Long-term Effectiveness of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis Is Independent of Baseline Forced Vital Capacity

Abstract

SESSION TITLE: Treatment of IPF SESSION TYPE: Original Investigation Slide PRESENTED ON: Monday, October 24, 2016 at 07:30 AM - 08:30 AM PURPOSE: A pooled analysis of data from the Phase III CAPACITY trials demonstrated that the effect of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) was independent of baseline percent predicted forced vital capacity (FVC). The objective of this analysis was to further examine the course of FVC during long-term treatment with pirfenidone in patients stratified by intervals of baseline percent predicted FVC in RECAP, a long-term extension study of the CAPACITY trials. METHODS: Patients in CAPACITY were randomized to receive placebo or pirfenidone; patients enrolled in RECAP then received open-label pirfenidone 2403 mg/day. Patients who entered RECAP were stratified by intervals of baseline percent predicted FVC (< 50%, 50% to < 60%, 60% to < 70%, 70% to < 80%, 80% to < 90% and ≥ 90%), reflecting their end-of-study FVC during the blinded treatment period in CAPACITY. Further changes in percent predicted FVC in RECAP were analyzed for up to 180 weeks of follow-up using descriptive statistics, with slope analyses including prior treatment as a covariate. Patients with missing baseline FVC values in RECAP were excluded from analysis. RESULTS: Of the 603 patients who completed the CAPACITY studies and enrolled in RECAP, 584 patients with baseline FVC values were included in this analysis. The further course of percent predicted FVC decline was very similar with slow progression across all patient groups when stratified by baseline percent predicted FVC. During the period of up to 180 weeks of follow-up in RECAP, the annual rates of FVC decline (standard error) stratified by baseline FVC were as follows: FVC < 50%, −0.71% (0.108); FVC 50% to < 60%, −1.13% (0.114); FVC 60% to < 70%, −1.24% (0.099); FVC 70% to < 80%, −1.09% (0.092); FVC 80% to < 90%, −1.10% (0.128); and FVC ≥ 90%, −1.10% (0.114). CONCLUSIONS: Among patients with IPF who completed the CAPACITY studies and enrolled in RECAP, there was no trend in efficacy differences by baseline FVC during the period of up to 180 weeks of follow-up. CLINICAL IMPLICATIONS: These observations suggest that the effectiveness of long-term treatment with pirfenidone for > 3 years was independent of baseline FVC. DISCLOSURE: Carlo Albera: Grant monies (from industry related sources): Roche/Genentech, Consultant fee, speaker bureau, advisory committee, etc.: Roche/Genentech Klaus-Uwe Kirchgaessler: Employee: Roche Frank Gilberg: Employee: Roche Ute Petzinger: Employee: Accovion GmbH Ulrich Costabel: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer Ingelheim, Roche/Genentech, Bayer, Gilead, GSK, Centocor The following authors have nothing to disclose: Paul Noble No Product/Research Disclosure Information