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

Paul W. Noble, Carlo Albera, Williamson Z. Bradford, Ulrich Costabel, Roland M.Du Bois, Elizabeth A. Fagan, Robert S. Fishman, Ian Glaspole, Marilyn K. Glassberg, Lisa Lancaster, David J. Lederer, Jonathan A. Leff, Steven D. Nathan, Carlos A. Pereira, Jeffrey J. Swigris, Dominique Valeyre, Talmadge E. King

Research output: Contribution to journalArticle

168 Scopus citations

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•day1 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.

Original languageEnglish (US)
Pages (from-to)243-253
Number of pages11
JournalEuropean Respiratory Journal
Volume47
Issue number1
DOIs
StatePublished - Jan 1 2016

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

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    Noble, P. W., Albera, C., Bradford, W. Z., Costabel, U., Bois, R. M. D., Fagan, E. A., Fishman, R. S., Glaspole, I., Glassberg, M. K., Lancaster, L., Lederer, D. J., Leff, J. A., Nathan, S. D., Pereira, C. A., Swigris, J. J., Valeyre, D., & King, T. E. (2016). Pirfenidone for idiopathic pulmonary fibrosis: Analysis of pooled data from three multinational phase 3 trials. European Respiratory Journal, 47(1), 243-253. https://doi.org/10.1183/13993003.00026-2015