Search

Your search keyword '"Torri Clerici, V."' showing total 68 results
Start Over Author "Torri Clerici, V."
68 results on '"Torri Clerici, V."'

1. 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

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

Author

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

Abstract

Introduction: Over the years, disease registers have been increasingly considered a source of reliable and valuable population studies. However, the validity and reliability of data from registers may be limited by missing data, selection bias or data quality not adequately evaluated or checked. This study reports the analysis of the consistency and completeness of the data in the Italian Multiple Sclerosis and Related Disorders Register. Methods: The Register collects, through a standardized Web-based Application, unique patients. Data are exported bimonthly and evaluated to assess the updating and completeness, and to check the quality and consistency. Eight clinical indicators are evaluated. Results: The Register counts 77,628 patients registered by 126 centres. The number of centres has increased over time, as their capacity to collect patients. The percentages of updated patients (with at least one visit in the last 24 months) have increased from 33% (enrolment period 2000–2015) to 60% (enrolment period 2016–2022). In the cohort of patients registered after 2016, there were ≥ 75% updated patients in 30% of the small centres (33), in 9% of the medium centres (11), and in all the large centres (2). Clinical indicators show significant improvement for the active patients, expanded disability status scale every 6 months or once every 12 months, visits every 6 months, first visit within 1 year and MRI every 12 months. Conclusions: Data from disease registers provide guidance for evidence-based health policies and research, so methods and strategies ensuring their quality and reliability are crucial and have several potential applications.

Published
2023

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

Author

Mosconi, P., Guerra, T., Paletta, P., D’Ettorre, A., Ponzio, M., Battaglia, M. A., Amato, M. P., Bergamaschi, R., Capobianco, M., Comi, G., Gasperini, C., Patti, F., Pugliatti, M., Ulivelli, M., Trojano, M., Lepore, V., Aguglia, U., Amato, M., Ancona, A., Ardito, B., Avolio, C., Balgera, R., Banfi, P., Barcella, V., Barone, P., Bellantonio, P., Berardinelli, A., Bertora, P., Bianchi, M., Bramanti, P., Brescia Morra, V., Brichetto, G., Brioschi, A., Buccafusca, M., Bucello, S., Busillo, V., Calchetti, B., Cantello, R., Capone, F., Capone, L., Cargnelutti, D., Carozzi, M., Cartechini, E., Cavaletti, G., Cavalla, P., Celani, M., Clerici, R., Clerico, M., Cocco, E., Torri Clerici, V., Coniglio, M., Conte, A., Corea, F., Cottone, S., Crociani, P., D’Andrea, F., Danni, M., De Luca, G., de Pascalis, D., De Riz, M., De Robertis, F., De Rosa, G., De Stefano, N., Della Corte, M., Di Sapio, A., Docimo, R., Falcini, M., Falcone, N., Fermi, S., Ferraro, E., Ferrò, M., Fortunato, M., Foschi, M., Gajofatto, A., Gallo, A., Gallo, P., Gatto, M., Gazzola, P., Giordano, A., Granella, F., Grasso, M., Grimaldi, L., Iaffaldano, P., Immovilli, P., Imperiale, D., Inglese, M., Iodice, R., Leva, S., Leuzzi, V., Lugaresi, A., Lus, G., Maimone, D., Mancinelli, L., Maniscalco, G., Marfia, G., Margari, L., Marinelli, F., Marini, B., Marson, A., Mascoli, N., Massacesi, L., Melani, F., Merello, M., Fioretti, C., Mirabella, Massimiliano, Montepietra, S., Nasuelli, D., Nicolao, P., Pasquali, L., Passantino, F., Pecori, C., Peresson, M., Pesci, I., Piantadosi, C., Piras, M. L., Pizzorno, M., Plewnia, K., Pozzilli, C., Protti, A., Quatrale, R., Realmuto, S., Ribizzi, G., Rinalduzzi, S., Rini, A., Romano, S., Filippi, M., Ronzoni, M., Rossi, P., Rovaris, M., Salemi, G., Santangelo, G., Santangelo, M., Leone, A., Sarchielli, P., Sinisi, L., Ferraro, D., Solaro, C., Spitaleri, D., Strumia, S., Tassinari, T., Santuccio, G., Tortorella, C., Totaro, R., Tozzo, A., Trivelli, G., Turano, G., Valentino, P., Venturi, S., Vianello, M., Zaffaroni, M., Zarbo, R., Mirabella M. (ORCID:0000-0002-7783-114X), Mosconi, P., Guerra, T., Paletta, P., D’Ettorre, A., Ponzio, M., Battaglia, M. A., Amato, M. P., Bergamaschi, R., Capobianco, M., Comi, G., Gasperini, C., Patti, F., Pugliatti, M., Ulivelli, M., Trojano, M., Lepore, V., Aguglia, U., Amato, M., Ancona, A., Ardito, B., Avolio, C., Balgera, R., Banfi, P., Barcella, V., Barone, P., Bellantonio, P., Berardinelli, A., Bertora, P., Bianchi, M., Bramanti, P., Brescia Morra, V., Brichetto, G., Brioschi, A., Buccafusca, M., Bucello, S., Busillo, V., Calchetti, B., Cantello, R., Capone, F., Capone, L., Cargnelutti, D., Carozzi, M., Cartechini, E., Cavaletti, G., Cavalla, P., Celani, M., Clerici, R., Clerico, M., Cocco, E., Torri Clerici, V., Coniglio, M., Conte, A., Corea, F., Cottone, S., Crociani, P., D’Andrea, F., Danni, M., De Luca, G., de Pascalis, D., De Riz, M., De Robertis, F., De Rosa, G., De Stefano, N., Della Corte, M., Di Sapio, A., Docimo, R., Falcini, M., Falcone, N., Fermi, S., Ferraro, E., Ferrò, M., Fortunato, M., Foschi, M., Gajofatto, A., Gallo, A., Gallo, P., Gatto, M., Gazzola, P., Giordano, A., Granella, F., Grasso, M., Grimaldi, L., Iaffaldano, P., Immovilli, P., Imperiale, D., Inglese, M., Iodice, R., Leva, S., Leuzzi, V., Lugaresi, A., Lus, G., Maimone, D., Mancinelli, L., Maniscalco, G., Marfia, G., Margari, L., Marinelli, F., Marini, B., Marson, A., Mascoli, N., Massacesi, L., Melani, F., Merello, M., Fioretti, C., Mirabella, Massimiliano, Montepietra, S., Nasuelli, D., Nicolao, P., Pasquali, L., Passantino, F., Pecori, C., Peresson, M., Pesci, I., Piantadosi, C., Piras, M. L., Pizzorno, M., Plewnia, K., Pozzilli, C., Protti, A., Quatrale, R., Realmuto, S., Ribizzi, G., Rinalduzzi, S., Rini, A., Romano, S., Filippi, M., Ronzoni, M., Rossi, P., Rovaris, M., Salemi, G., Santangelo, G., Santangelo, M., Leone, A., Sarchielli, P., Sinisi, L., Ferraro, D., Solaro, C., Spitaleri, D., Strumia, S., Tassinari, T., Santuccio, G., Tortorella, C., Totaro, R., Tozzo, A., Trivelli, G., Turano, G., Valentino, P., Venturi, S., Vianello, M., Zaffaroni, M., Zarbo, R., and Mirabella M. (ORCID:0000-0002-7783-114X)

Abstract

IntroductionOver the years, disease registers have been increasingly considered a source of reliable and valuable population studies. However, the validity and reliability of data from registers may be limited by missing data, selection bias or data quality not adequately evaluated or checked.This study reports the analysis of the consistency and completeness of the data in the Italian Multiple Sclerosis and Related Disorders Register.MethodsThe Register collects, through a standardized Web-based Application, unique patients.Data are exported bimonthly and evaluated to assess the updating and completeness, and to check the quality and consistency. Eight clinical indicators are evaluated.ResultsThe Register counts 77,628 patients registered by 126 centres. The number of centres has increased over time, as their capacity to collect patients.The percentages of updated patients (with at least one visit in the last 24 months) have increased from 33% (enrolment period 2000-2015) to 60% (enrolment period 2016-2022). In the cohort of patients registered after 2016, there were >= 75% updated patients in 30% of the small centres (33), in 9% of the medium centres (11), and in all the large centres (2).Clinical indicators show significant improvement for the active patients, expanded disability status scale every 6 months or once every 12 months, visits every 6 months, first visit within 1 year and MRI every 12 months.ConclusionsData from disease registers provide guidance for evidence-based health policies and research, so methods and strategies ensuring their quality and reliability are crucial and have several potential applications.

Published
2023

5. The Italian multiple sclerosis register

Author

Trojano, M, Bergamaschi, R, Amato, M, Comi, G, Ghezzi, A, Lepore, V, Marrosu, M, Mosconi, P, Patti, F, Ponzio, M, Zaratin, P, Battaglia, M, Acquistapace, D, Aguglia, U, Annunziata, P, Ardito, B, Avolio, C, Balgera, R, Bandini, F, Banfi, P, Barone, P, Bellantonio, P, Bertolotto, A, Bertora, P, Bombardi, R, Bosco Zimatore, G, Bossio, R, Bramanti, P, Brescia Morra, V, Brioschi, A, Bruzzone, M, Buccafusca, M, Busillo, V, Caneve, G, Caniatti, L, Capone, L, Capone, F, Cappellani, A, Cargnelutti, D, Cavaletti, G, Cavalla, P, Celani, M, Centonze, D, Chiveri, L, Clerici, R, Clerico, M, Cocco, E, Comi, C, Coniglio, M, Cordera, S, Corea, F, Cortese, A, Costantino, G, Cottone, S, Crociani, P, D’Andrea, F, Danni, M, De Luca, G, de Pascalis, D, De Robertis, F, De Stefano, N, Di Battista, G, Di Napoli, M, Falcini, M, Fausto, F, Ferrò, M, Florio, C, Fortunato, M, Frittelli, C, Galgani, S, Gallo, P, Gatto, M, Gazzola, P, Geda, C, Giordano, A, Granella, F, Grasso, M, Grimaldi, L, Imperiale, D, Lo Russo, L, Logullo, F, Lugaresi, A, Lus, G, Maccarrone, G, Maimone, D, Malagù, S, Marconi, R, Maritato, P, Massacesi, L, Mazzoni, M, Meucci, G, Mirabella, M, Montepietra, S, Nasuelli, D, Neri, W, Orefice, G, Parodi, S, Pasquali, L, Passarella, B, Peresson, M, Perla, F, Pesci, I, Piantadosi, C, Piras, M, Pizio, N, Pozzilli, C, Protti, A, Pugliatti, M, Quatrale, R, Ragno, M, Rezzonico, M, Ribizzi, G, Riva, M, Ronzoni, M, Rosso, M, Rottoli, M, Rovaris, M, Salemi, G, Salvetti, M, Santangelo, M, Santangelo, G, Santuccio, G, Sarchielli, P, Scarpini, E, Sechi, G, Severi, S, Sinisi, L, Sola, P, Spitaleri, D, Tassinari, T, Tedeschi, G, Tonietti, S, Torri Clerici, V, Totaro, R, Traccis, S, Turla, M, Uccelli, A, Ulivelli, M, Valentino, P, Valeriani, M, Venturi, S, Vianello, M, Zaffaroni, M, Trojano, Maria, Bergamaschi, Roberto, Amato, Maria Pia, Comi, Giancarlo, Ghezzi, Angelo, Lepore, Vito, Marrosu, Maria Giovanna, Mosconi, Paola, Patti, Francesco, Ponzio, Michela, Zaratin, Paola, Battaglia, Mario Alberto, Acquistapace, D., Aguglia, U., Amato, M. P., Annunziata, P., Ardito, B., Avolio, C., Balgera, R., Bandini, F., Banfi, P., Barone, P., Bellantonio, P., Bergamaschi, R., Bertolotto, A., Bertora, P., Bombardi, R., Bosco Zimatore, G., Bossio, R. B., Bramanti, P., Brescia Morra, V., Brioschi, A. M., Bruzzone, M., Buccafusca, M., Busillo, V., Caneve, G., Caniatti, L. M., Capone, L., Capone, F., Cappellani, A., Cargnelutti, D., Cavaletti, G., Cavalla, P., Celani, M. G., Centonze, D., Chiveri, L., Clerici, R., Clerico, M., Cocco, E., Comi, G., Comi, C., Coniglio, M. G., Cordera, S., Corea, F., Cortese, A., Costantino, G., Cottone, S., Crociani, P., D’Andrea, F., Danni, M. C., De Luca, G., de Pascalis, D., De Robertis, F., De Stefano, N., Di Battista, G., Di Napoli, M., Falcini, M., Fausto, F., Ferrò, M. T., Florio, C., Fortunato, M., Frittelli, C., Galgani, S., Gallo, P., Gatto, M., Gazzola, P., Geda, C., Giordano, A., Granella, F., Grasso, M. G., Grimaldi, L. M. E., Imperiale, D., Lo Russo, L., Logullo, F. O., Lugaresi, A., Lus, G., Maccarrone, G., Maimone, D., Malagù, S., Marconi, R., Maritato, P., Massacesi, L., Mazzoni, M., Meucci, G., Mirabella, M., Montepietra, S., Nasuelli, D., Neri, W., Orefice, G., Parodi, S., Pasquali, L., Passarella, B., Patti, F., Peresson, M., Perla, F., Pesci, I., Piantadosi, C., Piras, M. L., Pizio, N. R., Pozzilli, C., Protti, A., Pugliatti, M., Quatrale, R., Ragno, M., Rezzonico, M., Ribizzi, G., Riva, M., Ronzoni, M., Rosso, M. G., Rottoli, M., Rovaris, M., Salemi, G., Salvetti, M., Santangelo, M., Santangelo, G., Santuccio, G., Sarchielli, P., Scarpini, E., Sechi, G. P., Severi, S., Sinisi, L., Sola, P., Spitaleri, D., Tassinari, T., Tedeschi, G., Tonietti, S., Torri Clerici, V., Totaro, R., Traccis, S., Trojano, M., Turla, M., Uccelli, A., Ulivelli, M., Valentino, P., Valeriani, M., Venturi, S., Vianello, M., Zaffaroni, M., Trojano, M, Bergamaschi, R, Amato, M, Comi, G, Ghezzi, A, Lepore, V, Marrosu, M, Mosconi, P, Patti, F, Ponzio, M, Zaratin, P, Battaglia, M, Acquistapace, D, Aguglia, U, Annunziata, P, Ardito, B, Avolio, C, Balgera, R, Bandini, F, Banfi, P, Barone, P, Bellantonio, P, Bertolotto, A, Bertora, P, Bombardi, R, Bosco Zimatore, G, Bossio, R, Bramanti, P, Brescia Morra, V, Brioschi, A, Bruzzone, M, Buccafusca, M, Busillo, V, Caneve, G, Caniatti, L, Capone, L, Capone, F, Cappellani, A, Cargnelutti, D, Cavaletti, G, Cavalla, P, Celani, M, Centonze, D, Chiveri, L, Clerici, R, Clerico, M, Cocco, E, Comi, C, Coniglio, M, Cordera, S, Corea, F, Cortese, A, Costantino, G, Cottone, S, Crociani, P, D’Andrea, F, Danni, M, De Luca, G, de Pascalis, D, De Robertis, F, De Stefano, N, Di Battista, G, Di Napoli, M, Falcini, M, Fausto, F, Ferrò, M, Florio, C, Fortunato, M, Frittelli, C, Galgani, S, Gallo, P, Gatto, M, Gazzola, P, Geda, C, Giordano, A, Granella, F, Grasso, M, Grimaldi, L, Imperiale, D, Lo Russo, L, Logullo, F, Lugaresi, A, Lus, G, Maccarrone, G, Maimone, D, Malagù, S, Marconi, R, Maritato, P, Massacesi, L, Mazzoni, M, Meucci, G, Mirabella, M, Montepietra, S, Nasuelli, D, Neri, W, Orefice, G, Parodi, S, Pasquali, L, Passarella, B, Peresson, M, Perla, F, Pesci, I, Piantadosi, C, Piras, M, Pizio, N, Pozzilli, C, Protti, A, Pugliatti, M, Quatrale, R, Ragno, M, Rezzonico, M, Ribizzi, G, Riva, M, Ronzoni, M, Rosso, M, Rottoli, M, Rovaris, M, Salemi, G, Salvetti, M, Santangelo, M, Santangelo, G, Santuccio, G, Sarchielli, P, Scarpini, E, Sechi, G, Severi, S, Sinisi, L, Sola, P, Spitaleri, D, Tassinari, T, Tedeschi, G, Tonietti, S, Torri Clerici, V, Totaro, R, Traccis, S, Turla, M, Uccelli, A, Ulivelli, M, Valentino, P, Valeriani, M, Venturi, S, Vianello, M, Zaffaroni, M, Trojano, Maria, Bergamaschi, Roberto, Amato, Maria Pia, Comi, Giancarlo, Ghezzi, Angelo, Lepore, Vito, Marrosu, Maria Giovanna, Mosconi, Paola, Patti, Francesco, Ponzio, Michela, Zaratin, Paola, Battaglia, Mario Alberto, Acquistapace, D., Aguglia, U., Amato, M. P., Annunziata, P., Ardito, B., Avolio, C., Balgera, R., Bandini, F., Banfi, P., Barone, P., Bellantonio, P., Bergamaschi, R., Bertolotto, A., Bertora, P., Bombardi, R., Bosco Zimatore, G., Bossio, R. B., Bramanti, P., Brescia Morra, V., Brioschi, A. M., Bruzzone, M., Buccafusca, M., Busillo, V., Caneve, G., Caniatti, L. M., Capone, L., Capone, F., Cappellani, A., Cargnelutti, D., Cavaletti, G., Cavalla, P., Celani, M. G., Centonze, D., Chiveri, L., Clerici, R., Clerico, M., Cocco, E., Comi, G., Comi, C., Coniglio, M. G., Cordera, S., Corea, F., Cortese, A., Costantino, G., Cottone, S., Crociani, P., D’Andrea, F., Danni, M. C., De Luca, G., de Pascalis, D., De Robertis, F., De Stefano, N., Di Battista, G., Di Napoli, M., Falcini, M., Fausto, F., Ferrò, M. T., Florio, C., Fortunato, M., Frittelli, C., Galgani, S., Gallo, P., Gatto, M., Gazzola, P., Geda, C., Giordano, A., Granella, F., Grasso, M. G., Grimaldi, L. M. E., Imperiale, D., Lo Russo, L., Logullo, F. O., Lugaresi, A., Lus, G., Maccarrone, G., Maimone, D., Malagù, S., Marconi, R., Maritato, P., Massacesi, L., Mazzoni, M., Meucci, G., Mirabella, M., Montepietra, S., Nasuelli, D., Neri, W., Orefice, G., Parodi, S., Pasquali, L., Passarella, B., Patti, F., Peresson, M., Perla, F., Pesci, I., Piantadosi, C., Piras, M. L., Pizio, N. R., Pozzilli, C., Protti, A., Pugliatti, M., Quatrale, R., Ragno, M., Rezzonico, M., Ribizzi, G., Riva, M., Ronzoni, M., Rosso, M. G., Rottoli, M., Rovaris, M., Salemi, G., Salvetti, M., Santangelo, M., Santangelo, G., Santuccio, G., Sarchielli, P., Scarpini, E., Sechi, G. P., Severi, S., Sinisi, L., Sola, P., Spitaleri, D., Tassinari, T., Tedeschi, G., Tonietti, S., Torri Clerici, V., Totaro, R., Traccis, S., Trojano, M., Turla, M., Uccelli, A., Ulivelli, M., Valentino, P., Valeriani, M., Venturi, S., Vianello, M., and Zaffaroni, M.

Abstract

The past decade has seen extraordinary increase in worldwide availability of and access to several large multiple sclerosis (MS) databases and registries. MS registries represent powerful tools to provide meaningful information on the burden, natural history, and long-term safety and effectiveness of treatments. Moreover, patients, physicians, industry, and policy makers have an active interest in real-world observational studies based on register data, as they have the potential to answer the questions that are most relevant to daily treatment decision-making. In 2014, the Italian MS Foundation, in collaboration with the Italian MS clinical centers, promoted and funded the creation of the Italian MS Register, a project in continuity with the existing Italian MS Database Network set up from 2001. Main objective of the Italian MS Register is to create an organized multicenter structure to collect data of all MS patients for better defining the disease epidemiology, improving quality of care, and promoting research projects in high-priority areas. The aim of this article is to present the current framework and network of the Italian MS register, including the methodology used to improve the quality of data collection and to facilitate the exchange of data and the collaboration among national and international groups.

Published
2019

6. Real world experience with teriflunomide in multiple sclerosis: the TER-Italy study

Author

Bucello, S., Annovazzi, P., Ragonese, P., Altieri, M., Barcella, V., Bergamaschi, R., Bianchi, A., Borriello, G., Buscarinu, M. C., Callari, G., Capobianco, M., Capone, F., Cavalla, P., Cavarretta, R., Cortese, A., De Luca, G., Di Filippo, M., Dattola, V., Fantozzi, R., Ferraro, E., Filippi, M. M., Gasperini, C., Grimaldi, L. M. E., Landi, D., Re, M. L., Mallucci, G., Manganotti, P., Marfia, G. A., Mirabella, Massimiliano, Perini, P., Pisa, M., Realmuto, S., Russo, M., Tomassini, V., Torri-Clerici, V. L. A., Zaffaroni, M., Zuliani, C., Zywicki, S., Filippi, M., Prosperini, L., Mirabella M. (ORCID:0000-0002-7783-114X), Bucello, S., Annovazzi, P., Ragonese, P., Altieri, M., Barcella, V., Bergamaschi, R., Bianchi, A., Borriello, G., Buscarinu, M. C., Callari, G., Capobianco, M., Capone, F., Cavalla, P., Cavarretta, R., Cortese, A., De Luca, G., Di Filippo, M., Dattola, V., Fantozzi, R., Ferraro, E., Filippi, M. M., Gasperini, C., Grimaldi, L. M. E., Landi, D., Re, M. L., Mallucci, G., Manganotti, P., Marfia, G. A., Mirabella, Massimiliano, Perini, P., Pisa, M., Realmuto, S., Russo, M., Tomassini, V., Torri-Clerici, V. L. A., Zaffaroni, M., Zuliani, C., Zywicki, S., Filippi, M., Prosperini, L., and Mirabella M. (ORCID:0000-0002-7783-114X)

Abstract

Objective: To identify baseline factors associated with disease activity in patients with relapsing–remitting multiple sclerosis (RRMS) under teriflunomide treatment. Methods: This was an independent, multi-centre, retrospective post-marketing study. We analysed data of 1,507 patients who started teriflunomide since October 2014 and were regularly followed in 28 Centres in Italy. We reported the proportions of patients who discontinued treatment (after excluding 32 lost to follow-up) and who experienced clinical disease activity, i.e., relapse(s) and/or confirmed disability worsening, as assessed by the Expanded Disability Status Scale (EDSS). Decision tree-based analysis was performed to identify baseline factors associated with clinical disease activity during teriflunomide treatment. Results: At database lock (September 2020), approximately 29% of patients (430 out of 1,475) discontinued teriflunomide because of disease activity (~ 46%), adverse events (~ 37%), poor tolerability (~ 15%), pregnancy planning (~ 2%). Approximately 28% of patients experienced disease activity over a median follow-up of 2.75 years: ~ 9% had relapses but not disability worsening; ~ 13% had isolated disability worsening; ~ 6% had both relapses and disability worsening. The most important baseline factor associated with disease activity (especially disability worsening) was an EDSS > 4.0 (p < 0.001). In patients with moderate disability level (EDSS 2.0–4.0), disease activity occurred more frequently in case of ≥ 1 pre-treatment relapses (p = 0.025). In patients with milder disability level (EDSS < 2.0), disease activity occurred more frequently after previous exposure to ≥ 2 disease-modifying treatments (p = 0.007). Conclusions: Our study suggests a place-in-therapy for teriflunomide in naïve patients with mild disability level or in those who switched their initial treatment for poor tolerability. Adverse events related with teriflunomide were consistent with literat

Published
2021

8. Atypical Post-Injection Reactions with Delayed Onset Following Glatiramer Acetate 40 mg: Need for Titration?

Author

Zecca, Chiara, primary, Bellavia, G., additional, Brambilla, L., additional, Gutierrez, L. P., additional, Gerardi, C., additional, Fiori, A. M., additional, Bernardini, L. R., additional, Camera, G., additional, Disanto, G., additional, Petrini, L., additional, Perugini, J., additional, Antozzi, C. G., additional, Torri Clerici, V., additional, Bellino, A., additional, Confalonieri, P. A., additional, Gobbi, C., additional, Mantegazza, R. E., additional, and Rossi, S., additional

Published
2018
Full Text
View/download PDF

10. Comorbidities affect treatment choice and persistence in RRMS: a real-life multicenter study

Author

Laroni, A., Signori, A., Maniscalco, G., Lanzillo, Raffaella, Sacca', Filippo, Clerico, Marinella, Lo Fermo, S., Annovazzi, P., Bonavita, S., Baroncini, D., Rasia, S., Cordioli, C., Prosperni, L., Cocco, Eleonora, Torri Clerici, V., Sartori, A., Signoriello, E., Repice, A., Zarbo, I., Cerqua, R., Pontecorvo, S., Di Sapio, A., Lavorgna, L., Barillà, C., La Gioia, S., Frigeni, B., Iaffaldano, P., Binello, Eleonora, Russo, Valentina, Esposito, S., Frau, J., Gallo, F., and Sorman, M.

Published
2016

11. Home-based palliative approach for people with severe multiple sclerosis and their carers: Study protocol for a randomized controlled trial

Author

Solari, Alessandra, Giordano, Andrea, Grasso, Maria Grazia, Confalonieri, Paolo, Patti, Francesco, Lugaresi, Alessandra, Palmisano, Lucia, Amadeo, Roberta, Martino, Giovanni, Ponzio, Michela, Casale, Giuseppe, Borreani, Claudia, Causarano, Renzo, Veronese, Simone, Zaratin, Paola, Battaglia, MARIO ALBERTO, Radice, D., Oliver, D. J., Pucci, E., Tesio, L., Cugno, C., Morino, P., Lopes de Carvalho, M. L., Giuntoli, M., Motta, R., Stefanelli, M. C., Bianchi, E., Giovannetti, A., Torri Clerici, V., Rossetti, E., Totis, A., Campanella, A., Martini, F., Fittipaldo, A., Ferrari, G., Mantegazza, R., Rossi, I., Troisi, E., Pompa, A., Tucci, L., Ippoliti, F., Morone, G., Fusco, A., Da Col, D., Lissoni, B., Pietrolongo, E., Onofrj, M., Cilia, S., Leone, C., Cascio, V., Cimino, V., Occhipinti, G., Pappalardo, A., Cavallaro, C., Zagari, F., and Alessandra Solari, Andrea Giordano, Maria Grazia Grasso, Paolo Confalonieri, Francesco Patti, Alessandra Lugaresi, Lucia Palmisano, Roberta Amadeo, Giovanni Martino, Michela Ponzio, Giuseppe Casale, Claudia Borreani, Renzo Causarano, Simone Veronese, Paola Zaratin, Mario Alberto Battaglia, PeNSAMI project

Subjects
Complex intervention, Multiple sclerosis, Palliative care, Qualitative research, Randomized controlled trial, Home Care Service, Pediatrics, medicine.medical_specialty, Medicine (miscellaneous), law.invention, Quality of life (healthcare), law, Intervention (counseling), Multiple Sclerosi, medicine, Single-Blind Method, Pharmacology (medical), Clinical Protocol, business.industry, Caregiver, Focus group, Clinical trial, Mood, Family medicine, business, Human
Abstract

Preliminary evidence suggests that palliative care may be useful for people with severe multiple sclerosis (MS). The aim of this study is to determine the effectiveness of a home-based palliative approach (HPA) for people with severe MS and their carers. This is a single-blind randomized controlled trial with a nested qualitative study. Seventy-five severe MS-carer dyads are being randomized (at three centers, one in each area of Italy) to HPA or usual care (UC) in a 2:1 ratio. Each center has a specially trained team consisting of four professionals (physician, nurse, psychologist, social worker). The team makes a comprehensive assessment of the needs of the dyads. HPA content is then agreed on, discussed with the patient’s caring physician, and delivered over six months. The intervention is not intended to replace existing services. At later visits, the team checks the HPA delivery and reviews/modifies it as necessary. HPA and UC dyads are assessed at home by a blind examiner at baseline, and three and six months later; they also receive monthly telephone interviews. Dyads assigned to UC receive the examiner’s visits and telephone interviews, but not the team visits. Primary outcome measures are changes in symptoms (Palliative care Outcome Scale-Symptoms-MS, POS-S-MS), and quality of life (the Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SEIQoL-DW), not assessed in patients with severe cognitive compromise) at three and six months. Other outcomes are changes in patient functional status and mood; changes in carer quality of life, mood and caregiving burden; costs; incorporation with standard care; unplanned hospital admissions; referrals to hospice; and deaths. The experience of participants will be evaluated qualitatively by individual semi-structured interviews (HPA patients and carers) and focus group meetings (HPA patients’ caring physicians). The results of our study will show whether the HPA is feasible and beneficial to people with severe MS and their carers living in the three Italian geographic areas. The nested qualitative study will add to the understanding of the strengths and limitations of the intervention. The trial was registered with Current Controlled Trials (identifier: ISRCTN73082124 ) on 19 June 2014.

Published
2015

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

Author

Giordano A, Martinelli V, Lugaresi A, Pucci E, Granella F, Trojano M, Solari A, Messmer Uccelli M, Ferrari G, Martini F, Radice D, D'Annunzio G, Farina D, Travaglini D, Pietrolongo E, Onofrj M, Torri Clerici V, Bonanno S, Brambilla L, Confalonieri P, Radaelli M, Messina J, Comi G, Tortorella C, Luciannatelli E, Senesi C, Tsantes E, Conti M, Rottoli M, Bellantonio P, Fischetti M, Fantozzi R, Pala A, Traccis S, Di Battista G, Bianchi M, Benedetti M, Gaetani L, Di Filippo M, Carolei A, Totaro R, Lanzillo R, Brescia Morra V, Coppola R, Cottone S, Chiavazza C, Cavalla P, Leonardi C, Aguglia U, Ziuliani C, Valla P, Sasanelli F, Valentino P, Quattrone A, Martino PG, Russo M, Vita G, Immovilli P., Giordano A, Lugaresi A, Confalonieri P, Granella F, Radice D, Trojano M, Martinelli V, Solari A, on behalf of the SIMS-Practice groupa, Giordano, A, Lugaresi, A, Confalonieri, P, Granella, F, Radice, D, Trojano, M, Comi, Giancarlo, on behalf of the SIMS Practice, Group, and Radaelli, Marta

Subjects
Adult, Male, medicine.medical_specialty, Health Knowledge, Attitudes, Practice, Multiple Sclerosis, Adolescent, patient satisfaction, Health literacy, Group B, law.invention, Interviews as Topic, Young Adult, Patient satisfaction, complex health intervention, Randomized controlled trial, Patient Education as Topic, law, Surveys and Questionnaires, Multiple Sclerosi, Clinical endpoint, Medicine, Humans, Prospective Studies, Young adult, Prospective cohort study, disease knowledge, information aid, Internet, business.industry, Multiple sclerosis, multiple sclerosis, clinical practice, Middle Aged, medicine.disease, Health Literacy, Treatment Outcome, Neurology, Italy, Physical therapy, Female, Pamphlets, Neurology (clinical), business, Comprehension
Abstract

Background: The SIMS-Trial showed that the ‘Sapere Migliora’ information aid (IA) for newly diagnosed people with multiple sclerosis (PwMS) effectively improved patient knowledge and satisfaction with care. Objectives: The objectives of this paper are to assess the effectiveness of the IA in clinical practice and to compare the whole IA with the take-home booklet/website component alone. Methods: After updating the IA and replacing the CD with a website, a prospective, open-label non-randomised controlled trial compared the whole IA (group A, five SIMS-Trial centres) to take-home (group B, 16 centres). One month after the intervention, participants completed the MS Knowledge Questionnaire (MSKQ), care satisfaction questionnaire (COSM-R) (primary study outcomes), Hospital and Anxiety Depression Scale, and ad hoc questionnaire appraising the IA. Results: We enrolled 159 newly diagnosed PwMS (May 2012–March 2013). Drop-outs were four of 77 (5%, group A) and 11/82 (13%, group B). Primary endpoint (highest tertile both for MSKQ and COSM-R section 2 scores) was achieved by 38/77 (49%) group A and 33/82 (40%) group B ( p = 0.25). Attainment of secondary outcomes was also similar between groups. Conclusions: This study shows that the entire IA is not superior to the booklet/website alone, and that both are comparable in efficacy to the intervention arm of the SIMS-Trial. Trial registration number: ISRCTN78940214.

Published
2014

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

Author

Giordano, A, Lugaresi, A, Confalonieri, P, Granella, F, Radice, D, Trojano, M, Martinelli, V, Pucci E, Solari A., Messmer Uccelli, M, Ferrari, G, Martini, F, D'Annunzio, G, Farina, D, Travaglini, D, Pietrolongo, E, Onofrj, M, Torri Clerici, V, Bonanno, S, Brambilla, L, Radaelli, M, Messina, J, Comi, G, Tortorella, C, Luciannatelli, E, Senesi, C, Tsantes, E, Conti, M, Rottoli, M, Bellantonio, P, Fischetti, M, Fantozzi, R, Pala, A, Traccis, S, Di Battista, G, Bianchi, M, Benedetti, M, Gaetani, L, Di Filippo, M, Carolei, A, Totaro, R, Lanzillo, R, Brescia Morra, V, Coppola, R, Cottone, S, Chiavazza, C, Cavalla, P, Leonardi, C, Aguglia, U, Ziuliani, C, Valla, P, Sasanelli, F, Valentino, P, Quattrone, A, Martino, Pg, Russo, M, Vita, Giuseppe, and Immovilli, P.

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

14. Early effect of dalfampridine in patients with MS: A multi-instrumental approach to better investigate responsiveness

Author

Brambilla, L., primary, Rossi Sebastiano, D., additional, Aquino, D., additional, Torri Clerici, V., additional, Brenna, G., additional, Moscatelli, M., additional, Frangiamore, R., additional, Giovannetti, A.M., additional, Antozzi, C., additional, Mantegazza, R., additional, Franceschetti, S., additional, Bruzzone, M.G., additional, Erbetta, A., additional, and Confalonieri, P., additional

Published
2016
Full Text
View/download PDF

15. Development and validation of the multiple sclerosis questionnaire for the evaluation of job difficulties (MSQ-Job)

Author

Raggi, A., primary, Giovannetti, A. M., additional, Schiavolin, S., additional, Confalonieri, P., additional, Brambilla, L., additional, Brenna, G., additional, Cortese, F., additional, Covelli, V., additional, Frangiamore, R., additional, Moscatelli, M., additional, Ponzio, M., additional, Torri Clerici, V., additional, Zaratin, P., additional, Mantegazza, R., additional, and Leonardi, M., additional

Published
2015
Full Text
View/download PDF

16. Multiple Sclerosis Questionnaire for Job Difficulties

Author

Raggi, A., primary, Giovannetti, A. M., additional, Schiavolin, S., additional, Confalonieri, P., additional, Brambilla, L., additional, Brenna, G., additional, Cortese, F., additional, Covelli, V., additional, Frangiamore, R., additional, Moscatelli, M., additional, Ponzio, M., additional, Torri Clerici, V., additional, Zaratin, P., additional, Mantegazza, R., additional, and Leonardi, M., additional

Published
2015
Full Text
View/download PDF

18. Severe multiple sclerosis reactivation during prolonged lymphopenia after dimethyl fumarate discontinuation.

Author

Zecca, C., Antozzi, C. G., Torri Clerici, V., Ferrazzini, M., Mantegazza, R. E., Rossi, S., and Gobbi, C.

Subjects
MULTIPLE sclerosis, BISOPROLOL, LEUCOCYTES, BLOOD cell count, LYMPHOPENIA, DISEASE complications, THERAPEUTICS, DIMETHYL fumarate
Abstract

Background: Delayed‐release dimethyl fumarate (DMF) treatment can be associated with reduced lymphocyte and leucocyte counts, which might persist after DMF discontinuation. Case presentation: We report the case of a patient with severe disease reactivation despite prolonged lymphopenia after DMF discontinuation. We describe the frequency and impact of prolonged lymphopenia after DMF discontinuation at two tertiary MS centres. A 36‐year‐old female patient with multiple sclerosis was switched to DMF after 14 years of treatment with interferon beta‐1a. DMF was suspended after 4 months because of persistent lymphopenia for 3 months. Six months later, the patient had a severe relapse with multiple enhancing brain lesions at MRI although lymphopenia was still persistent. Haematological assessment excluded other causes of lymphopenia, which was evaluated as a probable iatrogenic complication of DMF. The patient was treated with i.v. methylprednisolone 1 gr daily for 3 days with clinical recovery. Conclusions: Prolonged lymphopenia after DMT discontinuation does not protect against disease reactivation. Starting a new immune therapy should be balanced against the option of a “wait and see.” A different immunotherapeutic strategy such as an anti‐B therapeutic approach could be considered. [ABSTRACT FROM AUTHOR]

Published
2018
Full Text
View/download PDF

19. MS diagnosis: quality of life and adjustment

Author

Giovannetti, A. M., Vicini, F., Brambilla, L., Torri-Clerici, V., Brenna, G., Rossi, S., Antozzi, C., Camera, G., Frangiamore, R., Mantegazza, R., Negri, A., and Confalonieri Paolo

Subjects
Multiple Sclerosis, quality of life, referential activity, Settore M-PSI/07 - Psicologia Dinamica

20. Comparing Natural History of Early and Late Onset Pediatric Multiple Sclerosis

Author

Ermelinda De Meo, Massimo Filippi, Maria Trojano, Giancarlo Comi, Francasco Patti, Vincenzo Brescia Morra, Giuseppe Salemi, Marco Onofrj, Giacomo Lus, Eleonora Cocco, Mattia Fonderico, Valentina Torri Clerici, Giorgia Teresa Maniscalco, Paola Valentino, Antonio Bertolotto, Alessandra Lugaresi, Roberto Bergamaschi, Marco Rovaris, Patrizia Sola, Gioacchino Tedeschi, Ilaria Pesci, Umberto Aguglia, Paola Cavalla, Davide Maimone, Franco Granella, Marika Vianello, Marta Simone, Emilio Portaccio, Maria Pia Amato, De Meo, E., Filippi, M., Trojano, M., Comi, G., Patti, F., Brescia Morra, V., Salemi, G., Onofrj, M., Lus, G., Cocco, E., Fonderico, M., Torri Clerici, V., Maniscalco, G. T., Valentino, P., Bertolotto, A., Lugaresi, A., Bergamaschi, R., Rovaris, M., Sola, P., Tedeschi, G., Pesci, I., Aguglia, U., Cavalla, P., Maimone, D., Granella, F., Vianello, M., Simone, M., Portaccio, E., Amato, M. P., De Meo, Ermelinda, Filippi, Massimo, Trojano, Maria, Comi, Giancarlo, Patti, Francasco, Brescia Morra, Vincenzo, Salemi, Giuseppe, Onofrj, Marco, Lus, Giacomo, Cocco, Eleonora, Fonderico, Mattia, Torri Clerici, Valentina, Maniscalco, Giorgia Teresa, Valentino, Paola, Bertolotto, Antonio, Lugaresi, Alessandra, Bergamaschi, Roberto, Rovaris, Marco, Sola, Patrizia, Tedeschi, Gioacchino, Pesci, Ilaria, Aguglia, Umberto, Cavalla, Paola, Maimone, Davide, Granella, Franco, Vianello, Marika, Simone, Marta, Portaccio, Emilio, Amato, Maria Pia, De Meo, E, Filippi, M, Trojano, M, Comi, G, Patti, F, Brescia Morra, V, Salemi, G, Onofrj, M, Lus, G, Cocco, E, Fonderico, M, Torri Clerici, V, Maniscalco, Gt, Valentino, P, Bertolotto, A, Lugaresi, A, Bergamaschi, R, Rovaris, M, Sola, P, Tedeschi, G, Pesci, I, Aguglia, U, Cavalla, P, Maimone, D, Granella, F, Vianello, M, Simone, M, Portaccio, E, and Amato, Mp

Subjects
Male, Natural History of Multiple Sclerosis, Multiple Sclerosis, Neurology, Recurrence, Pediatric Multiple Sclerosis, Disease Progression, Humans, Disabled Persons, Settore MED/26 - Neurologia, Neurology (clinical), Child, Prognosis
Abstract

Objective: This study was undertaken to describe and compare disease course and prognosis of early (ie, disease onset before age 11 years) and late (ie, disease onset after age 11 years) onset pediatric multiple sclerosis. Methods: Prospectively collected clinical information from Italian Multiple Sclerosis Register of 1993 pediatric multiple sclerosis patients, of whom 172 had early onset, was analyzed. Cox models adjusted for sex, baseline Expanded Disability Status Scale score, and disease-modifying treatments and stratified for diagnostic criteria adopted (Poser vs McDonald) were used to assess the risk of reaching irreversible Expanded Disability Status Scale scores of 3, 4, and 6, and conversion to secondary progressive phenotype in early versus late onset pediatric patients. Prognostic factors were also evaluated. Results: A greater proportion of males, isolated brainstem involvement, and longer time interval between first and second clinical episode were observed in early versus late onset pediatric patients. Compared to late onset, early onset pediatric patients took longer from disease onset to convert to secondary progressive phenotype and to reach all disability milestones. Recovery from first demyelinating event, time to first relapse, annualized relapse rate during the first 3 years of disease, and disease-modifying treatment exposure were independent predictors for long-term disability in early onset pediatric patients. In late onset pediatric patients, isolated optic neuritis, multifocal symptoms, and progressive course at disease onset were additional predictors for long-term disability. Interpretation: These findings point toward the existence of a different natural history in early versus late onset pediatric multiple sclerosis patients. ANN NEUROL 2022.

Published
2022

21. A real‐world study of alemtuzumab in a cohort of Italian patients

Author

Paola Cavalla, Laura Brambilla, Roberta Grasso, Cinzia Cordioli, Alice Laroni, Alessia Giugno, Valentina Torri Clerici, Maria Pia Sormani, Pietro Annovazzi, Francesco Saccà, Eleonora Cocco, Jessica Frau, Elisabetta Signoriello, Antonio Gallo, Marinella Clerico, Stefania Federica De Mercanti, Antonio Carotenuto, Simona Bonavita, Cinzia Valeria Russo, Giuseppe Fenu, Caterina Lapucci, Giorgia Teresa Maniscalco, Arianna Sartori, Francesca Caleri, Marco Capobianco, Alessio Signori, Rosa Iodice, Sara La Gioia, Giacomo Lus, Mauro Zaffaroni, Damiano Baroncini, Valeria Di Francescantonio, Russo, C. V., Sacca, F., Frau, J., Annovazzi, P., Signoriello, E., Bonavita, S., Grasso, R., Clerico, M., Cordioli, C., Laroni, A., Capobianco, M., Torri Clerici, V., Sartori, A., Cavalla, P., Maniscalco, G. T., La Gioia, S., Caleri, F., Giugno, A., Iodice, R., Carotenuto, A., Cocco, E., Fenu, G., Zaffaroni, M., Baroncini, D., Lus, G., Gallo, A., De Mercanti, S. F., Lapucci, C., Di Francescantonio, V., Brambilla, L., Sormani, M. P., Signori, A., Russo, CINZIA VALERIA, Sacca', Francesco, Frau, Jessica, Annovazzi, Pietro, Signoriello, Elisabetta, Bonavita, Simona, Grasso, Roberta, Clerico, Marinella, Cordioli, Cinzia, Laroni, Alice, Capobianco, Marco, Torri Clerici, Valentina, Sartori, Arianna, Cavalla, Paola, Teresa Maniscalco, Giorgia, La Gioia, Sara, Caleri, Francesca, Giugno, Alessia, Iodice, Rosa, Carotenuto, Antonio, Cocco, Eleonora, Fenu, Giuseppe, Zaffaroni, Mauro, Baroncini, Damiano, Lus, Giacomo, Gallo, Antonio, Federica De Mercanti, Stefania, Lapucci, Caterina, Di Francescantonio, Valeria, Brambilla, Laura, Pia Sormani, Maria, and Signori, Alessio

Subjects
Adult, safety, medicine.medical_specialty, efficacy, Multiple Sclerosis, Relapsing-Remitting, Natalizumab, Internal medicine, alemtuzumab, medicine, Humans, Glatiramer acetate, real-world evidence, Retrospective Studies, Expanded Disability Status Scale, Fingolimod Hydrochloride, business.industry, Multiple sclerosis, Glatiramer Acetate, cohort, medicine.disease, Fingolimod, Neurology, Relative risk, Cohort, Alemtuzumab, Neurology (clinical), business, medicine.drug
Abstract

Background and purpose: Real-world data on alemtuzumab are limited and do not provide evidence of its effectiveness after various disease-modifying therapies (DMTs). Our aim was to provide real-world data on the impact of clinical variables and previous DMTs on clinical response to alemtuzumab. Methods: Sixteen Italian multiple sclerosis centers retrospectively included patients who started alemtuzumab from January 2015 to December 2018, and recorded demographics, previous therapies, washout duration, relapses, Expanded Disability Status Scale (EDSS) score, and magnetic resonance imaging data. Negative binomial regression models were used to assess the effect of factors on annualized relapse (ARR) after alemtuzumab initiation. Results: We studied 322 patients (mean age 36.8years, median EDSS score 3, median follow-up 1.94years). Previous treatments were: fingolimod (106), natalizumab (80), first-line oral agents (56), first-line injectables (interferon/glatiramer acetate; 30), and other drugs (15). Thirty-five patients were treatment-naïve. The pre-alemtuzumab ARR was 0.99 and decreased to 0.13 during alemtuzumab treatment (p&nbsp

Published
2021

22. Defining the course of tumefactive multiple sclerosis: A large retrospective multicentre study

Author

Lorenzo Gaetani, Doriana Landi, Diana Ferraro, Paolo Ragonese, Alberto Gajofatto, Caterina Di Carmine, Paola Cavalla, Maria Pia Amato, Eleonora Cocco, Roberta Lanzillo, Alessia Manni, Roberta Fantozzi, Claudio Gasperini, D. Farina, Giuseppe Fenu, Sara Zagaglia, Raffaella Cerqua, Claudio Solaro, Antonio Gallo, Carolina Gabri Nicoletti, Pietro Iaffaldano, Federica Pinardi, Valentina Torri Clerici, Isabella Righini, Fabio Buttari, Damiano Paolicelli, Pietro Annovazzi, Carla Tortorella, Rocco Totaro, Giovanna De Luca, Chiara De Fino, Valentina Tomassini, Luca Prosperini, Marcello Moccia, Viviana Nociti, Maria Chiara Buscarinu, Maria Di Gregorio, Massimiliano Di Filippo, Di Gregorio M., Torri Clerici V.L.A., Fenu G., Gaetani L., Gallo A., Cavalla P., Ragonese P., Annovazzi P., Gajofatto A., Prosperini L., Landi D., Nicoletti C.G., Di Carmine C., Totaro R., Nociti V., De Fino C., Ferraro D., Tomassini V., Tortorella C., Righini I., Amato M.P., Manni A., Paolicelli D., Iaffaldano P., Lanzillo R., Moccia M., Buttari F., Fantozzi R., Cerqua R., Zagaglia S., Farina D., De Luca G., Buscarinu M.C., Pinardi F., Cocco E., Gasperini C., Solaro C.M., Di Filippo M., Di Gregorio, M., Torri Clerici, V. L. A., Fenu, G., Gaetani, L., Gallo, A., Cavalla, P., Ragonese, P., Annovazzi, P., Gajofatto, A., Prosperini, L., Landi, D., Nicoletti, C. G., Di Carmine, C., Totaro, R., Nociti, V., De Fino, C., Ferraro, D., Tomassini, V., Tortorella, C., Righini, I., Amato, M. P., Manni, A., Paolicelli, D., Iaffaldano, P., Lanzillo, R., Moccia, M., Buttari, F., Fantozzi, R., Cerqua, R., Zagaglia, S., Farina, D., De Luca, G., Buscarinu, M. C., Pinardi, F., Cocco, E., Gasperini, C., Solaro, C. M., and Di Filippo, M.

Subjects
Male, tumefactive demyelinating lesions (TDLs), 0302 clinical medicine, Retrospective Studie, Interquartile range, differential diagnosis, 030212 general & internal medicine, Prospective Studies, Young adult, Prospective cohort study, Child, treatment, Tumefactive multiple sclerosi, Tumefactive demyelinating lesions, Demyelinating Disease, Middle Aged, Magnetic Resonance Imaging, Differential diagnosis, Multiple sclerosis, Tumefactive demyelinating lesions, Tumefactive multiple sclerosis, Neurology, Multiple sclerosis, Tumefactive multiple sclerosis, Female, Human, Adult, medicine.medical_specialty, Multiple Sclerosis, Adolescent, differential diagnosi, Settore MED/26, 03 medical and health sciences, Young Adult, Oligoclonal Band, Internal medicine, medicine, Humans, Multiple sclerosi, Tumefactive multiple sclerosis (TuMS), Aged, Retrospective Studies, Tumefactive demyelinating lesion, Expanded Disability Status Scale, business.industry, Oligoclonal Bands, Retrospective cohort study, Odds ratio, medicine.disease, Confidence interval, Prospective Studie, Demyelinating Diseases, prognosis, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

Background and purpose: Tumefactive multiple sclerosis (TuMS) (i.e., MS onset presenting with tumefactive demyelinating lesions [TDLs]) is a diagnostic and therapeutic challenge. We performed a multicentre retrospective study to describe the clinical characteristics and the prognostic factors of TuMS. Methods: One hundred two TuMS patients were included in this retrospective study. Demographic, clinical, magnetic resonance imaging (MRI), laboratory data and treatment choices were collected. Results: TuMS was found to affect women more than men (female:male: 2.4), with a young adulthood onset (median age: 29.5years, range: 11–68 years, interquartile range [IQR]: 38 years). At onset, 52% of TuMS patients presented with the involvement of more than one functional system and 24.5% of them with multiple TDLs. TDLs most frequently presented with an infiltrative MRI pattern (38.7%). Cerebrospinal fluid immunoglobulin G oligoclonal bands were often demonstrated (76.6%). In 25.3% of the cases, more than one acute-phase treatment was administered, and almost one-half of the patients (46.6%) were treated with high-efficacy treatments. After a median follow-up of 2.3years (range: 0.1–10.7 years, IQR: 3.4 years), the median Expanded Disability Status Scale (EDSS) score was 1.5 (range: 0–7, IQR: 2). Independent risk factors for reaching an EDSS score ≥3 were a higher age at onset (odds ratio [OR]: 1.08, 95% confidence interval [CI]: 1.03–1.14, p&nbsp

Published
2021

23. First therapy choice in newly diagnosed Multiple Sclerosis patients: A multicenter Italian study

Author

Roberta Grasso, Doriana Landi, Luca Carmisciano, Simona Bonavita, Domenico Ippolito, Sara La Gioia, Marinella Clerico, Cinzia Valeria Russo, A. Repice, Maria Laura Stromillo, Roberta Lanzillo, Raffaella Cerqua, Alice Laroni, Lorena Pareja Gutierrez, Stefania Barone, Maria Pia Sormani, Simona Pontecorvo, E Binello, Pietro Annovazzi, Valentina Torri Clerici, Giorgia Mataluni, Cinzia Cordioli, Elisabetta Signoriello, Jessica Frau, Alessio Signori, Sarah Rasia, Arianna Sartori, Gabriella Turano, Francesco Saccà, Damiano Baroncini, Alessia Di Sapio, Ignazio Roberto Zarbo, Eleonora Cocco, Paola Perini, Luigi Lavorgna, Caterina Barrilà, Giorgia Teresa Maniscalco, B. Frigeni, Maniscalco, G. T., Sacca, F., Lanzillo, R., Annovazzi, P., Baroncini, D., Binello, E., Repice, A., Perini, P., Clerico, M., Mataluni, G., Bonavita, S., La Gioia, S., Gutierrez, L. P., Laroni, A., Frau, J., Cocco, E., Torri Clerici, V., Zarbo, I. R., Sartori, A., Signoriello, E., Rasia, S., Cordioli, C., Stromillo, M. L., Cerqua, R., Pontecorvo, S., Di Sapio, A., Grasso, R., Barone, S., Lavorgna, L., Barrila, C., Landi, D., Russo, C. V., Frigeni, B., Ippolito, D., Turano, G., Carmisciano, L., Sormani, M. P., and Signori, A.

Subjects
Male, medicine.medical_specialty, Dimethyl Fumarate, Settore MED/26, Logistic regression, Multiple sclerosis, 03 medical and health sciences, chemistry.chemical_compound, Multiple Sclerosis, Relapsing-Remitting, 0302 clinical medicine, Natalizumab, Internal medicine, Teriflunomide, Immunomodulatory therapy, Humans, Medicine, Relapsing-remitting, Multiple sclerosi, 030212 general & internal medicine, Glatiramer acetate, Determinants first therapy, Naive, Aged, Dimethyl fumarate, Fingolimod Hydrochloride, business.industry, General Medicine, medicine.disease, Fingolimod, Italy, Neurology, chemistry, Cohort, Neurology (clinical), business, Immunosuppressive Agents, 030217 neurology & neurosurgery, medicine.drug
Abstract

Background: The approval of an increasing number of disease modifying drugs for the treatment of Multiple Sclerosis (MS) creates new challenges for patients and clinicians on the first treatment choice. The main aim of this study was to assess factors impacting first therapy choice in a large Italian MS cohort. Methods: Newly diagnosed relapsing-remitting (RR) MS patients (2010-2018) followed in 24 Italian MS centres were included in the study. We evaluated the association of baseline demographics, clinical and MRI characteristics to the first treatment choice by logistic regression models applied to pre-defined binary alternatives: dimethyl fumarate vs injectables (interferon and glatiramer acetate), teriflunomide vs injectables, fingolimod vs dimethyl fumarate and fingolimod vs natalizumab. Results: We enrolled 3025 patients in the period between January 2010 and June 2018. Relapses in the previous year (OR = 2.75; p = 0.001), presence of spinal cord lesions (OR = 1.80; p = 0.002) and higher number (>9) of T2 lesions on the baseline brain MRI scan (OR = 1.65; p = 0.022) were the factors associated to dimethyl fumarate choice as first therapy vs an injectable drug. Older age (OR = 1.06; p < 0.001), male sex (OR = 2.29; p = 0.001) and higher EDSS (OR = 1.36; p < 0.001) were the factors associated with the choice of teriflunomide vs injectables. In more recent years, dimethyl fumarate (OR = 3.23; p < 0.001) and teriflunomide (OR = 2.53; p < 0.001) were chosen more frequently than injectables therapies. The main determinant for the choice of fingolimod as compared with dimethyl fumarate was a higher EDSS (OR = 1.56; p = 0.001), while there was a weak association with a longer disease duration (p = 0.068) and a longer time from onset to diagnosis (p = 0.085). Compared to fingolimod, natalizumab was preferred in patients with a younger age (OR = 0.95; p = 0.003) and higher EDSS (OR = 1.45; p = 0.007) and a shorter disease duration (OR = 0.52; p = 0.076). Conclusion: Many factors guided therapeutic decision for our Italian cohort of MS patients; they are mainly related to MS disease activity, baseline EDSS, disease duration and age.

Published
2020

24. Assessing association of comorbidities with treatment choice and persistence in MS: A real-life multicenter study

Author

Alice, Laroni, Alessio, Signori, Giorgia T, Maniscalco, Roberta, Lanzillo, Cinzia Valeria, Russo, Eleonora, Binello, Salvatore, Lo Fermo, Annamaria, Repice, Pietro, Annovazzi, Simona, Bonavita, Marinella, Clerico, Damiano, Baroncini, Luca, Prosperini, Sara, La Gioia, Silvia, Rossi, Eleonora, Cocco, Jessica, Frau, Valentina, Torri Clerici, Elisabetta, Signoriello, Arianna, Sartori, Ignazio Roberto, Zarbo, Sarah, Rasia, Cinzia, Cordioli, Raffaella, Cerqua, Alessia, Di Sapio, Luigi, Lavorgna, Simona, Pontecorvo, Caterina, Barrilà, Francesco, Saccà, Barbara, Frigeni, Sabrina, Esposito, Domenico, Ippolito, Fabio, Gallo, Maria Pia, Sormani, Laroni, Alice, Signori, Alessio, Maniscalco, Giorgia T., Lanzillo, Roberta, Russo, Cinzia Valeria, Binello, Eleonora, Lo Fermo, Salvatore, Repice, Annamaria, Annovazzi, Pietro, Bonavita, Simona, Clerico, Marinella, Baroncini, Damiano, Prosperini, Luca, La Gioia, Sara, Rossi, Silvia, Cocco, Eleonora, Frau, Jessica, Torri Clerici, Valentina, Signoriello, Elisabetta, Sartori, Arianna, Zarbo, Ignazio Roberto, Rasia, Sarah, Cordioli, Cinzia, Cerqua, Raffaella, Di Sapio, Alessia, Lavorgna, Luigi, Pontecorvo, Simona, Barrilà, Caterina, Saccà, Francesco, Frigeni, Barbara, Esposito, Sabrina, Ippolito, Domenico, Gallo, Fabio, Sormani, Maria Pia, Laroni, A, Signori, A, Maniscalco, Gt, Lanzillo, R, Russo, Cv, Binello, E, Lo Fermo, S, Repice, A, Annovazzi, P, Bonavita, S, Clerico, M, Baroncini, D, Prosperini, L, La Gioia, S, Rossi, S, Cocco, E, Frau, J, Torri Clerici, V, Signoriello, E, Sartori, A, Zarbo, Ir, Rasia, S, Cordioli, C, Cerqua, R, Di Sapio, A, Lavorgna, L, Pontecorvo, S, Barrilà, C, Saccà, F, Frigeni, B, Esposito, S, Ippolito, D, Gallo, F, and Sormani, Mp

Subjects
0301 basic medicine, Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Cardiovascular Abnormalities, Cohort Studies, Comorbidity, Disability Evaluation, Female, Humans, Immunosuppressive Agents, Italy, Mental Disorders, Metabolic Diseases, Middle Aged, Nervous System Diseases, Severity of Illness Index, Drug Substitution, Neurology (clinical), Immunosuppressive Agent, 03 medical and health sciences, 0302 clinical medicine, Natalizumab, Internal medicine, Multiple Sclerosi, Severity of illness, medicine, Cardiovascular Abnormalitie, Glatiramer acetate, Nervous System Disease, business.industry, Odds ratio, medicine.disease, Fingolimod, Metabolic Disease, 030104 developmental biology, Cohort, Mental Disorder, Cohort Studie, business, 030217 neurology & neurosurgery, Human, Cohort study, medicine.drug
Abstract

Objective:To assess whether the presence of concomitant diseases at multiple sclerosis (MS) diagnosis is associated with the choice and the treatment persistence in an Italian MS cohort.Methods:We included newly diagnosed patients (2010–2016) followed in 20 MS centers and collected demographic and clinical data. We evaluated baseline factors related to the presence of comorbidities and the association between comorbidities and the clinical course of MS and the time to the first treatment switch.Results:The study cohort included 2,076 patients. Data on comorbidities were available for 1,877/2,076 patients (90.4%). A total of 449/1,877 (23.9%) patients had at least 1 comorbidity at MS diagnosis. Age at diagnosis (odds ratio 1.05, 95% confidence interval [CI] 1.04–1.06; p < 0.001) was the only baseline factor independently related to the presence of comorbidities. Comorbidities were not significantly associated with the choice of the first disease-modifying treatment, but were significantly associated with higher risk to switch from the first treatment due to intolerance (hazard ratio 1.42, CI 1.07–1.87; p = 0.014). Association of comorbidities with risk of switching for intolerance was significantly heterogeneous among treatments (interferon β, glatiramer acetate, natalizumab, or fingolimod; interaction test, p = 0.04).Conclusions:Comorbidities at diagnosis should be taken into account at the first treatment choice because they are associated with lower persistence on treatment.

Published
2017

25. Active and non-active secondary progressive multiple sclerosis patients exhibit similar disability progression: results of an Italian MS registry study (ASPERA).

Author

Chisari CG, Amato MP, Di Sapio A, Foschi M, Iaffaldano P, Inglese M, Fermo SL, Lugaresi A, Lus G, Mascoli N, Montepietra S, Pesci I, Quatrale R, Salemi G, Torri Clerici V, Totaro R, Valentino P, Filippi M, and Patti F

Subjects
Humans, Male, Female, Italy epidemiology, Middle Aged, Adult, Magnetic Resonance Imaging, Disability Evaluation, Registries, Disease Progression, Multiple Sclerosis, Chronic Progressive physiopathology, Multiple Sclerosis, Chronic Progressive diagnostic imaging, Multiple Sclerosis, Chronic Progressive epidemiology
Abstract

'Active' and 'non-active' secondary progressive MS (SPMS) have distinct pathophysiological mechanisms and clinical characteristics, but there is still no consensus regarding the frequency of these MS forms in the real-world setting. We aimed to evaluate the frequency of 'active' and 'non-active' SPMS in a large cohort of Italian MS patients and the differences in terms of clinical and MRI characteristics and disease progression. This multicenter study collected data about MS patients who have transitioned to the SP form in the period between 1st January 2014 and 31st December 2019 and followed by the MS centers contributing to the Italian MS Registry. Patients were divided into 'active SPMS' and 'non-active SPMS', based on both reported MRI data and relapse activity in the year before conversion to SPMS. Out of 68,621, 8,316 (12.1%) patients were diagnosed with SPMS. Out of them, 872 (10.5%) were classified into patients with either 'active' or 'non-active' SPMS. A total of 237 were classified into patients with 'active SPMS' (27.2%) and 635 as 'non-active SPMS' (72.8%). 'Non-active SPMS' patients were older, with a longer disease duration compared to those with 'active SPMS'. The percentages of patients showing progression independent of relapse activity (PIRA) at 24 months were similar between 'active' and 'non-active' SPMS patients (67 [27.4%] vs 188 [29.6%]; p = 0.60). In the 'active' group, 36 (15.2%) patients showed relapse-associated worsening (RAW). Comparison of the survival curves to EDSS 6 and 7 according to disease activity did not show significant differences (p = 0.68 and p = 0.71). 'Active' and 'non-active' SPMS patients had a similar risk of achieving disability milestones, suggesting that progression is primarily attributed to PIRA and only to a small extent to disease activity., (© 2024. The Author(s).)

Published
2024
Full Text
View/download PDF

27. Effects of fingolimod on focal and diffuse damage in patients with relapsing-remitting multiple sclerosis - The "EVOLUTION" study.

Author

Filippi M, Pagani E, Turrini R, Bartezaghi M, Brescia Morra V, Borriello G, Torri Clerici V, Mirabella M, Pasquali L, Patti F, Totaro R, Gallo P, and Rocca MA

Subjects
Humans, Female, Male, Adult, Middle Aged, Prospective Studies, Immunosuppressive Agents therapeutic use, Disease Progression, Brain diagnostic imaging, Brain pathology, Brain drug effects, White Matter diagnostic imaging, White Matter pathology, White Matter drug effects, Multiple Sclerosis, Relapsing-Remitting drug therapy, Multiple Sclerosis, Relapsing-Remitting diagnostic imaging, Multiple Sclerosis, Relapsing-Remitting pathology, Fingolimod Hydrochloride therapeutic use, Magnetic Resonance Imaging
Abstract

Background and Objectives: In multiple sclerosis (MS), MRI markers can measure the potential neuroprotective effects of fingolimod beyond its anti-inflammatory activity. In this study we aimed to comprehensively explore, in the real-word setting, whether fingolimod not only reduces clinical/MRI inflammatory activity, but also influences the progression of irreversible focal and whole brain damage in relapsing-remitting [RR] MS patients., Methods: The "EVOLUTION" study, a 24-month observational, prospective, single-arm, multicenter study, enrolled 261 RRMS patients who started fingolimod at 32 Italian MS centers and underwent biannual neurological assessments and annual MRI evaluations. Study outcomes included the proportions of evaluable RRMS patients achieving at 24 months: (1) no new/enlarging T 2 -hyperintense white matter (WM) lesions and/or clinical relapses; (2) a modified classification of "No Evidence of Disease Activity 4" ("modified NEDA-4") defined as no new/enlarging T 2 -hyperintense WM lesions, clinical relapses, and 6-month confirmed disability progression, and a yearly percentage lateral ventricular volume change on T 2 -FLAIR images < 2%; (3) less than 40% of active lesions at baseline and month 12 evolving to permanent black holes (PBHs)., Results: At month 24, 76/160 (47.5%; 95% confidence interval [CI] = 39.8%;55.2%) RRMS patients had no clinical/MRI activity. Thirty-nine of 170 RRMS patients (22.9%; 95% CI = 16.6%;29.3%) achieved "modified NEDA-4" status. Forty-four of 72 RRMS patients (61.1%; 95% CI = 49.8%;72.4%) had less than 40% of active WM lesions evolving to PBHs. The study confirmed the established safety and tolerability profile of fingolimod., Discussion: By comparing our results with those from the literature, the EVOLUTION study seems to indicate a neuroprotective effect of fingolimod, limiting inflammatory activity, brain atrophy and PBH development., (© 2024. Springer-Verlag GmbH Germany, part of Springer Nature.)

Published
2024
Full Text
View/download PDF

28. A comparison of natalizumab and ocrelizumab on disease progression in multiple sclerosis.

Author

Iaffaldano P, Lucisano G, Guerra T, Paolicelli D, Portaccio E, Inglese M, Foschi M, Patti F, Granella F, Romano S, Cavalla P, De Luca G, Gallo P, Bellantonio P, Gallo A, Montepietra S, Di Sapio A, Vianello M, Quatrale R, Spitaleri D, Clerici R, Torri Clerici V, Cocco E, Brescia Morra V, Marfia GA, Boccia VD, Filippi M, Amato MP, and Trojano M

Subjects
Humans, Female, Male, Adult, Middle Aged, Multiple Sclerosis drug therapy, Multiple Sclerosis, Relapsing-Remitting drug therapy, Registries, Italy, Natalizumab adverse effects, Antibodies, Monoclonal, Humanized adverse effects, Antibodies, Monoclonal, Humanized pharmacology, Antibodies, Monoclonal, Humanized administration & dosage, Disease Progression, Immunologic Factors adverse effects, Immunologic Factors pharmacology, Immunologic Factors administration & dosage
Abstract

Objective: No direct comparisons of the effect of natalizumab and ocrelizumab on progression independent of relapse activity (PIRA) and relapse-associated worsening (RAW) events are currently available. We aimed to compare the risk of achieving first 6 months confirmed PIRA and RAW events and irreversible Expanded Disability Status Scale (EDSS) 4.0 and 6.0 in a cohort of naïve patients treated with natalizumab or ocrelizumab from the Italian Multiple Sclerosis Register., Methods: Patients with a first visit within 1 year from onset, treated with natalizumab or ocrelizumab, and ≥3 visits were extracted. Pairwise propensity score-matched analyses were performed. Risk of reaching the first PIRA, RAW, and EDSS 4.0 and 6.0 events were estimated using multivariable Cox proportional hazards models. Kaplan-Meier curves were used to show cumulative probabilities of reaching outcomes., Results: In total, 770 subjects were included (natalizumab = 568; ocrelizumab = 212) and the propensity score-matching retrieved 195 pairs. No RAW events were found in natalizumab group and only 1 was reported in ocrelizumab group. A first PIRA event was reached by 23 natalizumab and 25 ocrelizumab exposed patients; 7 natalizumab- and 10 ocrelizumab-treated patients obtained an irreversible EDSS 4.0, while 13 natalizumab- and 15 ocrelizumab-treated patients reached an irreversible EDSS 6.0. No differences between the two groups were found in the risk (HR, 95%CI) of reaching a first PIRA (1.04, 0.59-1.84; p = 0.88) event, an irreversible EDSS 4.0 (1.23, 0.57-2.66; p = 0.60) and 6.0 (0.93, 0.32-2.68; p = 0.89)., Interpretation: Both medications strongly suppress RAW events and, in the short term, the risk of achieving PIRA events, EDSS 4.0 and 6.0 milestones is not significantly different., (© 2024 The Author(s). Annals of Clinical and Translational Neurology published by Wiley Periodicals LLC on behalf of American Neurological Association.)

Published
2024
Full Text
View/download PDF

29. Progression independent of relapse activity in relapsing multiple sclerosis: impact and relationship with secondary progression.

Author

Portaccio E, Betti M, De Meo E, Addazio I, Pastò L, Razzolini L, Totaro R, Spitaleri D, Lugaresi A, Cocco E, Onofrj M, Di Palma F, Patti F, Maimone D, Valentino P, Torri Clerici V, Protti A, Ferraro D, Lus G, Maniscalco GT, Brescia Morra V, Salemi G, Granella F, Pesci I, Bergamaschi R, Aguglia U, Vianello M, Simone M, Lepore V, Iaffaldano P, Comi G, Filippi M, Trojano M, and Amato MP

Subjects
Humans, Male, Female, Adult, Middle Aged, Registries, Recurrence, Italy epidemiology, Follow-Up Studies, Disease Progression, Multiple Sclerosis, Relapsing-Remitting physiopathology, Multiple Sclerosis, Relapsing-Remitting epidemiology, Disability Evaluation
Abstract

Objectives: We investigated the occurrence and relative contribution of relapse-associated worsening (RAW) and progression independent of relapse activity (PIRA) to confirmed disability accrual (CDA) and transition to secondary progression (SP) in relapsing multiple sclerosis (MS)., Methods: Relapsing-onset MS patients with follow-up > / = 5 years (16,130) were extracted from the Italian MS Registry. CDA was a 6-month confirmed increase in Expanded Disability Status Scale (EDSS) score. Sustained disability accumulation (SDA) was a CDA with no EDSS improvement in all subsequent visits. Predictors of PIRA and RAW and the association between final EDSS score and type of CDA were assessed using logistic multivariable regression and multivariable ordinal regression models, respectively., Results: Over 11.8 ± 5.4 years, 16,731 CDA events occurred in 8998 (55.8%) patients. PIRA (12,175) accounted for 72.3% of CDA. SDA occurred in 8912 (73.2%) PIRA and 2583 (56.7%) RAW (p < 0.001). 4453 (27.6%) patients transitioned to SPMS, 4010 (73.2%) out of 5476 patients with sustained PIRA and 443 (24.8%) out of 1790 patients with non-sustained PIRA. In the multivariable ordinal regression analysis, higher final EDSS score was associated with PIRA (estimated coefficient 0.349, 95% CI 0.120-0.577, p = 0.003)., Discussion: In this real-world relapsing-onset MS cohort, PIRA was the main driver of disability accumulation and was associated with higher disability in the long term. Sustained PIRA was linked to transition to SP and could represent a more accurate PIRA definition and a criterion to mark the putative onset of the progressive phase., (© 2024. The Author(s).)

Published
2024
Full Text
View/download PDF

30. Ocrelizumab in MS patients with persistence of disease activity after alemtuzumab: A multi-center Italian study.

Author

Lapucci C, Frau J, Cocco E, Coghe G, Petracca M, Lanzillo R, Brescia Morra V, Nicoletti CG, Landi D, Marfia G, Vercellino M, Cavalla P, Bianco A, Mirabella M, Torri Clerici V, Tomas E, Ferrò MT, Grossi P, Nozzolillo A, Moiola L, Zaffaroni M, Ronzoni M, Pinardi F, Novi G, Cellerino M, Uccelli A, and Inglese M

Subjects
Humans, Female, Male, Adult, Italy, Retrospective Studies, Middle Aged, Multiple Sclerosis, Relapsing-Remitting drug therapy, Multiple Sclerosis drug therapy, Follow-Up Studies, Antibodies, Monoclonal, Humanized adverse effects, Antibodies, Monoclonal, Humanized therapeutic use, Alemtuzumab adverse effects, Immunologic Factors adverse effects
Abstract

Background: The reason why some multiple sclerosis (MS) patients show disease activity after alemtuzumab (ALM) is still unclear, but ocrelizumab (OCR) could represent an interesting sequential therapeutic approach., Objectives: To investigate safety and efficacy of OCR in MS patients with disease activity after two ALM courses., Methods: Observational retrospective multi-centers Italian cohort study., Results: Seventy-two subjects were included. Mean follow-up (FU) was 2.4 (±1) years. Forty-five patients (62.5%) experienced at least one adverse event (AE), with infections accounting for 96.7% of cases. A reduction in total lymphocytes was observed between OCR start and 6 months FU, driven by BCD19+ lymphocytes depletion ( p < 0.001). Immunoglobulin M (IgM) levels decreased between OCR start and 6 months FU ( p < 0.001). At 2-year FU, relapse, magnetic resonance imaging (MRI) activity and disability worsening-free survival were 92.1%, 90.8%, and 89.2%. The evidence of inflammatory activity between the two ALM courses was associated with higher risk of relapse, MRI activity, and NEDA-3 status loss in relapsing-remitting multiple sclerosis (RRMS; p = 0.02, p = 0.05, p = 0.01, respectively)., Conclusions: OCR after two ALM courses seemed to be safe and effective. Early IgM hypogammaglobulinemia occurred in a high proportion of patients. The evidence of inflammatory activity between ALM courses seemed to increase the risk of MS re-activation on OCR treatment., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: C. Lapucci has received honoraria for speaking, travel grants, and for participating in the advisory board from Merck, Sanofi, Novartis, Roche, Alexion. J. Frau served on scientific advisory boards for Biogen and Genzyme, and has received honoraria as a speaker from Merck Serono, Genzyme, Biogen, and Teva. E. Cocco reported grants, personal fees, and non-financial support from Biogen and Merck; personal fees and non-financial support from Novartis; grants from Roche; and personal fees from Genzyme. G. Coghe received honoraria for consultancy or speaking from Biogen, Novartis, Sanofi, Genzyme, Serono, Teva, and Almirall. M. Petracca has received travel/meeting expenses from Novartis, Janssen, Roche, and Merck; speaking honoraria from HEALTH&LIFE S.r.l., AIM Education S.r.l., Biogen, Novartis, and FARECOMUNICAZIONE E20; honoraria for consulting services and advisory board participation from Biogen; research grants from Baroni Foundation and the Italian Ministry of University and Research. R. Lanzillo has received honoraria from Biogen, Merck, Novartis, Roche, and Teva. V. Brescia Morra has received research grants from the Italian MS Society and Roche, and honoraria from Bayer, Biogen, Merck, Mylan, Novartis, Roche, Sanofi-Genzyme, and Teva. C.G. Nicoletti received travel funding from Biogen, Merck Serono, Sanofi-Genzyme, Roche, Teva, Novartis, Bristol Mayer Squibb, Janssen, Almirall and consultation fees from Sanofi, Almirall, Merck- Serono, Roche, Novartis, and Biogen. She is a sub-investigator in clinical trials being conducted for Biogen, Merck Serono, Roche, Biogen, Sanofi, Novartis, Teva, Bristol Mayer Squibb. D. Landi has received travel funding from Biogen, Merck Serono, Sanofi, Teva, Bristol Myers Squibb, Mylan; speaking or consultations fees from Sanofi, Merck Serono, Teva, Biogen, Roche, Novartis, Bristol Myers Squibb, BayerSchering. G. Marfia has received travel funding, speaking or consultation fees from Almirall, Bayer-Schering, Biogen, Sanofi, Merck Serono, Novartis, Teva, Mylan, Bristol Mayers Squibb and research grants from Roche and Biogen. M. Vercellino has received congress grants, speaker fees and advisory board fees from Merck-Serono, Novartis, Roche, Biogen, Sanofi Genzyme. P. Cavalla has received honoraria as speaker or travel grants to attend national and international conferences or consultation for advisory boards from Alexion, Almirall, Bayer Schering, Biogen, Cellgene-BMS, Merck-Serono, Teva, Roche, Novartis, Sanof-Genzyme, and Janssen. A. Bianco has received honoraria for speaking, advisory board/consulting from Biogen, Novartis, Merck Serono, Roche, Sanofi Genzyme. M. Mirabella has received honoraria for speaking, advisory board/consulting from Biogen, Novartis, Merck Serono, Roche, Almirall, Sanofi Genzyme, Janssen, Bristol-Myers Squibb, Viatris, Alexion. He is principal investigator in clinical trials for Biogen, Merck Serono, Novartis, Roche, Sanofi Genzyme, CSL Behring, Ultragenix, Argenx. V. Torri Clerici acted as an Advisory Board member of Biogen Idec, Novartis, Merck Serono, Roche, Sanofi Genzyme, Almirall, Lundbeck and Bristol Myers Squibb; she received funding for traveling and honoraria for speaking or writing from Novartis, Sanofi Genzyme, Horizon, Merck Serono, Roche, Bristol Myers Squibb, Janssen and Almirall. She received support for research project by Almirall. E. Tomas received funding for work contract from Roche. M.T. Ferrò has received consultancy fees or speaker compensation from Sanofi, Bristol, Biogen Idec, and Novartis. L. Moiola has received honoraria for speaking and for participating in advisory board from Merck, Celgene, Biogen, Sanofi, Novartis, Roche, Alexion. M. Zaffaroni has received advisory board membership, speakers honoraria, travel support, research grants, consulting fees or clinical trial support from Actelion, Almirall, Bayer Schering, Biogen, Celgene, Excemed, Genzyme, Merck, Novartis, Sanofi, Roche, Teva. M. Ronzoni has received travel grants for congresses participation from Biogen, Genzyme, Novartis e Merck. G. Novi has received speaker honoraria from Merck, Novartis, Roche, Alexion. M. Cellerino has received consulting fees from Novartis, Genzyme, Teva and Zambon. A. Uccelli has received grants (to his institution) from FISM, Biogen, Roche, Alexion, and Merck Serono and has participated on a data safety monitoring board or advisory board (to his institution) for BD, Biogen, Iqvia, Sanofi, Roche, Alexion, and Bristol Myers Squibb. M. Inglese received grants from NIH, NMSS, and FISM; received fees for consultation from BMS, Janssen, Roche, Genzyme, Merck, Biogen and Novartis. P. Grossi, A. Nozzolillo, and F. Pinardi have nothing to disclose.

Published
2024
Full Text
View/download PDF

31. Unprescribed cannabinoids and multiple sclerosis: a multicenter, cross-sectional, epidemiological study in Lombardy, Italy.

Author

Giossi R, Mercenari M, Filippi M, Zanetta C, Antozzi CG, Brambilla L, Confalonieri P, Crisafulli SG, Tomas Roldan E, Annovazzi P, Conti MZ, Barrilà C, Ronzoni M, Grobberio M, Negri A, Gustavsen S, and Torri Clerici V

Abstract

Introduction: Cannabinoids are approved for spasticity and pain in multiple sclerosis (MS). In 2017 the prevalence of current users in the Italian general population was 10.2%, while data on Italian MS patients are limited., Methods: From March 2022 to February 2023, we conducted a multicenter, cross-sectional study. Adult MS patients completed an anonymous online survey. The primary outcome was the estimated prevalence of unprescribed cannabis current use. Cannabis use patterns and associations with clinical and socio-demographical variables were investigated. The binomial method was used to estimate 95% confidence interval (95% CI) for primary outcome., Results: 5620 patients were invited and 2024 (36.0%) were included (mean age 45.2 years, females 64.5%). Relapsing remitting form was the most frequent (77.3%). Median expanded disability status scale (EDSS) was 2.0. The proportion of current users was 15.5% (95% CI 13.9-17.1) and 36.4% of them disclosed to their physician their unprescribed cannabis use. 15.0% patients were former users while 69.5% never used cannabis. Current users more frequently reported a medical use (i.e., current medical users) compared to former users (p < 0.001). 41.1% of never users would use cannabis if it was legal. Young age, being male, and a free marital status were associated with current use. Current medical users had higher disability, spasticity and pain, reduced quality of life, concomitant neurological/psychiatric drugs and analgesics use. Unprescribed cannabis appeared relatively safe, with limited addiction risk, and reported clinical benefits, including concomitant medications reduction., Conclusion: Unprescribed cannabis use is common in patients with MS in Italy, with observed prevalence seemingly superior to the general population, often intended for medical use and without the disclosure to the treating physician, although with potential clinical benefits., (© 2024. The Author(s).)

Published
2024
Full Text
View/download PDF

32. Multiple Sclerosis Progression and Relapse Activity in Children.

Author

Iaffaldano P, Portaccio E, Lucisano G, Simone M, Manni A, Guerra T, Paolicelli D, Betti M, De Meo E, Pastò L, Razzolini L, Rocca MA, Ferrè L, Brescia Morra V, Patti F, Zaffaroni M, Gasperini C, De Luca G, Ferraro D, Granella F, Pozzilli C, Romano S, Gallo P, Bergamaschi R, Coniglio MG, Lus G, Vianello M, Banfi P, Lugaresi A, Totaro R, Spitaleri D, Cocco E, Di Palma F, Maimone D, Valentino P, Torri Clerici V, Protti A, Maniscalco GT, Salemi G, Pesci I, Aguglia U, Lepore V, Filippi M, Trojano M, and Amato MP

Subjects
Adult, Child, Humans, Female, Male, Cohort Studies, Disease Progression, Chronic Disease, Recurrence, Multiple Sclerosis diagnostic imaging, Multiple Sclerosis epidemiology, Multiple Sclerosis, Relapsing-Remitting diagnostic imaging, Multiple Sclerosis, Relapsing-Remitting drug therapy, Multiple Sclerosis, Relapsing-Remitting epidemiology
Abstract

Importance: Although up to 20% of patients with multiple sclerosis (MS) experience onset before 18 years of age, it has been suggested that people with pediatric-onset MS (POMS) are protected against disability because of greater capacity for repair., Objective: To assess the incidence of and factors associated with progression independent of relapse activity (PIRA) and relapse-associated worsening (RAW) in POMS compared with typical adult-onset MS (AOMS) and late-onset MS (LOMS)., Design, Setting, and Participants: This cohort study on prospectively acquired data from the Italian MS Register was performed from June 1, 2000, to September 30, 2021. At the time of data extraction, longitudinal data from 73 564 patients from 120 MS centers were available in the register., Main Outcomes and Measures: The main outcomes included age-related cumulative incidence and adjusted hazard ratios (HRs) for PIRA and RAW and associated factors., Exposures: Clinical and magnetic resonance imaging features, time receiving disease-modifying therapy (DMT), and time to first DMT., Results: After applying the inclusion and exclusion criteria, the study assessed 16 130 patients with MS (median [IQR] age at onset, 28.7 [22.8-36.2 years]; 68.3% female). Compared with AOMS and LOMS, patients with POMS had less disability, exhibited more active disease, and were exposed to DMT for a longer period. A first 48-week-confirmed PIRA occurred in 7176 patients (44.5%): 558 patients with POMS (40.4%), 6258 patients with AOMS (44.3%), and 360 patients with LOMS (56.8%) (P < .001). Factors associated with PIRA were older age at onset (AOMS vs POMS HR, 1.42; 95% CI, 1.30-1.55; LOMS vs POMS HR, 2.98; 95% CI, 2.60-3.41; P < .001), longer disease duration (HR, 1.04; 95% CI, 1.04-1.05; P < .001), and shorter DMT exposure (HR, 0.69; 95% CI, 0.64-0.74; P < .001). The incidence of PIRA was 1.3% at 20 years of age, but it rapidly increased approximately 7 times between 21 and 30 years of age (9.0%) and nearly doubled for each age decade from 40 to 70 years (21.6% at 40 years, 39.0% at 50 years, 61.0% at 60 years, and 78.7% at 70 years). The cumulative incidence of RAW events followed a similar trend from 20 to 60 years (0.5% at 20 years, 3.5% at 30 years, 7.8% at 40 years, 14.4% at 50 years, and 24.1% at 60 years); no further increase was found at 70 years (27.7%). Delayed DMT initiation was associated with higher risk of PIRA (HR, 1.16; 95% CI, 1.00-1.34; P = .04) and RAW (HR, 1.75; 95% CI, 1.28-2.39; P = .001)., Conclusions and Relevance: PIRA can occur at any age, and although pediatric onset is not fully protective against progression, this study's findings suggest that patients with pediatric onset are less likely to exhibit PIRA over a decade of follow-up. However, these data also reinforce the benefit for DMT initiation in patients with POMS, as treatment was associated with reduced occurrence of both PIRA and RAW regardless of age at onset.

Published
2024
Full Text
View/download PDF

33. Nabiximols oromucosal spray in patients with multiple sclerosis-related bladder dysfunction: A prospective study.

Author

Torri Clerici V, Brambilla L, Politi PL, Viggiani F, Mercurio S, Tonietti S, Ronzoni M, Crisafulli SG, Antozzi C, Tramacere I, Redemagni C, and Confalonieri P

Subjects
Humans, Prospective Studies, Quality of Life, Urinary Bladder, Longitudinal Studies, Muscle Spasticity etiology, Muscle Spasticity complications, Multiple Sclerosis complications, Multiple Sclerosis drug therapy
Abstract

Background: Spasticity and urinary disturbances can profoundly impact the daily lives of persons with multiple sclerosis (pwMS). Cannabis has been associated with improvement in sphincteric disturbances. To our knowledge, few studies have evaluated the effect of nabiximols oromucosal spray (Sativex®) on urinary disturbances by instrumental methods., Objectives: This longitudinal study was conducted to assess the effect of nabiximols oromucosal spray on urinary disturbances by clinical and urodynamic evaluation in pwMS., Materials and Methods: Neurological, spasticity, and quality of life (QoL) assessments were performed before (T0), and at one (T1) and six (T6) months after the start of nabiximols treatment. At these same time points, patients were assessed for urinary disturbances by the International Prostatic Symptoms Score (IPSS) and a urodynamic test evaluating maximum detrusor pressure (P det ), bladder filling capacity (CC max ), uninhibited detrusor contractions (UDC), bladder volume at first desire (BVFD), post-void residual volume (PVR) and voluntary abdominal pressure (PA)., Results: Of 31 pwMS enrolled in the study, 25 reached T1 and 18 reached T6. Mean IPSS total score, its subscores, and IPSS QoL decreased significantly from T0 to T6 (p = 0.000), with no differences according to sex, age, MS type, disease duration and disability at baseline. P det improved significantly from T0 to T6 (p = 0.0171), and CC max changed only marginally (p = 0.0494); results were similar in patient subgroups naïve to or previously exposed to urological treatment. All patients with overactive bladder showed improvement in their urodynamic assessment based on significant reduction of P det (p = 0.0138). In patients with mainly hypotonic bladder, mean P det decreased from T0 to T6 without reaching statistical significance; most urodynamic parameters showed a trend to improve. Mean numerical scale scores for MS spasticity, and for spasms, pain and tremors, decreased significantly from T0 to T6. The mean 'physical health composite' score of the MS Quality of Life-54 questionnaire increased significantly from T0 to T6 (p = 0.0126)., Discussion and Conclusion: Our data suggest that nabiximols has an appreciable effect on ameliorating subjective perception of urinary disturbances and appears to have a positive effect on objective urodynamic parameters, particularly in patients with hyperactive bladder., Competing Interests: Declaration of Competing Interest Valentina Torri Clerici has acted as an Advisory Board member for Almirall, Merck, Novartis, Roche and Sanofi; has received funding for traveling and honoraria for speaking or writing from Almirall, Biogen, Bristol-Meyers Squibb, Novartis, Sanofi, and Teva; has received support for research projects from Almirall; is involved as principal investigator in clinical trials for FISM, Merck, Novartis, and Sanofi. Laura Brambilla has received honoraria for speaking from Novartis and Sanofi, and for traveling from Coloplast, Merck, Roche, and Sanofi. She has acted as an Advisory Board member for Biogen, Merck, Novartis, and Sanofi. She is involved as principal investigator in clinical trials for Merck and Roche. Simone Tonietti has received honoraria for lecturing from Sanofi and Teva; for writing from Teva; for participation in advisory boards from Biogen and Merck; and for travel expenses to attend congresses and meetings from Biogen, Merck, Novartis, Sanofi, and Teva. Marco Ronzoni has acted as an Advisory Board member for Biogen, Roche and Sanofi; has received honoraria for speaking from Sanofi and for traveling from Biogen, Mylan and Novartis. Sebastiano Crisafulli has received travel grants from Merck and Novartis. Carlo Antozzi has received honoraria for Advisory Board participation from Momenta Pharmaceuticals, and for meeting participation from Biogen and Sanofi. Paolo Confalonieri has received honoraria for speaking or consultation fees from Biogen, Novartis, and Roche; has received funding for travel to attend scientific events or speaker honoraria from Biogen, Merck, Mylan, Roche, and Teva; has received institutional research support from Merck, Mylan, Novartis, and Roche. He is also involved as principal investigator in clinical trials for Biogen, Merck, and Roche. Paolo Luca Politi, Federica Viggiani, Simone Mercurio, Irene Tramacere and Chiara Redemagni have nothing to disclose., (Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.)

Published
2023
Full Text
View/download PDF

34. Symptomatic COVID-19 course and outcomes after three mRNA vaccine doses in multiple sclerosis patients treated with high-efficacy DMTs.

Author

Capuano R, Prosperini L, Altieri M, Lorefice L, Fantozzi R, Cavalla P, Guaschino C, Radaelli M, Cordioli C, Nociti V, Boffa L, Ragonese P, Di Gregorio M, Pinardi F, Torri Clerici V, De Luca G, Gajofatto A, Paolicelli D, Tortorella C, Gasperini C, Solaro C, Cocco E, Bisecco A, and Gallo A

Subjects
Humans, COVID-19 Vaccines, SARS-CoV-2, Natalizumab therapeutic use, Fingolimod Hydrochloride, RNA, Messenger, mRNA Vaccines, Multiple Sclerosis drug therapy, COVID-19 prevention & control
Abstract

Background: Little is known about COVID-19 course and outcomes after a third booster dose of mRNA vaccine against SARS-CoV-2 (mRNA-Vax) in patients with multiple sclerosis (pwMS) treated with ocrelizumab (OCR) and fingolimod (FNG), which showed a weakened immune response to mRNA-vax., Objectives: The aim of this study was to evaluate COVID-19 course and outcomes in pwMS on OCR and FNG after receiving the third dose of mRNA-Vax and to compare it with pwMS on natalizumab (NTZ)., Methods: Inclusion criteria: >18 years of age, being treated with OCR/FNG/NTZ since the first mRNA-Vax dose; COVID-19 after a third booster dose of mRNA-Vax; no steroids use., Results: Overall, 290 pwMS (79 NTZ, 126 OCR, and 85 FNG) from 17 Italian MS centers were included. Age, Expanded Disability Status Scale (EDSS) score, MS phenotype, disease, and treatment duration were significantly different across groups. PwMS who had COVID-19 on OCR and FNG compared with those on NTZ were slightly more symptomatic with higher hospitalization rates (11.1% vs 7.1% vs 1.3%, respectively). Regression models showed that the majority of the differences observed were not related to the disease-modifying treatments (DMTs) used. No fatal cases were observed., Conclusion: Our results support the effectiveness of the third booster dose of mRNA-Vax against severe forms of COVID-19 in pwMS treated with OCR and FNG.

Published
2023
Full Text
View/download PDF

35. The contribute of cerebrospinal fluid free light-chain assay in the diagnosis of multiple sclerosis and other neurological diseases in an Italian multicenter study.

Author

Bernardi G, Biagioli T, Malpassi P, De Michele T, Vecchio D, Repice AM, Lugaresi A, Mirabella M, Torri Clerici V, and Crespi I

Subjects
Biomarkers, Humans, Immunoglobulin kappa-Chains, Oligoclonal Bands cerebrospinal fluid, ROC Curve, Multiple Sclerosis, Nervous System Diseases
Abstract

Background: Cerebrospinal fluid (CSF) free light chains (FLCs) can be an alternative assay to oligoclonal bands (OCBs) in inflammatory neurological disorders, but threshold has no consensus., Objective: To assess the diagnostic accuracy of CSF FLCs in multiple sclerosis (MS) and other neurological diseases., Methods: A total of 406 patients from five Italian centers. FLCs were measured in CSF and serum using Freelite MX assays on Optilite., Results: A total of 171 patients were diagnosed as MS, 154 non-inflammatory neurological diseases, 48 inflammatory central nervous system (CNS) diseases, and 33 peripheral neurological diseases. Both kFLC and λFLC indices were significantly higher in patients with MS compared to other groups ( p  < 0.0001). The kFLC index ⩾ 6.4 is comparable to OCB for MS diagnosis (area under the receiver operating characteristic curve (AUC) = 0.876; sensitivity 83.6% vs 84.2%; specificity 88.5% vs 90.6%). λFLC index ⩾ 5 showed an AUC of 0.616, sensitivity of 33.3% and specificity of 90.6%. In all, 12/27 (44.4%) MS patients with negative OCB had kFLC index ⩾ 6.4. Interestingly, 37.5% of 24 patients with a single CSF IgG band showed high kFLC index and 12.5% positive λFLC index., Conclusion: Our findings support the diagnostic utility of FLC indices in MS and other CNS inflammatory disorders, suggesting a combined use of FLC and OCB to help clinicians with complementary information.

Published
2022
Full Text
View/download PDF

36. Comparing Natural History of Early and Late Onset Pediatric Multiple Sclerosis.

Author

De Meo E, Filippi M, Trojano M, Comi G, Patti F, Brescia Morra V, Salemi G, Onofrj M, Lus G, Cocco E, Fonderico M, Torri Clerici V, Maniscalco GT, Valentino P, Bertolotto A, Lugaresi A, Bergamaschi R, Rovaris M, Sola P, Tedeschi G, Pesci I, Aguglia U, Cavalla P, Maimone D, Granella F, Vianello M, Simone M, Portaccio E, and Amato MP

Subjects
Child, Disease Progression, Humans, Male, Prognosis, Recurrence, Disabled Persons, Multiple Sclerosis diagnosis, Multiple Sclerosis epidemiology, Multiple Sclerosis therapy
Abstract

Objective: This study was undertaken to describe and compare disease course and prognosis of early (ie, disease onset before age 11 years) and late (ie, disease onset after age 11 years) onset pediatric multiple sclerosis., Methods: Prospectively collected clinical information from Italian Multiple Sclerosis Register of 1993 pediatric multiple sclerosis patients, of whom 172 had early onset, was analyzed. Cox models adjusted for sex, baseline Expanded Disability Status Scale score, and disease-modifying treatments and stratified for diagnostic criteria adopted (Poser vs McDonald) were used to assess the risk of reaching irreversible Expanded Disability Status Scale scores of 3, 4, and 6, and conversion to secondary progressive phenotype in early versus late onset pediatric patients. Prognostic factors were also evaluated., Results: A greater proportion of males, isolated brainstem involvement, and longer time interval between first and second clinical episode were observed in early versus late onset pediatric patients. Compared to late onset, early onset pediatric patients took longer from disease onset to convert to secondary progressive phenotype and to reach all disability milestones. Recovery from first demyelinating event, time to first relapse, annualized relapse rate during the first 3 years of disease, and disease-modifying treatment exposure were independent predictors for long-term disability in early onset pediatric patients. In late onset pediatric patients, isolated optic neuritis, multifocal symptoms, and progressive course at disease onset were additional predictors for long-term disability., Interpretation: These findings point toward the existence of a different natural history in early versus late onset pediatric multiple sclerosis patients. ANN NEUROL 2022;91:483-495., (© 2022 American Neurological Association.)

Published
2022
Full Text
View/download PDF

37. mRNA COVID-19 vaccines do not increase the short-term risk of clinical relapses in multiple sclerosis.

Author

Di Filippo M, Cordioli C, Malucchi S, Annovazzi P, Cavalla P, Torri Clerici V, Ragonese P, Nociti V, Radaelli M, Laroni A, Buttari F, Lorefice L, Ferraro D, Gajofatto A, Prosperini L, Fantozzi R, Boffa L, Lanzillo R, Moccia M, Clerico M, De Luca G, Tomassini V, Calabrese M, Borrelli A, Paolicelli D, Maniscalco GT, Gazzola P, Gallo A, Solaro C, Cocco E, Gasperini C, and Tortorella C

Subjects
COVID-19 Vaccines adverse effects, Humans, RNA, Messenger, Recurrence, COVID-19 prevention & control, Multiple Sclerosis
Abstract

Competing Interests: Competing interests: MDF participated on advisory boards for and received speaker or writing honoraria and funding for traveling from Bayer, Biogen Idec, Genzyme, Merck, Mylan, Novartis, Roche and Teva. CC received consulting fees for speaking and advisory board from Biogen, Novartis, Merck Serono, Almirall and Roche. SM received honoraria from speaking and advisory board from Biogen, Merck Serono, Novartis and Sanofi Genzyme. PC participated on advisory boards for, received speaker or writing honoraria and funding for traveling from Almirall, Biogen, Sanofi Genzyme, Merck-Serono, Novartis, Roche and Teva. VN has received consulting fees from Novartis, Roche, Mylan, Biogen Idec, Merck, Teva and Bayer; speaker and writing honoraria from Mylan, Teva, Biogen Idec, Bayer, Sanofi Genzyme and Merck and travel grants from Teva, Biogen Idec, Sanofi Genzyme, Roche and Novartis. MR received honoraria or consultation fees from Biogen Idec, Sanofi Genzyme, Novartis and Merck Serono. AL received grants from Fondazione Italiana Sclerosi Multipla, Italian Ministry of Health, Italian Ministry of University and received honoraria or consultation fees from Biogen, Roche, Merck, Genzyme and Novartis. FB received honoraria for speaking or consultation fees from Biogen, Roche, Merck Serono, Novartis, Sanofi Genzyme and Teva. LL received travel grant, speaker fees and consultancy from Biogen Idec, Teva, Genzyme, Merck Serono, Novartis, Roche and Almirall. DF has received travel grants and/or speaker/advisory board honoraria from Merck, Sanofi Genzyme, Roche, Teva, Binding Site, Biogen and Novartis. RF received honoraria or consultation fees from Roche, Novartis, Merck and Sanofi Genzyme. RL received honoraries from Biogen, Merck, Sanofi, Roche and Novartis for lectures or scientific boards. MM has received research grants from ECTRIMS-MAGNIMS, UK MS Society and Merck; honoraria from EMD Serono, Ipsen, Merck, Roche and Sanofi Genzyme and consultant fees from Veterans Evaluation Services. MaCl received personal compensations for public speaking from Merck, Biogen, Novartis, Sanofi Genzyme, Almirall, Roche and Viatris and received research grants from Merck, Biogen and Novartis. GDL served on scientific advisory boards and received speaking honoraria or travel grants from Biogen, Merck Serono, Novartis, Roche and Sanofi Genzyme. VT participated on advisory boards for and received speaker or writing honoraria and funding for traveling from Biogen, Sanofi Genzyme, Merck, Novartis, Roche and Almirall. MaCa has received consulting and/or lecture fees and/or travel grants from Roche, Biogen Idec, Sanofi Genzyme, Novartis and Merck Serono. AB received funding for traveling from Almirall. DP received honoraria for consultancy from and/or speaking at Biogen Idec, Merck‐Serono, Almirall, Sanofi‐Aventis, Teva, Novartis and Genzyme. GTM received personal compensation from Serono, Biogen, Novartis, Roche and Teva for public speaking and advisory boards. PG has received honoraria/consultation fees from Novartis, Merck and Sanofi Genzyme. CS received travel grant and honoraria from Merck, Biogen, Novartis and Amgen. EC has received consulting and/or lecture fees and/or travel grants from Biogen Idec, Sanofi Genzyme, Merck Serono, Novartis and Roche. CG received fees for speaking and advisory boards from Merck, Biogen, Novartis, Teva, Roche, Almirall, Bayer, Mylan and Sanofi. CT received honoraria for speaking and travel grants from Biogen, Sanofi Aventis, Merck Serono, Bayer Schering, Teva, Genzyme, Almirall and Novartis.

Published
2022
Full Text
View/download PDF

38. Anti-Spike IgG in multiple sclerosis patients after BNT162b2 vaccine: An exploratory case-control study in Italy.

Author

Giossi R, Consonni A, Torri Clerici V, Zito A, Rigoni E, Antozzi C, Brambilla L, Crisafulli SG, Bellino A, Frangiamore R, Bonanno S, Vanoli F, Ciusani E, Corsini E, Andreetta F, Baggi F, Tramacere I, Mantegazza R, Conte A, Bergamaschi R, and Confalonieri P

Subjects
Antibodies, Viral, BNT162 Vaccine, COVID-19 Vaccines adverse effects, Case-Control Studies, Humans, Immunoglobulin G, SARS-CoV-2, COVID-19 prevention & control, Multiple Sclerosis drug therapy
Abstract

Background: Patients with neuroimmunological conditions such as multiple sclerosis (MS) often receive disease-modifying therapies (DMTs) or immunosuppressants which may reduce the response to vaccines. BNT162b2 (Pfizer-BioNTech) is the first COVID-19 vaccine authorized in Italy. Its clinical efficacy and serological response were not evaluated in MS patients receiving DMTs or immunosuppressants. This early multicenter study evaluated serological response to BNT162b2 and safety in these patients., Methods: From February 2021 we enrolled consecutive MS patients, treated with at least one DMT and all healthcare workers (HCWs), having received or being scheduled to receive the first dose of BNT162b2. Blood samples were collected after the second vaccine dose and analyzed to quantitatively detect the presence of anti-Spike antibodies. Serological response was compared to the one from a control population of HCWs, with neither neuroimmunological conditions nor receiving immunosuppressants. Patients receiving treatments associated with a possible reduced response (Under-scrutiny treatment group) were also compared to those undergoing other treatments. Anti-Spike levels were described as median and interquartile range (IQR). Comparisons were performed with Wilcoxon-Mann-Whitney test. Solicited and unsolicited adverse events (AEs) were collected., Results: 39 MS patients and a control population of 273 HCWs were included. One patient, under treatment with ocrelizumab, did not respond to BNT162b2, while all the remaining patients and all controls developed a serological response to the vaccine. Median anti-Spike levels were similar between patients (1471.0 BAU/ml; IQR 779.7 to 2357.0) and controls (1479.0 BAU/ml; IQR 813.1 to 2528.0) (p = 0.53). Patients included in the Under-scrutiny treatments group showed reduced anti-Spike levels (156.4 BAU/ml; IQR 33.4 to 559.1) compared to those receiving other treatments (1582.4 BAU/ml; IQR 1296.5 to 2219.0) (p = 0.001). Solicited AEs were all mild to moderate in severity, generally reported in the first days after vaccination, and resolved in the following days. Two MS patients reported a clinical relapse after the second vaccine dose., Conclusion: BNT162b2 induced a serological response in MS patients treated with DMTs similar to controls not receiving DMTs or immunosuppressants. Some treatments were associated with reduced levels of anti-Spike antibodies in patients. These observations have relevant implications for treated patients receiving BNT162b2 and the community., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Published
2022
Full Text
View/download PDF

39. A real-world study of alemtuzumab in a cohort of Italian patients.

Author

Russo CV, Saccà F, Frau J, Annovazzi P, Signoriello E, Bonavita S, Grasso R, Clerico M, Cordioli C, Laroni A, Capobianco M, Torri Clerici V, Sartori A, Cavalla P, Maniscalco GT, La Gioia S, Caleri F, Giugno A, Iodice R, Carotenuto A, Cocco E, Fenu G, Zaffaroni M, Baroncini D, Lus G, Gallo A, De Mercanti SF, Lapucci C, Di Francescantonio V, Brambilla L, Sormani MP, and Signori A

Subjects
Adult, Alemtuzumab therapeutic use, Fingolimod Hydrochloride therapeutic use, Glatiramer Acetate therapeutic use, Humans, Natalizumab therapeutic use, Retrospective Studies, Multiple Sclerosis, Relapsing-Remitting diagnostic imaging, Multiple Sclerosis, Relapsing-Remitting drug therapy
Abstract

Background and Purpose: Real-world data on alemtuzumab are limited and do not provide evidence of its effectiveness after various disease-modifying therapies (DMTs). Our aim was to provide real-world data on the impact of clinical variables and previous DMTs on clinical response to alemtuzumab., Methods: Sixteen Italian multiple sclerosis centers retrospectively included patients who started alemtuzumab from January 2015 to December 2018, and recorded demographics, previous therapies, washout duration, relapses, Expanded Disability Status Scale (EDSS) score, and magnetic resonance imaging data. Negative binomial regression models were used to assess the effect of factors on annualized relapse (ARR) after alemtuzumab initiation., Results: We studied 322 patients (mean age 36.8 years, median EDSS score 3, median follow-up 1.94 years). Previous treatments were: fingolimod (106), natalizumab (80), first-line oral agents (56), first-line injectables (interferon/glatiramer acetate; 30), and other drugs (15). Thirty-five patients were treatment-naïve. The pre-alemtuzumab ARR was 0.99 and decreased to 0.13 during alemtuzumab treatment (p < 0.001). The number of previous-year relapses was associated with alemtuzumab ARR (adjusted risk ratio [RR] 1.38, p = 0.009). Progression-free survival was 94.5% after 1 year, and 89.2% after 2 years of alemtuzumab treatment. EDSS score improvement occurred in 13.5% after 1 year, and 20.6% after 2 years. Re-baselining patients after 6 months of alemtuzumab treatment, led to no evidence of disease activity status in 71.6% after 1 year and 58.9% after 2 years., Conclusions: Alemtuzumab decreases ARR independent of previous therapy, including patients with disease activity during natalizumab treatment. Overall, 90% of patients showed no disease progression, and 20% an improvement after 2 years of alemtuzumab., (© 2021 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.)

Published
2022
Full Text
View/download PDF

40. First therapy choice in newly diagnosed Multiple Sclerosis patients: A multicenter Italian study.

Author

Maniscalco GT, Saccà F, Lanzillo R, Annovazzi P, Baroncini D, Binello E, Repice A, Perini P, Clerico M, Mataluni G, Bonavita S, La Gioia S, Gutierrez LP, Laroni A, Frau J, Cocco E, Torri Clerici V, Zarbo IR, Sartori A, Signoriello E, Rasia S, Cordioli C, Stromillo ML, Cerqua R, Pontecorvo S, Di Sapio A, Grasso R, Barone S, Lavorgna L, Barrilà C, Landi D, Russo CV, Frigeni B, Ippolito D, Turano G, Carmisciano L, Sormani MP, and Signori A

Subjects
Aged, Dimethyl Fumarate therapeutic use, Fingolimod Hydrochloride therapeutic use, Humans, Immunosuppressive Agents, Italy, Male, Multiple Sclerosis diagnostic imaging, Multiple Sclerosis drug therapy, Multiple Sclerosis, Relapsing-Remitting diagnostic imaging, Multiple Sclerosis, Relapsing-Remitting drug therapy
Abstract

Background: The approval of an increasing number of disease modifying drugs for the treatment of Multiple Sclerosis (MS) creates new challenges for patients and clinicians on the first treatment choice. The main aim of this study was to assess factors impacting first therapy choice in a large Italian MS cohort., Methods: Newly diagnosed relapsing-remitting (RR) MS patients (2010-2018) followed in 24 Italian MS centres were included in the study. We evaluated the association of baseline demographics, clinical and MRI characteristics to the first treatment choice by logistic regression models applied to pre-defined binary alternatives: dimethyl fumarate vs injectables (interferon and glatiramer acetate), teriflunomide vs injectables, fingolimod vs dimethyl fumarate and fingolimod vs natalizumab., Results: We enrolled 3025 patients in the period between January 2010 and June 2018. Relapses in the previous year (OR = 2.75; p = 0.001), presence of spinal cord lesions (OR = 1.80; p = 0.002) and higher number (>9) of T2 lesions on the baseline brain MRI scan (OR = 1.65; p = 0.022) were the factors associated to dimethyl fumarate choice as first therapy vs an injectable drug. Older age (OR = 1.06; p < 0.001), male sex (OR = 2.29; p = 0.001) and higher EDSS (OR = 1.36; p < 0.001) were the factors associated with the choice of teriflunomide vs injectables. In more recent years, dimethyl fumarate (OR = 3.23; p < 0.001) and teriflunomide (OR = 2.53; p < 0.001) were chosen more frequently than injectables therapies. The main determinant for the choice of fingolimod as compared with dimethyl fumarate was a higher EDSS (OR = 1.56; p = 0.001), while there was a weak association with a longer disease duration (p = 0.068) and a longer time from onset to diagnosis (p = 0.085). Compared to fingolimod, natalizumab was preferred in patients with a younger age (OR = 0.95; p = 0.003) and higher EDSS (OR = 1.45; p = 0.007) and a shorter disease duration (OR = 0.52; p = 0.076)., Conclusion: Many factors guided therapeutic decision for our Italian cohort of MS patients; they are mainly related to MS disease activity, baseline EDSS, disease duration and age., Competing Interests: Deckaration of Competing Interest None, (Copyright © 2020 Elsevier B.V. All rights reserved.)

Published
2020
Full Text
View/download PDF

41. Simultaneous quantification of natural and inducible regulatory T-cell subsets during interferon-β therapy of multiple sclerosis patients.

Author

Chiarini M, Capra R, Serana F, Bertoli D, Sottini A, Giustini V, Scarpazza C, Rovaris M, Torri Clerici V, Ferraro D, Galgani S, Solaro C, Conti MZ, Visconti A, and Imberti L

Subjects
Humans, Interferon-beta therapeutic use, Longitudinal Studies, Prospective Studies, T-Lymphocyte Subsets, T-Lymphocytes, Regulatory, Multiple Sclerosis drug therapy, Multiple Sclerosis, Relapsing-Remitting
Abstract

Background: The mechanisms underlying the therapeutic activity of interferon-β in multiple sclerosis are still not completely understood. In the present study, we evaluated the short and long-term effects of interferon-β treatment on different subsets of regulatory T cells in relapsing-remitting multiple sclerosis patients biologically responsive to treatment because of mixovirus resistance protein A inducibility., Methods: In this prospective longitudinal study, subsets of natural regulatory T cells (naïve, central memory and effector memory) and inducible regulatory T cells (Tr1), as well as in vitro-induced regulatory T cells (Tr1-like cells), were simultaneously quantified by flow cytometry in samples prepared from 148 therapy-naïve multiple sclerosis patients obtained before and after 6, 12, 18, and 24 months of interferon-β-1a treatment. mRNA for interleukin-10 and Tr1-related genes (CD18, CD49b, and CD46, together with Cyt-1 and Cyt-2 CD46-associated isoforms) were quantified in Tr1-like cells., Results: Despite profound inter-individual variations in the modulation of all regulatory T-cell subsets, the percentage of natural regulatory T cells increased after 6, 12, and 24 months of interferon-β treatment. This increase was characterized by the expansion of central and effector memory regulatory T-cell subsets. The percentage of Tr1 significantly enhanced at 12 months of therapy and continued to be high at the subsequent evaluation points. Patients experiencing relapses displayed a higher percentage of naïve regulatory T cells and a lower percentage of central memory regulatory T cells and of Tr1 before starting interferon-β therapy. In addition, an increase over time of central memory and of Tr1 was observed only in patients with stable disease. However, in vitro-induced Tr1-like cells, prepared from patients treated for 24 months, produced less amount of interleukin-10 mRNA compared with pre-treatment Tr1-like cells., Conclusion: Interferon-β induces the expansion of T regulatory subsets endowed with a high suppressive activity, especially in clinically stable patients. The overall concurrent modulation of natural and inducible regulatory T-cell subsets might explain the therapeutic effects of interferon-β in multiple sclerosis patients.

Published
2020
Full Text
View/download PDF

42. Impact of natural menopause on multiple sclerosis: a multicentre study.

Author

Baroncini D, Annovazzi PO, De Rossi N, Mallucci G, Torri Clerici V, Tonietti S, Mantero V, Ferrò MT, Messina MJ, Barcella V, La Mantia L, Ronzoni M, Barrilà C, Clerici R, Susani EL, Fusco ML, Chiveri L, Abate L, Ferraro O, Capra R, Colombo E, Confalonieri P, and Zaffaroni M

Subjects
Adolescent, Adult, Disease Progression, Female, Humans, Italy epidemiology, Middle Aged, Recurrence, Retrospective Studies, Risk Factors, Time Factors, Young Adult, Menopause, Multiple Sclerosis epidemiology
Abstract

Objective: To study the effect of natural menopause on multiple sclerosis clinical course., Methods: This was an observational, retrospective, multicentre, cohort study. Menopause onset was defined by the final menstrual period (FMP) beyond which no menses occurred for 12 months. We included multiple sclerosis (MS) patients with FMP occurred after 2005 and a recorded follow-up of at least 2 years pre-FMP and post-FMP. We excluded patients with primary progressive course, iatrogenic menopause and with other confounders that could mask menopause onset. We compared relapse-rate and expanded disability status scale (EDSS) scores pre-FMP and post-FMP, searching for possible interactions with age, disease duration, cigarette smoking and nulliparity status., Results: 148 patients were included (mean observation: 3.5 years pre-FMP and post-FMP). Most patients (92%) received disease-modifying therapies, mainly first-lines. After menopause the annualised relapse rate (ARR) significantly decreased (from 0.21±0.31 to 0.13± 0.24; p=0.005), while disability worsened (increase of mean 0.4 vs 0.2 points after menopause; p<0.001). Older age and long-lasting disease were associated with ARR reduction (p=0.013), but not with disability worsening. Cigarette smokers showed a trend to a higher disability accumulation after menopause (p=0.059)., Conclusion: Natural menopause seems to be a turning point to a more progressive phase of MS. Relapse rate is also reduced after menopause, but this effect could be driven most by ageing and shifting to progressive phase in patients with long-lasting disease. Cigarette smoking could speed up disability progression after menopause., Competing Interests: Competing interests: DB received travel grants from Genzyme, Merck and Biogen for participation at national and international congresses; he received speaking honoraria from Sanofi and Novartis, and personal compensation from Almirall for scientific publication. POA received honoraria for lecturing and participation in advisory boards, and/or travel expenses for attending congresses and meetings from Merck, Biogen, Teva, Sanofi- Genzyme, Mylan, Almirall, Roche and Novartis. NDR received speaker honoraria from Biogen Idec, Genzyme, Novartis, Sanofi-Aventis; received funding for participation in advisory board to Novartis and Genzyme-Sanofi and for traveling to scientific meetings from Biogen Idec, teva, Sanofi-Genzyme, Roche, Almirall and NovartisGiulia Mallucci received support to travel to scientific meetings from Bayer Schering, Biogen Idec, Genzyme, Merck Serono, Novartis, Roche, Sanofi-Aventis, Teva; received speaker honoraria from Biogen Idec and served on the scientific advisory board for Biogen, Genzyme and Merck SeronoValentina Torri Clerici acted as an Advisory Board member of Novartis and Merck-Serono, received funding for travelling and honoraria for speaking or writing from Teva, Biogen, Genzyme, Merk-Serono and Almirall. She received support for research project by Almirall. Simone Tonietti received honoraria for lecturing from Teva and Sanofi-Genzime, for writing from Teva, for participation in advisory boards from Merck and Biogen and for travel expenses for attending congresses and meetings from Merck, Biogen, Teva, Sanofi-Genzyme and Novartis. MJM received funding for travelling and honoraria for speaking or writing from Genzyme. MR received travel grants for congresses participation from Biogen, Genzyme, Novartis e Merck. He received honoraria for conferences organisation from Biogen. He received honoraria from Merck, Novartis, Biogen for advisory boards participation. VB received speaking honoraria and/or consultant fees from Biogen Idec, Merck Serono, Bayer, Sanofi-Genzyme, Novartis. Vittorio Mantero received honoraria for participation to advisory boards and/or travel expenses for attending congresses and meetings from Merck, Biogen, Teva, Sanofi-Genzyme, Roche and Novartis. PC was a board member of Biogen Idec, received travel grants from Sanofi, Biogen and Merck Serono. RC was consulting fees from Biogen, Teva, Genzyme, Merck Serono, and Novartis. Mauro Zaffaroni received honoraria for lecturing or participation in advisory boards, and financial support for attending congresses from Almirall, Biogen Idec, Genzyme, Merck Serono, Novartis, and Teva. Emanuela Susani, Maria Letizia Fusco, Caterina Barrilà, Luca Chiveri, Loredana La Mantia, Maria Teresa Ferrò, Raffaella Clerici, Ottavia Ferraro, Elena Colombo and Lucia Abate have nothing to disclose., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2019
Full Text
View/download PDF

43. Older age, higher perceived disability and depressive symptoms predict the amount and severity of work-related difficulties in persons with multiple sclerosis.

Author

Raggi A, Giovannetti AM, Schiavolin S, Brambilla L, Brenna G, Confalonieri PA, Cortese F, Frangiamore R, Leonardi M, Mantegazza RE, Moscatelli M, Ponzio M, Torri Clerici V, Zaratin P, and De Torres L

Subjects
Adult, Age Factors, Cross-Sectional Studies, Disability Evaluation, Disabled Persons psychology, Disabled Persons rehabilitation, Female, Humans, Male, Middle Aged, Surveys and Questionnaires, Depression physiopathology, Depression prevention & control, Multiple Sclerosis diagnosis, Multiple Sclerosis psychology, Multiple Sclerosis rehabilitation, Rehabilitation, Vocational methods, Rehabilitation, Vocational psychology, Self Concept, Work Performance
Abstract

Purpose: This cross-sectional study aims to identify the predictors of work-related difficulties in a sample of employed persons with multiple sclerosis as addressed with the Multiple Sclerosis Questionnaire for Job Difficulties. Materials and methods: Hierarchical linear regression analysis was conducted to identify predictors of work difficulties: predictors included demographic variables (age, formal education), disease duration and severity, perceived disability and psychological variables (cognitive dysfunction, depression and anxiety). The targets were the questionnaire's overall score and its six subscales. Results: A total of 177 participants (108 females, aged 21-63) were recruited. Age, perceived disability and depression were direct and significant predictors of the questionnaire total score, and the final model explained 43.7% of its variation. The models built on the questionnaire's subscales show that perceived disability and depression were direct and significant predictors of most of its subscales. Conclusions: Our results show that, among patients with multiple sclerosis, those who were older, with higher perceived disability and higher depression symptoms have more and more severe work-related difficulties. The Multiple Sclerosis Questionnaire for Job Difficulties can be fruitfully exploited to plan tailored actions to limit the likelihood of near-future job loss in persons of working age with multiple sclerosis. Implications for rehabilitation Difficulties with work are common among people with multiple sclerosis and are usually addressed in terms of unemployment or job loss. The Multiple Sclerosis Questionnaire for Job Difficulties is a disease-specific questionnaire developed to address the amount and severity of work-related difficulties. We found that work-related difficulties were associated to older age, higher perceived disability and depressive symptoms. Mental health issues and perceived disability should be consistently included in future research targeting work-related difficulties.

Published
2019
Full Text
View/download PDF

44. Conversion to Secondary Progressive Multiple Sclerosis: Patient Awareness and Needs. Results From an Online Survey in Italy and Germany.

Author

Solari A, Giovannetti AM, Giordano A, Tortorella C, Torri Clerici V, Brichetto G, Granella F, Lugaresi A, Patti F, Salvetti M, Pesci I, Pucci E, Centonze D, Danni MC, Bonavita S, Ferraro D, Gallo A, Gajofatto A, Nociti V, Grimaldi L, Grobberio M, Lanzillo R, Di Giovanni R, Gregori S, Manni A, Pietrolongo E, Bertagnoli S, Ronzoni M, Compagnucci L, Fantozzi R, Allegri B, Arena S, Buscarinu MC, Sabattini L, Quartuccio ME, Tsantes E, Confaloneri P, Tacchino A, Schiffmann I, Rahn AC, Kleiter I, Messmer Uccelli M, Barabasch A, Heesen C, and The ManTra Project

Abstract

Background: Few studies have investigated the experiences of patients around the conversion to secondary progressive multiple sclerosis (SPMS). ManTra is a mixed-method, co-production research project conducted in Italy and Germany to develop an intervention for newly-diagnosed SPMS patients. In previous project actions, we identified the needs and experiences of patients converting to SPMS via literature review and qualitative research which involved key stakeholders. Aims: The online patient survey aimed to assess, on a larger and independent sample of recently-diagnosed SPMS patients: (a) the characteristics associated to patient awareness of SPMS conversion; (b) the experience of conversion; (c) importance and prioritization of the needs previously identified. Methods: Participants were consenting adults with SPMS since ≤5 years. The survey consisted of three sections: on general and clinical characteristics; on experience of SPMS diagnosis disclosure (aware participants only); and on importance and prioritization of 33 pre-specified needs. Results: Of 215 participants, those aware of their SPMS diagnosis were 57% in Italy vs. 77% in Germany ( p = 0.004). In both countries, over 80% of aware participants received a SPMS diagnosis from the neurologist; satisfaction with SPMS disclosure was moderate to high. Nevertheless, 28-35% obtained second opinions, and 48-56% reported they did not receive any information on SPMS. Participants actively seeking further information were 63% in Germany vs. 31% in Italy ( p < 0.001). Variables independently associated to patient awareness were geographic area (odds ratio, OR 0.32, 95% CI 0.13-0.78 for Central Italy; OR 0.21, 95% CI 0.08-0.58 for Southern Italy [vs. Germany]) and activity limitations (OR 7.80, 95% CI 1.47-41.37 for dependent vs. autonomous patients). All pre-specified needs were scored a lot or extremely important, and two prioritized needs were shared by Italian and German patients: "physiotherapy" and "active patient care involvement." The other two differed across countries: "an individualized health care plan" and "information on social rights and policies" in Italy, and "psychological support" and "cognitive rehabilitation" in Germany. Conclusions: Around 40% of SPMS patients were not aware of their disease form indicating a need to improve patient-physician communication. Physiotherapy and active patient care involvement were prioritized in both countries.

Published
2019
Full Text
View/download PDF

45. Determinants of therapy switch in multiple sclerosis treatment-naïve patients: A real-life study.

Author

Saccà F, Lanzillo R, Signori A, Maniscalco GT, Signoriello E, Lo Fermo S, Repice A, Annovazzi P, Baroncini D, Clerico M, Binello E, Cerqua R, Mataluni G, Bonavita S, Lavorgna L, Zarbo IR, Laroni A, Rossi S, Pareja Gutierrez L, La Gioia S, Frigeni B, Barcella V, Frau J, Cocco E, Fenu G, Torri Clerici V, Sartori A, Rasia S, Cordioli C, Di Sapio A, Pontecorvo S, Grasso R, Barrilà C, Russo CV, Esposito S, Ippolito D, Bovis F, Gallo F, and Sormani MP

Subjects
Adolescent, Adult, Aged, Drug Substitution, Female, Humans, Italy, Male, Middle Aged, Retrospective Studies, Young Adult, Immunologic Factors adverse effects, Immunologic Factors therapeutic use, Multiple Sclerosis, Relapsing-Remitting drug therapy
Abstract

Background: With many options now available, first therapy choice is challenging in multiple sclerosis (MS) and depends mainly on neurologist and patient preferences., Objectives: To identify prognostic factors for early switch after first therapy choice., Methods: Newly diagnosed relapsing-remitting MS patients from 24 Italian centers were included. We evaluated the association of baseline demographics, clinical, and magnetic resonance imaging (MRI) data to the switch probability for lack of efficacy or intolerance/safety with a multivariate Cox analysis and estimated switch rates by competing risks models., Results: We enrolled 3025 patients. The overall switch frequency was 48% after 3 years. Switch risk for lack of efficacy was lower with fingolimod (hazard ratio (HR) = 0.50; p  = 0.009), natalizumab (HR = 0.13; p  < 0.001), dimethyl-fumarate (HR = 0.60; p  = 0.037), teriflunomide (HR = 0.21; p  = 0.031) as compared to interferons. Younger age (HR = 0.96; p  < 0.001), diagnosis delay (HR = 1.23; p  = 0.021), higher baseline Expanded Disability Status Scale (HR = 1.17; p  = 0.001), and spinal cord lesions (HR = 1.46; p  = 0.001) were independently associated with higher inefficacy switch rates. We found lower switch for intolerance/safety with glatiramer acetate (HR = 0.61; p  = 0.001), fingolimod (HR = 0.35; p  = 0.002), and dimethyl-fumarate (HR = 0.57; p  = 0.022) as compared to interferons, while it increased with natalizumab (HR = 1.43; p  = 0.022). Comorbidities were associated with intolerance switch (HR = 1.28; p  = 0.047)., Conclusion: Several factors are associated with higher switch risk in patients starting a first-line therapy and could be integrated in the decision-making process of first treatment choice.

Published
2019
Full Text
View/download PDF

46. Participant perspectives of a home-based palliative approach for people with severe multiple sclerosis: A qualitative study.

Author

Giovannetti AM, Borreani C, Bianchi E, Giordano A, Cilia S, Cipollari S, Rossi I, Cavallaro C, Torri Clerici V, Rossetti E, Stefanelli MC, Totis A, Pappalardo A, Occhipinti G, Confalonieri P, Veronese S, Grasso MG, Patti F, Zaratin P, Battaglia MA, and Solari A

Subjects
Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, Patients, Home Care Services, Multiple Sclerosis therapy, Palliative Care, Severity of Illness Index
Abstract

Background: We performed a qualitative study to investigate the experiences of participants in a multicentre randomized controlled trial on a home-based palliative approach (HPA) for adults with severe multiple sclerosis (MS) and their caregivers. Our aim was to explore the strengths and challenges of the intervention, and circumstances that may have influenced its efficacy., Methods: Participants to the qualitative study were the patients, their caregivers, patient referring physicians, and the teams who delivered the HPA intervention. We performed semi-structured one-on-one interviews with 12 patients and 15 informal caregivers chosen using a maximum variation strategy, two focus group meetings with patient referring physicians (4 participants each), and one with the HPA teams (9 participants)., Results: From data analysis (framework method) 38 sub-categories emerged, which were grouped into 10 categories and 3 themes: 'expectations,' 'met and unmet needs', and 'barriers'. Intervention benefits were improved control of symptoms and reduced sense of isolation of the patient-caregiver dyads. Limitations were: factors related to experimental design (difficulty of dyads in identifying examiner and team roles, additional burden for caregivers); team issues (insufficient team building /supervision, competing priorities); limitations of the intervention itself (insufficient length, lack of rehabilitation input); and external factors (resource limitations, under-responsive services/professionals). The referring physician focus groups provided little experiential data., Conclusions: The HPA reduced patient symptoms and sense of isolation in patients and caregivers. The indirect role of the HPA teams, and insufficient length of the intervention were key limitations. The experimental design imposed additional burdens on the dyads. Key barriers were the paucity of available services, the demanding administrative procedures, and lack of networking facilities. These findings suggest that two major requirements are necessary for home palliative care to be effective in this patient population: HPA teams well-connected with MS rehabilitation services, and care delivered over the long-term, with variable intensity., Trial Registration: Current Controlled Trials ISRCTN73082124 (Registered 19/06/2014)., Competing Interests: FP has received speaking honoraria from, and has been a board member of: Alimirall, Bayer, Biogen, Celgene, Merck, Novartis, Roche, Sanofi Genzyme, and Teva. VTC has been a board member of Merck, Novartis, Sanofi Genzyme. She has received travel expenses from Almirall, Biogen, Merck; speaking/writing honoraria from Almirall, Merck, and Teva; and support from Almirall for a research project. AS has been a board member of Biogen, Merck, and Novartis; she has received speaker honoraria from Almirall, Excemed, Merck, Sanofi Genzyme, and Teva. The authors confirm that this declaration does not alter the authors’ adherence to all PLOS ONE policies on sharing data and materials.

Published
2018
Full Text
View/download PDF

47. Assessing association of comorbidities with treatment choice and persistence in MS: A real-life multicenter study.

Author

Laroni A, Signori A, Maniscalco GT, Lanzillo R, Russo CV, Binello E, Lo Fermo S, Repice A, Annovazzi P, Bonavita S, Clerico M, Baroncini D, Prosperini L, La Gioia S, Rossi S, Cocco E, Frau J, Torri Clerici V, Signoriello E, Sartori A, Zarbo IR, Rasia S, Cordioli C, Cerqua R, Di Sapio A, Lavorgna L, Pontecorvo S, Barrilà C, Saccà F, Frigeni B, Esposito S, Ippolito D, Gallo F, and Sormani MP

Subjects
Adult, Cardiovascular Abnormalities epidemiology, Cohort Studies, Comorbidity, Disability Evaluation, Female, Humans, Italy, Male, Mental Disorders epidemiology, Metabolic Diseases epidemiology, Middle Aged, Multiple Sclerosis diagnosis, Nervous System Diseases epidemiology, Severity of Illness Index, Drug Substitution trends, Immunosuppressive Agents therapeutic use, Multiple Sclerosis drug therapy, Multiple Sclerosis epidemiology
Abstract

Objective: To assess whether the presence of concomitant diseases at multiple sclerosis (MS) diagnosis is associated with the choice and the treatment persistence in an Italian MS cohort., Methods: We included newly diagnosed patients (2010-2016) followed in 20 MS centers and collected demographic and clinical data. We evaluated baseline factors related to the presence of comorbidities and the association between comorbidities and the clinical course of MS and the time to the first treatment switch., Results: The study cohort included 2,076 patients. Data on comorbidities were available for 1,877/2,076 patients (90.4%). A total of 449/1,877 (23.9%) patients had at least 1 comorbidity at MS diagnosis. Age at diagnosis (odds ratio 1.05, 95% confidence interval [CI] 1.04-1.06; p < 0.001) was the only baseline factor independently related to the presence of comorbidities. Comorbidities were not significantly associated with the choice of the first disease-modifying treatment, but were significantly associated with higher risk to switch from the first treatment due to intolerance (hazard ratio 1.42, CI 1.07-1.87; p = 0.014). Association of comorbidities with risk of switching for intolerance was significantly heterogeneous among treatments (interferon β, glatiramer acetate, natalizumab, or fingolimod; interaction test, p = 0.04)., Conclusions: Comorbidities at diagnosis should be taken into account at the first treatment choice because they are associated with lower persistence on treatment., (© 2017 American Academy of Neurology.)

Published
2017
Full Text
View/download PDF

48. Managing the transition (ManTra): a resource for persons with secondary progressive multiple sclerosis and their health professionals: protocol for a mixed-methods study in Italy.

Author

Giovannetti AM, Giordano A, Pietrolongo E, Confalonieri P, De Luca G, Tortorella C, Trojano M, Messmer Uccelli M, Torri Clerici V, Gitto L, Köpke S, Borreani C, Heesen C, and Solari A

Subjects
Consensus, Focus Groups, Health Resources, Humans, Italy, Linear Models, Research Design, Review Literature as Topic, Surveys and Questionnaires, Disease Progression, Health Knowledge, Attitudes, Practice, Health Personnel, Health Services Needs and Demand, Multiple Sclerosis, Chronic Progressive
Abstract

Introduction: 15 years after clinical onset, about 50% of patients with relapsing-remitting multiple sclerosis convert to secondary progressive multiple sclerosis (SPMS). Notwithstanding the importance of this transition, knowledge of the experiences and needs of patients and carers is fragmentary, and targeted interventions are not available. Managing the Transition to SPMS (ManTra) is a mixed methodology project to develop and test a user-led resource for newly diagnosed patients with SPMS. Here, we describe the developmental phase, consisting of a literature review and a new research study involving key stakeholders, in which we construct the resource., Methods and Analysis: Round 1: The literature review and study will be conducted in parallel. The latter will identify patient needs using a qualitative approach consisting of: personal semistructured interviews with >15 recently diagnosed patients with SPMS; three focus group meetings (one with significant others of patients, one with neurologists and one with other health professionals caring for patients with SPMS). An online survey (>200 recently diagnosed Italian patients with SPMS) will follow to verify needs in a larger independent sample. An expert panel will outline a set of candidate resources/interventions that aim to satisfy the needs thus identified. Round 2: Consensus on the final resource will be obtained in a 1-day meeting of recently diagnosed patients with SPMS, significant others, health professionals and other stakeholders, using the nominal group technique. The expert panel will refine the resource, identify the outcome measures to assess its efficacy and ascertain the most suitable comparator (ManTra Phase 2, not part of this protocol)., Ethics and Dissemination: The study protocol was approved by the ethics committees of each of the involved centres: Foundation IRCCS Neurological Institute C Besta, Milan ; G D'Annunzio University of Chieti-Pescara and the Aldo Moro University of Bari. The results will be published in peer-reviewed journals, presented at conferences and a lay summary sent to participants., Competing Interests: Competing interests: AS has been a board member of Biogen Idec, Merck Serono and Novartis; she has received speaker honoraria from Almirall, Excemed, Merck Serono, Sanofi Genzyme and Teva. CT has received speaker honoraria from Biogen, Merck Serono, Novartis, Genzyme, Teva, Almirall, Schering and Excemed., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Published
2017
Full Text
View/download PDF

49. Difficulties in adjustment to multiple sclerosis: vulnerability and unpredictability of illness in the foreground.

Author

Giovannetti AM, Brambilla L, Torri Clerici V, Antozzi C, Mantegazza R, Černiauskaitė M, and Confalonieri P

Subjects
Adult, Female, Humans, Interviews as Topic, Male, Qualitative Research, Adaptation, Psychological, Disabled Persons psychology, Multiple Sclerosis psychology, Vulnerable Populations psychology
Abstract

Purpose: Multiple Sclerosis (MS) is a progressive neurological disease characterized by an unpredictable risk to develop relevant disability over time. Few studies focused on the core psychological features of difficulties in adjustment to MS. This qualitative study aims to explore the illness experience of people with difficulties in adjustment to MS, paying more attention to both illness representation and shifting perspective., Method: Nineteen persons with difficulties in adjustment to MS participated in the study and their interviews were analyzed using thematic analysis., Results: Considering the Shifting Perspective Model, illness is rigidly placed in the foreground, and wellness decisively pushed in the background, with a lack of flexibility in shifting between the two perspectives. The thematic analysis delineated three main topics: illness representation; coping strategies; relationships with others. The illness representation is characterized by invalidating symptoms; unclear cause; sudden onset; unpredictable course and uncertain prognosis; severe impact on person's functioning; and low sense of internal control. Participants reported to mainly use emotion-focused coping strategies., Conclusions: Adjustment can be supported activating psychological intervention addressed to patients' illness representations and more flexibility in the shifting between illness and wellness in the foreground. Implications for Rehabilitation Adjustment to MS is influenced by illness perception. It is important to pay more attention to contents about vulnerability and unpredictability associated to MS. With regards to the Shifting Perspectives Model, difficulties in adjustment are related to the rigidity that prevents an adequate shift between the two perspectives (illness and wellness), with the predominance of the illness perspective in the foreground. Hence, it is important to assess the shifting perspectives preference and flexibility, and the contents of illness representation of a person with MS. Clinicians can support process of adjustment, activating psychological intervention addressed to patients' illness representations and promotion of a more flexibility in the shifting between illness and wellness in the foreground. The Illness Representation Model should be enriched by a social component, able to take into consideration the impact of the disease on interactions with others.

Published
2017
Full Text
View/download PDF

50. Psychosocial difficulties of individuals with multiple sclerosis: the PARADISE-24 questionnaire.

Author

Giovannetti AM, Schiavolin S, Raggi A, Quintas R, Cerniauskaite M, Confalonieri P, Mantegazza R, Torri Clerici V, Antozzi C, Brenna G, and Leonardi M

Subjects
Adult, Anxiety Disorders, Female, Health Services Accessibility, Humans, Male, Middle Aged, Multiple Sclerosis rehabilitation, Multiple Sclerosis, Relapsing-Remitting psychology, Multiple Sclerosis, Relapsing-Remitting rehabilitation, Neuroticism, Quality of Life psychology, Reproducibility of Results, Self Report, Social Support, Disability Evaluation, Multiple Sclerosis psychology, Psychometrics statistics & numerical data, Social Adjustment, Surveys and Questionnaires
Abstract

The aim of this study is to identify the most relevant psychosocial difficulties (PSDs) experienced by persons with multiple sclerosis (PwMS); to evaluate the relation between an overall level of PSDs measured with the PARADISE-24 and other variables; to assess which factors may predict PARADISE-24 overall score. Adults PwMS were consecutively enrolled and completed a battery of eight self-reported instruments (i.e. SCQ, EUROHIS-QOL 8, BRS, BFI-10, JSPE, OSS-3, WHODAS-12, PARADISE-24). A clinical evaluation was performed for each patient and the Expanded Disability Status Scale (EDSS) score was determined by neurologists. A total of 80 PwMS, mean age 41.0, 65% women, 62% married, and 76.3% working, 86.3% relapsing-remitting MS, with an EDSS median score of 1.5, took part in the study. The mean disease duration was 7.7 years. The most frequently reported PSDs involved motor and emotional functioning. Free of charge access to medicines; health treatments and family, friends and health professionals' assistance represented the most important facilitators. WHODAS-12 and EUROHIS-QOL 8 were excluded from regression because of their strong correlation with PARADISE-24. EDSS, BRS, OSS-3, and neuroticism were the main predictors of the PARADISE-24 score. Despite MS heterogeneity, a common pattern of PSDs can be observed among PwMS. The level of physical impairment and personal resilience were the main predictors of the overall level of PSDs in PwMS, with a lower but significant additional role played by social support and personality traits. Attention to PSDs and their predictors, using PARADISE-24, can help clinicians to plan tailored and personalized rehabilitation programs.

Published
2016
Full Text
View/download PDF

Catalog

Books, media, physical & digital resources
See catalog results