Abstract Details

Title Immune Response to Seasonal Influenza Vaccination in Patients with Relapsing Multiple Sclerosis Treated with Teriflunomide: The TERIVA Study

Topic MS and Related Diseases

Presentation(s) P01 - (-)

Poster/Presentation
Number 169

Objective

Background 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 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 (IFN?-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 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 IFN?-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 <40 achieving seroprotection was similar across groups for H1N1 and B strains (?80%), and lower for H3N2 in the teriflunomide 14mg (61.1%) group than the 7mg (77.8%) and IFN?-1 (81.8%) groups. Influenza vaccination was well tolerated in all groups.

Conclusions CONCLUSIONS: Teriflunomide-treated patients mount effective immune responses to seasonal influenza vaccination, suggesting teriflunomide does not significantly affect memory responses to influenza vaccine.

Authors/Disclosures
Paul W. O'Connor, MD PRESENTER	No disclosure on file
Amit Bar-Or, MD, FRCPC (University of Pennsylvania)	Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Genentech. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merk/EMD Serono. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for cabaletta. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck/EMD Serono. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi/Genzyme. The institution of Dr. Bar-Or has received research support from Novartis. The institution of Dr. Bar-Or has received research support from Biogen. The institution of Dr. Bar-Or has received research support from Roche/Genentech.
Mark S. Freedman, MD, FAAN (University of Ottawa)	Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Actelion(Janssen/J&J). Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BiogenIdec. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS/Celgene. Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Inc. Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Actelion (Janssen/J&J). Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Atara Biotherapeutics. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Bayer Healthcare. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for BiogenIdec. Dr. Freedman has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Clene Nanomedicine. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GRI Bio. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Magenta Therapeutics. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono. Dr. Freedman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Freedman has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Genzyme. Dr. Freedman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Freedman has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. The institution of Dr. Freedman has received research support from Sanofi Genzyme.
Steve Kanes, MD, PhD (Sage Therapeutics)	Dr. Kanes has received personal compensation for serving as an employee of Sage Therapeutics. Dr. Kanes has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Verge Genomics. Dr. Kanes has received intellectual property interests from a discovery or technology relating to health care.
Marcelo C. Kremenchutzky, MD, FAAN (Lhsc - UWO)	No disclosure on file
	No disclosure on file
	No disclosure on file
Philippe Truffinet, MD (Sanofi)	Dr. Truffinet has received personal compensation for serving as an employee of Sanofi.
	No disclosure on file

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