Teriflunomide in Patients with Relapsing-Remitting Forms of Multiple Sclerosis

The document reviewed the efficacy and safety of teriflunomide, an oral treatment for relapsing-remitting multiple sclerosis (RRMS), based on results from phase III clinical trials (TEMSO, TOWER, and TOPIC). Teriflunomide at a 14 mg dose was shown to significantly reduce the annualized relapse rate, the risk of confirmed disability progression, and MRI-detected lesion volume. The safety analysis, which included 2047 patients, reported common adverse events such as diarrhea, nausea, increased liver enzymes, and alopecia. Teriflunomide has a long half-life, is highly protein-bound, and is contraindicated in certain populations, including pregnant women and patients with severe hepatic impairment. The medication is slowly eliminated, but accelerated elimination protocols are available. It does not undergo significant cytochrome P450 metabolism, minimizing drug-drug interactions. Overall, teriflunomide has a positive benefit-risk profile for RRMS patients, with recommendations for pre-treatment assessments and ongoing monitoring to manage safety concerns. The clinical studies were supported by Genzyme, a Sanofi company, and some authors have received compensation from pharmaceutical companies, including Genzyme.