{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T20:12:16Z","timestamp":1791231136881,"version":"4.1.0"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2025,1,16]],"date-time":"2025-01-16T00:00:00Z","timestamp":1736985600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Amryt Research Ltd"},{"DOI":"10.13039\/100007560","name":"Chiesi Farmaceutici","doi-asserted-by":"publisher","award":["NCT03068780"],"award-info":[{"award-number":["NCT03068780"]}],"id":[{"id":"10.13039\/100007560","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007560","name":"Chiesi Farmaceutici","doi-asserted-by":"publisher","award":["2016-002066-32"],"award-info":[{"award-number":["2016-002066-32"]}],"id":[{"id":"10.13039\/100007560","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,5,19]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Epidermolysis bullosa (EB) is a group of rare and severe genetic disorders characterized by persistent skin fragility and open wounds. EB manifests as cutaneous and mucosal blistering, erosions and impaired wound healing.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>To determine the long-term efficacy, tolerability and safety of Oleogel-S10 (birch bark extract) in dystrophic EB (DEB) and junctional EB (JEB) in the 24-month open-label phase (OLP) of the EASE study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>EASE was a double-blind randomized controlled phase III study consisting of two phases: a 90-day double-blind phase (DBP) and a 24-month OLP. Patients from both former treatment groups in the DBP entered the single-arm OLP (n = 205). Patients received Oleogel-S10 on all partial-thickness EB wounds. OLP endpoints included the incidence and severity\/relatedness of adverse events (AEs), maximum wound infection severity, changes in body surface area percentage (BSAP) of wounds, EB Disease Activity and Scarring Index (EBDASI), pain, itch, disease severity and quality-of-life outcomes.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The OLP data demonstrated that Oleogel-S10 target wound treatment adherence was &amp;gt; 99% and mean (SD) treatment duration was 584.7 (246.1\u2005days). Seventy-two per cent of patients in the OLP were aged &amp;lt; 18\u2005years and 86.8% had DEB; recessive DEB predominated (78.0%). AEs were reported in 77.1% of patients and were typically mild-to-moderate in severity. Severe and serious AEs were seen in 18.0% and 24.4% of patients, respectively. AEs resulted in the withdrawal of 7.8% of patients (n = 16), including three with treatment-related AEs. Nine deaths were reported; none were attributable to the treatment. The incidence of target wound infections was low (n = 7); five were mild-to-moderate in severity and two were severe. In patients treated with Oleogel-S10 throughout, mean (SD) BSAP changes from DBP baseline at 3, 12 and 24\u2005months were \u22124.3% (8.1) (P &amp;lt; 0.001), \u22125.9% (8.6) (P &amp;lt; 0.001) and \u22123.7% (9.0) (P = 0.003), respectively. Similarly, significant changes in EBDASI skin activity score from DBP baseline were observed: \u22123.9 (8.3) (P &amp;lt; 0.001), \u22125.1 (8.2) (P &amp;lt; 0.001) and \u22123.0 (8.3) (P = 0.007) at 3, 12 and 24\u2005months, respectively.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>These data support an encouraging long-term safety profile of Oleogel-S10 and a sustained reduction in wound burden over at least 24\u2005months of Oleogel-S10 treatment.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/bjd\/ljaf022","type":"journal-article","created":{"date-parts":[[2025,1,16]],"date-time":"2025-01-16T18:52:19Z","timestamp":1737053539000},"page":"1007-1017","source":"Crossref","is-referenced-by-count":16,"title":["Long-term safety and efficacy of Oleogel-S10 (birch bark extract) in epidermolysis bullosa: 24-month results from the phase III EASE study"],"prefix":"10.1093","volume":"192","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2971-0199","authenticated-orcid":false,"given":"D\u00e9d\u00e9e F","family":"Murrell","sequence":"first","affiliation":[{"name":"Department of Dermatology, St George Hospital , Sydney, NSW ,","place":["Australia"]},{"name":"Faculty of Medicine, University of New South Wales , Sydney, NSW ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Bodemer","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Expert Centre for Genodermatoses (MAGEC) Necker-Enfants Malades Hospital, University Paris Centre , Paris ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna L","family":"Bruckner","sequence":"additional","affiliation":[{"name":"University of Colorado School of Medicine, Department of Dermatology , Aurora, CO ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tracy","family":"Cunningham","sequence":"additional","affiliation":[{"name":"Amryt Research Limited , Dublin ,","place":["Ireland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Davis","sequence":"additional","affiliation":[{"name":"CSD Biostatistics Inc. , Oro Valley, AZ ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mari\u00e1 Florencia","family":"Fern\u00e1ndez","sequence":"additional","affiliation":[{"name":"Fundaci\u00f3n Respirar, Centro M\u00e9dico Dra De Salvo , Capital Federal ,","place":["Argentina"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dimitra","family":"Kiritsi","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Medical Center, Faculty of Medicine, University of Freiburg , Freiburg ,","place":["Germany"]},{"name":"First Department of Dermatology, Aristotle University of Thessaloniki , Thessaloniki ,","place":["Greece"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Maher","sequence":"additional","affiliation":[{"name":"Amryt Research Limited , Dublin ,","place":["Ireland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eli","family":"Sprecher","sequence":"additional","affiliation":[{"name":"Division of Dermatology, Tel Aviv Sourasky Medical Center and Faculty of Medicine, Tel Aviv University , Tel Aviv ,","place":["Israel"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mauricio","family":"Torres-Pradilla","sequence":"additional","affiliation":[{"name":"Fundaci\u00f3n Universitaria de Ciencias de la Salud and Hospital Infantil de San Jos\u00e9 , Bogot\u00e1 ,","place":["Colombia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johannes S","family":"Kern","sequence":"additional","affiliation":[{"name":"The School of Translational Medicine, Monash University and Alfred 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