No evidence of disease activity (NEDA-3) and disability improvement after alemtuzumab treatment for multiple sclerosis: a 36-month real-world study

L Prosperini, P. Annovazzi, Laura Boffa, MC Buscarinu, A Gallo, M Matta, L Moiola, L Musu, P Perini, C Avolio, V Barcella, A Bianco, D Farina, E Ferraro, S Pontecorvo, F Granella, LME Grimaldi, A Laroni, Giacomo Lus, Francesco PattiEugenio Pucci, M Pasca, Paola Sarchielli, the Italian Alemtuzumab Study Group

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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. © 2018, Springer-Verlag GmbH Germany, part of Springer Nature.
Original languageEnglish
Pages (from-to)2851-2860
Number of pages10
JournalJournal of Neurology
Volume265
Issue number12
DOIs
Publication statusPublished - 2018

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Prosperini, L., Annovazzi, P., Boffa, L., Buscarinu, MC., 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, LME., Laroni, A., Lus, G., ... Group, T. I. A. S. (2018). 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, 265(12), 2851-2860. https://doi.org/10.1007/s00415-018-9070-x