The British Journal of Dermatology publishes results from EASE phase III trial of of Filsuvez in epidermolysis bullosa

EASE is the largest Phase III, randomised, controlled study in Epidermolysis Bullosa (EB), that examined the efficacy and safety of Filsuvez (birch bark extract) gel/Oleogel-S10 versus vehicle control gel in EB. Filsuvez is approved in the EU and Great Britain for the treatment of partial thickness wounds associated with junctional and dystrophic EB in patients 6 months and older.

Key outcomes from the EASE double-blind phase included: i. Filsuvez demonstrated accelerated target wound healing in patients with EB compared to control gel. ii. Patients with EB treated with Filsuvez experienced : a. Reduction in overall wound burden.b. Reduced frequency of dressing changes. c. Less pain associated with dressing changes.

Filsuvez was well tolerated, with a similar safety profile to control gel.

Professor Dedee Murrell, Head of Dept. of Dermatology, St George Hospital, University of NSW, Sydney, senior author and Principal Investigator of the trial commented: “I am very excited to see EASE data published in this international journal so we can share these pivotal data with the medical and scientific community. This was the first EB study to meet its primary endpoint and demonstrated a statistically significant acceleration of target wound healing by day 45. In addition, the favourable trends we see with key secondary endpoints such as reduced wound burden, pain and frequency of dressing changes are considered as being very meaningful for patients.”

About EASE: The EASE trial (NCT03068780) is the largest ever global Phase III trial conducted in patients with EB, performed across 58 sites in 28 countries. It comprises a 3-month double-blind randomized controlled phase followed by a 24-month open-label, single-arm phase. Patients with dystrophic EB (DEB) and junctional EB (JEB) target wounds of between 10 and 50cm in size that were present for greater than 21?days and less than 9?months were randomized in the double-blind phase to study treatment in a 1:1 ratio and wound dressings applied according to standard of care. 223 patients were enrolled into the trial, including 156 pediatric patients. Of those that completed the double-blind phase, 100% entered the open-label follow-up phase.

EASE met its primary endpoint: Complete target wound closure was achieved in 41.3% of target wounds treated with Filsuvez versus 28.9% of target wounds treated with control gel (p=0.013; relative risk [RR] 1.44, 95% confidence interval [CI] 1.01–2.05. This equates to a 44% increase in probability of wound closure with Filsuvez versus control gel. A reduction in overall wound burden using two different measures was observed: Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI) and Body Surface Area Percentage (BSAP). i. EBDASI: The mean change from baseline in the skin activity score exceeded the clinically important threshold of a 3-point reduction for patients treated with Filsuvez (–3.1 at Day 60 and –3.4 at Day 90 for Filsuvez versus –2.0 at Day 60 at –2.8 at Day 90 for control gel) ii. BSAP: Mean change in total BSAP also showed greater reduction at Day 60 and Day 90 for Filsuvez compared to the control gel. At Day 90, the mean change in BSAP was -4.3% (36%) from baseline for Filsuvez versus–2.5% (21%) for control gel.

Throughout the double-blind phase, patients treated with Filsuvez had a reduced requirement for daily dressing changes vs control gel. At Day 90, the change with Filsuvez equated to one less dressing change every 2 weeks (p=0.001) compared to no change for control gel. Filsuvez significantly improved pain associated with dressing changes at Day 14 and remained numerically lower throughout the 90-day treatment period of the study (Day 14: –1.4 versus –0.8; P=0.02) Filsuvez was well tolerated with a similar incidence of patients with adverse events in both groups (81.7% and 80.7% for Filsuvez and control, respectively). The majority of these AEs were classed as mild or moderate in severity.

See- "Efficacy and safety of Oleogel-S10 (birch triterpenes) for epidermolysis bullosa – results from the phase III, randomised, double-blind phase of the ‘EASE’ study .";Johannes S Kern, Eli Sprecher, Maria Florencia Fernandez, Franziska Schauer, Christine Bodemer, Tracy Cunningham, Sandra Löwe, Charles Davis, Mark Sumeray, Anna L Bruckner . British Journal of Dermatology, ljac001, https://doi.org/10.1093/bjd/ljac001. Published: 20 October 2022.