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TOPLINE:

Oleogel-S10, a birch bark extract approved by the FDA for treating wounds associated with dystrophic epidermolysis bullosa (DEB) and junctional EB (JEB), was well tolerated and was associated with improved wound healing and a reduced wound burden in analysis of long-term efficacy and safety.

METHODOLOGY:

• Researchers conducted a prespecified subgroup analysis of pediatric patients from the phase 3 EASE study between April 2017 and May 2022, which comprised a 90-day double-blind phase (DBP) and a 24-month open-label phase (OLP).
• A total of 156 children (median age, 9.5 years; range, 0.5-17 years) with DEB, JEB, or Kindler EB were enrolled in the DBP and randomly assigned to receive Oleogel-S10 gel (n = 74) or a vehicle control gel (n = 82) with one target wound selected per patient; 147 patients entered the OLP.
• Primary endpoints included first complete target wound closure by day 45 ± 7 and time to first complete target wound closure by day 90 ± 7.
• Other endpoints were total body wound burden assessed using body surface area percentage (BSAP) and Epidermolysis Bullosa Disease Activity and Scarring Index (EBDASI); patient-reported outcomes included dressing change burden and safety endpoints.

TAKEAWAY:

• Treatment with Oleogel-S10 was associated with a significantly higher rate of first complete target wound closure by day 45 than with the control gel (44.6% vs 25.6%; relative risk, 1.70; P = .012).
• Among the wounds that closed by 90 days, the mean time to first complete target wound closure by day 90 was shorter with Oleogel-S10 than with the control gel (30.4 days vs 45.8 days).
• Mean BSAP scores decreased from 12.5% at baseline in the DPB to 5.3% at month 24 in the OLP among those in the Oleogel-S10 group. Similar outcomes were observed for EBDASI (mean change, -4.4; P = .0038).
• At DBP day 90, 38% of patients receiving Oleogel-S10 no longer required daily dressing changes compared with 9% of those receiving control gel. Safety was similar between groups; most adverse events were mild or moderate, and there were fewer treatment-related events during long-term follow-up. The most frequent adverse event was wound complications.

IN PRACTICE:

In the analysis, which the authors wrote “provides the most robust long-term data to date for Oleogel-S10 in pediatric EB,” treatment was “associated with faster wound healing, sustained reductions in wound burden, and fewer dressing changes, leading to meaningful improvements in daily care and reducing the burden on patients and caregivers,” the authors of the study wrote. Oleogel-S10 was well tolerated and “long-term safety data were consistent with that observed for the overall EASE population,” they added, noting that the results “underscore the importance of ongoing real-world data to determine how early treatment may influence disease progression and the risk of severe complications in this vulnerable population.”

SOURCE:

The study was led by Eli Sprecher, MD, Tel Aviv Sourasky Medical Center and Faculty of Medicine and Health Sciences, Tel Aviv University, Tel Aviv, Israel, and was published online on May 28 in Pediatric Dermatology.

LIMITATIONS:

Small age subgroups restricted age-stratified analyses and meaningful interpretation. The open-label study design could have introduced bias in outcome assessment.

DISCLOSURES:

The EASE study received funding from Amryt Research (acquired by Chiesi Farmaceutici in 2023). Several authors reported receiving grants, fees, or other support from Amryt, Chiesi, or other dermatology and biotechnology companies. Two authors reported being employees of Chiesi. Full disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.