Europe's Committee for Medicinal Products for Human Use (CHMP) recommended the granting of marketing authorization for Anzupgo (delgocitinib; LEO Pharma) to treat moderate to severe chronic hand eczema in adults when topical corticosteroids are insufficient. A final decision from the European Commission is now pending.
Chronic hand eczema is an inflammatory skin condition of the hands and wrists. Symptoms include pain and itching during flare ups and dry skin, hyperkeratosis, and flaking between flares. It is often triggered by contact dermatitis and is very common among the European population.
The active substance in Anzupgo is delgocitinib, a pan–Janus kinase (JAK) inhibitor that inhibits JAK1, JAK2, JAK3, and tyrosine kinase 2 enzymes in a concentration-dependent manner.
Inhibition of the JAK-STAT pathway reduces signaling of several pro-inflammatory cytokines, downregulating immune and inflammatory responses in cells linked to the eczema's pathology.
Phase 3 Clinical Trial
The CHMP's recommendation follows results from two phase 3 clinical trials, DELTA 1 and DELTA 2, which evaluated delgocitinib's efficacy in treating 960 adults with moderate to severe chronic hand eczema across Europe and Canada. In both the trials, patients were randomly assigned delgocitinib cream 20 mg/g or cream vehicle twice daily for 16 weeks.
The primary clinical endpoint was Investigator's Global Assessment for Chronic Hand Eczema (IGA-CHE) treatment success at week 16, defined as an IGA-CHE score of 0 (clear) or 1 (almost clear).
Secondary endpoints were a reduction in the Hand Eczema Symptom Diary itch and pain scores and at least 75% and 90% improvement in the Hand Eczema Severity Index (HECSI-75 and HECSI-90) scores from baseline at the end of the study period.
At week 16, 20% patients using delgocitinib in DELTA 1 achieved IGA-CHE treatment success compared with 10% using cream vehicle. In DELTA 2, 29% patients using delgocitinib achieved IGA-CHE treatment success compared with 7% using the placebo (P ≤ .0055 for both trials).
Groups using delgocitinib had significantly lower eczema itch and pain scores than those using the vehicle cream. There were also higher percentages of patients with HECSI-75 and HECSI-90 scores in the delgocitinib cream groups at week 16.
The rate of adverse events was similar across all groups yet were considered mild to moderate and not related to treatment. The most frequent adverse events included COVID-19, nasopharyngitis, and headache.
Participants in DELTA 1 and DELTA 2 were offered to roll over to the 36-week DELTA 3 trial, which aimed to evaluate the long-term safety of delgocitinib. Findings from that trial are yet to be published.
Delgocitinib will be available as a 20 mg/g cream and should be initiated and supervised by a physician experienced in diagnosing and treating CHE.
Detailed recommendations for using the drug will appear in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European languages.
Annie Lennon is a medical journalist. Her writing appears on Medscape Medical News, Medical News Today, and Psych Central, among other outlets.