Pneumologie 2016; 70 - P368
DOI: 10.1055/s-0036-1571996

Pooled analysis of data from the TOMORROW and INPULSIS® trials of nintedanib in IPF

C Neurohr 1, L Richeldi 2, V Cottin 3, M Selman 4, T Kimura 5, S Stowasser 5, KK Brown 6
  • 1Ludwig-Maximilians-Universität, Member of the German Center of Lung Research (Dzl), Munich, Germany; Presenting on Behalf of the Authors
  • 2National Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton, UK
  • 3Louis Pradel Hospital, University of Lyon, France
  • 4Instituto Nacional de Enfermedades Respiratorias, Mexico City
  • 5Boehringer Ingelheim Pharma GmbH & Co. Kg, Ingelheim am Rhein
  • 6National Jewish Health, Denver, Colorado, USA

Background: The 52-week, Phase II TOMORROW trial and two replicate 52-week, Phase III INPULSIS® trials investigated the efficacy and safety of nintedanib 150 mg twice daily (bid) versus placebo in patients with idiopathic pulmonary fibrosis (IPF).

Aim: A pooled analysis of data from the TOMORROW and INPULSIS® trials was conducted to obtain a more precise estimate of the treatment effect of nintedanib.

Methods: Results for annual rate of decline in forced vital capacity (FVC), time to first investigator-reported acute exacerbation, change from baseline in St George's Respiratory Questionnaire (SGRQ) total score and mortality over 52 weeks were analysed.

Results: 1231 patients (nintedanib 150 mg bid n = 723, placebo n = 508, reflecting the 3:2 randomisation in the INPULSIS® trials) were included. Baseline characteristics were comparable between treatment groups and across trials. The overall adjusted annual rate of decline in FVC was –112.4 mL/year with nintedanib and –223.3 mL/year with placebo (difference: 110.9 mL/year [95% CI: 78.5, 143.3]; p < 0.0001). The overall hazard ratio for time to first acute exacerbation was 0.53 (95% CI: 0.34, 0.83; p = 0.0047) in favour of nintedanib. The overall adjusted mean change from baseline in SGRQ total score at week 52 was 2.92 with nintedanib and 4.97 with placebo (difference: –2.05 [95% CI: –3.59, –0.50; p = 0.0095]). Hazard ratios for time to all-cause and on-treatment mortality were 0.70 (95% CI: 0.46, 1.08; p = 0.0954) and 0.57 (95% CI: 0.34, 0.97; p = 0.0274), respectively, in favour of nintedanib.

Conclusion: Pooled data from the TOMORROW and INPULSIS® trials confirm a significant beneficial effect of nintedanib on reducing disease progression in patients with IPF.