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Diffuse Lung Disease |

Effect of Pirfenidone on IPF-Related Mortality Outcome Measures in Patients With Idiopathic Pulmonary Fibrosis (IPF): Pooled Data Analysis From the ASCEND and CAPACITY Trials

Steven Nathan; Carlo Albera; Williamson Bradford; David Kardatzke; Ulrich Costabel; Roland du Bois; Ian Glaspole; Marilyn Glassberg; Talmadge King; Klaus-Uwe Kirchgaessler; Lisa Lancaster; David Lederer; Carlos Pereira; Jeffrey Swigris; Dominique Valeyre; Paul Noble
Author and Funding Information

Inova Fairfax Hospital, Falls Church, VA; University of Turin, Turin, Italy; InterMune, Inc., Brisbane, CA; Ruhrlandklinik, Essen, Germany; Imperial College, London, United Kingdom; Alfred Hospital and Monash University, Melbourne, VIC, Australia; University of Miami Miller School of Medicine, Miami, FL; University of California, San Francisco, CA; Roche, Basel, Switzerland; Vanderbilt University Medical Center, Nashville, TN; Columbia University Medical Center, New York, NY; Paulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil; National Jewish Health, Denver, CO; Assistance Publique-Hôpitaux de Paris, Avicenne University, Bobigny, France; Cedars Sinai Medical Center, Los Angeles, CA


Chest. 2015;148(4_MeetingAbstracts):391A. doi:10.1378/chest.2278579
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Abstract

SESSION TITLE: Diffuse Lung Disease Poster Discussions

SESSION TYPE: Original Investigation Poster Discussion

PRESENTED ON: Wednesday, October 28, 2015 at 02:45 PM - 04:00 PM

PURPOSE: Disease-related mortality is a clinical outcome widely used across various disease states to evaluate treatment benefits. In clinical trials in patients with IPF, characterization of IPF-related and treatment emergent (TE) IPF-related mortality is an important supplement to all-cause mortality (ACM) analyses, as deaths due to causes other than IPF, especially in an older patient population, may obscure ACM findings.

METHODS: The effect of pirfenidone on IPF-related mortality outcomes at weeks 52, 72, and through the end of study was determined in the pooled patient population (N=1247) from the ASCEND (PIPF-016) and CAPACITY (PIPF-004/-006) Phase 3 trials. Patients were treated for 52 weeks in ASCEND and a minimum of 72 weeks in the CAPACITY studies. TE deaths were defined as those that occurred after the first dose and within 28 days of the last dose. The primary cause of death and relation to IPF were blindly assessed by an independent mortality assessment committee in ASCEND and by site investigators in CAPACITY.

RESULTS: At week 52, IPF-related mortality occurred in a smaller proportion of patients (10/623 [1.6%]) in the pirfenidone group compared with placebo (28/624 [4.5%]) (HR 0.35; 95% CI, 0.17-0.72; P=0.0029). TE IPF-related deaths occurred in significantly fewer patients in the pirfenidone group (7/623 [1.1%]) compared with placebo (22/624 [3.5%]) (HR 0.32; 95% CI, 0.14-0.76; P=0.0061). At week 72, a similar trend was observed; IPF-related death occurred in 17/623 (2.7%) patients in the pirfenidone group compared with 35/624 (5.6%) patients in the placebo group (HR 0.48; 95% CI, 0.27-0.85; P=0.0107). There were also fewer TE IPF-related deaths in the pirfenidone group (11/623 [1.8%]) compared with placebo (28/624 [4.5%]) (HR 0.40; 95% CI, 0.20-0.80; P=0.0072). Results at the end of study were consistent with earlier time points; fewer patients in the pirfenidone group compared with placebo died from IPF (22/623 [3.5%] vs. 39/624 [6.3%]) (HR 0.55; 95% CI, 0.33-0.93; P=0.0237). TE IPF-related death occurred in 15/623 (2.4%) and 32/624 (5.1%) patients in the pirfenidone and placebo groups, respectively, in the end of study analysis (HR 0.47; 95% CI, 0.25-0.87; P=0.0132).

CONCLUSIONS: A consistent trend favoring pirfenidone in reducing the risk of both IPF-related mortality and TE IPF-related mortality over time was observed in the pooled population from three Phase 3 trials.

CLINICAL IMPLICATIONS: These findings may inform clinical decisions regarding the assessment and management of patients with IPF.

DISCLOSURE: Steven Nathan: Consultant fee, speaker bureau, advisory committee, etc.: InterMune/Roche/Genentech Carlo Albera: Consultant fee, speaker bureau, advisory committee, etc.: InterMune Williamson Bradford: Employee: InterMune, Inc. Ulrich Costabel: Consultant fee, speaker bureau, advisory committee, etc.: InterMune, Consultant fee, speaker bureau, advisory committee, etc.: BI, Consultant fee, speaker bureau, advisory committee, etc.: Bayer, Consultant fee, speaker bureau, advisory committee, etc.: Roche, Consultant fee, speaker bureau, advisory committee, etc.: Gilead Roland du Bois: Consultant fee, speaker bureau, advisory committee, etc.: GSK, Consultant fee, speaker bureau, advisory committee, etc.: Roche, Consultant fee, speaker bureau, advisory committee, etc.: Asahi Ian Glaspole: Consultant fee, speaker bureau, advisory committee, etc.: Astra Zeneca, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer-Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: InterMune Marilyn Glassberg: Consultant fee, speaker bureau, advisory committee, etc.: InterMune, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer-Ingelheim David Kardatzke: Employee: InterMune, Inc. Talmadge King: Consultant fee, speaker bureau, advisory committee, etc.: InterMune, Consultant fee, speaker bureau, advisory committee, etc.: ImmuneWorks, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer-Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: GlaxoSmithKline, Consultant fee, speaker bureau, advisory committee, etc.: Daiichi Sankyo, Consultant fee, speaker bureau, advisory committee, etc.: Tracon Klaus-Uwe Kirchgaessler: Employee: Roche Lisa Lancaster: Consultant fee, speaker bureau, advisory committee, etc.: InterMune, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim David Lederer: Consultant fee, speaker bureau, advisory committee, etc.: InterMune, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim Jeffrey Swigris: Consultant fee, speaker bureau, advisory committee, etc.: InterMune/Genentech/Roche Dominique Valeyre: Consultant fee, speaker bureau, advisory committee, etc.: InterMune, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim Paul Noble: Consultant fee, speaker bureau, advisory committee, etc.: InterMune, Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, Consultant fee, speaker bureau, advisory committee, etc.: Genentech, Consultant fee, speaker bureau, advisory committee, etc.: GSK, Consultant fee, speaker bureau, advisory committee, etc.: Moerae Matrix The following authors have nothing to disclose: Carlos Pereira

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