PT  - JOURNAL ARTICLE
AU  - Ulrich Costabel
AU  - Carlo Albera
AU  - Marlies S. Wijsenbeek
AU  - Joao A. de Andrade
AU  - Wendi R. Mason
AU  - Steven D. Nathan
AU  - Joseph D. Zibrak
AU  - Maria L. Padilla
AU  - Frank Gilberg
AU  - Ute Petzinger
AU  - Klaus-Uwe Kirchgaessler
AU  - Lisa H. Lancaster
TI  - Fatigue in patients with idiopathic pulmonary fibrosis (IPF) from the pooled pirfenidone (PFD) Phase III trials
AID  - 10.1183/1393003.congress-2017.PA4875
DP  - 2017 Sep 01
TA  - European Respiratory Journal
PG  - PA4875
VI  - 50
IP  - suppl 61
4099  - http://erj.ersjournals.com/content/50/suppl_61/PA4875.short
4100  - http://erj.ersjournals.com/content/50/suppl_61/PA4875.full
SO  - Eur Respir J2017 Sep 01; 50
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.