This article is part of Pulmonology Advisor‘s coverage of the CHEST 2018 meeting, taking place in San Antonio, Texas. Our staff will report on medical research related to COPD, critical care medicine, and more conducted by experts in the field. Check back regularly for more news from CHEST 2018.
SAN ANTONIO — Pirfenidone is superior to placebo in improving exercise capacity and dyspnea in patients with idiopathic pulmonary fibrosis (IPF) and advanced impairment of lung function, according to a study presented at the CHEST Annual Meeting, held October 6-10, 2018, in San Antonio, Texas.
Investigators conducted a post hoc analysis of the ASCEND (ClinicalTrials.gov Identifier: NCT01366209) and CAPACITY (ClinicalTrials.gov Identifiers: NCT00287716; NCT00287729) clinical trials. Patients with IPF were randomly assigned to either 2403 mg/d pirfenidone (n=90) or placebo (n=80). Changes from baseline in the 6-minute walk distance (6MWD) and University of California San Diego Shortness of Breath Questionnaire (UCSD SOBQ) total score as well as changes in the composite outcome of a 6MWD decline of ≥50 m or death and an increase in UCSD SOBQ total score of ≥20 points or death were assessed at 52-week follow-up.
At baseline, the median 6MWD in the treatment and placebo groups were 385.5 m and 375.5 m, respectively, and baseline median UCSD SOBQ total scores were 42.0 and 43.8. The median change in the 6MWD from baseline to the 52-week follow-up was –34.0 m with pirfenidone vs –81.5 m with placebo (Hodges-Lehmann median difference, 36.7 m; 95% CI, 3.0-71.5, with the analysis favoring pirfenidone). A significantly lower proportion of patients with 6MWD decline ≥50 m or who had died were in the pirfenidone group (43.3% vs 61.5%; P =.0279).
The median change in the UCSD SOBQ total score from baseline to 52 weeks also favored pirfenidone (+17.0 [pirfenidone] vs +21.5 [placebo]; Hodges-Lehmann median difference, –8.0 points; 95% CI, –15.5 to –0.5). In addition, a significantly lower proportion of patients who experienced an increase in the UCSD SOBQ total score of ≥20 points or death by 52-week follow-up were randomly assigned to pirfenidone (43.8% vs 57.5%; P =.0081).
“The [Hodges-Lehmann] median differences for pirfenidone vs placebo over 52 weeks exceeded or met the minimally clinically important differences in 6MWD and UCSD SOBQ of 28 m and 8 points, respectively,” the researchers concluded.
Disclosures: Funding was provided by Genentech, Inc. and F. Hoffmann-La Roche, Ltd.
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Nathan S, Bradley S, Costabel U, et al. Effect of pirfenidone on exercise capacity and dyspnea in patients with idiopathic pulmonary fibrosis (IPF) and more advanced lung function impairment. Presented at: CHEST Annual Meeting 2018; October 6-10, 2018; San Antonio, TX.