Evidence map›Paper›PMID 39155737›Full record

ArticleAllergy, asthma & immunology research2024

Long-term Safety and Efficacy of Dupilumab in Patients With Uncontrolled, Moderate-to-Severe Asthma Recruited From Korean Centers: A Subgroup Analysis of the Phase 3 LIBERTY ASTHMA TRAVERSE Trial.

Chin Kook Rhee, Jung-Won Park, Heung-Woo Park, Hayeon Noh, Jerome Msihid, You Sook Cho

Registry-linked trialAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Allergy, asthma & immunology research, 2024. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

6 authors.

Chin Kook RheeDivision of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.ORCID https://orcid.org/0000-0003-4533-7937
Jung-Won ParkDivision of Allergy and Immunology, Department of Internal Medicine, Institute of Allergy, Yonsei University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0003-0249-8749
Heung-Woo ParkDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.ORCID https://orcid.org/0000-0002-6970-3228
Hayeon NohSanofi Specialty Care Medical Korea, Sanofi, Seoul, Korea.ORCID https://orcid.org/0009-0005-1235-0571
Jerome MsihidHEVA Analytics, Sanofi, Gentilly, France.ORCID https://orcid.org/0000-0003-4733-5855
You Sook ChoDivision of Allergy and Clinical Immunology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. yscho@amc.seoul.kr.ORCID https://orcid.org/0000-0001-8767-2667

Funding

Sanofi and Regeneron Pharmaceuticals, Inc.
6 · The paper itself

Abstract

purposeLong-term data are limited on the safety and efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma from Korea. The current subgroup analysis was designed to evaluate the long-term safety and efficacy of dupilumab in patients enrolled from Korean centers in the parent studies (phase 2b and QUEST) and who participated in the TRAVERSE open-label extension (OLE) study.

methodsTRAVERSE was a global, multicenter, OLE study that assessed the safety and efficacy of dupilumab 300 mg every 2 weeks for up to 96 weeks in patients (n = 2,282) with uncontrolled, moderate-to-severe asthma who completed prior dupilumab asthma clinical trials. The primary outcome was the incidence of any treatment-emergent adverse events (TEAEs); the secondary outcomes included annualized severe exacerbation rate, pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1), and 5-item Asthma Control Questionnaire (ACQ-5) score.

resultsSafety outcomes were consistent with the parent studies and the overall TRAVERSE population; out of 74 patients, 70 experienced ≥ 1 TEAE, and 6 (8.1%) discontinued because of adverse events. During the treatment period, the unadjusted annualized severe exacerbation rate was low (0.470). Improvement in pre-BD FEV1 was seen as early as Week 2 with a mean change from the parent study baseline (PSBL), standard deviation (SD) of 0.42 L (0.47), which was sustained until Week 96. Mean change from PSBL (SD) in ACQ-5 score was -1.32 (0.76) at Week 48.

conclusionsThis subgroup analysis of TRAVERSE showed the long-term safety and efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma enrolled from Korean centers.

trial registrationClinicalTrials.gov Identifier: NCT02134028.

Indexed as

asthmaclinical trialDupilumabefficacyKoreansphase IIIsafety

Identifiers

PMID39155737
PMCPMC11331194

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.