Benefit of continued pirfenidone treatment following hospitalisation within the first 6 months of therapy—Ad hoc analysis from three phase 3 trials in patients with idiopathic pulmonary fibrosis (IPF)

Abstract

Background: The assessment of therapeutic response and the management of patients with IPF who experience progression during treatment represent distinct clinical challenges. Notably, there is limited evidence to inform clinicians on whether treatment should be continued or adjusted in patients following hospitalisation.

Objective: To evaluate the effect of continued pirfenidone treatment after 6 months in patients with IPF who were hospitalised due to any cause within the first 6 months of study treatment.

Methods: Source data included all patients randomised to pirfenidone 2403 mg/d or placebo in the ASCEND and CAPACITY studies (N = 1247). From these, we identified all patients who were hospitalised due to any cause within the first 6 months of study treatment and assessed FVC and mortality outcomes during the next 6 months of continued treatment.

Results: A total of 44/623 (7.1%) and 49/624 (7.9%) patients in the pooled pirfenidone and placebo groups, respectively, were hospitalised due to any cause within the first 6 months of treatment. Outcomes after 6 months of continued treatment following hospitalisation are shown in the Table.

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Conclusions: These results suggest that continued treatment with pirfenidone may confer a benefit to patients with IPF who are hospitalised within the first 6 months of treatment.