Effect of Teriflunomide on Relapses with Sequelae and Relapse Leading to Hospitalization in a Population with Relapsing Forms of Multiple Sclerosis: Results from the TEMSO Study (S30.003)

Abstract

Objective: To assess whether teriflunomide reduces the occurrence of relapses with sequelae and relapses leading to hospitalization. Background Incomplete recovery from relapses leads to some degree of disability. Teriflunomide is a novel oral disease-modifying therapy in development for the treatment of RMS. The TEriflunomide Multiple Sclerosis Oral (TEMSO) study showed that teriflunomide reduced the annualized relapse rate by over 30% (p Design/Methods: TEMSO was a 2-year, randomized, double-blind study that assessed the efficacy and safety of teriflunomide 7mg and 14mg in patients with relapsing forms of MS (RMS) (N=1088); a typical patient was 38 years old, had experienced MS symptoms for over 8 years and 2.2 relapses within the past 2 years. Relapse with sequelae (investigator-defined) and relapse leading to hospitalization were analyzed (post hoc) on the intention-to-treat population (N=1086). Annualized rates were derived using a Poisson model, with treatment, Expanded Disability Status Scale (EDSS) score strata at baseline and region as covariates. The risks of sequelae and of hospitalization per relapse were calculated as a raw percentage observed over the study and compared with a Chi-square test. Results: Teriflunomide reduced the annualized rate of relapses with sequelae by 25% (ns) with 7mg and 53% (p Conclusions: In addition to its efficacy on overall relapse rates, teriflunomide significantly reduced the occurrence of relapses leading to hospitalization. Teriflunomide 14mg also significantly reduced the occurrence of relapses with sequelae, the risks of sequelae and of hospitalization per relapse. These benefits may suggest an effect on relapse severity. Supported by: sanofi-aventis. Disclosure: Dr. Miller has received personal compensation for activities with Acordia Therapeutics, Avanir, Biogen Idec, Chelsea Therapeutics, EMD Serono, GlaxoSmithKline, La-Ser, Merck Serono, Novartis, Nuron BiotechONO, Pfizer, Sanofi-Aventis, and Teva Neuroscience. Dr. Miller has received personal compensation in an editorial capacity for Continuum and Real Living with Multiple Sclerosis. Dr. Miller has received research support from Acorda, Biogen Idec, Genentech, Genzyme, Novartis, Roche, Sanofi-Aventis, and Teva Neuroscience. Dr. Lublin has received personal compensation for activities with Bayer HealthCare Pharmaceuticals, Biogen Idec, EMD Serono, Novartis, Pfizer, Teva Neuroscience, Genmab, Medicinova, Actelion, Allozyne, Sanofi, Acorda, Questcor, Avanir, Roche, Celgene, Abbott, MorphoSys, Johnson & Johnson, Revalesio, Coronado Bioscience, Genzyme, and MedImmune as a consultant.Dr. Lublin has received personal compensation in an editorial capacity for Elsevier: Multiple Sclerosis and Related Diseases. Dr. O9Connor has received personal compensation for activities with Abbott Labratories, Inc., Bayer Pharmaceuticals Corporation, Biogen Idec, BioMS, Cognosci, Daiichi Pharmaceuticals Corporation, Serono, Inc., Genentech, Inc., Genmab, Novartis, Roche Diagnostics Corporation, Sanofi-Aventis Pharmaceuticals, Inc., Teva Neuroscience, Warburg Pincus and Wyeth Pharmaceuticals as a consultant. Dr. O9Connor has received research support from Abbott Labratories, Bayer Pharmaceuticals Corporation, Biogen Idec, BioMS, Cognosci, Daiichi Pharmaceutical Corporation, Serono, Inc., Genentech, Inc., Genmab, Novartis, Roche Diagnostics Corporation, Sanofi-Aventis Pharmaceuticals, Teva Neuroscience, Warburg Pincus and Wyeth Pharmaceuticals. Dr. Wolinsky has received personal compensation for activities with Astellas, Bayer Pharmaceuticals Corporation, Bayer Multiple Sclerosis Council, Celgene Corporation, Eli Lilly & Company, Roche Diagnostics Corporation, Novartis, Sanofi-Aventis Pharmaceuticals and Teva Neuroscience as consultant and participant on monitoring and advisory boards. Dr. Wolinsky has received (royalty or license fee or contractual rights) payments from University of Texas Health Science Center at Houston. Dr. Wolinsky has received research support from Sanofi-Aventis Pharmaceuticals, Inc. Dr. Comi has received personal compensation for activities with Novartis, Teva Neuroscience, Sanofi-Aventis Pharmaceuticals, Inc., Merck Serono, Bayer Schering, and Biogen Dompe. Dr. Kappos has received research support from Acorda Therapeutics, Actelion, Allozyne, BaroFold, Inc., Bayer Pharmaceuticals Corporation, Bayhill Therapeutics, Biogen Idec, Boehringer Ingelheim Pharmaceuticals, Inc, Elan Corporation, Genmab, GlaxoSmithKline, Inc., Glenmark Pharma, Merck Serono, MediciNova, Novartis, Sanofi-Aventis Pharmaceuticals, Santhera Pharmaceuticals, Shire, Roche Diagnostics, Teva Neuroscience, UCB Pharma, Pfizer Inc, Swiss MS Society, Swiss National Research Foundation, European Union, Gianni Rubatto Foundation, Novartis and Roche Research Foundations. Dr. Freedman has received personal compensation for activities with Bayer Healthcare, Genzyme Corporation, EMD Serono, Novartis, Sanofi-Aventis Pharmaceuticals, Inc., and Teva Neuroscience. Dr. Freedman has received research support from Genzyme Corporation and Bayer Healthcare. Dr. Olsson has received personal compensation for activities with Biogen Idec, Merck & Co., Inc., Sanofi-Aventis Pharmaceuticals, Inc., Novartis, and Bayer Healthcare. Dr. Olsson has received research support from Biogen Idec, Merck & Co., Inc., Sanofi-Aventis Pharmaceuticals, Inc., Novartis and Bayer Healthcare. Ms. Dive-Pouletty has received personal compensation for activities with Sanofi-Aventis. Dr. Bego-Le-Bagousse has received personal compensation for activities with Sanofi-Aventis Pharmaceuticals, Inc. as an employee. Dr. Confavruex has received personal compensation for activities with Biogen Dompe, Biogen Idec, Gemacbio, Genzyme Corporation, Hertie Foundation, Novartis, Sanofi-Aventis Pharmaceuticals, Inc., Teva Neuroscience, UCB Pharma, Bayer Schering, and Merck Serono. Dr. Confavruex has received research support from Bayer Schering, Biogen Idec, Merck Serono, Novartis, Sanofi-Aventis Pharmaceuticals, and Teva Neuroscience.