PRAISE IPF study correlation between quantitative lung fibrosis (QLF) measured by quantitative high resolution computed tomography (qHRCT) and quality of life (QoL) assessed by St. George’s respiratory questionnaire (SGRQ)

Patient-reported outcomes (PROs) are key in assessing health-related QoL with SGRQ as one of the most common tools in IPF. qHRCT is used to diagnose IPF and assess treatment effect and disease progression. Pamrevlumab, a mAb against connective tissue growth factor, has shown favorable efficacy and safety results in PRAISE, a Phase 2, double-blind, placebo-controlled clinical study (NCT01890265) in IPF. To evaluate the correlation between changes from baseline to Week 48 in QLF and SGRQ total score, 103 IPF patients were randomized to pamrevlumab (N=50) 30 mg/kg or placebo (N=53) and followed for 48 weeks. HRCT scans were performed at baseline, and Weeks 24 and 48. SGRQ was completed at baseline and every 12 weeks thereafter. At Week 48, 71 subjects (pamrevlumab=36, placebo=35) had both SGRQ and qHRCT results available. Subject baseline characteristics were comparable with mean values for pamrevlumab and placebo, age 68.3 and 68.2 yrs; FVC%-predicted 74.5% and 72.8%; SGRQ total score 42.7 and 41.5, QLF volume (mL) 520.5 and 578.4, QLF score 13.9% and 14.7% respectively, with similar GAP score and GAP stage distribution. A positive correlation was observed between changes in SGRQ total score and QLF volume (Spearman corr=0.27, p=0.0235) and QLF (%) (Spearman corr=0.30, p=0.0125). In PRAISE, a statistically significant correlation was observed between SGRQ total score and the qHRCT (QLF) similar to the previously confirmed correlation between QLF score and ppFVC. Further confirmation may be needed.