title: Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials.
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 pre-specified 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.
authors.affiliation: Cedars-Sinai Medical Center, Los Angeles, CA, USA Paul.Noble@cshs.org.
authors.forename: Paul W
authors.initials: PW
authors.lastname: Noble
authors.affiliation: University of Turin, Turin, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Albera
authors.affiliation: InterMune Inc., Brisbane, CA, USA.
authors.forename: Williamson Z
authors.initials: WZ
authors.lastname: Bradford
authors.affiliation: Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Costabel
authors.affiliation: Imperial College, London, UK.
authors.forename: Roland M
authors.initials: RM
authors.lastname: du Bois
authors.affiliation: InterMune Inc., Brisbane, CA, USA.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Fagan
authors.affiliation: InterMune Inc., Brisbane, CA, USA.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Fishman
authors.affiliation: Alfred Hospital and Monash University, Melbourne, Australia.
authors.forename: Ian
authors.initials: I
authors.lastname: Glaspole
authors.affiliation: University of Miami Miller School of Medicine, Miami, FL, USA.
authors.forename: Marilyn K
authors.initials: MK
authors.lastname: Glassberg
authors.affiliation: Vanderbilt University Medical Center, Nashville, TN, USA.
authors.forename: Lisa
authors.initials: L
authors.lastname: Lancaster
authors.affiliation: Columbia University Medical Center, New York, NY, USA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Lederer
authors.affiliation: InterMune Inc., Brisbane, CA, USA.
authors.forename: Jonathan A
authors.initials: JA
authors.lastname: Leff
authors.affiliation: Inova Fairfax Hospital, Falls Church, VA, USA.
authors.forename: Steven D
authors.initials: SD
authors.lastname: Nathan
authors.affiliation: Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Pereira
authors.affiliation: National Jewish Health, Denver, CO, USA.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Swigris
authors.affiliation: Assistance Publique-Hôpitaux de Paris, Avicenne University Hospital, Bobigny, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Valeyre
authors.affiliation: University of California, San Francisco, San Francisco, CA, USA.
authors.forename: Talmadge E
authors.initials: TE
authors.lastname: King
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D017326:Clinical Trials, Phase III as Topic; D018450:Disease Progression; D005080:Exercise Test; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000188:drug therapy* / Q000503:physiopathology; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D011653:Pulmonary Diffusing Capacity; D011728:Pyridones / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D014797:Vital Capacity
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D011728:Pyridones; C093844:pirfenidone