RT Journal Article
SR Electronic
T1 Inhaled pirfenidone is associated with better quality of life scores in idiopathic pulmonary fibrosis
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 4625
DO 10.1183/13993003.congress-2022.4625
VO 60
IS suppl 66
A1 Kim, G
A1 Goldin, J
A1 Woodhead, F
A1 Thompson, C N
A1 Shaffer, M
A1 Otto, K
A1 Montgomery, B
YR 2022
UL https://publications.ersnet.org//content/60/suppl_66/4625.abstract
AB Introduction: AP01 is a novel formulation of inhaled pirfenidone with potentially improved efficacy and reduced toxicity compared to oral pirfenidone in Idiopathic Pulmonary Fibrosis (IPF).The serial change in Quantitative Lung Fibrosis (ΔQLF) on thoracic High-Resolution Computed Tomography (HRCT) correlates with changes in FVC. Correlation of longitudinal changes in quality of life (QOL) and ΔQLF is less established.Objective: AP01-002 was a Phase 1b trial comparing the safety and tolerability of AP01 50mg once daily (od) and 100mg twice daily (bd) in IPF.Methods: 91 patients were randomized to receive AP01 50 mg od or 100 mg bd. HRCTs were performed at baseline and 24 weeks. Forced Vital Capacity (FVC), and QOL measures, such as the King’s Brief Interstitial Lung Disease (KBILD) questionnaire, were collected. QLF improvement was defined as a > 2% reduction in QLF score from baseline to 24 weeks. KBILD Minimal Clinically Important Difference (MCID) is 5 points.Results: 69 patients underwent baseline and week 24 HRCT scans with appropriate image quality for analysis. The mean slope FVC decline at 48 weeks was 187 ml with 50mg od (n=38) and 57 ml with 100mg bd (n=31) AP01. Similar proportions on both regimes had a reduction in QLF (16% on 50mg od; 16% on 100mg bd) and QLF stabilization (47% 50 mg od; 55% 100mg bd). ΔQLF and change in FVC showed stronger correlation in 100mg bd. Subjects with improved QLF had higher average KBILD total scores from baseline. This was apparent from week 8 (8 points) and sustained until week 48 (>20 points) in 100 mg bd.Conclusion: This study shows a strong and lasting association between HRCT response and KBILD, a validated and meaningful study endpoint.FootnotesCite this article as Eur Respir J 2022; 60: Suppl. 66, 4625.This article was presented at the 2022 ERS International Congress, in session “-”.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).