Delgocitinib Improves Patients’ Chronic Hand Eczema

Overview

Chronic hand eczema (CHE) is a debilitating inflammatory skin condition characterized by recurrent episodes of erythema, pruritus, fissuring, and pain.¹ CHE affects approximately 5% to 10% of the general population and can significantly impair quality of life due to functional limitations and psychosocial burden.² Standard treatment typically involves topical corticosteroids, emollients, and avoidance of irritants; however, many patients experience inadequate responses, and prolonged corticosteroid use carries many risks.^1,2

In July 2025, the FDA approved Anzupgo (delgocitinib), a topical Janus kinase (JAK) inhibitor, for adults with moderate to severe CHE who have disease not adequately controlled with, or who cannot use, topical corticosteroids.³ Delgocitinib blocks signaling of several inflammatory cytokines implicated in eczema pathogenesis, thereby reducing activation of innate and adaptive immune cells.³ It is the first JAK inhibitor approved for topical use in CHE, expanding therapeutic options for patients with limited alternatives.

Efficacy

Approval was supported by 2 randomized, double-blind, vehicle-controlled phase 3 clinical trials (TRIAL 1 [NCT04871711] and TRIAL 2 [NCT04872101]; also known as DELTA 1 and DELTA 2, respectively) enrolling 960 adults with moderate to severe CHE.³ Eligible patients had an Investigator Global Assessment for CHE (IGA-CHE) score of 3 (moderate) or 4 (severe) and a Hand Eczema Symptom Diary itch score of greater than or equal to 4 at baseline.⁴ Both trials followed the same study design and end points but differed in study populations. TRIAL 1 primarily enrolled European patients, whereas TRIAL 2 included sites in North America and other regions, with a higher proportion of severe cases.

Patients applied delgocitinib or vehicle cream twice daily for 16 weeks. The primary end point was IGA-CHE treatment success (TS), defined as a score of 0 (clear) or 1 (almost clear) with at least a 2-point improvement from baseline.^3,4

• In TRIAL 1, 20% of delgocitinib-treated patients achieved IGA-CHE TS compared with 10% of vehicle-treated patients, yielding a treatment difference of 10% (95% CI, 4%-16%).
• In TRIAL 2, 29% of delgocitinib-treated patients achieved IGA-CHE TS compared with 7% of vehicle-treated patients, yielding a treatment difference of 22% (95% CI, 16%-29%).

Safety

In clinical trials, the most common adverse reactions (≤ 1%) were application site pain, paresthesia, pruritus, erythema, and bacterial skin infections. Rare events included leukopenia, neutropenia, eczema herpeticum, and herpes zoster.^3,4

There are no contraindications listed. Safety and efficacy have not been established in pediatric patients. In adults aged 65 years or older, no significant differences in safety or effectiveness were observed compared with younger patients. Data on use during pregnancy and lactation are insufficient, and caution is advised.³

Dosing

Delgocitinib cream contains 2% active drug (20 mg per gram) and is supplied in 30-g and 60-g laminated tubes.³

• Administration: Apply a thin layer twice daily to affected areas on the hands and wrists only.
• Maximum dose: Do not exceed 30 g every 2 weeks or 60 g per month.
• Important notes: For topical use only. Avoid eyes, mouth, and other mucous membranes. Complete age-appropriate vaccinations, including herpes zoster, prior to treatment. Store at controlled room temperature (68 °F to 77 °F); do not freeze.

References

1. Silverberg JI, Guttman-Yassky E, Agner T, et al. Chronic hand eczema guidelines from an expert panel of the International Eczema Council. Dermatitis. 2021;32(5):319-326. doi:10.1097/DER.0000000000000659

2. Diepgen TL, Andersen KE, Chosidow O, et al. Guidelines for diagnosis, prevention and treatment of hand eczema. J Dtsch Dermatol Ges. 2015;13(1):e1-e22. doi:10.1111/ddg.12510_1 Accessed October 27, 2025.

3. Anzupgo. Prescribing information. LEO Pharma Inc; 2025. https://www.leo-pharma.us/AnzupgoPI

4. 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. Lancet. 2024;404(10451):461-473. doi:10.1016/S0140-6736(24)01027-4