Key clinical point: Teriflunomide as a long-term immunomodulatory therapy in patients with relapsing multiple sclerosis (MS) has a favorable benefit-risk profile.
Major finding: The safety profile of teriflunomide 14 mg in the extension study was consistent with that in the core study, with similar incidences of adverse events (AEs) and serious AEs. There were differences in serious AE incidences between the placebo and teriflunomide 14 mg groups (6.4% vs. 12.4%). Teriflunomide was associated with reduction in annualized relapse rates in all treatment groups, irrespective of when treatment was initiated.
Study details: Long-term extension of the phase 3 TOWER study: Patients who received teriflunomide 14 mg in the core study were assigned to their original dose (14 mg/14 mg group); patients who received placebo or teriflunomide 7 mg in the core study were reassigned to teriflunomide 14 mg (placebo/14 mg and 7 mg/14 mg groups, respectively).
Disclosures: Development of the manuscript was supported by Sanofi. AL Lublin, P Truffinet, J Chavin, J Delhay, and A Purvis are employees of Sanofi, with ownership interest. M Benamor is an employee of Sanofi. The remaining authors reported ties with various pharmaceutical companies, including Sanofi.
Citation: Miller AE et al. Mult Scler Relat Disord. 2020 Aug 1. doi: 10.1016/j.msard.2020.102438 .