Post hoc Analysis of Clinical Outcomes in Placebo- and Pirfenidone-Treated Patients with IPF Stratified by BMI and Weight Loss

Background: Weight loss is frequently reported in patients with idiopathic pulmonary fibrosis (IPF) and may be associated with worse outcomes in these patients. Objective: The aim of this study was to investigate the relationships between body mass index (BMI) and weight loss, and outcomes over 1 year in patients with IPF. Methods: Data were included from placebo patients enrolled in ASCEND (NCT01366209) and CAPACITY (NCT00287716 and NCT00287729), and all patients in INSPIRE (NCT00075998) and RIFF Cohort A (NCT01872689). An additional analysis included data from pirfenidone-treated patients. Outcomes (annualized change in percent predicted forced vital capacity [%FVC], percent predicted carbon monoxide diffusing capacity, 6-min walk distance, St. George's Respiratory Questionnaire total score, hospitalization, mortality, and serious adverse events) were analyzed by baseline BMI (<25 kg/m(2), 25 kg/m(2)-<30 kg/m(2), or >= 30 kg/m(2)) and annualized percent change in body weight (no loss, >0-<5% loss, or >= 5% loss). Results: Placebo-treated patients with a baseline BMI Conclusions: Patients with a baseline BMI 0-<5% or >= 5% may experience worse outcomes over 1 year versus those with a baseline BMI >= 25 kg/m(2) or no weight loss.

Automated summary

This study examined the relationships between BMI, weight loss, and outcomes over 1 year in IPF patients, finding that patients with a baseline BMI <25 kg/m(2) and weight loss may experience worse outcomes over 1 year.