Delgocitinib Cream Outperforms Alitretinoin for Treatment of Severe Chronic Hand Eczema: Lancet
Spain: In the phase III DELTA FORCE trial, delgocitinib cream demonstrated superior efficacy and a more favorable safety profile than oral alitretinoin for patients with severe chronic hand eczema. Fewer adverse events were reported in the delgocitinib group (49%) versus the alitretinoin group (76%), highlighting it as a promising alternative in a field with limited treatment options.
The findings were published online in The Lancet on April 16, 2025.
Chronic hand eczema is a long-standing, persistent, and variable inflammatory skin condition that affects the hands and wrists, often causing significant disruption to daily life and overall well-being. The researchers note that topical corticosteroids may provide limited relief in severe cases, making systemic therapy necessary. Oral alitretinoin is one of the few approved systemic options for treatment-resistant cases; however, concerns regarding its side effects and long-term safety have highlighted the need for safer and more effective alternatives.
Against the above background, Prof Ana Maria Giménez-Arnau, Department of Dermatology, Hospital Del Mar Research Institute, Universitat Pompeu Fabra, Barcelona, Spain, and colleagues conducted the head-to-head, phase 3 DELTA FORCE trial to evaluate the efficacy and safety of topical delgocitinib cream in comparison to oral alitretinoin, which is currently the only approved systemic treatment for severe chronic hand eczema.
The randomized, assessor-masked trial was carried out across 102 centers in ten countries, including the UK, Germany, and Canada. Adults aged 18 and above with severe chronic hand eczema were randomly assigned to receive either delgocitinib cream (20 mg/g, twice daily) or alitretinoin capsules (30 mg, once daily) for up to 24 weeks.
The main goal was to measure the change in the Hand Eczema Severity Index (HECSI) score from the start of the trial to week 12. Efficacy was analyzed in patients with baseline data, and safety was evaluated in all who received the treatment.
The following were the key findings:
- A total of 513 patients (65% female, 35% male) were enrolled between June 15, 2022, and Dec 5, 2023, and randomly assigned to receive either delgocitinib cream (n=254) or alitretinoin (n=259).
- Ten patients were excluded after randomization due to not meeting eligibility criteria, resulting in 250 patients in the delgocitinib group and 253 in the alitretinoin group for analysis.
- One patient from the delgocitinib group and three from the alitretinoin group were excluded from the primary analysis due to missing baseline HECSI data.
- Delgocitinib cream showed a significantly greater reduction in HECSI score at week 12 (–67.6) compared to alitretinoin (–51.5), with a between-group difference of –16.1.
- Fewer adverse events were reported in the delgocitinib group (49%) than in the alitretinoin group (76%).
- Headache occurred in 4% of patients using delgocitinib versus 32% with alitretinoin.
- Nasopharyngitis was reported in 12% of the delgocitinib group and 14% of the alitretinoin group.
- Nausea was rare with delgocitinib (<1%) compared to 6% with alitretinoin.
"The findings demonstrated that delgocitinib cream provided better effectiveness and a more favorable safety profile than oral alitretinoin over 24 weeks," the authors noted, concluding that "these results highlight the potential of delgocitinib cream as a promising treatment option for patients with severe chronic hand eczema."
Reference:
Giménez-Arnau AM, Pinter A, Sondermann W, Reguiai Z, Woolf R, Lynde C, Legat FJ, Costanzo A, Silvestre JF, Mellerup N, Østerdal ML, Plohberger U, Ryttig L, Bauer A; trial investigators. Efficacy and safety of topical delgocitinib cream versus oral alitretinoin capsules in adults with severe chronic hand eczema (DELTA FORCE): a 24-week, randomised, head-to-head, phase 3 trial. Lancet. 2025 Apr 16:S0140-6736(25)00001-7. doi: 10.1016/S0140-6736(25)00001-7. Epub ahead of print. PMID: 40252681.
