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August 06, 2013; 81 (6) Article

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
First published July 12, 2013, DOI: https://doi.org/10.1212/WNL.0b013e31829e6fbf
Amit Bar-Or
From McGill University (A.B.-O.), Montreal, Quebec, Canada; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ottawa, Ontario, Canada; Western University (M.K.), London, Ontario, Canada; Genzyme, a Sanofi company (F.M.-V., P.T.), Chilly Mazarin, France; Sanofi (D.B.), Bridgewater, NJ; Kleinmachnow (S.J.), Germany; Sanofi (M.B.), Chilly Mazarin, France; Fishawack Communications Ltd. (S.C.), Abingdon, UK; and University of Toronto (P.W.O.), Toronto, Ontario, Canada.
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Mark S. Freedman
From McGill University (A.B.-O.), Montreal, Quebec, Canada; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ottawa, Ontario, Canada; Western University (M.K.), London, Ontario, Canada; Genzyme, a Sanofi company (F.M.-V., P.T.), Chilly Mazarin, France; Sanofi (D.B.), Bridgewater, NJ; Kleinmachnow (S.J.), Germany; Sanofi (M.B.), Chilly Mazarin, France; Fishawack Communications Ltd. (S.C.), Abingdon, UK; and University of Toronto (P.W.O.), Toronto, Ontario, Canada.
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Marcelo Kremenchutzky
From McGill University (A.B.-O.), Montreal, Quebec, Canada; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ottawa, Ontario, Canada; Western University (M.K.), London, Ontario, Canada; Genzyme, a Sanofi company (F.M.-V., P.T.), Chilly Mazarin, France; Sanofi (D.B.), Bridgewater, NJ; Kleinmachnow (S.J.), Germany; Sanofi (M.B.), Chilly Mazarin, France; Fishawack Communications Ltd. (S.C.), Abingdon, UK; and University of Toronto (P.W.O.), Toronto, Ontario, Canada.
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Françoise Menguy-Vacheron
From McGill University (A.B.-O.), Montreal, Quebec, Canada; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ottawa, Ontario, Canada; Western University (M.K.), London, Ontario, Canada; Genzyme, a Sanofi company (F.M.-V., P.T.), Chilly Mazarin, France; Sanofi (D.B.), Bridgewater, NJ; Kleinmachnow (S.J.), Germany; Sanofi (M.B.), Chilly Mazarin, France; Fishawack Communications Ltd. (S.C.), Abingdon, UK; and University of Toronto (P.W.O.), Toronto, Ontario, Canada.
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Deborah Bauer
From McGill University (A.B.-O.), Montreal, Quebec, Canada; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ottawa, Ontario, Canada; Western University (M.K.), London, Ontario, Canada; Genzyme, a Sanofi company (F.M.-V., P.T.), Chilly Mazarin, France; Sanofi (D.B.), Bridgewater, NJ; Kleinmachnow (S.J.), Germany; Sanofi (M.B.), Chilly Mazarin, France; Fishawack Communications Ltd. (S.C.), Abingdon, UK; and University of Toronto (P.W.O.), Toronto, Ontario, Canada.
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Stefan Jodl
From McGill University (A.B.-O.), Montreal, Quebec, Canada; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ottawa, Ontario, Canada; Western University (M.K.), London, Ontario, Canada; Genzyme, a Sanofi company (F.M.-V., P.T.), Chilly Mazarin, France; Sanofi (D.B.), Bridgewater, NJ; Kleinmachnow (S.J.), Germany; Sanofi (M.B.), Chilly Mazarin, France; Fishawack Communications Ltd. (S.C.), Abingdon, UK; and University of Toronto (P.W.O.), Toronto, Ontario, Canada.
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Philippe Truffinet
From McGill University (A.B.-O.), Montreal, Quebec, Canada; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ottawa, Ontario, Canada; Western University (M.K.), London, Ontario, Canada; Genzyme, a Sanofi company (F.M.-V., P.T.), Chilly Mazarin, France; Sanofi (D.B.), Bridgewater, NJ; Kleinmachnow (S.J.), Germany; Sanofi (M.B.), Chilly Mazarin, France; Fishawack Communications Ltd. (S.C.), Abingdon, UK; and University of Toronto (P.W.O.), Toronto, Ontario, Canada.
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Myriam Benamor
From McGill University (A.B.-O.), Montreal, Quebec, Canada; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ottawa, Ontario, Canada; Western University (M.K.), London, Ontario, Canada; Genzyme, a Sanofi company (F.M.-V., P.T.), Chilly Mazarin, France; Sanofi (D.B.), Bridgewater, NJ; Kleinmachnow (S.J.), Germany; Sanofi (M.B.), Chilly Mazarin, France; Fishawack Communications Ltd. (S.C.), Abingdon, UK; and University of Toronto (P.W.O.), Toronto, Ontario, Canada.
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Scott Chambers
From McGill University (A.B.-O.), Montreal, Quebec, Canada; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ottawa, Ontario, Canada; Western University (M.K.), London, Ontario, Canada; Genzyme, a Sanofi company (F.M.-V., P.T.), Chilly Mazarin, France; Sanofi (D.B.), Bridgewater, NJ; Kleinmachnow (S.J.), Germany; Sanofi (M.B.), Chilly Mazarin, France; Fishawack Communications Ltd. (S.C.), Abingdon, UK; and University of Toronto (P.W.O.), Toronto, Ontario, Canada.
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Paul W. O’Connor
From McGill University (A.B.-O.), Montreal, Quebec, Canada; University of Ottawa and the Ottawa Hospital Research Institute (M.S.F.), Ottawa, Ontario, Canada; Western University (M.K.), London, Ontario, Canada; Genzyme, a Sanofi company (F.M.-V., P.T.), Chilly Mazarin, France; Sanofi (D.B.), Bridgewater, NJ; Kleinmachnow (S.J.), Germany; Sanofi (M.B.), Chilly Mazarin, France; Fishawack Communications Ltd. (S.C.), Abingdon, UK; and University of Toronto (P.W.O.), Toronto, Ontario, Canada.
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Citation
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
Neurology Aug 2013, 81 (6) 552-558; DOI: 10.1212/WNL.0b013e31829e6fbf

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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.

GLOSSARY

CI=
confidence interval;
DMT=
disease-modifying therapy;
GMT=
geometric mean titer;
HIA=
hemagglutination inhibition assay;
IFN-β-1a=
interferon-β-1a;
MS=
multiple sclerosis;
RMS=
relapsing forms of multiple sclerosis;
SAE=
serious adverse event;
TEAE=
treatment-emergent adverse event;
TEMSO=
Teriflunomide Multiple Sclerosis Oral (trial);
TERIVA=
Teriflunomide and Vaccination (study)

Footnotes

  • Coinvestigators are listed on the Neurology® Web site at www.neurology.org.

  • Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • Supplemental data at www.neurology.org

  • Received January 8, 2013.
  • Accepted in final form April 24, 2013.
  • © 2013 American Academy of Neurology
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