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
- PMID: 40252681
- DOI: 10.1016/S0140-6736(25)00001-7
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
Abstract
Background: Chronic hand eczema is a heterogeneous, fluctuating, and long-lasting disease affecting the hands and wrists that substantially affects quality of life. For severe chronic hand eczema, topical corticosteroids are often unsatisfactory and systemic treatment can be required. The aim of the head-to-head, phase 3 DELTA FORCE trial was to evaluate the efficacy and safety of topical delgocitinib cream versus oral alitretinoin, the only currently approved systemic drug for severe chronic hand eczema.
Methods: This randomised, assessor-masked, trial was conducted at 102 trial centres in Austria, Canada, France, Germany, Italy, Norway, Poland, Slovakia, Spain, and the UK. Adults (aged ≥18 years) with severe chronic hand eczema were randomly assigned (1:1) via an interactive response technology system to delgocitinib cream 20 mg/g (twice daily) or alitretinoin 30 mg (once daily) for up to 24 weeks. The primary endpoint was change in Hand Eczema Severity Index (HECSI) score from baseline to week 12. Efficacy of delgocitinib cream versus alitretinoin was assessed in all eligible randomly assigned patients who had available data at baseline, and safety was assessed in all patients exposed to trial treatment. The trial is registered with ClinicalTrials.gov (NCT05259722) and is complete.
Findings: Between June 15, 2022, and Dec 5, 2023, 513 (334 [65%] female and 179 [35%] male) patients were randomly assigned to receive delgocitinib cream (n=254) or alitretinoin (n=259). Ten patients were excluded after randomisation due to not meeting eligibility criteria, so the full analysis set consisted of 250 patients in the delgocitinib group and 253 in the alitretinoin group. One patient in the delgocitinib group and three in the alitretinoin group were excluded from the primary analysis as they had missing HECSI data at baseline. A significantly greater least squares mean change in HECSI score from baseline to week 12 was observed with delgocitinib cream (-67·6 [SE 3·4]; n=249) versus alitretinoin (-51·5 [3·4]; n=250; difference -16·1 [95% CI -23·3 to -8·9], p<0·0001). Fewer patients reported adverse events in the delgocitinib group (125 [49%] of 253 patients) than in the alitretinoin group (188 [76%] of 247). The most frequent adverse events were headache (ten [4%] in the delgocitinib group vs 80 [32%] in the alitretinoin group), nasopharyngitis (30 [12%] vs 34 [14%]), and nausea (one [<1%] vs 14 [6%]).
Interpretation: Delgocitinib cream showed superior efficacy and a more favourable safety profile versus oral alitretinoin over 24 weeks. These results support the benefit of delgocitinib cream in patients with severe chronic hand eczema.
Funding: LEO Pharma.
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Conflict of interest statement
Declaration of interests AMG-A is or recently was a speaker or advisor for or has received research funding from Almirall, Amgen, AstraZeneca, Avene, Blueprint, Celldex, Escient Pharmaceuticals, Genentech, GSK, Harmonic Bio, Instituto Carlos III- FEDER, Jaspers, LEO Pharma, Menarini, Mitsubishi Tanabe Pharma, Noucor, Novartis, Sanofi–Regeneron, Septerna, Servier, Thermo Fisher Scientific, and Uriach Pharma. AP has served as an investigator, speaker, or advisor for AbbVie, Almirall-Hermal, Amgen, Biogen Idec, Biontec, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, GSK, Eli Lilly, Galderma, Hexal, Janssen, LEO Pharma, MC2, Medac, Merck Serono, Mitsubishi, MSD, Novartis, Pascoe, Pfizer, Tigercat Pharma, Regeneron, Roche, Sandoz Biopharmaceuticals, Sanofi-Genzyme, Schering-Plough, UCB Pharma, and Zuellig Pharma. WS received travel support for participation in congresses, speaker honoraria, or research grants from AbbVie, Almirall, Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Celgene, GSK, Janssen, LEO Pharma, Eli Lilly, Medi Bayreuth, MSD, Novartis, Pfizer, Roche, Sanofi Genzyme, and UCB. ZR has received consulting fees and honoraria from AbbVie, Almirall, Amgen, Avene, Bristol Myers Squibb, Celgene, Cerave, GSK, Janssen-Cilag, La Roche Posay, LEO Pharma, Eli Lilly, Medac, MSD, Novartis, Pierre Fabre Dermatologie, Pfizer, UCB, and Sanofi, and has been an investigator for AbbVie, Actelion, Almirall, Amgen, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Forward Pharma, GSK, Galderma, Genentec, Incyte, Janssen Cilag, LEO Pharma, Novartis, Pfizer, Roche, Regeneron, UCB, and Sanofi. RW has received travel support for participation in congresses, speaker honoraria, or research grants from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galderma, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, Sanofi, and UCB. CL has been a speaker or consultant to AbbVie, Amgen, Aralez, Arcutis, Bausch Health, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Cipher, Dermavant, Devonian, Eli Lilly, Fresnius Kabi, Galderma, GSK, InCyte, Innovaderm, Intega Skin, Janssen, Kyowa Kirin, La Roche Posay, LEO Pharma, L'Oreal, Medexus, MedX, Merck, Novartis, P&G, Pediapharm, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sandoz, Sentrex, SunPharma, TEVA, Tribute, UCB, Valeant, Viatris, and Volo Health, and has been a principal investigator for AbbVie, Acelyrin, Akros, Altius, Amgen, Aralez, Arcutis, Avillion, Bausch Health, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Cipher, Concert, Dermavant, Devonian, Eli Lilly, Evelo, Galderma, GSK, Incyte, Innovaderm, Intega Skin, Janssen, Kyowa Kirin, La Roche Posay, LEO Pharma, L'Oreal, Medexus, MedX, Merck, MoonLake, Novartis, Procter & Gamble, Pediapharm, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sandoz, Sentrex, SunPharma, TEVA, Tribute, UCB, Valeant, Viatris, and Volo Health. FJL has received consulting fees or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or education events, and has participated on advisory boards or served as an investigator for AbbVie, Almirall, Amgen, Celgene, DS Biopharma, Eli Lilly and Company, Galderma, Incyte, Janssen Cilag, Kiniksa Pharmaceuticals, LEO Pharma, Menlo Therapeutics, Novartis, Pelpharma, Pfizer, Regeneron, Sanofi, Trevi Therapeutics, and Vifor Pharma. AC has served as advisory board member and consultant and has received fees and speakers' honoraria or has participated in clinical trials for AbbVie, Almirall, Amgen, LEO Pharma, Eli Lilly, Galderma, Incyte, Janssen, Novartis, Sanofi Genzyme, Boehringer Ingelheim, and UCB. JFS has been an investigator, speaker, or advisor for AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Galderma, Incyte, LEO Pharma, Novartis, Pfizer, Regeneron, and Sanofi Genzyme. NM, MLØ, UP, and LR are employees of LEO Pharma. AB has been a speaker, advisor, or, investigator for or has received research funding from AbbVie, Almirall, Amgen, AstraZeneca, Biofrontera, Blueberry Therapeutics, Bristol Myers Squibb, Celldex, Centogene, Escient, Galderma, Genentech, Gilead, Jasper, Incyte, LEO Pharma, Eli Lilly, L'Oréal, Novartis, Sanofi, Regeneron, and Takeda.
Comment in
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Chronic hand eczema treatment: exploring topical JAK inhibition further.Lancet. 2025 May 10;405(10490):1644-1645. doi: 10.1016/S0140-6736(25)00554-9. Epub 2025 Apr 16. Lancet. 2025. PMID: 40252682 No abstract available.
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