Open AccessPost hoc Analysis of Clinical Outcomes in Placebo- and Pirfenidone-Treated Patients with IPF Stratified by BMI and Weight Loss
Author(s) -
S. Jouneau,
Bruno Crestani,
Ronan Thibault,
Mathieu Léderlin,
Laurent Vernhet,
Ming Yang,
Elizabeth Morgenthien,
Klaus-Uwe Kirchgaessler,
Vincent Cottin
Publication year - 2021
Publication title -
respiration
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.264
H-Index - 81
eISSN - 1423-0356
pISSN - 0025-7931
DOI - 10.1159/000518855
Subject(s) - medicine , weight loss , pirfenidone , body mass index , placebo , idiopathic pulmonary fibrosis , vital capacity , weight change , cohort , post hoc analysis , obesity , surgery , diffusing capacity , lung , lung function , alternative medicine , pathology
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 <25 kg/m 2 or annualized weight loss may experience worse outcomes versus those with a baseline BMI ≥25 kg/m 2 or no weight loss. The proportion of placebo-treated patients who experienced a relative decline of ≥10% in %FVC or death up to 1 year post-randomization was highest in patients with a baseline BMI <25 kg/m 2 . Pirfenidone-treated patients with an annualized weight loss ≥5% may also experience worse outcomes versus those with no weight loss. Conclusions: Patients with a baseline BMI <25 kg/m 2 or annualized weight loss of >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.