A Phase IIb Randomized Clinical Study of an Anti-αvβ6 Monoclonal Antibody in Idiopathic Pulmonary Fibrosis
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Le résumé fourni par la source
Abstract Rationale Treatment options for idiopathic pulmonary fibrosis (IPF) are limited. Objectives To evaluate the efficacy and safety of BG00011, an anti-αvβ6 IgG1 monoclonal antibody, in the treatment of patients with IPF. Methods In a phase IIb randomized, double-blind, placebo-controlled trial, patients with IPF (FVC ⩾50% predicted, on or off background therapy) were randomized 1:1 to once-weekly subcutaneous BG00011 56 mg or placebo. The primary endpoint was FVC change from baseline at Week 52. Because of early trial termination (imbalance in adverse events and lack of clinical benefit), endpoints were evaluated at Week 26 as an exploratory analysis. Measurements and Main Results One hundred six patients were randomized and received at least one dose of BG00011 (n = 54) or placebo (n = 52). At Week 26, there was no significant difference in FVC change from baseline between patients who received BG00011 (n = 20) or placebo (n = 23), least squares mean (SE) −0.097 L (0.0600) versus −0.056 L (0.0593), respectively (P = 0.268). However, after Week 26, patients in the BG00011 group showed a worsening trend. Eight (44.4%) of 18 who received BG00011 and 4 (18.2%) of 22 who received placebo showed worsening of fibrosis on high-resolution computed tomography at the end of treatment. IPF exacerbation/or progression was reported in 13 patients (all in the BG00011 group). Serious adverse events occurred more frequently in BG00011 patients, including four deaths. Conclusions The results do not support the continued clinical development of BG00011. Further research is warranted to identify new treatment strategies that modify inflammatory and fibrotic pathways in IPF. Clinical trial registered with www.clinicaltrials.gov (NCT03573505).
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- A Phase IIb Randomized Clinical Study of an Anti-αvβ6 Monoclonal Antibody in Idiopathic Pulmonary Fibrosis
- Date Crossref
- 01/11/2022
- Éditeur
- Oxford University Press (OUP)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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University of Washington Medical Center Center for Interstitial Lung Diseases pays non établi dans la noticeÉtablissement de santé
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Biogen (United States) pays non établi dans la noticeEntreprise
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The University of Queensland pays non établi dans la noticeUniversité ou école supérieure
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Prince Charles Hospital Queensland Lung Transplant Program pays non établi dans la noticeÉtablissement de santé
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NewYork–Presbyterian Hospital pays non établi dans la noticeÉtablissement de santé
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Cornell University pays non établi dans la noticeUniversité ou école supérieure
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New York Hospital Queens pays non établi dans la noticeÉtablissement de santé
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Presbyterian Hospital Department of Pulmonary Critical Care Medicine pays non établi dans la noticeÉtablissement de santé
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Weill Cornell Medical Center pays non établi dans la noticeÉtablissement de santé
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Università Cattolica del Sacro Cuore pays non établi dans la noticeUniversité ou école supérieure
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Vanderbilt University Department of Medicine pays non établi dans la noticeUniversité ou école supérieure
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University of Kansas Medical Center Pulmonary and Critical Care Medicine pays non établi dans la noticeOrganisme public
Center for Interstitial Lung Diseases — University of Washington Medical Center, Biogen (United States) et The University of Queensland, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.