The aim of this multicenter study was to assess the efficacy of alemtuzumab for relapsing-remitting multiple sclerosis patients in a real-world clinical setting in central Italy.

Alemtuzumab is a humanized monoclonal antibody approved for the treatment of relapsing-remitting multiple sclerosis, given as two annual courses on five consecutive days at baseline and on three consecutive days 12 months later. Despite large use of treatment, little real world data about no evidence of disease acidity (NEDA) we reported.

84 patients starting alemtuzumab for RR-MS referred to 8 MS centers in central Italy between October 2014 and November 2018 were enrolled. 49 (58.3%) were female and 35 (41.7%) mean with a mean age of 39.1±9.3 years.  5 patients were naïve to treatment while 79 switched from another treatment. Among patients switching from another therapy, 47 (61%) switched from first-line treatment and 25 (32.5%) from second-line therapy. The mean duration of follow-up was 21 months (range:0.1-48). The main end point was the proportion of patients achieving NEDA at the end of follow-up, i.e. free from clinical relapses, 12-weeks confirmed EDSS progression and radiological activity (new or newly enlarging T2 and/or gadolinium enhancing lesions). Efficacy of treatment between naïve and switching patients was also explored.

The proportion of patients treated with alemtuzumab achieving NEDA-3 at the end of follow-up was 66.7%. NEDA-3 was similar in patients switched from first line (64.3%) or second line (66.7%) (P=0.73). All 3 naive patients assessed achieved NEDA-3.

Our results showed higher rate of patients achieving NEDA-3 than those reported in clinical trials. This rate was similar both in patients switching from first-line and second-line treatments.