Teriflunomide

(Aubagio®)

Teriflunomide

Drug updated on 4/15/2024

Dosage FormTablet (oral; 7 mg, 14 mg)
Drug ClassPyrimidine synthesis inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • For the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

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Summary
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  • Teriflunomide (Aubagio) is indicated for the treatment of relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
  • Nine studies were reviewed to gather information about Teriflunomide's efficacy, safety profile, and adverse effects compared with other disease-modifying therapies (DMTs).
  • Compared to drugs like natalizumab, cladribine, and alemtuzumab, which significantly decrease MS relapses more effectively than others, Teriflunomide shows higher frequencies of treatment discontinuation due to adverse events when compared with placebo.
  • In a direct comparison with Dimethyl Fumarate (DMF), Teriflunomide showed slightly less effectiveness in reducing short-term relapse risk but was associated with a lower risk of treatment discontinuation due to side effects or adverse events, suggesting better tolerability for some patients.
  • Network meta-analyses comparing the adverse effects suggest that certain DMTs may decrease serious adverse events compared to placebo. However, Teriflunomide meets non-inferiority criteria versus placebo based on moderate certainty evidence.
  • The effectiveness varies depending on subgroups such as those who are treatment-naive or have different demographic characteristics like younger patients. This suggests that choice could be tailored based on individual patient profiles and history.

Product Monograph / Prescribing Information

Document TitleYearSource
Aubagio (teriflunomide) Prescribing Information.2022Genzyme Corporation., Cambridge, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.2024The Cochrane Database of Systematic Reviews
Dimethyl fumarate or teriflunomide for relapsing-remitting multiple sclerosis: a meta-analysis of post-marketing studies. 2023Neurotherapeutics
Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis.2023The Cochrane Database of Systematic Reviews
Safety and monitoring of the treatment with Disease-Modifying Therapies (DMTs) for Multiple Sclerosis (MS).2023Current Reviews in Clinical and Experimental Pharmacology
Post marketing new adverse effects of oral therapies in multiple sclerosis: a systematic review. 2022Multiple Sclerosis and Related Disorders
Outcomes of ublituximab compared to teriflunomide for relapsing multiple sclerosis: a meta-analysis. 2022Multiple Sclerosis and Related Disorders
Comparative efficacy of relapsing multiple sclerosis therapies: model-based meta-analyses for confirmed disability accumulation and annualized relapse rate. 2022Multiple Sclerosis and Related Disorders
Ocular adverse events from pharmacological treatment in patients with multiple sclerosis—A systematic review of the literature.2021Systematic Reviews
Comparative efficacy and acceptability of disease‑modifying therapies in patients with relapsing–remitting multiple sclerosis: A systematic review and network meta‑analysis.2020Journal of Neurology
Adherence to oral disease-modifying therapy in multiple sclerosis patients: A systematic review. 2019Multiple Sclerosis and Related Disorders

Clinical Practice Guidelines