AT A GLANCE

In a landmark development for chronic hand eczema (CHE), the FDA has approved delgocitinib cream (brand name ANZUPGO^®) as the first and only treatment specifically indicated for adults with moderate-to-severe CHE. The approval marks a critical milestone in addressing a dermatologic condition that has long lacked FDA-approved options, particularly for patients who do not respond to topical corticosteroids or for whom such treatments are unsuitable.

Delgocitinib is a topical pan-Janus kinase (JAK) inhibitor that modulates immune signaling by inhibiting JAK1, JAK2, JAK3, and TYK2—key mediators in the JAK-STAT pathway implicated in inflammatory skin diseases. Its mechanism of action allows for targeted suppression of the inflammatory cascade associated with both the persistence and flaring of CHE, a disease characterized by intense itch, pain, and skin barrier disruption.

The FDA's decision was based on robust data from the DELTA 1 and DELTA 2 trials—two identically designed, randomized, double-blind, vehicle-controlled Phase 3 studies enrolling 960 adults with moderate-to-severe CHE. At Week 16, treatment success, defined as clear or almost clear skin with at least a two-point improvement on the Investigator’s Global Assessment (IGA-CHE TS), was achieved by 20% and 29% of delgocitinib-treated patients in DELTA 1 and DELTA 2, respectively—versus 10% and 7% in the vehicle arms (p=0.006 and p<0.0001).

Secondary endpoints, including symptom relief measured via the Hand Eczema Symptom Diary (HESD), further supported efficacy: nearly half of treated patients reported a ≥4-point reduction in both pain and itch severity, a significant improvement over control (p<0.0001 across both trials). The treatment was well tolerated, with a safety profile comparable to vehicle, and low incidence of adverse events.

"In my career as a dermatologist, I have witnessed firsthand the significant burden that the itch and pain of CHE places on patients, and the challenges they face living with it," said Dr. Linda Stein Gold, MD, Henry Ford Hospital, in a press release. "I believe this new treatment option will be welcomed by dermatologists who are looking for effective and safe ways to address these symptoms."

This approval not only introduces a new therapeutic modality into the dermatology armamentarium but also underscores the emerging role of topical JAK inhibitors in treating localized inflammatory conditions. Future research may explore delgocitinib’s long-term safety profile and potential application in other dermatologic diseases driven by dysregulated JAK-STAT signaling.

DRUG AT A GLANCE
Delgocitinib cream (ANZUPGO®) is a steroid-free, topical pan-JAK inhibitor approved for the treatment of moderate-to-severe chronic hand eczema (CHE) in adults. By targeting key components of the JAK-STAT signaling pathway—JAK1, JAK2, JAK3, and TYK2—it helps suppress the inflammatory responses that drive CHE, offering a novel therapeutic option for patients who have limited alternatives due to poor response or intolerance to topical corticosteroids.