Post hoc Analysis of Clinical Outcomes in Placebo- and Pirfenidone-Treated Patients with IPF Stratified by BMI and Weight Loss
S. Jouneau, Bruno Crestani, Ronan Thibault, Mathieu Léderlin, Laurent Vernhet, Ming Yang, Elizabeth Morgenthien, Klaus-Uwe Kirchgaessler, Vincent Cottin
Abstract
<b><i>Background:</i></b> Weight loss is frequently reported in patients with idiopathic pulmonary fibrosis (IPF) and may be associated with worse outcomes in these patients. <b><i>Objective:</i></b> 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. <b><i>Methods:</i></b> 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 (&#x3c;25 kg/m<sup>2</sup>, 25 kg/m<sup>2</sup>–&#x3c;30 kg/m<sup>2</sup>, or ≥30 kg/m<sup>2</sup>) and annualized percent change in body weight (no loss, &#x3e;0–&#x3c;5% loss, or ≥5% loss). <b><i>Results:</i></b> Placebo-treated patients with a baseline BMI &#x3c;25 kg/m<sup>2</sup> or annualized weight loss may experience worse outcomes versus those with a baseline BMI ≥25 kg/m<sup>2</sup> 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 &#x3c;25 kg/m<sup>2</sup>. Pirfenidone-treated patients with an annualized weight loss ≥5% may also experience worse outcomes versus those with no weight loss. <b><i>Conclusions:</i></b> Patients with a baseline BMI &#x3c;25 kg/m<sup>2</sup> or annualized weight loss of &#x3e;0–&#x3c;5% or ≥5% may experience worse outcomes over 1 year versus those with a baseline BMI ≥25 kg/m<sup>2</sup> or no weight loss.