Article Text

P8 Pooled analysis of data from the TOMORROW and INPULSIS® trials of nintedanib in IPF
  1. L Richeldi1,
  2. KK Brown2,
  3. V Cottin3,
  4. M Selman4,
  5. T Kimura5,
  6. S Stowasser5
  1. 1National Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton, UK
  2. 2National Jewish Health, Denver, Colorado, USA
  3. 3Louis Pradel Hospital, University of Lyon, Lyon, France
  4. 4Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico
  5. 5Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim Am Rhein, Germany


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.

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