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DOI 10.1111/cod.14303

Медицинская библиотека · Contact dermatitis · 2023

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.

Bauer Andrea, Thyssen Jacob P, Buhl Timo, Nielsen Thor Schütt Svane, Larsen Lotte Seiding, Østerskov Anne Birk, Agner Tove

Рандомизированное исследованиеСтатьяПеревод пока не подготовлен

Аннотация

BACKGROUND

Measuring patient-reported outcomes is crucial to fully capture the burden of chronic hand eczema (CHE).

OBJECTIVES

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).

METHODS

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.

RESULTS

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).

CONCLUSIONS

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.

Для цитирования: Bauer Andrea, Thyssen Jacob P, Buhl Timo, Nielsen Thor Schütt Svane, Larsen Lotte Seiding, Østerskov Anne Birk, Agner Tove. 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.. Contact dermatitis. 2023. DOI: 10.1111/cod.14303.

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