Effect of pamrevlumab on the UCSD-SOBQ (University of California San Diego–Shortness of Breath Questionnaire) in patients with Idiopathic Pulmonary Fibrosis (IPF)

Dyspnea is a meaningful outcome to patients with IPF. Pamrevlumab, a mAb against connective tissue growth factor, has shown favorable safety, efficacy and QoL (SGRQ) results in PRAISE, a Phase 2, placebo-controlled trial. The UCSD-SOBQ is a respiratory questionnaire used in IPF trials, and in a subset of patients in PRAISE. The UCSD-SOBQ assesses dyspnea associated with activities of daily living (ADL). Subjects indicate severity of SOB on a 6-point scale in 21 ADL. Three additional questions ask about fear of harm from overexertion, limitations and fear caused by SOB. A total score ranges from 0 to 120, with higher scores indicating greater impairment. In a subset (N=42) of patients in PRAISE the UCSD-SOBQ was administered at baseline and every 12 weeks. Data were analyzed using ANCOVA, with missing data imputed using the predicted value from a random coefficient linear regression model. Baseline mean values for pamrevlumab and placebo were: age 68.6 and 65.9 years; FVC%-predicted 74.5 and 73.1%; GAP Score 3.5 and 3.2 and similar GAP Stage distribution. The mean baseline UCSD-SOBQ total score was 39.1 and 31.8 points. The between-groups absolute difference from baseline to Week 48 was statistically significant. These UCSD-SOBQ results suggest that pamrevlumab attenuates dyspnea progression in IPF patients in comparison to placebo.