Delgocitinib cream safe, efficacious in chronic hand eczema

Key takeaways:

• In two phase 3 trials, delgocitinib cream improved hand eczema in a greater proportion of patients vs. vehicle.
• Those treated with delgocitinib cream also had significant reductions in itch and pain.

Delgocitinib cream has shown efficacy in the treatment of hand eczema in two phase 3 trials.

A pan-Janus kinase (JAK) inhibitor, delgocitinib cream (LEO Pharma) inhibits the activation of JAK-dependent signaling cytokines. A previous phase 2b dose-ranging trial determined the two highest concentrations of the cream product had greater efficacy in hand eczema treatment.

“Chronic hand eczema is an heterogenous disease with significant interpatient variability in Th1, Th2, Th17 and Th22 activation,” Robert Bissonnette, MD, MSc, CEO and medical director of Innovaderm, told Healio. “A pan-JAK inhibitor could have an effect on all these pathways and be an interesting option for chronic hand eczema patients, regardless of its etiology.”

The randomized, double-blind, parallel group DELTA 1 and DELTA 2 trials compared 16 weeks of twice-daily treatment with delgocitinib cream 20 mg/g vs. vehicle cream in patients with moderate to severe hand eczema.

Of the 487 patients in the DELTA 1 trial and 473 in the DELTA 2 trial, 325 and 314 were in the respective delgocitinib groups and 162 and 159 were in the vehicle groups.

The pooled results, published in The Lancet, found that 20% and 29% of patients in the treatment groups achieved treatment success, defined as an IGA score of 0 (clear) or 1 (almost clear) with a 2-grade improvement by week 16. This compared with 10% and 7% of those treated with vehicle.

The trial also met all key secondary endpoints, including a reduction of at least 4 points in pain and itch as measured by the Hand Eczema Symptom Diary and a greater percentage of patients achieving a 75% or 90% improvement in the Hand Eczema Severity Index at week 16.

“The onset of action was very fast. We observed a clear separation between vehicle and delgocitinib after only a few weeks of treatment,” Bissonnette said.

Adverse events were recorded in 147 (45%) and 143 (46%) of patients in the treatment groups and 82 (51%) and 71 (45%) of those in the vehicle groups, with most being mild or moderate. COVID-19 and nasopharyngitis were the most common. Adverse events leading to discontinuation occurred more frequently in the vehicle groups.

“Delgocitinib, a pan-JAK inhibitor, was very effective and well tolerated in patients with chronic hand eczema,” Bissonnette said. “If eventually approved for the treatment of chronic hand eczema, it would give clinicians a simple, non-corticosteroid topical option to gain rapid control of moderate to severe chronic hand eczema.”