Real-world outcomes of teriflunomide in relapsing–remitting multiple sclerosis: a prospective cohort study

Objectives To explore efficacy, risk factors, safety, and persistence of teriflunomide in relapsing–remitting multiple sclerosis (RRMS) cohort. Methods This prospective, observational cohort study included 217 consecutive teriflunomide treated RRMS patients, 192 of which with at least 3-month persistence on teriflunomide were included in effectiveness and risk factor analyses. Multivariate Cox proportional regression analysis was performed to identify factors associated with failure of no evidence of disease activity (NEDA) 3. Results At baseline 82% patients were treatment naïve while 18.0% interferon-β1b treated patients had stopped treatments for more than 1 year. After treatment, 79.0% patients achieved NEDA 3 at 12-month, mean annualized relapse rate (ARR) reduced significantly (0.79 ± 0.80 vs 0.16 ± 0.70; P < 0.001), and mean expanded disability status score (EDSS) remained stable (1.40 ± 1.67 vs 1.56 ± 1.88; P > 0.05) . Male sex (hazard ratio [HR] 1.856; 95% confidence interval [CI] 1.118–3.082, P < 0.05), baseline EDSS score ≥ 4 (HR 2.682; 95% CI 1.375–5.231, P < 0.01), and frequent relapses before treatment (HR 3.056; 95% CI 1.737–5.377, P < 0.01) were independent factors significantly associated with failure of NEDA 3. The most frequent adverse events (AEs) were hair thinning, alanine aminotransferase (ALT) elevation, and leukopenia, the latter two most commonly lead to teriflunomide discontinuation during the first 3 months. Persistence rates at 6, 12, and 24 months after teriflunomide initiation were 86.9%, 72.4%, and 52.8%, respectively. Conclusions Our results support efficacy and tolerability of teriflunomide for treatment-naïve RRMS patients in real-world practice. Female patients, patients with less relapses and less disability before treatment are most likely to benefit from teriflunomide treatment.