LAUSR

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.