Nintedanib in patients with idiopathic pulmonary fibrosis: Combined evidence from the TOMORROW and INPULSIS®trials

Luca Richeldi, Vincent Cottin, Roland M. Du Bois, Moisés Selman, Toshio Kimura, Zelie Bailes, Rozsa Schlenker-Herceg, Susanne Stowasser, Kevin K. Brown

Risultato della ricerca: Contributo in rivistaArticolo in rivista

211 Citazioni (Scopus)

Abstract

Background and purpose: The Phase II TOMORROW trial and two Phase III INPULSIS®trials investigated the efficacy and safety of nintedanib versus placebo in patients with idiopathic pulmonary fibrosis (IPF). To obtain an overall estimate of the treatment effect of nintedanib 150 mg twice daily (bid), pooled and meta-analyses of data from these three trials were conducted. Methods: Pooled and meta-analyses were conducted for annual rate of decline in forced vital capacity (FVC), time to first acute exacerbation, change from baseline in St George's Respiratory Questionnaire (SGRQ) total score and mortality over 52 weeks. Results: 1231 patients (nintedanib n = 723, placebo n = 508) were included in the pooled analysis. 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 hazard ratio for time to first acute exacerbation was 0.53 (95% CI: 0.34, 0.83; p = 0.0047). Adjusted mean change from baseline in SGRQ 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. The meta-analysis was generally consistent with the pooled analysis. Diarrhoea was the most frequent adverse event in the nintedanib group (61.5% of patients treated with nintedanib versus 17.9% of patients treated with placebo). Conclusion: Nintedanib has a beneficial effect on slowing disease progression in patients with IPF.
Lingua originaleEnglish
pagine (da-a)74-79
Numero di pagine6
RivistaRespiratory Medicine
Volume113
DOI
Stato di pubblicazionePubblicato - 2016

Keywords

  • Acute exacerbations
  • Aged
  • Clinical Trials, Phase II as Topic
  • Clinical Trials, Phase III as Topic
  • Diarrhea
  • Disease progression
  • Drug Administration Schedule
  • Enzyme Inhibitors
  • Female
  • Forced vital capacity
  • Humans
  • Idiopathic Pulmonary Fibrosis
  • Indoles
  • Male
  • Middle Aged
  • Mortality
  • Pulmonary and Respiratory Medicine
  • Quality of life
  • Randomized Controlled Trials as Topic
  • Treatment Outcome
  • Vital Capacity

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