Long-term Safety and Efficacy of Delgocitinib Cream for Up to 52 Weeks in Adults with Chronic Hand Eczema: Results of the Phase 3 Open-label Extension DELTA 3 Trial Following the DELTA 1 and 2 Trials

Background: There are no topical treatments that have been specifically developed and approved for moderate to severe Chronic Hand Eczema (CHE).

Objective: To evaluate the long-term safety and efficacy of delgocitinib cream 20 mg/g as needed for 36 weeks in adults with CHE.

Methods: In phase 3 open-label DELTA 3 (NCT04949841), patients who completed the 16-week(W) treatment period in DELTA 1 and 2 were treated on an as-needed basis with twice-daily delgocitinib for 36 weeks (n=801). Patients with Investigator's Global Assessment for CHE (IGA-CHE)≥2 received treatment until IGA-CHE≤1 was achieved. Primary endpoint was number of treatment-emergent adverse events (AEs). Key secondary endpoints were IGA-CHE 0/1 and ≥75%/≥90% improvement in Hand Eczema Severity Index (HECSI-75/90) scores.

Results: Delgocitinib was well tolerated (n=801; R=231.1; PYO=535.7), with most frequent AEs being COVID-19 and nasopharyngitis. DELTA 3 baseline IGA-CHE 0/1 (24.6%), HECSI-75/HECSI-90 (51.8%/31.8%) were maintained to W36 (30.0% and 58.6%/36.6%, respectively) among delgocitinib-treated patients in the parent trials. Among those previously treated with cream vehicle, corresponding response rates improved from DELTA 3 baseline (9.1% and 23.7%/12.0%, respectively) to W36 (29.5% and 51.5%/35.7%).

Limitations: Open-label trial.

Conclusion: Delgocitinib cream treatment was well-tolerated and efficacious in maintaining disease control in CHE patients up to 52 weeks.