RT Journal Article
SR Electronic
T1 Fatigue in patients with idiopathic pulmonary fibrosis (IPF) from the pooled pirfenidone (PFD) Phase III trials
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP PA4875
DO 10.1183/1393003.congress-2017.PA4875
VO 50
IS suppl 61
A1 Ulrich Costabel
A1 Carlo Albera
A1 Marlies S. Wijsenbeek
A1 Joao A. de Andrade
A1 Wendi R. Mason
A1 Steven D. Nathan
A1 Joseph D. Zibrak
A1 Maria L. Padilla
A1 Frank Gilberg
A1 Ute Petzinger
A1 Klaus-Uwe Kirchgaessler
A1 Lisa H. Lancaster
YR 2017
UL http://erj.ersjournals.com/content/50/suppl_61/PA4875.abstract
AB Background: Fatigue is often reported as an adverse event (AE) in patients (pts) with IPF treated with PFD but is also an important symptom of IPF.Objective: To compare fatigue in pts with IPF receiving PFD or placebo (PBO) in the Phase III CAPACITY and ASCEND trials.Methods: All pts who received PFD 2403 mg/day (n=623) or PBO (n=624) from the pooled Phase III trials were analyzed to describe the frequency and time course of fatigue AEs using descriptive statistics and time-to-event analyses.Results: Fatigue AEs occurred in 162 pts treated with PFD (26.0%) and 119 with PBO (19.1%). Moderate and severe fatigue occurred in 67 (10.8%) and 7 (1.1%) PFD pts vs 26 (4.2%) and 5 (0.8%) PBO pts, respectively. Dose modification occurred following 17.6% of fatigue AEs with PFD (39/222) vs 7.0% (10/142) with PBO. Fatigue occurred sooner after randomization (median [IQR], 30.5 [13.0-231.0] vs 36.0 [7.0-168.0] days) and for shorter duration (64.0 [7.0-214.5] vs 109.5 [24.0-267.0] days) in the PFD vs PBO groups, respectively (Figure). There were no meaningful differences in baseline characteristics between pts with fatigue vs those without in either PFD or PBO groups.Conclusions: Fatigue AEs tended to be more frequent, shorter and slightly more severe in pts with IPF treated with PFD vs PBO. A fatigue questionnaire to quantitatively assess fatigue in pts with IPF might be considered in future IPF trials.