34650 Correlation between wound burden and procedural pain in patients with EB ≥4 years of age: An exploratory analysis from the EASE study

Abstract

Epidermolysis bullosa (EB) is a rare, multisystem genetic disease that results in patients having severe wound burden and pain. EASE was a prospective, randomized, phase 3, double-blind, controlled study evaluating Oleogel-S10 (birch triterpenes) efficacy and safety vs control gel in EB (DEB and JEB). EASE met its primary endpoint with a higher percentage of patients having complete target wound closure by Day 45 with Oleogel-S10 vs control gel (P = .013). An exploratory analysis of the double-blind phase was carried out to determine a correlation between total wound burden (EBDASI and BSAP) and procedural pain (Wong-Baker FACES) in patients ≥4 years. At baseline, an association was observed between EBDASI skin activity and procedural pain. At each study visit (Day 30, 60, and 90) this remained the case with the strongest correlation being observed at Day 90, where a correlation between EBDASI and procedural pain was observed with Oleogel-S10 and control gel (Pearson: n = 78; r = 0.333; P = .003 and n = 80; r = 0.283; P = .011, respectively). In patients with RDEB a correlation between EBDASI and procedural pain was observed with Oleogel-S10 at Day 90 (Pearson: n = 66; r = 0.399; P < .001). The association with BSAP and procedural pain was weaker; however, it was most apparent at Day 90 in all patients and RDEB patients within the Oleogel-S10 arm (Pearson: n = 79; r = 0.240; P = .033 and n = 66; r = 0.300; P = .014, respectively). There is a correlation between total wound burden and procedural pain in patients with EB. Decreasing total wound burden is clinically meaningful for patients with this intractable disease.