Drug updated on 11/1/2024
Dosage Form | Tablet (oral; 7 mg, 14 mg) |
Drug Class | Pyrimidine 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
- 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 Title | Year | Source |
---|---|---|
Aubagio (teriflunomide) Prescribing Information. | 2024 | Genzyme Corporation, Cambridge, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Real-world effectiveness and safety profile of teriflunomide in the management of multiple sclerosis in the Gulf Cooperation Council countries: An expert consensus narrative review | 2022 | Multiple Sclerosis Journal - Experimental, Translational and Clinical |
How to switch disease-modifying treatments in multiple sclerosis: Guidelines from the French Multiple Sclerosis Society (SFSEP) | 2021 | Multiple Sclerosis and Related Disorders |
Consensus recommendations for the diagnosis and treatment of multiple sclerosis: 2019 revisions to the MENACTRIMS guidelines | 2020 | Multiple Sclerosis and Related Disorders |