No effect of danazol treatment in patients with advanced idiopathic pulmonary fibrosis

Thijs W. Hoffman, Coline H.M. van Moorsel, Joanne J. van der Vis, Douwe H. Biesma, Jan C. Grutters
In: ERJ Open Research · 2023 · vol. 9(5) , pp. 00131–2023 · doi:10.1183/23120541.00131-2023 · PMID:37753281 · W4387018373
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This observational study found that danazol treatment in advanced idiopathic pulmonary fibrosis patients did not slow lung function decline and caused significant side effects.

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Abstract

Background: Telomere dysfunction can underly the development of idiopathic pulmonary fibrosis (IPF), and recent work suggests that patients with telomere syndromes might benefit from treatment with androgens, such as danazol. Methods: This was a prospective observational cohort study. 50 patients with IPF received off-label treatment with danazol after they showed progressive disease under treatment with pirfenidone or nintedanib. The primary outcome was the difference in yearly decline in forced vital capacity (FVC) prior to (pre) and after (post) start of treatment with danazol. Results: post 198 mL (95% CI 16-380); p=0.04). Median survival post danazol was 14.9 months (95% CI 11.0-18.8). Conclusion: Danazol as a treatment of last resort in patients with IPF did not lead to slowing of lung function decline and was associated with significant side-effects. It remains to be determined if earlier treatment or treatment of specific patient subgroups is beneficial.

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