%0 Journal Article %A Vincent Cottin %A Tamera J. Corte %A Michael Kreuter %A Maria Molina-Molina %A Judit Axmann %A Frank Gilberg %A Klaus-Uwe Kirchgaessler %A Toby M. Maher %T Pirfenidone in unclassifiable ILD (uILD): subgroup analysis of patients with/without a surgical lung biopsy (SLB) %D 2020 %R 10.1183/13993003.congress-2020.1802 %J European Respiratory Journal %P 1802 %V 56 %N suppl 64 %X Introduction: SLB is recommended when HRCT is inconclusive, but in many cases, it is not a feasible option.Aims and Objectives: Baseline characteristics, efficacy and safety of pirfenidone were assessed in patients with uILD who did/did not ever have SLB.Methods: This was a subgroup analysis of a double-blind, randomised, placebo-controlled Phase II trial (NCT03099187). Assessments included demographic/disease characteristics, FVC, DLco and 6MWD decline, and AE incidence over 24 weeks.Results: 253 patients were randomised: 88 had SLB (n=40 pirfenidone; n=48 placebo) and 165 had no SLB (n=87 pirfenidone; n=78 placebo). Patients with SLB were younger with higher baseline 6MWD and fewer vascular and cardiovascular comorbidities vs those with no SLB (Table). Pirfenidone was associated with reduced FVC decline vs placebo in the SLB (–72.9 vs –146.3 mL, respectively) and no SLB subgroups (8.4 vs –92.0 mL, respectively; Table). AE and SAE incidences were similar between subgroups.Conclusions: Patients with SLB were younger, had higher baseline 6MWD, had fewer vascular and cardiovascular comorbidities, and had faster ILD progression over 24 weeks vs patients with no SLB (irrespective of treatment). Pirfenidone potentially had a comparable treatment benefit on FVC change in mL in the SLB and no SLB subgroups. These results merit further study in other cohorts.FootnotesCite this article as: European Respiratory Journal 2020; 56: Suppl. 64, 1802.This abstract was presented at the 2020 ERS International Congress, in session “Respiratory viruses in the "pre COVID-19" era”.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). %U