Real-world data on the effectiveness and safety of teriflunomide in patients with relapsing–remitting multiple sclerosis: The EFFECT study

Abstract

IntroductionThe objective of the present study was to evaluate the effectiveness and safety of teriflunomide in relapsing–remitting multiple sclerosis (RRMS) patients treated in a real-world setting. MethodsThis retrospective study was conducted at neurology departments of 15 hospitals in 2 Spanish Autonomous Regions. The primary endpoint was annualized relapse rate (ARR) during teriflunomide treatment. Secondary endpoints included changes in Expanded Disability Status Scale (EDSS), radiological activity, and adverse events (AEs). Results485 patients (72.2% women, mean of 36.5 years) were included; 74.8% had previously received other disease-modifying treatment. EDSS score at inclusion was 2.0. Mean time receiving teriflunomide was 2.5 years. The ARR during teriflunomide treatment was 0.16, a 20% lower than at baseline (0.20), although the difference did not reach statistical significance (P = 0.098). The mean number of relapses significantly decreased after teriflunomide initiation, with 0.17 relapses at month 12, 0.11 at month 24, and 0.13 at month 36, compared to 0.50 in the year before teriflunomide initiation (P < 0.001). EDSS scores were maintained over the study period. The percentage of patients without gadolinium-enhanced T1-weighted lesions was significantly higher after teriflunomide (P = 0.01), and the percentage of patients without new/enlarged lesions on T2 remained stable. The proportion of patients with AEs was 41.9% (1.4% serious), being hair thinning (19.4%) and gastrointestinal disorders (18.4%) the most frequent. DiscussionOver teriflunomide treatment, the ARR was low, radiologic evidence of disease activity decreased, and disability stabilized. These findings, together with the acceptable safety profile observed, support the use of teriflunomide in RRMS patients.