Delgocitinib Cream Reduces Itch and Pain in Moderate to Severe Chronic Hand Eczema: Phase 3 DELTA 1 and 2 Pooled Analyses

Delgocitinib乳膏可减轻中重度慢性手部湿疹的瘙痒和疼痛:DELTA 1和2期3期汇总分析

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Abstract

INTRODUCTION: Itch and pain are two of the most common and burdensome symptoms for moderate to severe Chronic Hand Eczema (CHE). Here, we assess changes in itch/pain in patients with moderate to severe CHE treated with delgocitinib cream 20 mg/g or cream vehicle for 16 weeks. METHODS: In a pooled DELTA 1 (NCT04871711)/DELTA 2 (NCT04872101) analysis (delgocitinib [n = 639]; cream vehicle [n = 321]; twice-daily), the Hand Eczema Symptom Diary captured patient-reported itch/pain severity on a numeric rating scale. Changes in itch/pain from baseline were assessed daily during week 1 and weekly from week 1 to 16. RESULTS: In delgocitinib-treated patients, a statistically significant least square mean reduction from baseline was observed for itch from day 1 ([delgocitinib cream/cream vehicle] 0.75/0.32; P < 0.001) and pain from day 3 (0.98/0.58; P = 0.001) after the first application. Among patients with ≥ 4-point baseline itch/pain score, a significantly greater percentage of delgocitinib-treated patients achieved ≥ 4-point reduction from week 2 (14.2%/17.3%) versus cream vehicle (6.3%/6.9%; P < 0.001). Reductions were maintained up to week 16 with delgocitinib cream treatment. Delgocitinib cream was well tolerated. CONCLUSION: Early onset of itch/pain reduction was observed within week 1 for delgocitinib-treated patients, thereby providing further support of the use and efficacy of delgocitinib cream in adults with moderate to severe CHE.

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