Pooled Safety and Tolerability Data from Four Placebo-Controlled Teriflunomide Studies and Extensions

The document summarizes the safety and tolerability of teriflunomide, an oral immunomodulator for relapsing-remitting multiple sclerosis, from four placebo-controlled trials and their extensions, involving 2,042 patients treated with teriflunomide and 997 on placebo, over a period of up to 12 years and more than 6800 patient-years. The findings indicate that adverse events, including hair thinning and increases in alanine aminotransferase (ALT), were similar between the teriflunomide and placebo groups, with most events being mild-to-moderate and not leading to treatment discontinuation. Hair thinning was more frequent with teriflunomide, especially at the 14 mg dose, but was typically reversible. There was no increased risk of serious infections, malignancies, or drug-induced liver injury, and the safety profile of teriflunomide was consistent and manageable, supporting its use in treating relapsing-remitting MS.