Safety and tolerability of nintedanib in patients with fibrosing interstitial lung diseases: pooled data from four trials

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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.

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