Title: EFFECT OF PIRFENIDONE ON EXERCISE CAPACITY AND DYSPNEA IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) AND MORE ADVANCED LUNG FUNCTION IMPAIRMENT
Abstract: SESSION TITLE: Diagnosis and Treatment of Idiopathic Pulmonary Fibrosis SESSION TYPE: Original Investigations PRESENTED ON: 10/08/2018 07:30 am - 08:30 am PURPOSE: This post-hoc analysis investigated the efficacy of pirfenidone vs placebo on exercise capacity and dyspnea in patients with IPF and more advanced lung function impairment, defined as percent predicted forced vital capacity <50% and/or carbon monoxide diffusing capacity <35%. METHODS: Patients randomized to pirfenidone 2403 mg/day or placebo in ASCEND (NCT01366209) and CAPACITY (NCT00287716; NCT00287729) with more advanced baseline lung function impairment were included.Outcomes were assessed over 52 weeks, including changes from baseline in 6-minute walk distance (6MWD) and University of California–San Diego Shortness of Breath Questionnaire (UCSD SOBQ) total score, and two composite outcomes: 6MWD decline ≥50 m or death and an increase in UCSD SOBQ total score of ≥20 points or death. P-values were calculated using ranked analysis of covariance adjusted for study and standardized ranked baseline value. RESULTS: 170 patients with more advanced disease were included (pirfenidone n=90; placebo n=80). Baseline median (Q1, Q3) 6MWD was 385.5 m (320.0, 435.0) and 375.5 m (322.5, 426.0) for pirfenidone and placebo, respectively. Baseline median (Q1, Q3) UCSD SOBQ total score was 42.0 (28.0, 55.0) and 43.8 (29.9, 64.8) for pirfenidone and placebo, respectively.At Week 52, median (Q1, Q3) change from baseline in 6MWD was –34.0 m (–107.0, 5.5) with pirfenidone vs –81.5 m (–187.0, 2.5) with placebo (Hodges-Lehmann [HL] median difference [95% confidence interval (CI)] = 36.7 m [3.0, 71.5] favoring pirfenidone). The proportion of patients with 6MWD decline ≥50 m or death at Week 52 was significantly lower with pirfenidone vs placebo (43.3% vs 61.5%; P=0.0279). For UCSD SOBQ total score, median (Q1, Q3) change from baseline at Week 52 was +17.0 (4.5, 29.0) with pirfenidone vs +21.5 (7.6, 42.1) with placebo (HL median difference [95% CI] = –8.0 points [–15.5, –0.5] favoring pirfenidone). The proportion of patients with an increase in UCSD SOBQ total score of ≥20 points or death at Week 52 was significantly lower with pirfenidone vs placebo (43.8% vs 57.5%; P=0.0081). CONCLUSIONS: In this population of patients with IPF and more advanced lung function impairment, pirfenidone was associated with significant reductions in the proportion of patients with 6MWD decline ≥50 m or death and an increase in UCSD SOBQ total score of ≥20 points or death over 52 weeks. The HL median differences for pirfenidone vs placebo over 52 weeks exceeded or met the minimal clinically important differences in 6MWD and UCSD SOBQ of 28 m and 8 points, respectively. CLINICAL IMPLICATIONS: These results suggest that pirfenidone has clinically meaningful benefits on both exercise capacity and dyspnea in patients with IPF and more advanced lung function impairment.Funding: Genentech, Inc. and F. Hoffmann-La Roche, Ltd. DISCLOSURES: Speaker relationship with Roche (formerly InterMune) Boheringer Ingelheim GSK Fibrogen Please note: $5001 - $20000 Added 02/23/2018 by Carlo Albera, source=Web Response, value=unrestricted grant, speaker Lectures relationship with Boehringer-Ingelheim Please note: $20001 - $100000 Added 02/22/2018 by Jürgen Behr, source=Web Response, value=Honoraria Lectures relationship with Roche Please note: $20001 - $100000 Added 02/22/2018 by Jürgen Behr, source=Web Response, value=Consulting fee Consultant relationship with Actelion Please note: $1001 - $5000 Added 02/22/2018 by Jürgen Behr, source=Web Response, value=Consulting fee Advisory Committee Member relationship with asdfsdfasd Please note: $1001 - $5000 Added 02/13/2018 by Sarah Bradley, source=Web Response, value=Grant/Research SupportRemoved 02/22/2018 by Sarah Bradley, source=Web Response Consultant relationship with Roche-Genentech Please note: $20001 - $100000 Added 02/22/2018 by Sarah Bradley, source=Web Response, value=Consulting feeRemoved 02/22/2018 by Sarah Bradley, source=Web Response Speaker/Speaker's Bureau relationship with Roche-Genentech Please note: $20001 - $100000 Added 02/22/2018 by Sarah Bradley, source=Web Response, value=HonorariaRemoved 02/22/2018 by Sarah Bradley, source=Web Response Advisory Committee Member relationship with Roche - Genentech Please note: $1001 - $5000 Added 02/22/2018 by Sarah Bradley, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Roche - Genentech Please note: $20001 - $100000 Added 02/22/2018 by Sarah Bradley, source=Web Response, value=Honoraria Speaker/Speaker's Bureau relationship with Roche - Genentech Please note: $5001 - $20000 Added 02/22/2018 by Sarah Bradley, source=Web Response, value=Travel Advisory Committee Member relationship with Roche Please note: $1001 - $5000 Added 02/28/2018 by Ulrich Costabel, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Roche Please note: $1001 - $5000 Added 02/28/2018 by Ulrich Costabel, source=Web Response, value=Honoraria Advisory Committee Member relationship with Boehringer Please note: $1001 - $5000 Added 02/28/2018 by Ulrich Costabel, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with Boehringer Please note: $5001 - $20000 Added 02/28/2018 by Ulrich Costabel, source=Web Response, value=Honoraria Consultant relationship with Fibrogen Please note: $1001 - $5000 Added 02/28/2018 by Ulrich Costabel, source=Web Response, value=Consulting fee Speaker/Speaker's Bureau relationship with AstraZeneca Please note: $1001 - $5000 Added 02/28/2018 by Ulrich Costabel, source=Web Response, value=Honoraria Employee relationship with F. 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Publication Year: 2018
Publication Date: 2018-10-01
Language: en
Type: article
Indexed In: ['crossref']
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Cited By Count: 1
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