Seasonal flares of disease activity that can lead to idiopathic pulmonary fibrosis (IPF) patients being hospitalized, especially in the winter months, appear to be effectively countered by treatment with Esbriet (pirfenidone) compared to placebo, a new retrospective analysis of data from Phase 3 clinical trials shows.
Results were presented by Brett Ley, MD, a pulmonologist at University of California San Francisco, in the poster, “The Effect of Season on Hospitalization and Mortality in Patients with Idiopathic Pulmonary Fibrosis Treated with Pirfenidone Versus Placebo” at the 2018 American Thoracic Society (ATS) International Conference held May 18-23 in San Diego, California.
Seasonal patterns of disease activity are common in chronic lung diseases, with winter months typically being a period of peak activity in IPF and other pulmonary fibrosis patients.
In their study, researchers analyzed data from Phase 3 trials testing Esbriet (marketed by Genentech) against placebo in IPF patients — the ASCEND (NCT01366209) and CAPACITY (NCT00287729 and NCT00287716) studies — to determine if the season influenced hospitalization and mortality rates in this patient population.
Specifically, they looked at seasonal effects on respiratory-related and non-respiratory-related hospitalizations, and deaths linked to respiratory problems, across 12 months.
The opening of each season was set in the study as March 22 (spring), June 22 (summer), Sept. 22 (fall), and Dec. 22 (winter). Within each season, researchers compared clinical outcomes between placebo and 623 Esbriet-treated IPF patients and 624 given placebo.
Analysis showed that placebo-treated patients had a significant trend for a seasonal effect in respiratory-related hospitalizations or deaths — while no significant trend was observed among Esbriet-treated patients.
During winter months, in particular, placebo-treated patients had a 52% higher rate of respiratory hospitalizations compared to those given Esbriet.
Season changes did not at influence the rate of non-respiratory hospitalizations in either group, placebo or Esbriet, the study reported.
“In patients with IPF who received placebo in the ASCEND and CAPACITY studies, more respiratory hospitalizations and respiratory-related hospitalizations or deaths from any cause were observed in Fall and Winter than in Spring and Summer,” the researches concluded. “Pirfenidone [Esbriet] appears to blunt seasonal peaks in respiratory hospitalizations.”