spasticity, Cannabinoid, Multiple Sclerosis, Cost–benefit analysis, business.industry, Multiple sclerosis, spasticity, General Medicine, Cost-effectiveness analysis, cannabinoid, medicine.disease, Quality-adjusted life year, Settore MED/26 - NEUROLOGIA, Physical therapy, medicine.symptom, business
Abstract

Introduction: Multiple sclerosis (MS) is a highly symptomatic disease, with a wide range of disabilities affecting many bodily functions, even in younger persons with a short disease history. The availability of a cannabinoid oromucosal spray (Sativex) for the management of treatment-resistant MS spasticity has provided a new opportunity for many patients. Objective: Our study aimed to assess the cost effectiveness of Sativex in Italian patients with treatment-resistant MS spasticity. The analysis was based on the real-world data of a large registry of Italian patients. Methods: A cost-utility analysis was conducted using data collected prospectively from an electronic registry of all patients who began to use Sativex for MS-resistant spasticity between January 2014 and February 2015 in 30 specialized MS units across Italy and were followed up for ≤ 6months. Data on drug consumption and spasticity/utility were used to estimate the incremental cost-effectiveness ratio (ICER) of Sativex, as compared with no intervention. No costs or spasticity/utility changes were assumed for no treatment intervention. The ICER was expressed as quality-adjusted life-years (QALYs) gained, using the Italian NHS perspective and a 6-month time horizon. Results: Sativex effectiveness and consumption was estimated analyzing data of 1350 patients from the registry. These patients reported a mean (SD) utility increment of 0.087 (0.069) after 1month of treatment, 0.118 (0.073) after 3months’ treatment and 0.127 (0.080) after 6months’ treatment. The 6-month cost of treating the entire population with Sativex was €1,361,266, with a €1008 cost and 0.0284 QALYs gained per patient. The estimated ICER was €35,516 per QALY gained, with little variability around the central estimate of cost-effectiveness, as shown by the cost-effectiveness acceptability curve. Conclusion: The use of Sativex could improve the quality of life of patients with a reasonable incremental cost resulting as a cost-effective option for patients with MS-resistant spasticity. These results could help clinicians and decision makers to develop improved management strategies for spasticity in patients with MS, optimizing the use of available resources.

Published
2020

12. 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

13. 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

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

Author

Carotenuto A., Moccia M., Costabile T., Signoriello E., Paolicelli D., Simone M., Lus G., Brescia Morra V., Lanzillo R., Rosa L., Barbarulo A. M., Falco F., Viterbo R. G., Lauro F., Carotenuto, Antonio, Moccia, Marcello, Costabile, Teresa, Signoriello, Elisabetta, Paolicelli, Damiano, Simone, Marta, Lus, Giacomo, Brescia Morra, Vincenzo, Lanzillo, Roberta, Carotenuto, A., Moccia, M., Costabile, T., Signoriello, E., Paolicelli, D., Simone, M., Lus, G., Brescia Morra, V., Lanzillo, R., Rosa, L., Barbarulo, A. M., Falco, F., Viterbo, R. G., and Lauro, F.

Subjects
Adult, Male, medicine.medical_specialty, Multiple Sclerosis, 020205 medical informatics, Adolescent, Population, lcsh:Medicine, 02 engineering and technology, Predictive markers, Risk Assessment, Article, 03 medical and health sciences, Disability Evaluation, Young Adult, 0302 clinical medicine, Cognition, Visual memory, Recurrence, Internal medicine, 0202 electrical engineering, electronic engineering, information engineering, medicine, Humans, Cognitive Dysfunction, Longitudinal Studies, Young adult, Age of Onset, 10. No inequality, education, lcsh:Science, Child, Retrospective Studies, education.field_of_study, Multidisciplinary, Proportional hazards model, business.industry, Multiple sclerosis, lcsh:R, Retrospective cohort study, Cognitive neuroscience, medicine.disease, Disease Progression, lcsh:Q, Female, Age of onset, business, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract

Differently from the adult multiple sclerosis (MS) population, the predictive value of cognitive impairment in early-onset MS is still unknown. We aim to evaluate whether cognitive performances at disease onset predict disease progression in young people with MS. This is a retrospective study on early onset (

Published
2019

16. A multicenter survey on access to care in Multiple Sclerosis-related trigeminal neuralgia

Author

Ferraro, D., Annovazzi, P., Lanzillo, R., Calabrese, M., Fantozzi, R., De Luca, G., Cordioli, C., Paolicelli, D., Ragonese, P., Gajofatto, A., Lo Fermo, S., Cavalla, P., Tortorella, C., Pesci, I., Gallo, A., Pinardi, F., Di Filippo, M., Maniscalco, G.T., Nociti, V., Radaelli, M., Tomassini, V., Buscarinu, M.C., Moccia, M., Camera, V., Cocco, E., Gasperini, C., and Solaro, C.

Published
2021
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17. Post-marketing of disease modifying drugs in multiple sclerosis: An exploratory analysis of gender effect in interferon beta treatment

Author

Trojano, M., Pellegrini, F., Paolicelli, D., Fuiani, A., Zimatore, G.B., Tortorella, C., Simone, I.L., Patti, F., Ghezzi, A., Portaccio, E., Rossi, P., Pozzilli, C., Salemi, G., Lugaresi, A., Bergamaschi, R., Millefiorini, E., Clerico, M., Lus, G., Vianello, M., Avolio, C., Cavalla, P., Iaffaldano, P., Direnzo, V., D'Onghia, M., Lepore, V., Livrea, P., Comi, G., and Amato, M.P.

Published
2009
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19. Disease modifying therapies and Covid‐19 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., the Musc-19 Study Group, 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., Ferrò, M. T., Ercolani, M. V., Bianco, M., M. L., Re, Vianello, M., Clerico, M., di Napoli, M., Ponzano, M., Conti, M. Z., Calabrese, M., Mirabella, M., Filippi, M., Inglese, M., Lucchini, M., Pozzato, M., Danni, M. C., Zaffaroni, M., Zampolini, M., Ponzio, M., De Riz, M., De Stefano, N., Cavalla, P., De Mitri, P., Grossi, P., Confalonieri, P., Gallo, P., Ragonese, P., Sola, P., Annovazzi, P., Iaffaldano, P., Nardone, R., Cerqua, R., Clerici, R., Lanzillo, R., Motta, R., Balgera, R., Bergamaschi, R., Totaro, R., Iodice, R., Capra, R., Marangoni, S., Realmuto, S., Cottone, S., Montepietra, S., Rasia, S., Arena, S., Bucello, S., Banfi, S., Bonavita, S., Malucchi, S., Tonietti, S., Vollaro, S., Cordera, S., Aguglia, U., Clerici, V. T., Barcella, V., Bergamaschi, V., Morra, V. B., Dattola, V., and Mantero, V.

Published
2021

20. 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

21. 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

23. Postpartum relapses increase the risk of disability progression in multiple sclerosis: the role of disease modifying drugs

Author

Portaccio, Emilio, Ghezzi, Angelo, Hakiki, Bahia, Sturchio, Andrea, Martinelli, Vittorio, Moiola, Lucia, Patti, Francesco, Mancardi, Gian Luigi, Solaro, Claudio, Tola, Maria Rosaria, Pozzilli, Carlo, De Giglio, Laura, Totaro, Rocco, Lugaresi, Alessandra, De Luca, Giovanna, Paolicelli, Damiano, Marrosu, Maria Giovanna, Comi, Giancarlo, Trojano, Maria, Amato, Maria Pia, Amato, MP, Portaccio, E, Hakiki, B, Sturchio, A, Pastò, L, Giannini, M, Razzolini, L, Piscolla, E, Siracusa, G, Ghezzi, A, Rizzo, A, Zaffaroni, M, Martinelli, V, Radaelli, M, Moiola, L, Comi, G, Protti, A, Spreafico, C, Marazzi, R, Cavalla, P, Masera, S, Bergamaschi, R, Mancardi, G, Capello, E, Solaro, C, Tola, MR, Caniatti, L, Granella, F, Immovilli, P, Annunziata, P, De Santi, L, Plewnia, K, Guidi, L, Bartolozzi, ML, Mazzoni, M., Pozzilli, C, De Giglio, L, Totaro, R, Carolei, A, Rossi, M, Lugaresi, A, De Luca, G., Di Tommaso, V, Trojano, M, Paolicelli, D, Carrozzo, A, DʼOnghia, M, Marrosu, MG, Musu, L, Patti, F, Carmela, L, and Lo Fermo, S

Published
2014
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25. Variations of the perforin gene in patients with multiple sclerosis

Author

Cappellano, G, Orilieri, E, Comi, C, Chiocchetti, A, Bocca, S, Boggio, E, Bernardone, I S, Cometa, A, Clementi, R, Barizzone, N, D'Alfonso, S, Corrado, L, Galimberti, D, Scarpini, E, Guerini, F R, Caputo, D, Paolicelli, D, Trojano, M, Figà-Talamanca, L, Salvetti, M, Perla, F, Leone, M, Monaco, F, and Dianzani, U

Published
2008
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27. Characteristics and treatment of Multiple Sclerosis-related trigeminal neuralgia: An Italian multi-centre study

Author

Ferraro, D., Annovazzi, P., Moccia, M., Lanzillo, R., De Luca, G., Nociti, Viviana, Fantozzi, R., Paolicelli, D., Ragonese, P., Gajofatto, A., Boffa, L., Cavalla, P., Lo Fermo, S., Buscarinu, M. C., Lorefice, L., Cordioli, C., Calabrese, M., Gallo, A., Pinardi, F., Tortorella, C., Di Filippo, M., Camera, V., Maniscalco, G. T., Radaelli, M., Buttari, F., Tomassini, V., Cocco, E., Gasperini, C., Solaro, C., Nociti V. (ORCID:0000-0002-4607-3948), Ferraro, D., Annovazzi, P., Moccia, M., Lanzillo, R., De Luca, G., Nociti, Viviana, Fantozzi, R., Paolicelli, D., Ragonese, P., Gajofatto, A., Boffa, L., Cavalla, P., Lo Fermo, S., Buscarinu, M. C., Lorefice, L., Cordioli, C., Calabrese, M., Gallo, A., Pinardi, F., Tortorella, C., Di Filippo, M., Camera, V., Maniscalco, G. T., Radaelli, M., Buttari, F., Tomassini, V., Cocco, E., Gasperini, C., Solaro, C., and Nociti V. (ORCID:0000-0002-4607-3948)

Abstract

Background: The prevalence of trigeminal neuralgia (TN) in Multiple Sclerosis (MS) patients is higher than in the general population and its management can be particularly challenging. Our aim is to describe the characteristics, treatment and prognostic factors of MS-related TN in a retrospective multicentre study. Methods: Neurologists members of the RIREMS group (Rising Researchers in MS) enrolled MS patients with a TN diagnosis and filled out a spreadsheet comprising their clinical data. Results: Population consisted of 298 patients. First-choice preventive treatments were carbamazepine and oxcarbazepine. A surgical procedure was performed in 81 (30%) patients, most commonly gamma knife stereotactic radiosurgery (37%), followed by microvascular decompression (22%) and radiofrequency thermocoagulation (21%); one third of patients underwent at least two procedures. Surgery was associated with higher disability, male sex and longer interval between MS and TN onset. Patients (77%) who stayed on at least one preventive medication at most recent follow-up, after a mean period of 8 years, had a higher disability compared to the untreated group. Furthermore, patients with higher disability at TN onset were less likely to discontinue their first preventive medication due to pain remission, had bilateral TN more frequently and underwent surgical interventions earlier. Conclusion: MS patients with a higher disability at TN onset and with a longer interval between MS and TN onset had differing clinical features and outcomes: pain was more frequently bilateral, surgery was more frequent and anticipated, and preventive medication discontinuation due to pain remission was less common.

Published
2020

28. 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

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

Author

Patti F., Messina S., Solaro C., Amato M. P., Bergamaschi R., Bonavita S., Bruno Bossio R., Brescia Morra V., Costantino G. F., Cavalla P., Centonze D., Comi G., Cottone S., Danni M., Francia A., Gajofatto A., Gasperini C., Ghezzi A., Iudice A., Lus G., Maniscalco G. T., Marrosu M. G., Matta M., Mirabella M., Montanari E., Pozzilli C., Rovaris M., Sessa E., Spitaleri D., Trojano M., Valentino P., Zappia M., Benedetti MD, Bertolotto A, Berra E, Bianco A, Buttari F, Cerqua R, Florio C, Fuiani A, Guareschi A, Ippolito D, Nuara A, Palmieri V, Paolicelli D, Petrucci L, Pontecorvo S, Saccà Francesco, Salamone G, Signoriello E, Spinicci G, Russo M, Tavazzi E Trabucco E, Trotta M, Zaffaroni M., Patti, F, Messina, S., Solaro, C., Amato, M. P., Bergamaschi, R., Bonavita, Simona, Bruno Bossio, R., Brescia Morra, V., Costantino, G. F., Cavalla, P., Centonze, D., Comi, G., Cottone, S., Danni, M., Francia, A., Gajofatto, A., Gasperini, C., Ghezzi, A., Iudice, A., Lus, Giacomo, Maniscalco, G. T., Marrosu, M. G., Matta, M., Mirabella, M., Montanari, E., Pozzilli, C., Rovaris, M., Sessa, E., Spitaleri, D., Trojano, M., Valentino, P., Zappia, M., Patti, F., Bonavita, S., Lus, G., Benedetti, Md, Bertolotto, A, Berra, E, Bianco, A, Buttari, F, Cerqua, R, Florio, C, Fuiani, A, Guareschi, A, Ippolito, D, Nuara, A, Palmieri, V, Paolicelli, D, Petrucci, L, Pontecorvo, S, Saccà, Francesco, Salamone, G, Signoriello, E, Spinicci, G, Russo, M, Tavazzi, E Trabucco E, Trotta, M, Zaffaroni, M., Messina, S, Solaro, C, Amato, Mp, Bergamaschi, R, Bonavita, S, Bossio, Rb, Morra, Vb, Costantino, Gf, Cavalla, P, Centonze, D, Comi, Giancarlo, Cottone, S, Danni, M, Francia, A, Gajofatto, A, Gasperini, C, Ghezzi, A, Iudice, A, Lus, G, Maniscalco, Gt, Marrosu, Mg, Matta, M, Mirabella, M, Montanari, E, Pozzilli, C, Rovaris, M, Sessa, E, Spitaleri, D, Trojano, M, and Valentino, P

Subjects
Multivariate analysis, assessment, Administration, Oral, patients, 0302 clinical medicine, Drug Combination, Multiple Sclerosi, 9- δ -tetrahydocannabinol, cannabidiol, Sativex, multiple sclerosis, treatment-resistant spasticity, Italy, Cannabidiol, Medicine, Dronabinol, 030212 general & internal medicine, cannabinoid, Drug Combinations, Muscle Spasticity, Psychiatry and Mental Health, Humans, Multiple Sclerosis, Plant Extracts, Safety, Surgery, Neurology (clinical), Administration, Settore MED/26 - Neurologia, medicine.symptom, Human, medicine.drug, Oral, medicine.medical_specialty, Nabiximols, Plant Extract, 03 medical and health sciences, Arts and Humanities (miscellaneous), Rating scale, Internal medicine, Spasticity, Adverse effect, multiple sclerosis, cannabinoid, business.industry, Multiple sclerosis, medicine.disease, Physical therapy, Observational study, business, 030217 neurology & neurosurgery
Abstract

Background The approval of 9-δ-tetrahydocannabinol and cannabidiol (THC:CBD) oromucosal spray (Sativex) for the management of treatment-resistant multiple sclerosis (MS) spasticity opened a new opportunity for many patients. The aim of our study was to describe Sativex effectiveness and adverse events profile in a large population of Italian patients with MS in the daily practice setting. Methods We collected data of all patients starting Sativex between January 2014 and February 2015 from the mandatory Italian medicines agency (AIFA) e-registry. Spasticity assessment by the 0–10 numerical rating scale (NRS) scale is available at baseline, after 1 month of treatment (trial period), and at 3 and 6 months. Results A total of 1615 patients were recruited from 30 MS centres across Italy. After one treatment month (trial period), we found 70.5% of patients reaching a ≥20% improvement (initial response, IR) and 28.2% who had already reached a ≥30% improvement (clinically relevant response, CRR), with a mean NRS score reduction of 22.6% (from 7.5 to 5.8). After a multivariate analysis, we found an increased probability to reach IR at the first month among patients with primary and secondary progressive MS, (n=1169, OR 1.4 95% CI 1.04 to 1.9, p=0.025) and among patients with >8 NRS score at baseline (OR 1.8 95% CI 1.3–2.4 p

Published
2016

36. Guidelines on the clinical use for the detection of neutralizing antibodies (NAbs) to IFN beta in multiple sclerosis therapy: report from the Italian Multiple Sclerosis Study group

Author

Bertolotto A, Capobianco M, Amato MP, Capello E, Capra R, Centonze D, Di Ioia M, Grimaldi L, Imberti L, Lugaresi A, Mancinelli C, Marrosu MG, Moiola L, Montanari E, Romano S, Musu L, Paolicelli D, Patti F, Pozzilli C, Rossi S, Salvetti M, Tola MR, Troiano M, Zaffaroni M, Malucchi S, Italian Multiple Sclerosis Study group, GALLO, Antonio, TEDESCHI, Gioacchino, Bertolotto A, Capobianco M, Amato MP, Capello E, Capra R, Centonze D, Di Ioia M, Gallo A, Grimaldi L, Imberti L, Lugaresi A, Mancinelli C, Marrosu MG, Moiola L, Montanari E, Romano S, Musu L, Paolicelli D, Patti F, Pozzilli C, Rossi S, Salvetti M, Tedeschi G, Tola MR, Troiano M, Zaffaroni M, Malucchi S, Bertolotto, A, Capobianco, M, Amato, Mp, Capello, E, Capra, R, Centonze, D, Di Ioia, M, Gallo, Antonio, Grimaldi, L, Imberti, L, Lugaresi, A, Mancinelli, C, Marrosu, Mg, Moiola, L, Montanari, E, Romano, S, Musu, L, Paolicelli, D, Patti, F, Pozzilli, C, Rossi, S, Salvetti, M, Tedeschi, Gioacchino, Tola, Mr, Troiano, M, Zaffaroni, M, Malucchi, S, and Italian Multiple Sclerosis Study, Group

Subjects
Myxovirus Resistance Proteins, Oncology, medicine.medical_specialty, Multiple Sclerosis, Neurology, neutralizing antibodies, guidelines, immunogenicity, ifnβ, multiple sclerosis, ifn beta, interferon, antibodies, multiple sclerosis, Dermatology, Disease activity, Multiple Sclerosis, Relapsing-Remitting, Internal medicine, medicine, Humans, Immunologic Factors, Clinical significance, Beta (finance), Randomized Controlled Trials as Topic, medicine.diagnostic_test, biology, business.industry, Multiple sclerosis, Magnetic resonance imaging, Interferon-beta, General Medicine, medicine.disease, Antibodies, Neutralizing, Magnetic Resonance Imaging, Psychiatry and Mental health, Early Diagnosis, Italy, Immunology, biology.protein, Settore MED/26 - Neurologia, Neurology (clinical), Neurosurgery, Antibody, business
Abstract

Interferon beta (IFNβ) was the first specific disease-modifying treatment licensed for relapsing-remitting multiple sclerosis, and is still one of the most commonly prescribed treatments. A strong body of evidence supports the effectiveness of IFNβ preparations in reducing the annual relapse rate, magnetic resonance (MRI) disease activity and disease progression. However, the development of binding/neutralizing antibodies (BAbs/NAbs) during treatment negatively affects clinical and MRI outcomes. Therefore, guidelines for the clinical use for the detection of NAbs in MS may result in better treatment of these patients. In October 2012, a panel of Italian neurologists from 17 MS clinics convened in Milan to review and discuss data on NAbs and their clinical relevance in the treatment of MS. In this paper, we report the panel's recommendations for the use of IFNβ Nabs detection in the early identification of IFNβ non-responsiveness and the management of patients on IFNβ treatment in Italy, according to a model of therapeutically appropriate care.

Published
2014

37. 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

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

Author

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

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

39. TREATMENT CHOICE AFTER 24 NATALIZUMAB DOSES IN PATIENTS WITH MULTIPLE SCLEROSIS: A PROSPECTIVE OBSERVATIONAL STUDY, THE TY-STOP

Author

CLERICO, M, DE MERCANTI, S, PIAZZA, F, GNED, D, DURELLI, L, SCHIAVETTI, L, SORMANI, M, GHEZZI, A, BIANCHI, A, BARONCINI, D, LANZILLO, R, VACCHIANO, L, AMATO, L, BRESCIA MORRA, V, QUARANTELLI, G, SOLA, P, VITETTA, F, FERRARO, D, SIMONE, A, PINESSI, L, CAVALLA, P, SUPERTI, G, FERRÒ, M, D’ONGHIA, M, PAOLICELLI, D, TROJANO M., SALEMI, Giuseppe, REALMUTO, Sabrina, RAGONESE, Paolo, MAZZOLA, Maria Antonietta, CLERICO, M, DE MERCANTI, S, PIAZZA, F, GNED, D, DURELLI, L, SCHIAVETTI, L, SORMANI, M, GHEZZI, A, BIANCHI, A, BARONCINI, D, LANZILLO, R, VACCHIANO, L, AMATO, L, BRESCIA MORRA, V, QUARANTELLI, G, SALEMI, G, REALMUTO, S, RAGONESE, P, MAZZOLA, MA, SOLA, P, VITETTA, F, FERRARO, D, SIMONE, A, PINESSI, L, CAVALLA, P, SUPERTI, G, FERRÒ, M, D’ONGHIA, M, PAOLICELLI, D, and TROJANO M.

Subjects
Multiple scleorsi, natalizumab, Settore MED/26 - Neurologia
Published
2014

40. The diagnosis of multiple sclerosis: pinpointing the concept of 'no better explanation'

Author

Calabrese, Massimiliano, Gasperin, C., Tortorella, C., Malucchi, S., Ragonese, P., De Luca, G., Fantozzi, R., Lo Fermo, S., Boffa, L., Paolicelli, D., Gajofatto, Alberto, Pesci, I., Annovazzi, P., Cordioli, C., Lanzillo, R., Giorgio, A., Gallo, A., Tomassini, V., Frisullo, G., Prosperini, L., Cocco, E., Rodegher, M., Solaro, C., CALABRESE, M, GASPERINI, C, TORTORELLA, C, MALUCCHI, S, RAGONESE, P, DE LUCA, G, FANTOZZI, R, LO FERMO, S, BOFFA, L, PAOLICELLI, D, GAJOFATTO, D, PESCI, I, ANNOVAZZI, P, CORDIOLI, C, LANZILLO, R, GIORGIO, A, GALLO, A, TOMASSINI, V, FRISULLO, G, PROSPERINI, L, COCCO, E, RODEGHER, M, and SOLARO C.

Subjects
diagnosis, Multiple sclerosi, Settore MED/26 - Neurologia, multiple sclerosis
Published
2014

41. Post-marketing of disease modifying drugs in multiple sclerosis: an exploratory analysis of gender effect in interferon beta treatment

Author

Trojano, M, Pellegrini, F, Paolicelli, D, Fuiani, A, Zimatore, Gb, Tortorella, C, Simone, Il, Patti, F, Ghezzi, A, Portaccio, E, Rossi, P, Pozzilli, C, Salemi, G, Lugaresi, A, Bergamaschi, R, Millefiorini, E, Clerico, Marinella, Lus, G, Vianello, M, Avolio, C, Cavalla, P, Iaffaldano, P, Direnzo, V, D'Onghia, M, Lepore, V, Livrea, P, Comi, G, Amato, Mp, Italian Multiple Sclerosis Database Network Group, Trojano, M., Pellegrini, F., Paolicelli, D., Fuiani, A., Zimatore, G., Tortorella, C., Simone, I., Patti, F., Ghezzi, A., Portaccio, E., Rossi, P., Pozzilli, C., Salemi, G., Lugaresi, A., Bergamaschi, R., Millefiorini, E., Clerico, M., Lus, Giacomo, Vianello, M., Avolio, C., Cavalla, P., Iaffaldano, P., Direnzo, V., D'Onghia, M., Lepore, V., Livrea, P., Comi, G., Amato, M., ITALIAN MULTIPLE SCLEROSIS DATABASE NETWORK, . ., Trojano M, Pellegrini F, Paolicelli D, Fuiani A, Zimatore GB, Tortorella C, Simone IL, Patti F, Ghezzi A, Portaccio E, Rossi P, Pozzilli C, Salemi G, Lugaresi A, Bergamaschi R, Millefiorini E, Clerico M, Lus G, Vianello M, Avolio C, Cavalla P, Iaffaldano P, Direnzo V, D'Onghia M, Lepore V, Livrea P, Comi G, Amato MP, M Trojano, F Pellegrini, D Paolicelli, A Fuiani, GB Zimatore, C Tortorella C, IL Simone, F Patti, A Ghezzi, E Portaccio, P Rossi, C Pozzilli, G Salemi, A Lugaresi, and on behalf of Italian Multiple Sclerosis Database Network (MSDN) group

Subjects
Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Propensity score, Disease, gender, interferon beta, multiple sclerosis, observational study, propensity score, Lower risk, Severity of Illness Index, Multiple sclerosis, Interferon beta, Gender, Observational study, Propensity score, Cohort Studies, Disability Evaluation, Young Adult, Sex Factors, gender, multiple sclerosis, treatment, interferon, Double-Blind Method, Internal medicine, Observational study, medicine, Confidence Intervals, Odds Ratio, Product Surveillance, Postmarketing, Humans, Immunologic Factors, Multiple sclerosi, Proportional Hazards Models, Expanded Disability Status Scale, Proportional hazards model, business.industry, Multiple sclerosis, Drug Administration Routes, Interferon-beta, medicine.disease, Interferon beta, Surgery, Neurology, Italy, Cohort, Propensity score matching, Regression Analysis, Settore MED/26 - Neurologia, Female, Neurology (clinical), business
Abstract

Background: There are a few and conflicting results from randomised controlled trials (RCTs) pertaining to the influence of gender in response to currently used disease modifying drugs in Multiple Sclerosis (MS). Observational studies may be especially valuable for answering effectiveness questions in subgroups not studied in RCTs. Objective: To conduct a post-marketing analysis aimed to evaluate the gender effect on Interferon beta (IFN beta) treatment response in a cohort of relapsing (RR) MS patients. Methods: A cohort of 2570 IFN beta-treated RRMS was prospectively followed for Lip to 7 years in 15 Italian MS Centers. Cox proportional hazards regression models were used to assess gender differences for risk of reaching 1st relapse and risk of progression by I point on Expanded Disability Status Scale (EDSS) score. Gender effects were also explored by a propensity score (PS) matching algorithm, and a tree-growing technique. Results: The multivariate Cox Regression analyses showed that male patients had a significant (p = 0.0097) lower risk for 1st relapse and a trend (p = 0.0897) for a higher risk to reach I point EDSS progression than females. The PS matched multivariate Cox Regression confirmed these results. The RECPAM analysis showed that male sex conferred a significant reduction in the risk for 1st relapse (HR = 0.86; 95% Cl = 0.76-0.98; p = 0.0226) in the subgroup with a low pre-treatment number of bouts, and a significant increase in the risk for I point EDSS progression (HR = 1.33; 95% Cl: 1.00-1.76; p

Published
2009

42. Real-life impact of early interferon beta therapy in relapsing multiple sclerosis

Author

Trojano, M., Pellegrini, F., Paolicelli, D., Fuiani, A., Zimatore, G., Tortorella, C., Simone, I., Patti, F., Ghezzi, A., Zipoli, V., Rossi, P., Pozzilli, C., Salemi, G., Lugaresi, A., Bergamaschi, R., Millefiorini, E., Clerico, M., Lus, G., Vianello, M., Avolio, C., Cavalla, P., Lepore, V., Livrea, P., Comi, G., Amato, M., Di Monte, E., Iaffaldano, P., Direnzo, V., D'Onghia, M., Lo Fermo, S., Messina, S., D'Amico, E., Rizzo, A., Zaffaroni, M., Portaccio, E., Martinelli, V., Prosperini, L., Onesti, E., Aridon, P., D'Amelio, M., Ragonese, P., De Luca, G., Farina, D., Di Tommaso, V., Tavazzi, E., Bargiggia, V., Crivelli, P., Cortese, A., Di Rezze, S., Durastanti, V., Alfieri, G., Rosellini, I., Modesto, M., Notariello, M., Tortorella, P., Trojano M, Pellegrini F, Paolicelli D, Fuiani A, Zimatore GB, Tortorella C, Simone IL, Patti F, Ghezzi A, Zipoli V, Rossi P, Pozzilli C, Salemi G, Lugaresi A, Bergamaschi R, Millefiorini E, Clerico M, Lus G, Vianello M, Avolio C, Cavalla P, Lepore V, Livrea P, Comi G, Amato MP, Di Monte E, Iaffaldano P, Direnzo V, D'Onghia M, Lo Fermo S, Messina S, D'Amico E, Rizzo A, Zaffaroni M, Portaccio E, Martinelli V, Prosperini L, Onesti E, Aridon P, D'Amelio M, Ragonese P, De Luca G, Farina D, Di Tommaso V, Tavazzi E, Bargiggia V, Crivelli P, Cortese A, Di Rezze S, Durastanti V, Alfieri G, Rosellini I, Modesto M, Notariello M, Tortorella P, Trojano, M, Pellegrini, F, Paolicelli, D, Fuiani, A, Zimatore, Gb, Tortorella, C, Simone, Il, Patti, F, Ghezzi, A, Zipoli, V, Rossi, P, Pozzilli, C, Salemi, G, Lugaresi, Alessandra, Bergamaschi, R, Millefiorini, E, Clerico, M, Lus, G, Vianello, M, Avolio, C, Cavalla, P, Lepore, V, Livrea, P, Comi, G, and Amato, Mp

Subjects
Adult, Male, Time Factors, Multiple Sclerosis, Interferon beta, Interferon-beta, Cohort Studies, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Treatment Outcome, observational study, multiple sclerosis, interferon, treatment, early, Sickness Impact Profile, Multiple Sclerosi, Quality of Life, Humans, Female, Settore MED/26 - Neurologia, Prospective Studies, Follow-Up Studies
Abstract

OBJECTIVE: Recent findings support greater efficacy of early vs. delayed interferon beta (IFNbeta) treatment in patients with a first clinical event suggestive of multiple sclerosis (MS). We aimed to evaluate the effectiveness of early IFNbeta treatment in definite relapsing-remitting MS (RRMS) and to assess the optimal time to initiate IFNbeta treatment with regard to the greatest benefits on disability progression. METHODS: A cohort of 2,570 IFNbeta-treated RRMS patients was prospectively followed for up to 7 years in 15 Italian MS Centers. A Cox proportional hazards regression model adjusted for propensity score (PS) quintiles was used to assess differences between groups of patients with early vs. delayed IFNbeta treatment on risk of reaching a 1-point progression in the Expanded Disability Status Scale (EDSS) score, and the EDSS 4.0 and 6.0 milestones. A set of PS-adjusted Cox hazards regression models were calculated according to different times of treatment initiation (within 1 year up to within 5 years from disease onset). A sensitivity analysis was performed to assess the robustness of findings. RESULTS: The lowest hazard ratios (HRs) for the three PS quintiles-adjusted models were obtained by a cutoff of treatment initiation within 1 year from disease onset. Early treatment significantly reduced the risk of reaching a 1-point progression in EDSS score (HR = 0.63; 95% CI = 0.48-0.85; p < 0.002), and the EDSS 4.0 milestone (HR = 0.56; 95% CI = 0.36-0.90; p = 0.015). Sensitivity analysis showed the bound of significance for unmeasured confounders. INTERPRETATION: Greater benefits on disability progression may be obtained by an early IFNbeta treatment in RRMS.

Published
2009

43. The Italian Multiple Sclerosis Database Network (MSDN): The risk of worsening according to IFNβ exposure in multiple sclerosis

Author

Trojano, M, Russo, P, Fuiani, A, Paolicelli, D, DI MONTE, E, Granieri, Enrico Gavino Giuseppe, Rosati, G, Savettieri, G, Comi, G, Livrea, P, MSDN STUDY GROUP, TROJANO M, RUSSO P, FUIANI A, PAOLICELLI D, DI MONTE E, GRANIERI E, ROSATI G, SAVETTIERI G, COMI G, LIVREA P, MSDN STUDY GROUP, Trojano, M, Russo, P, Fuiani, A, Paolicelli, D, DI MONTE, E, Granirei, E, Rosati, G, Savettieri, G, Comi, Giancarlo, Livrea, P, and MSDN STUDY, Group

Subjects
Adult, Male, Time Factors, computer.software_genre, Central nervous system disease, Cohort Studies, 03 medical and health sciences, Disability Evaluation, 0302 clinical medicine, Adjuvants, Immunologic, medicine, Humans, Immunologic Factors, 030212 general & internal medicine, Risk factor, MULTIPLE SCLEROSIS, Demography, Proportional Hazards Models, RISK, Analysis of Variance, Database, business.industry, Proportional hazards model, Multiple sclerosis, Interferon-beta, IFNP, Long term effectiveness, Observational studies, Middle Aged, medicine.disease, Treatment Outcome, Neurology, Databases as Topic, Italy, Propensity score matching, Disease Progression, Regression Analysis, Observational study, Female, Neurology (clinical), Analysis of variance, business, computer, 030217 neurology & neurosurgery, Cohort study
Abstract

We evaluated the risk of worsening according to the length of exposure to interferon beta (IFNβ)ina large cohort of 2090 multiple sclerosis patients collected by the Italian MS Database Network. Overall 44-140 patient-visits with a follow-up of 22-143 patient-years were evaluated. Forty-one per cent of patients were exposed to IFNβ for up to 2 years, 39% for 2- 4 years and 20% for more than 4 years. A Cox regression model was used to analyse two clinical outcomes: disability progression and worsening of relapse rate. The technique of propensity score was applied to reduce bias in the comparison of non-randomized groups. The risks of disability progression (HR=0.23; 95% CI: 0.17 - 0.30) and worsening of relapse rate (HR=0.19; 95% CI: 0.14 - 0.27) were reduced by about 4- 5- fold in patients exposed to IFNβ for more than four years, compared with patients exposed for up to two years. The propensity score technique confirmed the findings. The proportion of days covered by IFNβ treatment was lower ( P

Published
2006

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

Author

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

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

47. Management of multiple sclerosis patients after the 24th Natalizumab course: the Ty-STOP study

Author

Marinella CLERICO, Mercanti, S., Versino, E., Piazza, F., Gned, D., Morra, V. Brescia, Lanzillo, R., Amato, L., Quarantelli, M., Ghezzi, A., Bianchi, A., Baroncini, D., Salemi, G., Realmuto, S., Ferro, M. T., Vitetta, F., Donghia, M., Paolicelli, D., Trojano, M., Durelli, L., Clerico, M., De Mercanti, S., Versino, E., Piazza, F., Gned, D., BRESCIA MORRA, Vincenzo, Lanzillo, Roberta, Amato, L., Quarantelli, M., Ghezzi, A., Bianchi, A, Baroncini, D., Salemi, G., Realmuto, S., Ferro, Mt, Vitetta, F., Donghia, M., Paolicelli, D., Trojano, M., and Durelli, L.

Subjects
Multiple Sclerosis, Natalizumab, MRI
Published
2013

48. 10-year progression predictors after first treatment initiation in a relapsing-remitting MS cohort

Author

Jokubaitis, V. G., Spelman, T., Kalincik, T., Travaglini, D., Paolicelli, D., Duquette, P., Verheul, F., and Ondokuz Mayıs Üniversitesi

Abstract

31st Congress of the European-Committee-for-Treatment-and-Research-in-Multiple-Sclerosis (ECTRIMS) -- OCT 07-10, 2015 -- Barcelona, SPAIN Lugaresi, Alessandra/0000-0003-2902-5589; Horakova, Dana/0000-0003-1915-0036; McCombe, Pamela/0000-0003-2704-8517; Havrdova, Eva Kubala/0000-0002-9543-4359 WOS: 000365729400172 … European Comm Treatment & Res Multiple Sclerosis

Published
2015

49. THC:CBD discontinuation in a large population of Italian multiple sclerosis patients (SA.FE. study)

Author

Patti, F, Messina, S, Amato, Mp, Benedetti, Md, Bergamaschi, R, Morra, Vb, Buttari, F, Cavalla, P, Danni, M, Fuiani, A, Gasperini, C, Ippolito, D, Maniscalco, Gt, Matta, M, Mirabella, M, Montanari, E, Nuara, A, Palmieri, V, Paolicelli, D, Petrucci, L, Pontecorvo, S, Pozzilli, C, Russo, M, Salamone, G, Signoriello, E, Spinicci, G, Spitaleri, D, Tavazzi, E, Trabucco, E, Trotta, M, Zaffaroni, M, Solaro, C, and Zappia, M

Published
2015

50. THC:CBD oromucosal spray as an add-on therapy in a large population of Italian multiple sclerosis patients (SA.FE. study)

Author

Patti, F, Messina, S, Amato, Mp, Benedetti, Md, Bergamaschi, R, Morra, Vb, Buttari, F, Cavalla, P, Danni, M, Fuiani, A, Gasperini, C, D'Ippolito, Gennaro, Maniscalco, Gt, Matta, M, Mirabella, M, Montanari, E, Nuara, A, Palmieri, V, Paolicelli, D, Petrucci, L, Pontecorvo, S, Pozzilli, C, Russo, M, Salamone, G, Signoriello, E, Spinicci, G, Spitaleri, D, Tavazzi, E, Trabucco, E, Trotta, M, Zaffaroni, M, Solaro, C, and Zappia, M

Published
2015

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