Effect of Delgocitinib Cream on Health-Related Quality of Life in Patients With Moderate to Severe Chronic Hand Eczema.

BACKGROUND

Chronic Hand Eczema (CHE) is a multifactorial, fluctuating inflammatory disease of the hands and wrists that negatively impacts patients' health-related quality of life (HRQoL).

OBJECTIVES

To assess the effects of delgocitinib cream versus cream vehicle on HRQoL.

METHODS

DELTA 1 and DELTA 2 were phase 3 trials of identical design in which adults with moderate to severe CHE were randomised (2:1) to double-blind treatment with delgocitinib cream 20 mg/g or cream vehicle twice daily for 16 weeks. Data were pooled from both trials and changes in EQ-5D, Dermatology Life Quality Index (DLQI), and Hand Eczema Impact Scale (HEIS), including the HEIS Proximal Daily Activity Limitations (PDAL) and HEIS Embarrassment (Emb) subsets, were compared.

RESULTS

Across the two trials, 639 patients were randomised to delgocitinib cream and 321 to cream vehicle. Delgocitinib cream resulted in significantly greater improvement in EQ-5D, DLQI, HEIS, HEIS PDAL, and HEIS Emb compared with cream vehicle at week 16 (all p < 0.001). More patients achieved clinically meaningful improvement from baseline in patient-reported outcomes at week 16 (all p < 0.001), and the mean time spent in an improved HRQoL state increased with delgocitinib cream.

CONCLUSIONS

Delgocitinib cream resulted in clinically significant improvement in HRQoL compared with cream vehicle.

CLINICAL TRIAL ID: DELTA 1 (NCT04871711) and DELTA 2 (NCT04872101).