Effectiveness and Safety of Teriflunomide in Patients with Multiple Sclerosis: A Real-World Study from WEST China Hospital, China
Author(s)
Wang J, Lang Y, Kong L, Zhang Y, Du Q, Qiu Y, Zhou H
West China Hospital, Chengdu, China
OBJECTIVES 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. METHODS 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. RESULTS 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. CONCLUSIONS 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.
Conference/Value in Health Info
2021-05, ISPOR 2021, Montreal, Canada
Value in Health, Volume 24, Issue 5, S1 (May 2021)
Code
PRO8
Topic
Clinical Outcomes, Epidemiology & Public Health, Patient-Centered Research
Topic Subcategory
Clinical Outcomes Assessment, Patient-reported Outcomes & Quality of Life Outcomes, Safety & Pharmacoepidemiology
Disease
Rare and Orphan Diseases