Teriflunomide effect on immune response to influenza vaccine in patients with multiple sclerosis
Amit Bar-Or, Mark S Freedman, Marcelo Kremenchutzky, Françoise Menguy-Vacheron, Deborah Bauer, Stefan Jodl, Philippe Truffinet, Myriam Benamor, Scott Chambers, Paul W O'Connor, Amit Bar-Or, Mark S Freedman, Marcelo Kremenchutzky, Françoise Menguy-Vacheron, Deborah Bauer, Stefan Jodl, Philippe Truffinet, Myriam Benamor, Scott Chambers, Paul W O'Connor
Abstract
Objective: To investigate the effect of teriflunomide on the efficacy and safety of seasonal influenza vaccine.
Methods: The 2011/2012 seasonal influenza vaccine (containing H1N1, H3N2, and B strains) was administered to patients with relapsing forms of multiple sclerosis (RMS) treated for ≥6 months with teriflunomide 7 mg (n = 41) or 14 mg (n = 41), or interferon-β-1 (IFN-β-1; n = 46). The primary endpoint was the proportion of patients with influenza strain-specific antibody titers ≥40, 28 days postvaccination.
Results: More than 90% of patients achieved postvaccination antibody titers ≥40 for H1N1 and B in all groups. For H3N2, titers ≥40 were achieved in ≥90% of patients in the 7 mg and IFN-β-1 groups, and in 77% of the 14-mg group, respectively. A high proportion of patients already had detectable antibodies for each influenza strain at baseline. Geometric mean titer ratios (post/prevaccination) were ≥2.5 for all groups and strains, except for H1N1 in the 14-mg group (2.3). The proportion of patients with a prevaccination titer <40 achieving seroprotection was ≥61% across the 3 treatment groups and 3 influenza strains. However, fewer patients in the 14-mg than the 7-mg or IFN-β-1 groups exhibited seroprotection to H3N2 (61% vs. 78% and 82%, respectively).
Conclusion: Teriflunomide-treated patients generally mounted effective immune responses to seasonal influenza vaccination, consistent with preservation of protective immune responses.
Classification of evidence: This study provides Class II evidence that teriflunomide generally does not adversely impact the ability of patients with RMS to mount immune responses to influenza vaccination.
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References
- Gold R, Wolinsky JS. Pathophysiology of multiple sclerosis and the place of teriflunomide. Acta Neurol Scand 2011;124:75–84
- Wolinsky JS, Narayana AP, Nelson F, et al. Magnetic resonance imaging outcomes from a phase III trial of teriflunomide. Mult Scler Epub 2013 Feb 27
- O'Connor P, Wolinsky JS, Confavreux C, et al. Randomized trial of oral teriflunomide for relapsing multiple sclerosis. N Engl J Med 2011;365:1293–1303
- Schwid SR, Decker MD, Lopez-Bresnahan M. Immune response to influenza vaccine is maintained in patients with multiple sclerosis receiving interferon beta-1a. Neurology 2005;65:1964–1966
- O'Connor PW, Li D, Freedman MS, et al. A phase II study of the safety and efficacy of teriflunomide in multiple sclerosis with relapses. Neurology 2006;66:894–900
- Confavreux C, Li DK, Freedman MS, et al. Long-term follow-up of a phase 2 study of oral teriflunomide in relapsing multiple sclerosis: safety and efficacy results up to 8.5 years. Mult Scler 2012;18:1278–1289
- O'Connor P, Wolinsky JS, Confavreux C, et al. Extension of a phase III trial (TEMSO) of oral teriflunomide in multiple sclerosis with relapses: clinical and MRI data 5 years after initial randomisation. Mult Scler 2011;17(suppl 17):S414.P924
- Comi G, O'Connor P, Wolinsky J, et al. Extension of a phase III trial (TEMSO) of oral teriflunomide in multiple sclerosis with relapses: safety outcomes with up to 4 years of follow-up. Mult Scler 2011;17(suppl 17):S182.P439
- European Agency for the Evaluation of Medicinal Products Committee for Proprietary Medicinal Products: Note for Guidance on Harmonization of Requirements for Influenza Vaccines. London: European Agency for the Evaluation of Medicinal Products; 1997
- Confavreux C, Suissa S, Saddier P, Bourdès V, Vukusic S. Vaccinations and the risk of relapse in multiple sclerosis. N Engl J Med 2001;344:319–326
- De Keyser J, Zwanikken C, Boon M. Effect of influenza vaccination and influenza illness on exacerbations in multiple sclerosis. J Neurol Sci 1998;195:51–53
Source: PubMed