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

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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.
OriginalsprogEngelsk
BogserieContact Dermatitis
Vol/bind89
Udgave nummer1
Sider (fra-til)46-53
Antal sider8
ISSN0105-1873
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
This phase IIb trial of delgocitinib cream (LP0133‐1273; NCT03683719) was sponsored by LEO Pharma (Ballerup, Denmark).

Funding Information:
Andrea Bauer has been a speaker/advisor/investigator and/or received research funding from AbbVie, Amgen, AstraZeneca, Biofrontera, Eli Lilly, Genentech, Gilead, Incyte, LEO Pharma, L'Oréal, Novartis, Pfizer, Pharvaris, Sanofi/Regeneron and Shire/Takeda. Jacob P. Thyssen has been a speaker/investigator/advisor for AbbVie, Almirall, Arena Pharmaceuticals, Aslan Pharmaceuticals, Eli Lilly, LEO Pharma, OM Pharma, Pfizer, Regeneron, Sanofi‐Genzyme and Union Therapeutics. Timo Buhl has been a speaker/investigator/advisor for AbbVie, ALK, AstraZeneca, Bencard, Eli Lilly, Galderma, Janssen, Kiniksa Pharmaceuticals, LEO Pharma, Novartis and Sanofi. Thor Schütt Svane Nielsen, Lotte Seiding Larsen and Anne Birk Østerskov are current or former employees of LEO Pharma A/S. Tove Agner has been a speaker/investigator/advisor for AbbVie, Eli Lilly, LEO Pharma, Pfizer, Regeneron and Sanofi‐Genzyme.

Publisher Copyright:
© 2023 The Authors. Contact Dermatitis published by John Wiley & Sons Ltd.

ID: 363441065