Evidence map›Paper›PMID 37780074›Full record

ArticleThe journal of allergy and clinical immunology. Global2022

Preclinical and clinical experience with dupilumab on the correlates of live attenuated vaccines.

Michael E Wechsler, Adelmir Souza-Machado, Christine Xu, Xuezhou Mao, Upender Kapoor, Faisal A Khokhar, John T O'Malley, Christopher D Petro, Veronica Mas Casullo, Leda P Mannent and 6 more

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in The journal of allergy and clinical immunology. Global, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02134028 (Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
3.3field-weighted citation impact, top 7% of its field
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.

NCT02134028 phase3completednot on this map

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study

TypeinterventionalSponsorSanofiRan2014 to 2019Enrolled2,282ConditionsAsthmaArmsDupilumab
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. MMR and varicella immunization during dupilumab therapy.The journal of allergy and clinical immunology. Global · 2026
    Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Review
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

16 authors at 5 institutions in 3 countries.

Michael E WechslerDivision of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, Denver, Colo.
Adelmir Souza-MachadoUniversidade Federal da Bahia, Salvador, Brazil.
Christine XuSanofi, Bridgewater, NJ.
Xuezhou MaoSanofi, Bridgewater, NJ.
Upender KapoorSanofi, Bridgewater, NJ.
Faisal A KhokharRegeneron Pharmaceuticals, Inc, Tarrytown, NY.
John T O'MalleySanofi, Cambridge, Mass.
Christopher D PetroRegeneron Pharmaceuticals, Inc, Tarrytown, NY.
Veronica Mas CasulloRegeneron Pharmaceuticals, Inc, Tarrytown, NY.
Leda P MannentSanofi, Chilly-Mazarin, France.
Paul J RoweSanofi, Bridgewater, NJ.
Juby A Jacob-NaraSanofi, Bridgewater, NJ.
Marcella RuddyRegeneron Pharmaceuticals, Inc, Tarrytown, NY.
Elizabeth LawsSanofi, Bridgewater, NJ.
Lisa A PurcellRegeneron Pharmaceuticals, Inc, Tarrytown, NY.
Megan HardinSanofi, Cambridge, Mass.
Sanofi (United States) · USRegeneron (United States) · USSanofi (France) · FRNational Jewish Health · USUniversidade Federal da Bahia · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The safety and tolerability of live attenuated vaccines in patients administered dupilumab for moderate-to-severe asthma have not been previously evaluated. During the LIBERTY ASTHMA TRAVERSE open-label extension study (ClinicalTrials.gov identifier NCT02134028), a yellow fever outbreak in Brazil required administration of a live attenuated vaccine to at-risk individuals. Objective: Our aim was to evaluate immune response to a live attenuated vaccine in the context of IL-4 receptor blockade (REGN1103, a dupilumab surrogate) in mice and in dupilumab-treated patients with moderate-to-severe asthma who participated in TRAVERSE. Methods: In the preclinical study, mice were coadministered REGN1103/isotype control and live attenuated influenza vaccine/control, followed by influenza virus challenge. During TRAVERSE, 37 patients discontinued dupilumab treatment and were administered 17D live attenuated yellow fever vaccine (YFV). Safety and tolerability data, dupilumab serum concentrations, and plaque reduction neutralization titers before and after vaccination were collected. Results: In the preclinical study, there was no impact of REGN1103 on vaccine efficacy in mice. In TRAVERSE, all 37 patients who received YFV achieved seroprotection despite most having therapeutic levels of dupilumab, with the magnitude of response appearing unrelated to prevaccination dupilumab concentrations. No instances of vaccine-related adverse events or vaccine hypersensitivity were reported in 36 patients; 1 patient reported nonserious body ache, malaise, and dizziness 7 days after vaccination but recovered fully. Conclusion: The preclinical model suggested that dupilumab does not affect the efficacy of live attenuated influenza vaccine. The live attenuated YFV did not raise safety concerns and appeared to be well tolerated in patients with asthma who recently discontinued dupilumab treatment, and dupilumab concentrations had no apparent impact on immunologic response to the vaccine.

Indexed as

Asthmadupilumabimmunogenicityinfluenza vaccinelive attenuated vaccinemouse modelsafetyyellow fever

Identifiers

PMID37780074
PMCPMC10509883
OpenAlexW4200406558

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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.