To evaluate immune responses to neoantigen and recall antigens in healthy subjects treated with teriflunomide.
This was a randomized, double-blind, placebo-controlled study. Subjects received oral teriflunomide (70 mg once daily for 5 days followed by 14 mg once daily for 25 days) or placebo for 30 days. Antibody responses were evaluated following rabies vaccination (neoantigen) applied at days 5, 12, and 31 of the treatment period. Occurrence of delayed-type hypersensitivity (DTH) to Candida albicans, Trichophyton, and tuberculin (recall antigens) was assessed before and at the end of treatment to investigate cellular memory response. Safety and pharmacokinetics were evaluated.
Forty-six randomized subjects were treated (teriflunomide, n = 23; placebo, n = 23) and completed the rabies vaccination. Geometric mean titers for rabies antibodies were lower with teriflunomide at days 31 and 38 than with placebo. However, all subjects achieved sufficient seroprotection following rabies vaccination (titers well above the 0.5 IU/mL threshold). Overall, the DTH response to recall antigens in the teriflunomide group did not notably differ from responses in the placebo group.
Following vaccination, geometric mean titers for rabies antibodies were lower with teriflunomide than with placebo. However, teriflunomide did not limit the ability to achieve seroprotective titers against this neoantigen. Evaluation of DTH showed that teriflunomide had no adverse impact on the cellular memory response to recall antigens.
Diogenix, Advisor, Scientific Board, 2008-Ono Pharmacia, Advisor, Scientific Board, 2008-Receptos, Advisor, Scientific Board, 2011 - Roche, Advisor, Scientific Board, 2008-Novartis, Advisor, Scientific Board, 2012- GSK, Advisor 2012 - Guthy Jackson Greater Good Foundation, Scientific Advisor, 2008-
Diogenix, Advisor, Scientific Board, 2008- Ono Pharmacia, Advisor, Scientific Board, 2008- Receptos, Advisor, Scientific Board, 2011 - Roche, Advisor, Scientific Board, 2008-Novartis, Advisor, Scientific Board, 2012- GSK, Advisor 2012 -
Neurology, Editorial Board Member, 2008- Clinical and Experimental Neuroimmunology, Editorial BoardMember, 2010 -
Diogenix, Advisor, Scientific Board, 2008-Ono Pharmacia, Advisor, Scientific Board, 2008-Receptos, Advisor, Scientific Board, 2011 - Roche, Advisor, Scientific Board, 2008-Novartis, Advisor, Scientific Board, 2012- GSK, Advisor 2012 -
H. Wiendl received honoraria for lecturing and travel expenses for attending meetings and received financial research support from Bayer, Biogen Idec/Elan, Sanofi-Aventis, Schering, Serono, and Teva Pharmaceuticals. H.W. has served or serves as consultant for Serono, Medac, Sanofi-Aventis/TEVA, Biogen Idec, BayerVital/Schering, NOvartis and NovoNordisk.)
H. Wiendl has received honoraria for lecturing and travel expenses for attending meetings and received financial research support from Bayer, Biogen Idec/Elan, Sanofi Aventis, Schering GmbH, MerckSerono, Teva, Novartis, Medac, Genzyme and NovoNordisk
- Support of research projects by pharmaceutical industry (Bayer, Biogen Idec/Elan, Sanofi Aventis, Schering GmbH, MerckSerono, Teva, Novartis, Medac, Genzyme and NovoNordisk)
Go to Neurology.org/nn for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article. The Article Processing Charge was paid by Fishawack Communications, Inc., on behalf of study sponsor Genzyme, a Sanofi company.
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