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
Dr. Vishnu M Moodalgiri
MBBS, MD (Dermatology, Venereology & Leprology), FRGUHS (Cosmetology), Consultant – Dermatology & Aesthetics
Apollo Health and Lifestyle limited
Long-term treatment with delgocitinib is well-tolerated and raises no major safety concerns among patients with chronic hand eczema (CHE), results of the DELTA 3 trial have shown. Its use also maintains disease control for up to 52 weeks.
Efficacy rates were maintained among patients treated with delgocitinib cream in the parent trials (DELTA 1 and 2) and further improved among patients previously treated with cream vehicle. In DELTA 3, 801 patients who completed the 16-week treatment period in the DELTA 1 and 2 trials received delgocitinib cream twice daily on an as-needed basis for 36 weeks. Those with Investigator’s Global Assessment for CHE (IGA-CHE) ≥2 received treatment until they achieved IGA-CHE ≤1. The number of treatment-emergent adverse events (AEs) was the primary endpoint, while IGA-CHE 0/1 and ≥75%/≥90% improvement in Hand Eczema Severity Index (HECSI-75/90) scores served as key secondary endpoints.
Delgocitinib was well-tolerated, with COVID-19 and nasopharyngitis being the most common AEs. In DELTA 3, the proportion of patients with IGA-CHE 0/1 (24.6%) and HECSI-75/90 (51.8%/31.8%) at baseline were maintained at week 36 (IGA-CHE 0/1: 30.0%; HECSI-75/90: 58.6%/36.6%). Among those who have been treated with cream vehicle, the response rates significantly improved from baseline (IGA-CHE 0/1: 9.1%; HECSI-75/90: 23.7%/12.0%) to week 36 (IGA-CHE 0/1: 29.5%; HECSI-75/90: 51.5%/ 35.7%).
Patients who stopped treatment due to disease remission (IGA-CHE 0/1) were able to regain response upon restart of treatment, thereby helping clinicians contextualize the potential benefits of delgocitinib cream to patients with CHE. These DELTA 3 data support the benefit of long-term, as-needed use of delgocitinib cream in patients with moderate to severe CHE.
DELTA 3 applied the same stringent definition of IGA-CHE treatment success used in the parent trials (i.e., IGA-CHE 0: clear, no perceptible erythema; IGA-CHE 1: Almost clear, barely perceptible erythema), with a ≥2-step improvement from baseline. The IGA-CHE instrument, as a single-item measure of CHE severity, is a strong, valid, and reliable measure of CHE severity and corresponding clinically meaningful changes, supporting its use as an endpoint in CHE clinical trials and practice.
The current study was limited by its open-label design and the predominantly White patient pool (91.4%), which limits the generalization of the findings to other ethnic groups. On the other hand, the open-label, nonrandomized design of DELTA 3 reflected clinical practice with the treatment of flares until the skin is clear or almost clear, according to the investigators.
Real-world evidence data will be required to further assess the effectiveness and safety of delgocitinib cream 20 mg/g treatment in clinical practice, particularly for as-needed long-term use. Delgocitinib cream is the only topical treatment that has been specifically developed and approved for moderate to severe CHE.
Delgocitinib cream treatment was well-tolerated and efficacious in maintaining disease control in patients with CHE for up to 52 weeks.
Reference: Gooderham M, Molin S, Bissonnette R, et al. 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. J Am Acad Dermatol. 2025;93(1):95–103.
