Delgocitinib Cream Shows "Super-Response" in Nearly Half of Chronic Hand Eczema Patients

Key Insights

• Nearly 50% of patients with moderate to severe chronic hand eczema achieved a "deep response" with delgocitinib cream 20 mg/g by week 16, demonstrating significant relief from disease burden.
• Approximately 25% of patients exhibited "consistent response" with sustained improvement in pain or itch scores, maintaining ≥75% improvement in disease severity throughout the treatment period.
• One-third of patients who achieved complete clearance maintained their results even after stopping treatment, suggesting delgocitinib provides lasting therapeutic benefit beyond the application period.

New data presented at the American Academy of Dermatology (AAD) Annual Meeting in Orlando reveals that delgocitinib cream 20 mg/g produces exceptional outcomes in a significant subset of patients with moderate to severe chronic hand eczema (CHE).

Dr. April W. Armstrong, professor and chief of dermatology at the University of California, presented findings from a post hoc analysis of the DELTA 1 and DELTA 2 clinical trials, highlighting a group of "super-responders" to the topical pan-Janus kinase inhibitor.

"[Delgocitinib] has shown to be about three-times more efficacious than placebo in this very difficult-to-treat patient population," Armstrong stated during her presentation.

Defining "Super-Response" in Chronic Hand Eczema

The analysis categorized super-responders into three distinct groups based on their treatment outcomes:

1. Deep responders: Patients achieving a Hand Eczema Symptom Diary (HESD) itch score of 0-1, HESD pain score of 0-1, and/or a Dermatology Life Quality Index (DLQI) score of 0-1 within 16 weeks of treatment.
2. Consistent responders: Patients showing a 4-point or greater reduction in HESD itch or pain scores, or achieving Hand Eczema Severity Index-75 (HECSI-75) at weeks 4, 8, 12, and 16.
3. Maintained responders: Patients reaching an Investigator's Global Assessment-CHE (IGA-CHE) score of 0 at week 16 and maintaining an IGA-CHE score of 0-1 while off treatment.

Impressive Response Rates Across Categories

The data revealed substantial benefits of delgocitinib cream compared to vehicle treatment:

• 48% of delgocitinib-treated patients achieved at least one deep response criterion by week 16, compared to 23.8% in the vehicle group
• 19.2% of the delgocitinib group met all three deep response criteria, versus only 5.4% in the vehicle group
• Over 24% of delgocitinib patients demonstrated consistent responses throughout the treatment period
• 32.9% of patients who achieved complete clearance (IGA-CHE 0) maintained their results for 8 weeks after stopping treatment

Clinical Significance for CHE Management

Chronic hand eczema represents a significant therapeutic challenge, often impacting patients' quality of life and ability to perform daily activities. The condition can be particularly debilitating due to its visibility and functional impact.

"About a quarter of the patients have achieved either significant improvement in their pain or itch score, or maintained at least 75% improvement in their severity through not only at week 16, but also in the weeks prior to week 16. We call this consistent response as a part of the definition of super responders," Armstrong explained in an interview at the AAD meeting.

Study Design and Patient Population

The DELTA 1 and DELTA 2 trials included 639 patients with moderate to severe CHE who received either delgocitinib cream 20 mg/g or vehicle cream twice daily for 16 weeks. Patients had the option to enroll in the DELTA 3 extension trial afterward, where treatment was continued or discontinued based on their IGA-CHE score.

Potential Impact on Treatment Landscape

Delgocitinib represents a novel approach to CHE treatment as a topical JAK inhibitor. The drug is already approved in Europe under the brand name Anzupgo (LEO Pharma) and is awaiting FDA review in the United States.

Armstrong expressed optimism about the potential FDA approval, which would provide a new topical option for patients with moderate to severe CHE who currently have limited effective treatment options.

Durability of Response

One of the most promising aspects of the findings was the durability of response after treatment discontinuation. Among patients who achieved complete clearance (IGA-CHE 0) by week 16, approximately one-third maintained clear or almost clear skin (IGA-CHE 0-1) for 8 weeks after stopping delgocitinib application.

This suggests the drug may provide lasting benefits beyond the treatment period, potentially allowing for intermittent therapy or treatment holidays in some patients.

Implications for Clinical Practice

If approved in the US, delgocitinib could fill an important gap in the treatment armamentarium for CHE. The identification of super-responders may help clinicians set appropriate expectations and potentially predict which patients might achieve exceptional outcomes with this therapy.

The data presented at AAD adds to the growing body of evidence supporting delgocitinib's efficacy in CHE and highlights its potential to significantly improve outcomes in this challenging dermatological condition.