PRO8 Effectiveness and Safety of Teriflunomide in Patients with Multiple Sclerosis: A Real-World Study from WEST China Hospital, China

Abstract

This study was conducted to collect and review clinical data in patients who had ever been on teriflunomide 14 mg/day in the West China hospital, and to assess effectiveness and safety of teriflunomide in a cohort of MS patients. In this single-center, retrospective, observational, real world study, we collected clinical data of patients treated with teriflunomide 14 mg/day for at least 3 months. Primary endpoint was the annualized relapse rate (ARR). Secondary endpoints were the mean change from baseline in expanded disability status scale (EDSS), the proportion of relapse-free and disability progression-free patients at last follow-up visit and the overall safety of teriflunomide. Of 90 patients identified, 74 were eligible and included in the analysis. Women represented 68.9% of the cohort. Median age and median disease duration were 32.81 and 5.92 years, respectively. A total of 35.0% of the patients received prior disease-modifying therapies. Median duration of teriflunomide exposure was 9 months. The mean ARR was significant lower at last follow-up visit (0.20 ± 0.47) compared to the prior to teriflunomide treatment (1.02 ± 0.81) (p = 0.005), with a 78.0% reduction. A total of 75.0% of teriflunomide-treated patients remained relapse-free during the data collection period. The mean EDSS score showed a reduction from a baseline score of 1.90 ± 1.71 to a mean post-treatment score of 1.88 ± 1.85. Proportion of patients free from disability progression was 82.0%. The most common adverse events (AEs) were hair thinning (22.9%), leukopenia (5.4%), and cheilitis (2.7%), followed by abnormal liver function and abnormal menstruation (1.3% each). Although no serious AEs were reported, 18.9% of patients discontinued teriflunomide. The real-world teriflunomide benefits observed in this study were similar than those observed in previous clinical trials. Teriflunomide was well tolerated and no new safety findings were observed in this study.