Contact dermatitis · 2026
Effect of Delgocitinib Cream on Health-Related Quality of Life in Patients With Moderate to Severe Chronic Hand Eczema.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Bauer Andrea, Guenther Lyn, Woolf Richard, Didriksen Apol Eydna, Maslin Douglas, Nyholm Nanna, Thoning Henrik, Schuttelaar Marie Louise
Аннотация
BACKGROUND: Chronic Hand Eczema (CHE) is a multifactorial, fluctuating inflammatory disease of the hands and wrists that negatively impacts patients' health-related quality of life (HRQoL).
OBJECTIVES: To assess the effects of delgocitinib cream versus cream vehicle on HRQoL.
METHODS: DELTA 1 and DELTA 2 were phase 3 trials of identical design in which adults with moderate to severe CHE were randomised (2:1) to double-blind treatment with delgocitinib cream 20 mg/g or cream vehicle twice daily for 16 weeks. Data were pooled from both trials and changes in EQ-5D, Dermatology Life Quality Index (DLQI), and Hand Eczema Impact Scale (HEIS), including the HEIS Proximal Daily Activity Limitations (PDAL) and HEIS Embarrassment (Emb) subsets, were compared.
RESULTS: Across the two trials, 639 patients were randomised to delgocitinib cream and 321 to cream vehicle. Delgocitinib cream resulted in significantly greater improvement in EQ-5D, DLQI, HEIS, HEIS PDAL, and HEIS Emb compared with cream vehicle at week 16 (all p < 0.001). More patients achieved clinically meaningful improvement from baseline in patient-reported outcomes at week 16 (all p < 0.001), and the mean time spent in an improved HRQoL state increased with delgocitinib cream.
CONCLUSIONS: Delgocitinib cream resulted in clinically significant improvement in HRQoL compared with cream vehicle.
CLINICAL TRIAL ID: DELTA 1 (NCT04871711) and DELTA 2 (NCT04872101).
OBJECTIVES: To assess the effects of delgocitinib cream versus cream vehicle on HRQoL.
METHODS: DELTA 1 and DELTA 2 were phase 3 trials of identical design in which adults with moderate to severe CHE were randomised (2:1) to double-blind treatment with delgocitinib cream 20 mg/g or cream vehicle twice daily for 16 weeks. Data were pooled from both trials and changes in EQ-5D, Dermatology Life Quality Index (DLQI), and Hand Eczema Impact Scale (HEIS), including the HEIS Proximal Daily Activity Limitations (PDAL) and HEIS Embarrassment (Emb) subsets, were compared.
RESULTS: Across the two trials, 639 patients were randomised to delgocitinib cream and 321 to cream vehicle. Delgocitinib cream resulted in significantly greater improvement in EQ-5D, DLQI, HEIS, HEIS PDAL, and HEIS Emb compared with cream vehicle at week 16 (all p < 0.001). More patients achieved clinically meaningful improvement from baseline in patient-reported outcomes at week 16 (all p < 0.001), and the mean time spent in an improved HRQoL state increased with delgocitinib cream.
CONCLUSIONS: Delgocitinib cream resulted in clinically significant improvement in HRQoL compared with cream vehicle.
CLINICAL TRIAL ID: DELTA 1 (NCT04871711) and DELTA 2 (NCT04872101).