Evidence map›Paper›PMID 25738167›Full record

ArticleNeurology(R) neuroimmunology & neuroinflammation2015

Randomized study of teriflunomide effects on immune responses to neoantigen and recall antigens.

Amit Bar-Or, Heinz Wiendl, Barry Miller, Myriam Benamor, Philippe Truffinet, Meg Church, Francoise Menguy-Vacheron

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Neurology(R) neuroimmunology & neuroinflammation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Amit Bar-OrMontreal Neurological Institute (A.B.-O.), McGill University, Montreal, Quebec, Canada; University of Münster (H.W.), Münster, Germany; Sanofi (B.M.), Bridgewater, NJ; Genzyme, a Sanofi company (M.B., P.T., F.M.-V.), Chilly-Mazarin, France; and Fishawack Communications, Inc. (M.C.), Horsham, PA.
Heinz WiendlMontreal Neurological Institute (A.B.-O.), McGill University, Montreal, Quebec, Canada; University of Münster (H.W.), Münster, Germany; Sanofi (B.M.), Bridgewater, NJ; Genzyme, a Sanofi company (M.B., P.T., F.M.-V.), Chilly-Mazarin, France; and Fishawack Communications, Inc. (M.C.), Horsham, PA.
Barry MillerMontreal Neurological Institute (A.B.-O.), McGill University, Montreal, Quebec, Canada; University of Münster (H.W.), Münster, Germany; Sanofi (B.M.), Bridgewater, NJ; Genzyme, a Sanofi company (M.B., P.T., F.M.-V.), Chilly-Mazarin, France; and Fishawack Communications, Inc. (M.C.), Horsham, PA.
Myriam BenamorMontreal Neurological Institute (A.B.-O.), McGill University, Montreal, Quebec, Canada; University of Münster (H.W.), Münster, Germany; Sanofi (B.M.), Bridgewater, NJ; Genzyme, a Sanofi company (M.B., P.T., F.M.-V.), Chilly-Mazarin, France; and Fishawack Communications, Inc. (M.C.), Horsham, PA.
Philippe TruffinetMontreal Neurological Institute (A.B.-O.), McGill University, Montreal, Quebec, Canada; University of Münster (H.W.), Münster, Germany; Sanofi (B.M.), Bridgewater, NJ; Genzyme, a Sanofi company (M.B., P.T., F.M.-V.), Chilly-Mazarin, France; and Fishawack Communications, Inc. (M.C.), Horsham, PA.
Meg ChurchMontreal Neurological Institute (A.B.-O.), McGill University, Montreal, Quebec, Canada; University of Münster (H.W.), Münster, Germany; Sanofi (B.M.), Bridgewater, NJ; Genzyme, a Sanofi company (M.B., P.T., F.M.-V.), Chilly-Mazarin, France; and Fishawack Communications, Inc. (M.C.), Horsham, PA.
Francoise Menguy-VacheronMontreal Neurological Institute (A.B.-O.), McGill University, Montreal, Quebec, Canada; University of Münster (H.W.), Münster, Germany; Sanofi (B.M.), Bridgewater, NJ; Genzyme, a Sanofi company (M.B., P.T., F.M.-V.), Chilly-Mazarin, France; and Fishawack Communications, Inc. (M.C.), Horsham, PA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate immune responses to neoantigen and recall antigens in healthy subjects treated with teriflunomide.

methodsThis 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.

resultsForty-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.

conclusionsFollowing 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. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that in normal subjects treated with teriflunomide, antibody titer responses to rabies vaccination are lower than with placebo but sufficient for seroprotection.

Identifiers

PMID25738167
PMCPMC4335822

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.