Antifibrotic treatment adherence, efficacy and outcomes for patients with idiopathic pulmonary fibrosis in Spain: a real-world evidence study

BMJ Open Respir Res. 2024 Apr 24;11(1):e001687. doi: 10.1136/bmjresp-2023-001687.

Abstract

Background: Idiopathic pulmonary fibrosis (IPF) is a rare disorder associated with increased mortality and morbidity. There are currently two drugs approved for IPF but their safety and efficacy profile in real-world settings in Spain is not well understood.

Methods: An observational, multicentre, prospective study was carried out among patients with IPF who started treatment with pirfenidone or nintedanib from 2015 to 2021. Data regarding clinical characteristics, drug adherence, safety profiles and clinical outcomes between these two drugs were collected.

Results: 232 patients were included in the analysis. There were no meaningful differences between both groups at baseline. Patients who started pirfenidone showed a decreased risk for treatment withdrawal compared with those starting nintedanib (HR 0.65 (95% CI 0.46 to 0.94; p=0.002)). Time to first adverse event and all-cause mortality was similar between study groups. Risk factors for withdrawal were female sex, diarrhoea and photosensitivity.

Conclusions: in this real-world study, both pirfenidone and nintedanib showed similar efficacy profiles. Pirfenidone was associated with less treatment discontinuations due to side effects.

Keywords: interstitial fibrosis.

Publication types

  • Observational Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Antifibrotic Agents / therapeutic use
  • Female
  • Humans
  • Idiopathic Pulmonary Fibrosis* / drug therapy
  • Idiopathic Pulmonary Fibrosis* / mortality
  • Indoles* / adverse effects
  • Indoles* / therapeutic use
  • Male
  • Medication Adherence / statistics & numerical data
  • Middle Aged
  • Prospective Studies
  • Pyridones* / adverse effects
  • Pyridones* / therapeutic use
  • Spain
  • Treatment Outcome

Substances

  • pirfenidone
  • nintedanib
  • Pyridones
  • Indoles
  • Antifibrotic Agents