Immune Response to Seasonal Influenza Vaccination in Patients with Relapsing Multiple Sclerosis Treated with Teriflunomide: The TERIVA Study (P01.169)

OBJECTIVE: To determine whether recall antigen responses were preserved with teriflunomide treatment. BACKGROUND: Teriflunomide is a once-daily, oral, disease-modifying therapy recently approved in the US for the treatment of relapsing forms of multiple sclerosis (RMS). Teriflunomide inhibits the mitochondrial enzyme, DHODH, required for de novo pyrimidine synthesis, reducing the proliferation of stimulated T and B cells. Cells that rely largely on existing pyrimidine pools (eg. resting lymphocytes) are not significantly affected by teriflunomide. DESIGN/METHODS: In this multicenter, multinational, parallel-group study, antibody responses to the 2011/12 seasonal influenza vaccine (including strains H1N1, H3N2, and B) considered as a recall antigen in most patients, were assessed in patients with RMS treated with teriflunomide 7mg (n=41) or 14mg (n=41) (median duration 5.7 years), and a reference population of patients with RMS treated with interferon beta (IFNβ-1, n=46, median duration 5.7 years). The primary endpoint was proportion of patients with seroprotective influenza antibody titers ≥40, 28 days post-vaccination for each vaccine strain. RESULTS: The proportion of patients meeting the primary endpoint following vaccination was >90% for H1N1 and B in all treatment groups, ≥90% for H3N2 in the teriflunomide 7mg and IFNβ-1 groups, and 77% for H3N2 in the teriflunomide 14mg group. Geometric mean titer (GMT) ratios post-/pre-vaccination were ≥2.5 for all treatment groups and vaccine strains, except in the teriflunomide 14mg group for H1N1 (GMT ratio: 2.3). The proportion of patients with a pre-vaccination titer CONCLUSIONS: Teriflunomide-treated patients mount effective immune responses to seasonal influenza vaccination, suggesting teriflunomide does not significantly affect memory responses to influenza vaccine. Supported by: Genzyme, a Sanofi company. Disclosure: Dr. O9Connor has received personal compensation for activities with Biogen Idec, EMD Serono, Novartis, Roche, Genzyme Corporation, and Teva Neuroscience. Dr. O9Conner has received research support from Biogen Idec, Novartis, Roche, Genzyme Corporation, and Teva Neuroscience. Dr. Bar-Or has received personal compensation for activities with Amplimmune, Aventis Pharmaceuticals Inc., Bayhill Therapeutics, Berlex, Bayer, Biogen Idec, BioMS, Diogenix, Eli Lilly & Company, Genentech, Inc., Genzyme Corporation, GlaxoSmithKline, Inc., Guthy-Jackson/GGF, EMD Serono, Medimmune, Mitsubishi Pharma, Novartis, Ono Pharma, Receptos, Roche Diagnostics, Sanofi-Aventis Pharmaceuticals, Inc., Teva Neuroscience, and Wyeth Pharmaceuticals. Dr. Bar-Or has received research support Aventis Pharmaceuticals Inc., Bayhill Therapeutics, Biogen Idec, Berlex, Eli Lilly & Company, Genentech, Inc. GlaxoSmithKline, Inc., Ono Pharma, Diogenix, Roche Diagnostics,, Merck Serono, Novartis, and Teva Neuroscience. Dr. Freedman has received personal compensation for activities with Bayer, Biogen Idec, Teva, Merck Serono, Novartis, Sanofi, and Celgene. Dr. Freedman9s institution has received research support from Bayer Healthcare and Genzyme. Dr. Kremenchutzky has received personal compensation for activities with Bayer, Biogen Idec, EMD Serono, Genzyme, Novartis, Sanofi-Aventis Pharmaceuticals, Inc. and Teva Neuroscience. Dr. Menguy-Vacheron has received personal compensation for activities with Sanofi as an employee. Dr. Bauer has received personal compensation for activities with Sanofi-Aventis Pharmaceuticals, Inc. Dr. Truffinet has received personal compensation for activities with Sanofi-Aventis Pharmaceuticals, Inc. Dr. Benamor has received personal compensation for activities with Sanofi-Aventis Pharmaceuticals, Inc. as an employee.