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Observational Study
. 2019 Jun;266(6):1405-1411.
doi: 10.1007/s00415-019-09272-6. Epub 2019 Mar 12.

Efficacy and safety of alemtuzumab in a real-life cohort of patients with multiple sclerosis

Jessica Frau  1 , Giancarlo Coghe  2 , Lorena Lorefice  2 , Giuseppe Fenu  2 , Luigina Musu  2 , Eleonora Cocco  2
Affiliations
Observational Study

Efficacy and safety of alemtuzumab in a real-life cohort of patients with multiple sclerosis

Jessica Frau et al. J Neurol. 2019 Jun.

Abstract

Background: No postmarketing randomised clinical trials are available about alemtuzumab, and real-world data are limited. We aimed to analyse the efficacy and safety of alemtuzumab in a single-centre cohort of patients with relapsing-remitting MS.

Methods: Patients who took alemtuzumab were enrolled. We collected the following data: age, sex, MS history, expanded disability status scale (EDSS), relapses, magnetic resonance imaging (MRI) parameters after alemtuzumab, and adverse events. EDSS scores before alemtuzumab and at the last follow-up were compared by Wilcoxon test. Time to first relapse was analysed after dividing the cohort on the basis of previous treatment.

Results: Ninety patients were enrolled [women 74.4%; naïve 7; mean follow-up 27 months (SD 23)]. The EDSS was reduced from a median of 2.5 (IQR 1.5-4) before alemtuzumab to 2.0 (IQR 1.5-3.5) after (p = 0.025). The time to first relapse was shorter in patients shifting from a second-line therapy (p = 0.011). Over 2 years, 43.7% had no evidence of disease activity. We observed infusion-related reactions in 95.5% patients, including 11.1% with pneumonitis, thyroiditis in 11%, and thrombocytopenia in 3.3%.

Conclusions: We confirmed the clinical and MRI efficacy of alemtuzumab in the clinical setting and the frequency of infusion-related reactions. Compared with that in clinical trials, higher number of patients developed pneumonitis during infusion.

Keywords: Alemtuzumab; Efficacy; Real-life; Safety.

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