TY - JOUR T1 - Safety and tolerability of nintedanib in patients with fibrosing interstitial lung diseases: pooled data from four trials JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.congress-2021.PA2539 VL - 58 IS - suppl 65 SP - PA2539 AU - Claudia Valenzuela AU - Shervin Assassi AU - Francesco Bonella AU - Toby M Maher AU - Lazaro Loaiza AU - Inga Tschoepe AU - Leticia Orsatti AU - Martin Kolb Y1 - 2021/09/05 UR - http://erj.ersjournals.com/content/58/suppl_65/PA2539.abstract N2 - Background: The effects of nintedanib have been investigated in trials across progressive fibrosing ILDs.Aim: To characterise the safety and tolerability of nintedanib in patients with fibrosing ILDs using pooled data from four clinical trials.Methods: Data were pooled from Phase III trials in subjects with idiopathic pulmonary fibrosis (INPULSIS-1 and -2), other progressive fibrosing ILDs (INBUILD), and systemic sclerosis-associated ILD (SENSCIS). Subjects were randomised to receive nintedanib 150 mg bid or placebo. Dose reductions to 100 mg bid and treatment interruptions were allowed to manage adverse events. All adverse events reported by investigators, irrespective of causality, over 52 weeks were analysed.Results: Mean (SD) exposure to nintedanib was 10.3 (3.5) months (n=1258) and to placebo was 11.1 (2.7) months (n=1042). Maximum exposure was 13 months in both groups. In the nintedanib and placebo groups, respectively, adverse events that led to dose reduction occurred in 24.6% and 2.5% of patients, and adverse events that led to permanent treatment discontinuation occurred in 18.7% and 10.9% of patients. In the nintedanib and placebo groups, respectively, diarrhoea was reported in 66.3% and 23.8% of patients, led to dose reduction in 14.7% and 0.6% of patients, and led to permanent treatment discontinuation in 5.4% and 0.3% of patients.Conclusions: In clinical trials, the adverse events associated with nintedanib were manageable for most patients with progressive fibrosing ILDs. Diarrhoea was the most frequent adverse event in patients treated with nintedanib but was managed without treatment discontinuation in most patients.FootnotesCite this article as: European Respiratory Journal 2021; 58: Suppl. 65, PA2539.This abstract was presented at the 2021 ERS International Congress, in session “Prediction of exacerbations in patients with COPD”.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). ER -