Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials

Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials

Author Noble, Paul W. Google Scholar
Albera, Carlo Google Scholar
Bradford, Williamson Z. Google Scholar
Costabel, Ulrich Google Scholar
du Bois, Roland M. Google Scholar
Fagan, Elizabeth A. Google Scholar
Fishman, Robert S. Google Scholar
Glaspole, Ian Google Scholar
Glassberg, Marilyn K. Google Scholar
Lancaster, Lisa Google Scholar
Lederer, David J. Google Scholar
Leff, Jonathan A. Google Scholar
Nathan, Steven D. Google Scholar
Pereira, Carlos A. Autor UNIFESP Google Scholar
Swigris, Jeffrey J. Google Scholar
Valeyre, Dominique Google Scholar
King, Talmadge E., Jr. Google Scholar
Abstract Pirfenidone is an antifibrotic agent that has been evaluated in three multinational phase 3 trials in patients with idiopathic pulmonary fibrosis (IPF). We analysed pooled data from the multinational trials to obtain the most precise estimates of the magnitude of treatment effect on measures of disease progression. All patients randomised to pirfenidone 2403 mg . day(-1) or placebo in the CAPACITY or ASCEND studies were included in the analysis. Pooled analyses of outcomes at 1 year were based on the prespecified end-points and analytic methods described in the ASCEND study protocol. A total of 1247 patients were included in the analysis. At 1 year, pirfenidone reduced the proportion of patients with a. 10% decline in per cent predicted forced vital capacity or death by 43.8% (95% CI 29.3-55.4%) and increased the proportion of patients with no decline by 59.3% (95% CI 29.0-96.8%). A treatment benefit was also observed for progression-free survival, 6-min walk distance and dyspnoea. Gastrointestinal and skin-related adverse events were more common in the pirfenidone group, but rarely led to discontinuation. Analysis of data from three phase 3 trials demonstrated that treatment with pirfenidone for 1 year resulted in clinically meaningful reductions in disease progression in patients with IPF.
Language English
Sponsor InterMune Inc. (Brisbane, CA, USA)
Date 2016
Published in European Respiratory Journal. Sheffield, v. 47, n. 1, p. 243-253, 2016.
ISSN 0903-1936 (Sherpa/Romeo, impact factor)
Publisher European Respiratory Soc Journals Ltd
Extent 243-253
Origin http://dx.doi.org/10.1183/13993003.00026-2015
Access rights Closed access
Type Article
Web of Science ID WOS:000367443900030
URI http://repositorio.unifesp.br/handle/11600/49680

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