Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 7 mg, 14 mg) |
Drug Class | Pyrimidine 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
Summary
- 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 Title | Year | Source |
---|---|---|
Aubagio (teriflunomide) Prescribing Information. | 2022 | Genzyme Corporation., Cambridge, MA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
The ULTIMATE trials: are there advantages of ublituximab over teriflunomide in relapsing multiple sclerosis? | 2022 | Expert Opinion of Biological therapy |
Practice guideline recommendations summary: disease-modifying therapies for adults with multiple sclerosis. | 2019 | American Academy of Neurology |