Long-term Disability Outcomes in Patients Treated With Teriflunomide for up to 14 Years: Group- and Patient-Level Data From the Phase 2 Extension Study (P6.389)

Objective: To report long-term outcomes, including patient-level data, for patients who continued in the teriflunomide phase 2 extension (NCT00228163) study until final study termination (up to 14 years of treatment exposure). Background: In the phase 2 extension, disease activity, as measured by MRI and annualized relapse rate, remained low in patients who continued teriflunomide treatment for up to 14 years. Here, we report long-term disability outcomes. Design/Methods: In the 36-week placebo-controlled core study (NCT01487096), patients with relapsing MS were randomized (1:1:1) to placebo, teriflunomide 7 mg, or teriflunomide 14 mg. In the extension, patients initially receiving placebo were re-randomized (1:1) to teriflunomide 7 mg or 14 mg; patients initially receiving teriflunomide continued the same dose. Expanded Disability Status Scale (EDSS) and Multiple Sclerosis Severity (MSS) scores were assessed at baseline, every 12 weeks until core study end, and then every 24 weeks throughout the extension. Results: A total of 173 patients were exposed to teriflunomide at any point during the core and extension studies. Cumulative duration of exposure was 1136 patient-years. Mean EDSS scores for patients ever exposed to teriflunomide 14 mg were as follows: baseline, 2.45 (n=83); Year 5, 2.21 (n=42); Year 10, 2.14 (n=32). After Year 10, although patient numbers were small, EDSS scores remained stable. In 69.5% of patients, EDSS scores were stable or improved vs baseline at the last evaluation. Individual EDSS score changes for patients still on study at termination will be presented. Mean MSS scores decreased over the course of the extension (vs baseline) in patients ever exposed to teriflunomide 14 mg: Year 5, 3.23 (0.54-point reduction); Year 10, 2.17 (1.32-point reduction). Conclusions: EDSS scores remained stable or improved through to the last evaluation for the majority of patients receiving teriflunomide. MSS scores, indicative of the rate of disability worsening over time, decreased over the course of the extension. Study Supported by: Sanofi Disclosure: Dr. Freedman has received personal compensation for activities compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Actelion, Bayer Healthcare, Biogen, Canada Innovation, Chugai, Clene Nanomedicine, EMD Canada, Hoffman-La Roche, Merck Serono, Novartis, Opexa, Sanofi Aventis, Sanofi Genzyme, and Teva. Dr. Bar-Or has nothing to disclose. Dr. Benamor has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi. Dr. Truffinet has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi, with ownership interest. Dr. Truffinet has received compensation for serving on the Board of Directors of Employee of Sanofi, with ownership interest. Dr. Poole has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi. Dr. Mandel has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Employee of Sanofi, with ownership interest. Dr. Mandel has received compensation for serving on the Board of Directors of Employee of Sanofi, with ownership interest. Dr. Kremenchutzky has nothing to disclose.