Chronic Hand Eczema Treatment Shows Positive Results in Phase 3 Trials
Delgocitinib cream from LEO Pharmaceuticals showed superior efficacy compared to cream vehicle and was well tolerated over 16 weeks.
Positive results from 2 phase 3 trials evaluating the safety and efficacy of twice-daily delgocitinib cream for the treatment of adult patients with moderate to severe chronic hand eczema (CHE) have been announced, according to a release from LEO Pharmaceuticals.1
Chronic Hand Eczema Treatment Shows Positive Results in Phase 3 Trials / Ольга Тернавская - stock.adobe.com
Results from the DELTA 1 (NCT04871711) and DELTA 2 (NCT04872101) trials showed that twice-daily delgocitinib cream met its primary endpoint of an Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) score of 0 or 1. The therapy also met all of its key secondary endpoints, including a reduction in itch and pain scores of 4 or less points as measured by the Hand Eczema Symptom Diary (HESD).
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Results from the 2 studies were published in The Lancet, marking the first time the journal has published data on an investigational topical pan-Janus kinase (JAK) inhibitor for the treatment of moderate to severe CHE.2
“Historically, CHE has been under researched, so the publication of the DELTA 1 and 2 trials in The Lancet is a positive step towards highlighting the condition, and in turn indicates the increased quality and rate of research in the space,” Robert Bissonnette, MD, lead author on the study, said in a release.1 “Publication of milestones like this have a valuable role in our efforts to improve the day-to-day reality of those living with CHE.”
Both of the randomized, double-blinded, vehicle-controlled phase 3 studies assessed twice-daily 20 mg/g delgocitinib cream or cream vehicle for 16 weeks in adult patients with moderate to severe CHE. DELTA 1 took place at 53 trial centers in Canada, France, Germany, Italy, Poland, and the UK. DELTA 2 took place at 50 trial centers in Belgium, Canada, Denmark, Germany, the Netherlands, Poland, and Spain.
The DELTA 1 study cohort included 487 patients between May 2021 and October 2022, and the DELTA 2 cohort included 473 patients between May 2021 and January 2023. Of the patients in DELTA 1, 325 received the therapy, while 314 received it in DELTA 2. Patients who completed 16 weeks in both DELTA 1 and DELTA 2 were offered to roll-over to the DELTA 3 open-label, multi-site 36 week, extension trial, which evaluated the long-term safety of delgocitinib cream.
Investigators found that a greater proportion of patients treated with delgocitinib cream had IGA-CHE treatment success compared to those who received cream vehicle after 16 weeks. Additionally, the proportion of adverse events was similar between the 2 groups. The most common adverse events were COVID-19 and nasopharyngitis.
“Having the DELTA 1 and 2 trial results featured in one of the most highly regarded peer-reviewed medical journals in the world is a vital step on our mission to raise awareness and develop potential new treatment options for those living with CHE,” Kreesten Meldgaard Madsen, chief development officer at LEO Pharma, said in a release.1 “The publication of our research in The Lancet is a proud milestone for everyone who has worked tirelessly on the DELTA 1 and 2 trials, and proves LEO Pharma’s commitment to pioneering new potential treatment options for those living with skin conditions. We are excited to share this analysis with the broader scientific and medical community to help drive further research advances for CHE.”
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References
1. LEO Pharma Announces Publication of Chronic Hand Eczema Phase 3 Data in The Lancet. News Release. LEO Pharma. July 19, 2024. Accessed July 19, 2024. https://www.leo-pharma.com/media-center/news/2024-leo-pharma-announces-publication-of-chronic-hand-eczema-phase-3-data-in-the-lancet
2. Bissonnette R, Warren RB, Pinter A, et al. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. The Lancet. 2024. ISSN 0140-6736, https://doi.org/10.1016/S0140-6736(24)01027-4.
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