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

Publikation: Beitrag in FachzeitschriftForschungsartikelBeigetragenBegutachtung

Beitragende

  • Andrea Bauer - , Klinik und Poliklinik für Dermatologie, Universitäts Allergiecentrum (Autor:in)
  • Jacob P Thyssen - , Universität Kopenhagen (Autor:in)
  • Timo Buhl - , Georg-August-Universität Göttingen (Autor:in)
  • Thor Schütt Svane Nielsen - , LEO Pharma AS (Autor:in)
  • Lotte Seiding Larsen - , LEO Pharma AS (Autor:in)
  • Anne Birk Østerskov - , LEO Pharma AS (Autor:in)
  • Tove Agner - , Universität Kopenhagen (Autor:in)

Abstract

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.

Details

OriginalspracheEnglisch
Seiten (von - bis)46-53
Seitenumfang8
FachzeitschriftContact dermatitis
Jahrgang89
Ausgabenummer1
PublikationsstatusVeröffentlicht - Juli 2023
Peer-Review-StatusJa

Externe IDs

Scopus 85152693516
ORCID /0000-0002-4411-3088/work/148145496

Schlagworte

Schlagwörter

  • Adult, Humans, Dermatitis, Allergic Contact, Eczema/drug therapy, Pruritus/drug therapy, Emollients/therapeutic use, Double-Blind Method, Pain, Treatment Outcome