Teriflunomide

(Aubagio®)

Aubagio®

Drug updated on 11/1/2024

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

Indication

  • Indicated 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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  • This summary is based on the review of 12 systematic review(s)/meta-analysis(es). [1-12]
  • Teriflunomide (TRF) significantly reduced brain volume loss in relapsing multiple sclerosis (RMS) patients at two years, with a mean difference (MD) of 0.38 compared to placebo (95% CI (confidence interval): 0.20 - 0.55).
  • Over 24 months, teriflunomide likely achieved a moderate decrease in relapse rates in relapsing-remitting multiple sclerosis (RRMS) with a relative risk (RR) of 0.62 versus placebo (95% CI: 0.55 - 0.70), while no moderate- or high-certainty evidence was available for relapse reduction at 36 months.
  • In real-world comparisons, dimethyl fumarate (DMF) showed a slight advantage over teriflunomide in short-term relapse reduction (RR (relative risk) = 0.92, p = 0.01) without significant differences in confirmed disability worsening (RR = 0.99, p = 0.69).
  • Cladribine tablets were more effective than teriflunomide in achieving no evidence of disease activity (NEDA-3) with an odds ratio (OR) of 2.78 (95% CrI: 1.60-4.83), although they were not more effective than fingolimod in this outcome.
  • Teriflunomide may result in a slight increase in treatment discontinuation due to adverse events (OR 1.82, 95% CI 1.19 to 2.79), with no drug significantly reducing withdrawals due to adverse events compared to placebo.
  • Moderate-certainty evidence suggests teriflunomide meets non-inferiority criteria for serious adverse events compared to placebo (RR 1.08, 95% CI 0.88 to 1.31).
  • Long-term teriflunomide treatment demonstrated a low risk of lymphopenia and infections, with Grade 1 lymphopenia at 7.3% and Grade 2 lymphopenia at 2.2%.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Aubagio (teriflunomide) Prescribing Information.2024Genzyme Corporation, Cambridge, MA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Brain volume loss in relapsing multiple sclerosis: indirect treatment comparisons of available disease-modifying therapies2024BMC Neurology
Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis2024The Cochrane Database of Systematic Reviews
Adverse effects of immunotherapies for multiple sclerosis: a network meta-analysis2023The Cochrane Database of Systematic Reviews
Dimethyl Fumarate or Teriflunomide for Relapsing-Remitting Multiple Sclerosis: A Meta-analysis of Post-marketing Studies2023Neurotherapeutics
Ocular adverse events from pharmacological treatment in patients with multiple sclerosis-A systematic review of the literature2021Systematic Reviews
Matching-adjusted indirect treatment comparison of ozanimod versus teriflunomide for relapsing multiple sclerosis2021Multiple Sclerosis and Related Disorders
Cladribine tablets versus other disease-modifying oral drugs in achieving no evidence of disease activity (NEDA) in multiple sclerosis-A systematic review and network meta-analysis2021BMC Neurology
Real-world adherence to, and persistence with, once- and twice-daily oral disease-modifying drugs in patients with multiple sclerosis: a systematic review and meta-analysis2020BMC Neurology
The efficacy and safety of oral disease-modifying therapies for relapsing-remitting multiple sclerosis: A systematic review2020Current Journal of Neurology
Characterizing lymphocyte counts and infection rates with long-term teriflunomide treatment: Pooled analysis of clinical trials2020Multiple Sclerosis
Comparative efficacy and acceptability of disease-modifying therapies in patients with relapsing-remitting multiple sclerosis: a systematic review and network meta-analysis2020Journal of Neurology
Nocebo in multiple sclerosis trials: A meta-analysis on oral and newer injectable disease-modifying treatments2019Multiple Sclerosis and Related Disorders

Clinical Practice Guidelines