PMID- 35403875 OWN - NLM STAT- MEDLINE DCOM- 20220811 LR - 20220811 IS - 1432-1459 (Electronic) IS - 0340-5354 (Print) IS - 0340-5354 (Linking) VI - 269 IP - 9 DP - 2022 Sep TI - Real-world outcomes of teriflunomide in relapsing-remitting multiple sclerosis: a prospective cohort study. PG - 4808-4816 LID - 10.1007/s00415-022-11118-7 [doi] AB - 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 naive while 18.0% interferon-beta1b 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-naive 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. CI - (c) 2022. The Author(s). FAU - Zhang, Yao AU - Zhang Y AD - Center of Multiple Sclerosis and Related Disorders, Peking Union Medical College Hospital, Beijing, People's Republic of China. AD - Department of Neurology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, 100730, People's Republic of China. FAU - Yin, Hexiang AU - Yin H AD - Center of Multiple Sclerosis and Related Disorders, Peking Union Medical College Hospital, Beijing, People's Republic of China. AD - Department of Neurology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, 100730, People's Republic of China. FAU - Zhang, Dingding AU - Zhang D AD - Medical Research Center, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, People's Republic of China. FAU - Xu, Yan AU - Xu Y AUID- ORCID: 0000-0003-3618-8271 AD - Center of Multiple Sclerosis and Related Disorders, Peking Union Medical College Hospital, Beijing, People's Republic of China. xuyanpumch@hotmail.com. AD - Department of Neurology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, 100730, People's Republic of China. xuyanpumch@hotmail.com. FAU - Peng, Bin AU - Peng B AD - Department of Neurology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, 100730, People's Republic of China. FAU - Cui, Liying AU - Cui L AD - Department of Neurology, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, 100730, People's Republic of China. AD - Neurosciences Center, Chinese Academy of Medical Sciences, Beijing, People's Republic of China. LA - eng GR - 2016YFC0901500/National Key Research and Development Program of China/ GR - 2020-12M-CoV19-001/CAMS Innovation Fund for Medical Sciences/ GR - 2017zlgc0121/Peking Union Medical College Education Reform Fund/ GR - ZC201904188/Peking Union Medical College Deposition Research Fund/ PT - Journal Article PT - Observational Study DEP - 20220411 PL - Germany TA - J Neurol JT - Journal of neurology JID - 0423161 RN - 0 (Crotonates) RN - 0 (Hydroxybutyrates) RN - 0 (Nitriles) RN - 0 (Toluidines) RN - 1C058IKG3B (teriflunomide) SB - IM MH - Cohort Studies MH - Crotonates/therapeutic use MH - Female MH - Humans MH - Hydroxybutyrates MH - Male MH - *Multiple Sclerosis/chemically induced MH - *Multiple Sclerosis, Relapsing-Remitting/chemically induced/drug therapy MH - Nitriles MH - Prospective Studies MH - Recurrence MH - Toluidines/therapeutic use PMC - PMC8995164 OTO - NOTNLM OT - Efficacy OT - Multiple sclerosis OT - No evidence of disease activity (NEDA) OT - Real-world OT - Safety OT - Teriflunomide COIS- The authors declare that they have no conflict of interest. EDAT- 2022/04/12 06:00 MHDA- 2022/08/12 06:00 PMCR- 2022/04/11 CRDT- 2022/04/11 12:02 PHST- 2022/02/11 00:00 [received] PHST- 2022/03/30 00:00 [accepted] PHST- 2022/03/29 00:00 [revised] PHST- 2022/04/12 06:00 [pubmed] PHST- 2022/08/12 06:00 [medline] PHST- 2022/04/11 12:02 [entrez] PHST- 2022/04/11 00:00 [pmc-release] AID - 10.1007/s00415-022-11118-7 [pii] AID - 11118 [pii] AID - 10.1007/s00415-022-11118-7 [doi] PST - ppublish SO - J Neurol. 2022 Sep;269(9):4808-4816. doi: 10.1007/s00415-022-11118-7. Epub 2022 Apr 11.