Teriflunomide

(Aubagio®)

Teriflunomide

Drug updated on 9/4/2024

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.

Latest News

loading GIF

Summary
This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

  • Aubagio (teriflunomide) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.
  • This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-10]
  • Relapse Rate (RR) in RRMS: Alemtuzumab, natalizumab, and fingolimod were most effective in preventing clinical relapses over 24 months. Dimethyl fumarate (DMF) reduced short-term relapse risk slightly more than teriflunomide (TRF) (RR=0.92, p=0.01). Ponesimod significantly reduced the annualized relapse rate by 53% compared to placebo (RR: 0.47; 95% CI: 0.39-0.58).
  • Confirmed Disability Worsening (CDW): Natalizumab showed a positive effect on disability worsening. No significant difference was observed between DMF and TRF in short-term CDW risk (RR=0.99, p=0.69). Ponesimod reduced 12-week confirmed disability accumulation by 39% compared to placebo (HR: 0.61; 95% CI: 0.45-0.82).
  • Overall Effectiveness in Reducing Relapse Rate: Alemtuzumab, natalizumab, mitoxantrone, and fingolimod demonstrated superior effectiveness in reducing relapse rates in the first 24 months. Ponesimod showed robust efficacy in treating RMS.
  • Low-certainty evidence suggested that interferon beta-1a, dimethyl fumarate, and glatiramer acetate may decrease serious adverse events (SAEs) compared to placebo, while several drugs, including teriflunomide, met non-inferiority criteria for SAEs versus placebo with moderate to low-certainty evidence.
  • No drug reduced withdrawals due to adverse events compared with placebo, though teriflunomide showed a slightly lower risk of treatment discontinuation than dimethyl fumarate, particularly after adjusting for potential publication bias.
  • The effectiveness difference between dimethyl fumarate (DMF) and teriflunomide (TRF) tends to diminish in younger patients and those who are treatment-naïve, while ponesimod shows a smaller relative treatment effect in trials with more patients having prior disease-modifying therapy (DMT) usage. Additionally, specific therapies such as fingolimod and siponimod are associated with ocular treatment-emergent adverse events.

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