Aaron E Miller1, Patrick Vermersch2, Ludwig Kappos3, Giancarlo Comi4, Mark S Freedman5, Jiwon Oh6, Jérôme de Seze7, Philippe Truffinet8, Myriam Benamor8, Annie Purvis9, Jerry S Wolinsky10. 1. Department of Neurology, Icahn School of Medicine at Mount Sinai, 5 E. 98th Street-Box 1138, New York, NY 10029, United States. Electronic address: aaron.miller@mssm.edu. 2. Univ. Lille, INSERM U995 - Lille International Research Inflammation Center (LIRIC), CHU Lille, FHU Imminent, Lille, France. 3. Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital of Basel, Basel, Switzerland. 4. Department of Neurology and INSPE, University Vita-Salute San Raffaele, Milan, Italy. 5. Multiple Sclerosis Research Clinic, University of Ottawa and the Ottawa Hospital Research Institute, Ottawa, ON, Canada. 6. Division of Neurology, Department of Medicine, St Michael's Hospital, University of Toronto, Toronto, ON, Canada. 7. Strasbourg University, Hôpital Civil, Strasbourg, France. 8. Sanofi, Chilly-Mazarin, France. 9. Sanofi, Cambridge, MA, United States. 10. McGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth), Houston, TX, United States.
Abstract
BACKGROUND: In the phase 3 TOPIC study, teriflunomide significantly reduced the risk of relapse determining conversion to clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndrome, versus placebo. We assessed clinical and safety outcomes associated with extended teriflunomide treatment in the TOPIC extension study. METHODS:Patients who completed the TOPIC core study (including those still on study at early termination) or converted to CDMS after at least 24 weeks in the core study were eligible to participate in the extension. The primary efficacy endpoint in the extension was time to conversion to CDMS. RESULTS:Risk of relapse determining conversion to CDMS was 47.1% lower in patients treated with teriflunomide 14 mg during the core and extension studies compared with patients treated with placebo during the core study and teriflunomide 14 mg during the extension. The incidence of adverse events was 75.8% and 81.9% for 7 and 14 mg teriflunomide, respectively. CONCLUSIONS: Reduced risk of relapse determining conversion to CDMS in patients with early MS receiving teriflunomide 14 mg in the core study remained throughout the extension supporting the benefits of early treatment. No new safety signals were observed for teriflunomide 7 or 14 mg.
RCT Entities:
BACKGROUND: In the phase 3 TOPIC study, teriflunomide significantly reduced the risk of relapse determining conversion to clinically definite multiple sclerosis (CDMS) in patients with clinically isolated syndrome, versus placebo. We assessed clinical and safety outcomes associated with extended teriflunomide treatment in the TOPIC extension study. METHODS:Patients who completed the TOPIC core study (including those still on study at early termination) or converted to CDMS after at least 24 weeks in the core study were eligible to participate in the extension. The primary efficacy endpoint in the extension was time to conversion to CDMS. RESULTS: Risk of relapse determining conversion to CDMS was 47.1% lower in patients treated with teriflunomide 14 mg during the core and extension studies compared with patients treated with placebo during the core study and teriflunomide 14 mg during the extension. The incidence of adverse events was 75.8% and 81.9% for 7 and 14 mg teriflunomide, respectively. CONCLUSIONS: Reduced risk of relapse determining conversion to CDMS in patients with early MS receiving teriflunomide 14 mg in the core study remained throughout the extension supporting the benefits of early treatment. No new safety signals were observed for teriflunomide 7 or 14 mg.
Authors: Jiwon Oh; Sandra Vukusic; Klaus Tiel-Wilck; Jihad Said Inshasi; David Rog; Darren P Baker; Yelena Pyatkevich; Elizabeth M Poole; Patrick Vermersch Journal: J Cent Nerv Syst Dis Date: 2021-07-29