Introduction The INPULSIS® trials assessed the efficacy and safety of nintedanib 150 mg twice daily in patients with idiopathic pulmonary fibrosis. Nintedanib significantly reduced the annual rate of decline in forced vital capacity (FVC) compared with placebo in both trials. Patients who completed the 52-week treatment period and follow-up visit 4 weeks later (n = 807) could receive open-label nintedanib in an extension trial.
Aim To assess the long-term efficacy and safety of nintedanib.
Methods Patients treated with placebo in the INPULSIS® trials initiated treatment with nintedanib in the extension; patients treated with nintedanib continued to receive nintedanib.
Results 734 patients were treated in the extension trial (430 continuing nintedanib; 304 initiating nintedanib). Baseline characteristics were similar between groups. For patients initiating nintedanib, mean (SD) duration of exposure was 16.0 (7.3) months; for patients continuing nintedanib, mean (SD) duration of exposure in the extension was 17.2 (6.6) months, resulting in a mean (SD) duration of exposure across the parent and extension trial of 29.2 (6.6) months. Among all patients treated in the extension, mean (SD) change in FVC from the start of the extension to week 48 was -87 (240) mL (-1.95 [7.09]% FVC predicted). In total, 92.8% of patients continuing nintedanib and 96.7% initiated on nintedanib had ≥1 adverse event during the extension. The most frequent adverse event was diarrhoea, reported in 63.3% of patients continuing nintedanib and 64.1% of patients initiated on nintedanib.
Conclusion An interim analysis of data from the INPULSIS®-ON extension trial confirmed the efficacy and safety observed in the INPULSIS® trials.
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