Delgocitinib ointment beneficial in chronic hand eczema

The pan-Janus kinase (JAK) inhibitor delgocitinib in an ointment formulation is well tolerated and demonstrates a dose-response effect in the treatment of patients with chronic hand eczema, according to the results of a phase IIb trial.

A total of 258 adult patients were randomized to treatment with delgocitinib cream at a dose of 1, 3, 8, 20 mg g^–1 or vehicle, administered twice daily for 16 weeks. All patients had recent history of inadequate response or contraindication to topical corticosteroids.

The primary endpoint was the Investigator’s Global Assessment for CHE (IGA-CHE) treatment success, defined as a score of 0 (clear) or 1 (almost clear) with a ≥ two-point improvement from baseline to week 16. Secondary endpoints included the time to IGA-CHE treatment success and changes in Hand Eczema Severity Index (HECSI). Researchers also assessed the presence of itch and pain numerical rating scale (NRS) scores, and Patient’s Global Assessment (PaGA) at week 16.

Results showed a significant dose–response relationship was established for the primary endpoint (p<0.025), with the highest IGA-CHE treatment success documented in groups that received higher doses. IGA-CHE treatment success at week 16 was achieved in 37.7 percent of patients with 20 mg g^–1 delgocitinib cream, 36.5 percent with 8 mg g^–1, 7.8 percent with 3 mg g^–1, 21.2 percent with 1 mg g^–1, and 8.0 percent with the vehicle.

Of note, the treatment effect obtained with delgocitinib 8 and 20 mg g^–1 was superior to that seen with the vehicle (p<0.001).

There also were improvements observed in HECSI, itch and pain NRS scores, and PaGA.

In terms of safety, delgocitinib cream was well tolerated, with most adverse events (AEs) being mild or moderate and considered unrelated to treatment. The most common AEs were nasopharyngitis (17.3–29.4 percent in delgocitinib groups vs 40 percent in the vehicle group), eczema (5.8–11.3 percent vs 16.0 percent) and headache (3.8–11.5 percent vs 4.0 percent).