Efficacy and safety of Oleogel-S10 (birch triterpenes) for epidermolysis bullosa: results from the phase III randomized double-blind phase of the EASE study

Epidermolysis bullosa (EB) is a heterogeneous group of rare, difficult-to-treat, inherited multisystem diseases affecting epithelial integrity. Patients with EB are affected by mechanical fragility of epithelial surfaces including the skin and, as a result, extensive recurrent blistering is a charac...

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Published in:British journal of dermatology (1951) 2023-01, Vol.188 (1), p.12-21
Main Authors: Kern, Johannes S, Sprecher, Eli, Fernandez, Maria Florencia, Schauer, Franziska, Bodemer, Christine, Cunningham, Tracy, Löwe, Sandra, Davis, Charles, Sumeray, Mark, Bruckner, Anna L, Murrell, Dédée F
Format: Article
Language:English
Subjects:
Betula
Double-Blind Method
Epidermolysis Bullosa
Epidermolysis Bullosa Dystrophica
Humans
Triterpenes
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container_title British journal of dermatology (1951)
container_volume 188
creator Kern, Johannes S
Sprecher, Eli
Fernandez, Maria Florencia
Schauer, Franziska
Bodemer, Christine
Cunningham, Tracy
Löwe, Sandra
Davis, Charles
Sumeray, Mark
Bruckner, Anna L
Murrell, Dédée F
description Epidermolysis bullosa (EB) is a heterogeneous group of rare, difficult-to-treat, inherited multisystem diseases affecting epithelial integrity. Patients with EB are affected by mechanical fragility of epithelial surfaces including the skin and, as a result, extensive recurrent blistering is a characteristic of the condition. Chronic wounds predispose patients with EB to the development of squamous cell carcinoma, which is a major cause of premature death. EASE was a double-blind, randomized, vehicle-controlled, phase III study to determine the efficacy and safety of the topical gel Oleogel-S10 (birch triterpenes) in EB. EASE was funded by Amryt Research Limited. Patients with dystrophic EB, junctional EB or Kindler EB and a target partial-thickness wound lasting ≥ 21 days and
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Patients with EB are affected by mechanical fragility of epithelial surfaces including the skin and, as a result, extensive recurrent blistering is a characteristic of the condition. Chronic wounds predispose patients with EB to the development of squamous cell carcinoma, which is a major cause of premature death. EASE was a double-blind, randomized, vehicle-controlled, phase III study to determine the efficacy and safety of the topical gel Oleogel-S10 (birch triterpenes) in EB. EASE was funded by Amryt Research Limited. Patients with dystrophic EB, junctional EB or Kindler EB and a target partial-thickness wound lasting ≥ 21 days and &lt; 9 months that was 10-50 cm2, were enrolled and randomized via computer-generated allocation tables 1 : 1 to Oleogel-S10 or control gel - both with standard-of-care dressings. Study gel was applied to all wounds at least every 4 days. The primary endpoint was the proportion of patients with first complete closure of target wound within 45 days. A total of 223 patients were enrolled and treated (109 treated with Oleogel-S10, 114 with control gel). The primary endpoint was met; Oleogel-S10 resulted in 41·3% of patients with first complete target wound closure within 45 days, compared with 28·9% in the control gel arm (relative risk 1·44, 95% confidence interval (CI) 1·01-2·05; P = 0·013). Adverse events (AEs) occurred with similar frequency for Oleogel-S10 (81·7%) compared with control gel (80·7%). AEs were predominantly of mild-to-moderate intensity (4·6% were severe). Oleogel-S10 is the first therapy to demonstrate accelerated wound healing in EB. 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subjects Betula
Double-Blind Method
Epidermolysis Bullosa
Epidermolysis Bullosa Dystrophica
Humans
Triterpenes
title Efficacy and safety of Oleogel-S10 (birch triterpenes) for epidermolysis bullosa: results from the phase III randomized double-blind phase of the EASE study
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