Registry confirms nintedanib efficacy under real-life conditions

Data from the German INSIGHTS-IPF registry have shown that therapy with nintedanib reduces mortality in idiopathic pulmonary fibrosis (IPF) patients by 37% compared with placebo [1].

Registries are an important tool to assess the efficacy and safety of drugs in a real-world scenario. To assess the effects of nintedanib under real-life conditions, Prof. Jürgen Behr (Ludwig-Maximilian-University Munich, Germany) and his colleagues analysed data from a non-interventional, prospective cohort study of consecutively enrolled IPF patients in 20 interstitial lung disease (ILD) expert centres in Germany, the INSIGHTS-IPF registry.

Data of 588 IPF patients with a disease duration of 1.8 ± 3.4 years were included in the analysis. Propensity scores were applied to account for known differences in baseline characteristics of patients.

During a mean follow-up of 1.2 ± 0.7 years, 33% of patients died. The 1-year and 2-year survival for patients with versus without antifibrotic therapy was 92% versus 78% and 76% versus 63%, respectively. This translates into a 37% lower risk of death in patients treated with antifibrotic therapy (P=0.005). “Our results were robust and remained statistically significant in multivariate analysis,” said Prof. Behr during the presentation of this trial. However, patients on antifibrotic therapy did not differ significantly in the decline of FVC values compared with patients in the placebo group; a difference that might be explained by the observational study design.

The results show that despite relative functional stability, IPF patients without antifibrotic therapy carry an increased risk of death.

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   1. Behr J, et al. Abstract 5404, ERS 2019, 29 Sept-2 Oct, Madrid, Spain.

 



Posted on 28 November 201917 May 2024