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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. [ABSTRACT FROM AUTHOR]

Background Objectives Methods Results Conclusions The Hand Eczema Severity Index (HECSI) is a Clinician‐Reported Outcome measure of the severity of hand eczema (HE).This study aimed to evaluate the validity, reliability and ability to detect change of the HECSI, and the HECSI‐75 and HECSI‐90 as responder definitions.Analyses were performed using data from a sample of n = 258 patients with Chronic Hand Eczema (CHE) from a Phase 2b, randomised, double‐blind, vehicle‐controlled trial of delgocitinib cream, pooled across treatment groups. The measurement properties of the HECSI were assessed and the adequacy of the HECSI‐75 and HECSI‐90 as responder definitions was explored through cross‐tabulation.Inter‐item correlations provided support for the scoring, whereby items are grouped by areas of the hand. HECSI demonstrated good test–retest reliability with intra‐class correlations >0.70. Construct validity was supported by a logical pattern of correlations with concurrent measures and significant differences in HECSI scores across severity groups (p < 0.001). HECSI was responsive with statistically significant improvements over time and with significant differences (p < 0.001) between improved and stable groups. Data provided support for both HECSI‐75 and HECSI‐90 as within‐patient responder definitions.HECSI has strong validity, reliability and ability to detect change as a measure of CHE severity. HECSI‐75 and HECSI‐90 are appropriate responder definitions. [ABSTRACT FROM AUTHOR]