In this retrospective, multicenter, real-world study we collected clinical and magnetic resonance imaging (MRI) data of all patients (n = 40) with relapsing-remitting multiple sclerosis (RRMS) treated with alemtuzumab according to a “free-of-charge” protocol available before the drug marketing approval in Italy. Almost all (39/40) started alemtuzumab after discontinuing multiple disease-modifying treatments (DMTs) because of either lack of response or safety concerns. We considered the proportion of alemtuzumab-treated patients who had no evidence of disease activity (NEDA-3) and disability improvement over a 36-month follow-up period. NEDA-3 was defined as absence of relapses, disability worsening, and MRI activity. Disability improvement was defined as a sustained reduction of ≥ 1-point in Expanded Disability Status Scale (EDSS) score. At follow-up, 18 (45%) patients achieved NEDA-3, 30 (75%) were relapse-free, 33 (82.5%) were EDSS worsening-free, and 25 (62.5%) were MRI activity-free. Eleven (27.5%) patients had a sustained disability improvement. We found no predictor for the NEDA-3 status, while the interaction of higher EDSS score by higher number of pre-alemtuzumab relapses was associated with a greater chance of disability improvement (odds ratio 1.10, p = 0.049). Our study provides real-world evidence that alemtuzumab can promote clinical and MRI disease remission, as well as disability improvement, in a significant proportion of patients with RRMS despite prior multiple DMT failures. The drug safety profile was consistent with data available from clinical trials.
Prosperini, L., Annovazzi, P., Boffa, L., Buscarinu, M. C., Gallo, A., Matta, M., Moiola, L., Musu, L., Perini, P., Avolio, C., Barcella, V., Bianco, A., Farina, D., Ferraro, E., Pontecorvo, S., Granella, F., Grimaldi, L. M. E., Laroni, A., Lus, G., Patti, F., Pucci, E., Pasca, M., Sarchielli, P., Ghezzi, A., Zaffaroni, M., Baroncini, D., Buttari, F., Centonze, D., Fornasiero, A., Salvetti, M., Docimo, R., Signoriello, E., Tedeschi, G., Bertolotto, A., Capobianco, M., Comi, G., Cocco, E., Gallo, P., Puthenparampil, M., Grasso, R., Di Francescantonio, V., Rottoli, M. R., Mirabella, M., Lugaresi, A., De Luca, G., Di Ioia, M., Di Tommaso, V., Mancinelli, L., Di Battista, G., Francia, A., Ruggieri, S., Pozzilli, C., Curti, E., Tsantes, E., Palmeri, B., Lapicci, C., Mancardi, G. L., Uccelli, A., Chisari, C., D'Amico, E., Cartechini, E., Repice, A. M., Magnani, E., Massaccesi, L., Calabresi, P., Di Filippo, M., Di Gregorio, M., No evidence of disease activity (NEDA-3) and disability improvement after alemtuzumab treatment for multiple sclerosis: a 36-month real-world study, <<JOURNAL OF NEUROLOGY>>, 2018; 265 (12): 2851-2860. [doi:10.1007/s00415-018-9070-x] [http://hdl.handle.net/10807/165312]
No evidence of disease activity (NEDA-3) and disability improvement after alemtuzumab treatment for multiple sclerosis: a 36-month real-world study
Bianco, Assunta;Mirabella, Massimiliano;Calabresi, Paolo;Di Filippo, Mario;
2018
Abstract
In this retrospective, multicenter, real-world study we collected clinical and magnetic resonance imaging (MRI) data of all patients (n = 40) with relapsing-remitting multiple sclerosis (RRMS) treated with alemtuzumab according to a “free-of-charge” protocol available before the drug marketing approval in Italy. Almost all (39/40) started alemtuzumab after discontinuing multiple disease-modifying treatments (DMTs) because of either lack of response or safety concerns. We considered the proportion of alemtuzumab-treated patients who had no evidence of disease activity (NEDA-3) and disability improvement over a 36-month follow-up period. NEDA-3 was defined as absence of relapses, disability worsening, and MRI activity. Disability improvement was defined as a sustained reduction of ≥ 1-point in Expanded Disability Status Scale (EDSS) score. At follow-up, 18 (45%) patients achieved NEDA-3, 30 (75%) were relapse-free, 33 (82.5%) were EDSS worsening-free, and 25 (62.5%) were MRI activity-free. Eleven (27.5%) patients had a sustained disability improvement. We found no predictor for the NEDA-3 status, while the interaction of higher EDSS score by higher number of pre-alemtuzumab relapses was associated with a greater chance of disability improvement (odds ratio 1.10, p = 0.049). Our study provides real-world evidence that alemtuzumab can promote clinical and MRI disease remission, as well as disability improvement, in a significant proportion of patients with RRMS despite prior multiple DMT failures. The drug safety profile was consistent with data available from clinical trials.
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