5PSQ-105 Effectiveness and toxicity profile analysis of antifibrotic agents in idiopathic pulmonary fibrosis

BackgroundNintedanib and pirfenidone are the only antifibrotic agents commercialised for the treatment of idiopathic pulmonary fibrosis (IPF). Both were approved after being compared to placebo, so comparative studies are needed.PurposeTo evaluate the effectiveness and safety of nintedanib and pirfenidone in patients with IPF in real clinical practice.Material and methodsA retrospective observational study including all patients with IPF who started treatment with nintedanib or pirfenidone (March 2015–June 2018) was carried out.Demographics (age, sex), clinical (forced vital capacity (FVC)) and safety (dose reductions, adverse effects (AEs)) variables were collected. Differences in FVC at the end of the study were evaluated with the t-student test.Statistical analysis was carried out using Stata®14.ResultsThroughout the study 67 patients (70% males, median age 71.4±8 years, median FVC 70%±19%) started treatment with nintedanib (n=25) or pirfenidone (n=42). Six patients with nintedanib and five with pirfenidone were excluded for lack of monitoring.The median FVC percentage change at the end of the study was −4.1±9.9% in the nintedanib group and −2.1±10.2% in the pirfenidone group (p=0.48).Nine patients (47%) showed an improvement in FVC during treatment with nintedanib and 17 (46%) with pirfenidone, with a median change of 4.9%±4.6% and 6.6%±6%, respectively. In the other patients, FVC value decreased with a median change of −11.7±6.4% (nintedanib) and −9.5±6.5% (pirfenidone).Five patients treated with nintedanib and nine with pirfenidone would be candidates to discontinue treatment due to a lack of effectiveness, according to discontinuation criteria established at the hospital (absolute decrease of ≥10% in FVC during the first year of treatment).The most frequent AEs related to nintedanib were diarrhoea (60%, n=15), weight loss (32%, n=8) and hepatotoxicity (32%, n=8), whereas with pirfenidone, hepatotoxicity (38%, n=16), gastrointestinal intolerance (33%, n=14) and cutaneous toxicity (26%, n=11).Dose reductions were necessary to manage AEs in 16% of the patients treated with nintedanib and in 26% with pirfenidone.Twelve per cent of the patients discontinued nintedanib due to diarrhoea (n=1), gastrointestinal intolerance (n=1) and cutaneous toxicity (n=1), and 26% pirfenidone due to cutaneous toxicity (n=5), hepatotoxicity (n=3), asthaenia (n=2) and gastrointestinal intolerance (n=1).ConclusionIn our study, nintedanib and pirfenidone have similar effectiv