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Efficacy and safety of topical delgocitinib in patients with chronic hand eczema: data from a randomized, double-blind, vehicle-controlled phase IIa study

Worm M, Bauer A, Elsner P, Mahler V, Molin S, Nielsen TSS (2019)

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Publication Type: Journal article

Publication year: 2019

Journal

DOI: 10.1111/bjd.18469

Abstract

Background Management of chronic hand eczema (CHE) remains a challenge; effective topical treatment is limited to corticosteroids. Objectives To assess the efficacy and safety of a novel, pan-Janus kinase inhibitor (delgocitinib) in patients with CHE. Methods In this randomized, double-blind, phase IIa study, patients with CHE received delgocitinib ointment 30 mg g(-1) or vehicle ointment for 8 weeks. The primary end point was the proportion of patients achieving treatment success ['clear'/'almost clear' skin with >= 2-point improvement in the Physician's Global Assessment of disease severity (PGA)] at week 8. Secondary end points included Hand Eczema Severity Index (HECSI) score changes and the proportion of patients achieving treatment success on the Patient's Global Assessment of disease severity (PaGA). Results Ninety-one patients were randomized. More patients receiving delgocitinib (46%) than vehicle (15%) [odds ratio 4 center dot 89, 95% confidence interval (CI) 1 center dot 49-16 center dot 09; P = 0 center dot 009] achieved treatment success (PGA). Adjusted mean HECSI score at week 8 was lower with delgocitinib (13 center dot 0) than with vehicle (25 center dot 8) (adjusted mean difference -12 center dot 88, 95% CI -21 center dot 47 to -4 center dot 30; P = 0 center dot 003). More patients receiving delgocitinib than vehicle achieved treatment success by PaGA, but this did not reach statistical significance. The incidence of adverse events was similar with delgocitinib and vehicle; none led to discontinuation of delgocitinib. Conclusions Delgocitinib ointment was efficacious and well tolerated. As a plateau of efficacy was not observed, a longer treatment period may lead to increased efficacy. Further clinical studies are warranted to confirm these findings in patients with CHE.

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How to cite

APA:

Worm, M., Bauer, A., Elsner, P., Mahler, V., Molin, S., & Nielsen, T.S.S. (2019). Efficacy and safety of topical delgocitinib in patients with chronic hand eczema: data from a randomized, double-blind, vehicle-controlled phase IIa study. British Journal of Dermatology. https://doi.org/10.1111/bjd.18469

MLA:

Worm, M., et al. "Efficacy and safety of topical delgocitinib in patients with chronic hand eczema: data from a randomized, double-blind, vehicle-controlled phase IIa study." British Journal of Dermatology (2019).

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