AT A GLANCE

A recent phase 3 clinical trial, known as DELTA FORCE, has revealed that delgocitinib cream, an investigational topical pan-Janus kinase (JAK) inhibitor, significantly outperforms the standard oral treatment alitretinoin in adults with severe chronic hand eczema (CHE) in the European Union. The findings, now published in The Lancet, highlight delgocitinib's superior efficacy and safety profile, offering hope for patients unresponsive to topical corticosteroids.

In the 24-week, randomized, assessor-blinded trial involving 513 participants, delgocitinib cream achieved the primary outcome measure by significantly reducing Hand Eczema Severity Index (HECSI) scores from baseline to Week 12 compared to alitretinoin. Additionally, delgocitinib met all key secondary endpoints, including Investigator’s Global Assessment (IGA)-CHE treatment success, further reductions in HECSI scores by Week 24, and improvements in health-related quality of life as measured by the Dermatology Life Quality Index (DLQI).

Notably, patients treated with delgocitinib experienced fewer treatment-emergent adverse events compared to those receiving alitretinoin, underscoring its favorable safety profile.

Delgocitinib functions by inhibiting the JAK-STAT signaling pathway, which plays a crucial role in the inflammatory processes underlying CHE. By targeting multiple cytokine-mediated pathways, delgocitinib effectively reduces inflammation and alleviates symptoms such as pain and itching. Clinical trials have demonstrated its effectiveness in improving disease severity and enhancing patient-reported outcomes compared to vehicle. Topical delgocitinib has shown a favorable safety profile, with most adverse events being mild and unrelated to treatment. Serious adverse events were rare, and treatment discontinuation due to adverse events was minimal. 

Given its superior efficacy and safety profile, delgocitinib cream represents a promising topical alternative to systemic therapies for patients with moderate-to-severe CHE. Further comparative studies are needed to evaluate its efficacy against oral JAK inhibitors and other topical immunosuppressants, providing insight into optimizing treatment strategies for this chronic condition.

“It is so exciting to see such a strong response in a subgroup of patients treated with delgocitinib cream,” said April W Armstrong, MD, Professor and Chief of Dermatology at the University of California-Los Angeles (UCLA), in a press release. “The results across the various treatment metrics are promising and demonstrate the future potential that delgocitinib cream may have in offering a new treatment option for those living with this unique and burdensome disease.” 

DRUG AT A GLANCE

Delgocitinib is a topical pan-Janus kinase (JAK) inhibitor that blocks multiple JAK enzymes (JAK1, JAK2, JAK3, and TYK2), thereby inhibiting the JAK-STAT signaling pathway involved in cytokine-mediated inflammation. It is designed to reduce inflammatory responses associated with chronic skin conditions.

Delgocitinib is approved in the European Union for the treatment of adults with moderate-to-severe CHE who are not adequately controlled with topical corticosteroids. It is also under review by the U.S. FDA for the same indication.

The recommended dosage of delgocitinib for adults with moderate-to-severe CHE is 20 mg/g (2%) cream, applied twice daily to affected areas. It is intended for topical use only and is not to be used on mucosal surfaces or in the eyes.