Delgocitinib Could Aid Adults With Moderate to Severe Chronic Hand Eczema

An investigational topical pan-Janus kinase (JAK) inhibitor to treat chronic hand eczema (CHE) was recently featured in The Lancet, making it the first in its kind to be featured in the journal, according to study authors.¹

Image credit: Ольга Тернавская | stock.adobe.com

“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,” said Kreesten Meldgaard Madsen, MD, PhD, chief development officer at LEO Pharma, in a news release.¹

CHE is a painful inflammatory, pruritic disease that effects the hands and wrists, impacting the individual’s overall quality of life and occupational abilities.² The condition usually persists for more than 3 months and individuals can experience a relapse twice or more in a year. Individuals that experience CHE have reported symptoms of itching, pain, erythema, scaling, lichenification, hyperkeratosis, vesicles, edema, and fissures on the hands and wrists, according to study authors.¹

Researchers assessed the use of the topical pan-JAK inhibitor delgocitinib cream in the DELTA 1 and DELTA 2 randomized, double-blinded, multi-center vehicle-controlled clinical phase 3 trials.² Study authors noted that the aim of the study was to evaluate the safety and efficacy of twice-daily applications of 20 mg/g of delgocitinib cream among individuals with severe chronic hand eczema.²

The study authors noted that delgocitinib cream plays a significant role in the pathogenesis of CHE by activating the JAK-STAT signaling.¹

A total of 487 individuals were enrolled in the DELTA 1 trial, and 473 individuals were enrolled in the DELTA 2 trial. Among the enrolled individuals, 325 in DELTA 1 and 314 in DELTA 2 received delgocitinib cream and 162 in DELTA 1 and 159 in DELTA 2 received the cream vehicle.²

The primary endpoint of the trials followed the Investigator’s Global Assessment (IGA-CHE) for chronic hand eczema treatment success at week 16 with a score of 0 for clear or 1 for almost clear. However, additional scores included 2 for mild, 3 for moderate, and 4 for severe, according to study authors. The key secondary endpoints included a reduction of itch and pain scores of less than or equal to 4 points, measured by the Hand Eczema Symptom Diary from baseline to week 16.¹

Published in The Lancet, the results displayed at week 16 of the trials showed individuals receiving delgocitinib cream experienced IGA-CHE treatment success compared with individuals that received the cream vehicle.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,” said Robert Bissonnette, MD, lead author from Innovaderm Research in Montreal, in a news release. “Publication of milestones like this have a valuable role in our efforts to improve the day-to-day reality of those living with CHE.”¹

The study authors noted that proportion of reported adverse events were similar among individuals that received delgocitinib (147 [45%] of 325 in DELTA 1 and 143 [46%] of 313 in DELTA 2) and the cream vehicle (82 [51%] of 162 in DELTA 1 and 71 [45%] of 159 in DELTA 2). However, the most common adverse events included COVID-19 and nasopharyngitis—only occurring in at least 2% of individuals in both treatment groups.²

“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,” said Madsen, in a news release.¹

References

1. LEO Pharma Announces Publication of Chronic Hand Eczema Phase 3 Data in The Lancet. Leo Pharma. News release. July 19, 2024. Accessed July 25, 2024.

2. 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. July 18, 2024. Accessed July 25, 2024. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)01027-4/abstract.