Drug updated on 4/15/2024
| 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.
Summary
- 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 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 |