Treatment with delgocitinib cream improves itch, pain and other signs and symptoms of chronic hand eczema: Results from the Hand Eczema Symptom Diary in a phase IIb randomized clinical trial

被引:11
作者
Bauer, Andrea [1 ]
Thyssen, Jacob P. P. [2 ]
Buhl, Timo [3 ]
Nielsen, Thor Schutt Svane [4 ]
Larsen, Lotte Seiding [4 ]
Osterskov, Anne Birk [4 ]
Agner, Tove [2 ]
机构
[1] Tech Univ Dresden, Univ Allergy Ctr, Univ Hosp Carl Gustav Carus, Dept Dermatol, Dresden, Germany
[2] Univ Copenhagen, Bispebjerg Hosp, Dept Dermatol & Venereol, Copenhagen, Denmark
[3] Georg August Univ, Dept Dermatol Venereol & Allergol, Gottingen, Germany
[4] LEO Pharm AS, Ballerup, Denmark
关键词
chronic hand eczema; hand eczema; itch; occupational; pain; PRO; treatment;
D O I
10.1111/cod.14303
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
<bold>Background: </bold>Measuring patient-reported outcomes is crucial to fully capture the burden of chronic hand eczema (CHE). <bold>Objectives: </bold>To assess the effect of delgocitinib cream on itch, pain and nine additional key signs and symptoms reported by patients with CHE using the Hand Eczema Symptom Diary (HESD). <bold>Methods: </bold>In a double-blind, phase IIb dose-ranging trial (NCT03683719), 258 adults with mild to severe CHE were randomized to delgocitinib cream 1, 3, 8 or 20 mg/g or cream vehicle twice daily for 16 weeks. Patients assessed 11 signs and symptoms of CHE daily through the HESD using an 11-point numeric rating scale; this was an exploratory endpoint. <bold>Results: </bold>Delgocitinib cream 20 mg/g was associated with an early and sustained reduction in itch and pain, along with clinically relevant reductions of =4 points from baseline to Week 16 in 48.4% and 63.6% of patients, respectively (17.9% and 5.9% with cream vehicle). There were improvements versus cream vehicle in all assessed CHE signs and symptoms (20 mg/g, p < 0.05). <bold>Conclusions: </bold>Delgocitinib cream reduced itch, pain and other signs and symptoms in patients with CHE. This data correlated with clinician-reported outcomes, indicating that the HESD may be a useful assessment tool for CHE management.
引用
收藏
页码:46 / 53
页数:8
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