Pre-specified subgroup analyses of pooled data from the INPULSIS™ trials of nintedanib in idiopathic pulmonary fibrosis

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Background: The two replicate randomized, double-blind, placebo-controlled, 52-week Phase III INPULSIS™ trials assessed the efficacy and safety of nintedanib 150 mg twice daily in patients with IPF. Nintedanib significantly reduced the annual rate of decline in forced vital capacity (FVC) in mL/year, the primary endpoint, in both trials (p < 0.001 for both), consistent with slowing disease progression. Statistically significant differences in favour of nintedanib on the key secondary endpoints (time to first acute exacerbation and change from baseline in St George's Respiratory Questionnaire [SGRQ] total score over 52 weeks) were observed in INPULSIS™-2, but not in INPULSIS™-1. Methods: Subgroup analyses were conducted for the primary and key secondary endpoints using pooled data from both trials. Pre-specified subgroups included gender, age (< 65, ≥65 years), race (White, Asian), baseline FVC % predicted (≤70%, > 70%), baseline SGRQ total score (≤40, > 40), smoking status (never, ex/current), baseline corticosteroid use (yes, no) and baseline bronchodilator use (yes, no). Results: A total of 1061 patients were treated in the INPULSIS™ trials (n= 638 in the nintedanib group, n= 423 in the placebo group). Mean age was 66.8 years, 79.3% were male, mean FVC % predicted was 79.6%. Baseline characteristics were comparable between the treatment groups. No significant treatment by subgroup interaction was observed for the primary (Figure) or key secondary endpoints, indicating consistency of the results for these endpoints across subgroups. Conclusion: Analyses of pooled data from the INPULSIS™ trials suggest a consistent effect of nintedanib on slowing disease progression across pre-specified subgroups of patients defined by baseline characteristics. Presented at ICLAF 2014

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