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Open Access 16-05-2024 | Teriflunomide | ORIGINAL RESEARCH

Sustained Effectiveness and Safety Over Time of Teriflunomide in Chinese Patients with Relapsing Multiple Sclerosis in the Greater Bay Area of China: Insights from Real-World Data

Authors: Rui Li, Jing Zhou, Haotian Wu, Yuge Wang, Juanjuan Chen

Published in: Neurology and Therapy | Issue 4/2024

Abstract

Introduction

The real-world data on the medium- to long-term effectiveness and safety of teriflunomide in Chinese patients with relapsing multiple sclerosis (MS) is limited. Therefore, this study aims to assess the treatment outcomes of teriflunomide in Chinese patients with MS over a medium- to long-term period.

Methods

This cohort study was carried out in three tertiary hospitals and regional MS centers located in the Greater Bay Area of China. We obtained the historical clinical data of patients who underwent teriflunomide treatment for at least 6 months. The primary objective was to evaluate the proportion of patients achieving no evidence of disease activity (NEDA)-3 status, which is characterized by the absence of relapses, confirmed disability worsening, and new or enlarging MRI lesions, over time. Secondary objectives included assessing the proportion of patients meeting each NEDA-3 criterion, changes in motor and cognitive function, as well as the incidence of adverse events and treatment discontinuations.

Results

A total of 160 patients with MS were enrolled, including 125 patients treated with teriflunomide for at least 1 year (≥ 1-year completers) and 71 patients treated for at least 2 years (≥ 2-year completers). A total of 85.63% of the overall population achieved clinical NEDA-3 status at 6 months of teriflunomide treatment, and 71.20% of ≥ 1-year completers achieved NEDA-3 status at 12 months of teriflunomide treatment. The median timed 25-foot walk test (T25FW), nine-hole peg test (9-HPT), and paced auditory serial addition test (PASAT) results were relatively stable before and after treatment.

Conclusion

Medium- to long-term MS disease activity, as indicated by NEDA-3 status, is well controlled in patients treated with continuous teriflunomide treatment in real-world settings.

Koch-Henriksen N, Sørensen PS. The changing demographic pattern of multiple sclerosis epidemiology. Lancet Neurol. 2010;9(5):520–32. https://doi.org/10.1016/s1474-4422(10)70064-8.CrossRefPubMed

Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: disease-modifying therapies for adults with multiple sclerosis: report of the guideline development, dissemination, and implementation subcommittee of the American Academy of Neurology. Neurology. 2018;90(17):777–88. https://doi.org/10.1212/wnl.0000000000005347.CrossRefPubMed

Giorgio A, De Stefano N. Effective utilization of MRI in the diagnosis and management of multiple sclerosis. Neurol Clin. 2018;36(1):27–34. https://doi.org/10.1016/j.ncl.2017.08.013.CrossRefPubMed

Bevan CJ, Cree BA. Disease activity free status: a new end point for a new era in multiple sclerosis clinical research? JAMA Neurol. 2014;71(3):269–70. https://doi.org/10.1001/jamaneurol.2013.5486.CrossRefPubMed

Gold R, Wolinsky JS. Pathophysiology of multiple sclerosis and the place of teriflunomide. Acta Neurol Scand. 2011;124(2):75–84. https://doi.org/10.1111/j.1600-0404.2010.01444.x.CrossRefPubMed

Miller AE, O’Connor P, Wolinsky JS, et al. Pre-specified subgroup analyses of a placebo-controlled phase III trial (TEMSO) of oral teriflunomide in relapsing multiple sclerosis. Mult Scler. 2012;18(11):1625–32. https://doi.org/10.1177/1352458512450354.CrossRefPubMedPubMedCentral

Confavreux C, O’Connor P, Comi G, et al. Oral teriflunomide for patients with relapsing multiple sclerosis (TOWER): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13(3):247–56. https://doi.org/10.1016/s1474-4422(13)70308-9.CrossRefPubMed

Miller AE, Wolinsky JS, Kappos L, et al. Oral teriflunomide for patients with a first clinical episode suggestive of multiple sclerosis (TOPIC): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Neurol. 2014;13(10):977–86. https://doi.org/10.1016/s1474-4422(14)70191-7.CrossRefPubMed

Radue EW, Sprenger T, Gaetano L, et al. Teriflunomide slows BVL in relapsing MS: a reanalysis of the TEMSO MRI data set using SIENA. Neurol Neuroimmunol Neuroinflamm. 2017;4(5):e390. https://doi.org/10.1212/nxi.0000000000000390.CrossRefPubMedPubMedCentral

10.

Bu B, Quan C, Li W, et al. The effectiveness of teriflunomide in patients with multiple sclerosis in China: a real-world comparison to no DMT treatment in the first year after diagnosis. Ther Adv Neurol Disord. 2023;16:17562864231181170. https://doi.org/10.1177/17562864231181170.CrossRefPubMedPubMedCentral

11.

Zhou R, Li H, Yang H, et al. Serological markers exploration and real-world effectiveness and safety of teriflunomide in south Chinese patients with multiple sclerosis. Mult Scler Relat Disord. 2022;58:103446. https://doi.org/10.1016/j.msard.2021.103446.CrossRefPubMed

12.

Cree BA, Gourraud PA, Oksenberg JR, et al. Long-term evolution of multiple sclerosis disability in the treatment era. Ann Neurol. 2016;80(4):499–510. https://doi.org/10.1002/ana.24747.CrossRefPubMedPubMedCentral

13.

Cree BAC, Hollenbach JA, Bove R, et al. Silent progression in disease activity-free relapsing multiple sclerosis. Ann Neurol. 2019;85(5):653–66. https://doi.org/10.1002/ana.25463.CrossRefPubMedPubMedCentral

14.

Kappos L, Wolinsky JS, Giovannoni G, et al. Contribution of relapse-independent progression vs relapse-associated worsening to overall confirmed disability accumulation in typical relapsing multiple sclerosis in a pooled analysis of 2 randomized clinical trials. JAMA Neurol. 2020;77(9):1132–40. https://doi.org/10.1001/jamaneurol.2020.1568.CrossRefPubMed

15.

Planche V, Gibelin M, Cregut D, Pereira B, Clavelou P. Cognitive impairment in a population-based study of patients with multiple sclerosis: differences between late relapsing-remitting, secondary progressive and primary progressive multiple sclerosis. Eur J Neurol. 2016;23(2):282–9. https://doi.org/10.1111/ene.12715.CrossRefPubMed

16.

O’Connor P, Comi G, Freedman MS, et al. Long-term safety and efficacy of teriflunomide: nine-year follow-up of the randomized TEMSO study. Neurology. 2016;86(10):920–30. https://doi.org/10.1212/wnl.0000000000002441.CrossRefPubMedPubMedCentral

17.

Miller AE, Olsson TP, Wolinsky JS, et al. Long-term safety and efficacy of teriflunomide in patients with relapsing multiple sclerosis: results from the TOWER extension study. Mult Scler Relat Disord. 2020;46:102438. https://doi.org/10.1016/j.msard.2020.102438.CrossRefPubMed

18.

Miller AE, Vermersch P, Kappos L, et al. Long-term outcomes with teriflunomide in patients with clinically isolated syndrome: results of the TOPIC extension study. Mult Scler Relat Disord. 2019;33:131–8. https://doi.org/10.1016/j.msard.2019.05.014.CrossRefPubMed

19.

Miller AE. Oral teriflunomide in the treatment of relapsing forms of multiple sclerosis: clinical evidence and long-term experience. Ther Adv Neurol Disord. 2017;10(12):381–96. https://doi.org/10.1177/1756285617722500.CrossRefPubMedPubMedCentral

20.

Giovannoni G, Tomic D, Bright JR, Havrdová E. “No evident disease activity”: the use of combined assessments in the management of patients with multiple sclerosis. Mult Scler. 2017;23(9):1179–87. https://doi.org/10.1177/1352458517703193.CrossRefPubMedPubMedCentral

21.

Zhang Y, Yin H, Zhang D, Xu Y, Peng B, Cui L. Real-world outcomes of teriflunomide in relapsing-remitting multiple sclerosis: a prospective cohort study. J Neurol. 2022;269(9):4808–16. https://doi.org/10.1007/s00415-022-11118-7.CrossRefPubMedPubMedCentral

22.

Zivadinov R, Kresa-Reahl K, Weinstock-Guttman B, et al. Comparative effectiveness of teriflunomide and dimethyl fumarate in patients with relapsing forms of MS in the retrospective real-world Teri-RADAR study. J Comp Eff Res. 2019;8(5):305–16. https://doi.org/10.2217/cer-2018-0135.CrossRefPubMed

23.

Bucello S, Annovazzi P, Ragonese P, et al. Real world experience with teriflunomide in multiple sclerosis: the TER-Italy study. J Neurol. 2021;268(2):2922–32. https://doi.org/10.1007/s00415-021-10455-3.CrossRefPubMed

24.

Ziemssen T, Derfuss T, De Stefano N, et al. Optimizing treatment success in multiple sclerosis. J Neurol. 2016;263(6):1053–65. https://doi.org/10.1007/s00415-015-7986-y.CrossRefPubMed

25.

Cadavid D, Cohen JA, Freedman MS, et al. The EDSS-plus, an improved endpoint for disability progression in secondary progressive multiple sclerosis. Mult Scler. 2017;23(1):94–105. https://doi.org/10.1177/1352458516638941.CrossRefPubMed

26.

Sprenger T, Kappos L, Sormani MP, et al. Effects of teriflunomide treatment on cognitive performance and brain volume in patients with relapsing multiple sclerosis: post hoc analysis of the TEMSO core and extension studies. Mult Scler. 2022;28(11):1719–28. https://doi.org/10.1177/13524585221089534.CrossRefPubMedPubMedCentral

27.

Coyle PK, Khatri B, Edwards KR, et al. Patient-reported outcomes in relapsing forms of MS: real-world, global treatment experience with teriflunomide from the Teri-PRO study. Mult Scler Relat Disord. 2017;17:107–15. https://doi.org/10.1016/j.msard.2017.07.006.CrossRefPubMed

Title: Sustained Effectiveness and Safety Over Time of Teriflunomide in Chinese Patients with Relapsing Multiple Sclerosis in the Greater Bay Area of China: Insights from Real-World Data
Authors: Rui Li
Jing Zhou
Haotian Wu
Yuge Wang
Juanjuan Chen
Publication date: 16-05-2024
Publisher: Springer Healthcare
Keywords: Teriflunomide
Multiple Sclerosis
Published in: Neurology and Therapy / Issue 4/2024
Print ISSN: 2193-8253
Electronic ISSN: 2193-6536
DOI: https://doi.org/10.1007/s40120-024-00599-5

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Sustained Effectiveness and Safety Over Time of Teriflunomide in Chinese Patients with Relapsing Multiple Sclerosis in the Greater Bay Area of China: Insights from Real-World Data

Abstract

Introduction

Methods

Results

Conclusion

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