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Clinical course of mild-to-moderate idiopathic pulmonary fibrosis during therapy with pirfenidone: Results of the
Jens Schreiber1, Wolfgang Schütte2, Wolfgang Koerber3
1Pneumonology, Otto-von-Guericke-Universität Magdeburg, Magdeburg, Germany.
Introduction:
Pirfenidone was the first anti-fibrotic drug approved in Europe in 2011 for the treatment of mild-to-moderate idiopathic pulmonary fibrosis.
Objectives:
To investigate the clinical course of mild-to-moderate idiopathic pulmonary fibrosis in pirfenidone-treated patients in a real-world setting.
Methods:
The non-interventional study was conducted at 18 sites in Germany from 6/2014-12/2016. Adult patients with mild-to-moderate idiopathic pulmonary fibrosis were treated with pirfenidone (escalated from 3×1 to 3×3 capsules of 267 mg/day within 3 weeks) for 12 months. The observation period comprised 4 follow-up visits at months 3, 6, 9 and 12. Disease progression was defined as decrease of ≥10% in vital capacity or ≥15% in diffusing capacity of the lung for carbon monoxide (DLCO) and/or ≥50m in 6-minute walking distance vs. baseline, or "lack of response/progression" as reason for therapy discontinuation.
Results:
A total of 51 patients (80.4% male, mean age 70.6 years) were included in the full analysis set. Disease progression at any visit was reported for 23 (67.6%) of 34 patients with available data. Over the course of the study, lung function parameters, physical resilience, impact of cough severity on quality of life, and the mean Gender, Age and Physiology Index (stage II) remained stable. In total, 29 patients (56.9%) experienced at least one adverse drug reaction (11 patients discontinued due to adverse drug reactions); serious adverse reactions were reported in 12 patients (23.5%).
Conclusions:
The results of this study are in line with the established benefit-risk profile of pirfenidone. Therefore, pirfenidone can be considered a valuable treatment option to slow disease progression in mild-to-moderate idiopathic pulmonary fibrosis. NCT02622477.
Insights
Pirfenidone treatment for mild-to-moderate idiopathic pulmonary fibrosis showed stable lung function and physical resilience in a real-world setting. The drug demonstrated a benefit-risk profile consistent with expectations, supporting its use in slowing disease progression.
Area of Science:
- Pulmonology
- Pharmacology
- Clinical Medicine
Background:
- Pirfenidone is the first anti-fibrotic medication approved for mild-to-moderate idiopathic pulmonary fibrosis (IPF) in Europe since 2011.
- Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease characterized by fibrosis.
Purpose of the Study:
- To evaluate the real-world clinical course of patients with mild-to-moderate IPF treated with pirfenidone.
- To assess the effectiveness and safety of pirfenidone in a non-interventional setting.
Main Methods:
- A non-interventional study conducted across 18 German sites from June 2014 to December 2016.
- Adult patients with mild-to-moderate IPF received pirfenidone, with dose escalation over 3 weeks, for 12 months.
- Disease progression was monitored through lung function tests (vital capacity, DLCO) and the 6-minute walking distance, with follow-up visits at 3, 6, 9, and 12 months.
Main Results:
- Out of 51 patients, 67.6% showed disease progression based on available data.
- Lung function, physical resilience, and quality of life related to cough remained stable throughout the study.
- Adverse drug reactions were reported in 56.9% of patients, leading to discontinuation in 11 patients; 23.5% experienced serious adverse reactions.
Conclusions:
- Pirfenidone's real-world performance aligns with its known benefit-risk profile for mild-to-moderate IPF.
- The study supports pirfenidone as a valuable therapeutic option for slowing disease progression in IPF.
- Clinical trial registration: NCT02622477.
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