Long-term tolerability of real-life use of antifibrotic agents (AFA) in Idiopathic Pulmonary Fibrosis (IPF)

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Introduction: The AFA pirfenidone and nintedanib are approved for the treatment of IPF in the EU and USA. Drug tolerability is key for long term adherence and persistence. Aims: To assess real life tolerability of AFA based on PROOF-NEXT registry Methods: PROOF-NEXT is a longitudinal registry of IPF patients enrolled between 10/2013 and 8/2020 from 8 centers in Belgium and 1 in Luxembourg. This analysis includes all patients treated with AFA with follow up data available. Results: Of the 692 registered patients (77% male, median age 72 years), 622 (90%) were treated with AFA (74% pirfenidone, 40% nintedanib, 14% switched between both). The mean number of months exposed to pirfenidone was 28 months and 18 months to nintedanib. Over a 5 year period, 15.8% of patients discontinued pirfenidone treatment due to adverse drug reactions (ADR) and 13.5% discontinued nintedanib. ADR mostly occur in the 1st year (figure 1). Gastrointestinal complaints are the most reported reasons for dose reductions and discontinuation of both AFA (figure 2). Conclusions: Tolerance of AFA in real-life is in line with findings in clinical trials.

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