To evaluate the effectiveness of alemtuzumab on quality of life (QoL) of relapsing-remitting multiple sclerosis (RRMS) patients in a real-world setting.

Alemtuzumab is a humanized anti-CD52 monoclonal antibody approved for the treatment of adults with highly active RRMS and has been shown to be efficacious for patients with active disease, resulting in prolonged remission periods. Alemtuzumab had proved to improve QoL in patients with multiple sclerosis in phase 3 clinical trials.

This was a multicenter and 3-year prospective study of patients with RRMS treated with alemtuzumab in clinical practice. QoL outcomes were assessed at baseline and every 6 months using the Multiple Sclerosis Impact Scale (MSIS-29). Clinical data, fatigue (Modified Fatigue Impact Scale-21), depression (Beck Depression Inventory II), and safety were also collected.

A total of 165 patients were included (67.9% female, 6.7% MS treatment-naive). Patients had a mean (SD) age of 38.6 (9.1) years, a mean disease duration of 8.5 (6.0) years, with a baseline EDSS score of 3.3 (1.7) and 1.8 (1.3) relapses in the 2 years before. 47.7% of patients had gadolinium-enhancing lesions (5.1 [6.8]). After 3 years of treatment with alemtuzumab, significant improvements were observed in MSIS-29 (n=85) both in the physical (27.9 (24.1) vs 33.6 (24.0) at baseline; p=0.007) and psychological domains (30.8 (25.8) vs 44.1(27.9); p=0.002). Measures of fatigue (n=63) and depression (n=54) were significantly reduced after 3 years. Alemtuzumab reduced the annualized-relapse rate (ARR) by 83.4% (to 0.15 (95% CI: 0.11-0.19) and EDSS score (to 2.9 (1.8); p<0.001). Fifty-five serious adverse events were reported, including 2 deaths, one of which was related to alemtuzumab.

Alemtuzumab improved physical and psychological QoL in patients with RRMS over 3 years of treatment. Results also showed its clinical effectiveness and safety over the follow-up period.