Hand eczema is characterised by painful, pruritic, non-infectious inflammatory skin changes on the hands and wrist. The disease is considered chronic when it is lasting ≥3 months or relapsing at least twice a year. Current treatment options are limited to emollients, topical corticosteroids, and calcineurin inhibitors.
The topical pan-JAK inhibitor delgocitinib prevents inflammation by blocking several cytokine-mediated signalling cascades involved in the pathophysiology of chronic hand eczema. This explains the motivation for the phase 2b, dose-finding study in chronic hand eczema patients assessing the safety and efficacy of this agent. Participants (n=258) were randomised to delgocitinib cream in 4 different doses (i.e. 1 mg/g, 3 mg/g, 8 mg/g, and 20 mg/g) or a vehicle cream. All treatments were applied twice daily. The participants all had mild-to-severe chronic hand eczema (Investigator´s Global Assessment [IGA] ≥2) and had shown inadequate response to topical corticosteroids within 1 year before screening. The primary study endpoint was an IGA for chronic hand eczema (IGA-CHE) score of 0 (i.e. clear) or 1 (i.e. almost clear) with at least a 2-step improvement from baseline to week 16. In addition, a change in Hand Eczema Severity Index (HECSI) from baseline to week 16 was assessed.
The baseline characteristics were balanced between the groups. “Most of the 258 patients had moderate chronic hand eczema, reflected by a HECSI score of 44.5,” Prof. Margitta Worm (Charité Universitätsmedizin Berlin, Germany) explained during the presentation of the study. More patients in the vehicle group compared with the delgocitinib groups discontinued the study. A statistically significant response was observed in the primary endpoint for the patients receiving delgocitinib 8 mg/g and 20 mg/g (P<0.0004 vs vehicle). This significant effect was consistently demonstrated from week 4 for the 8 mg/g delgocitinib group and week 6 for the 20 mg/g delgocitinib group. An IGA-CHE treatment success was achieved by 37.7% of patients treated with 20 mg/g delgocitinib and 36.5% of patients treated with 8 mg/g delgocitinib. In addition, a statistically significant dose-response was also established for the change in HECSI from baseline to week 16; all active arms had a significantly greater change in HECSI from baseline to week 16 than vehicle (P<0.05), which was most pronounced in the highest 2 doses. A significant treatment effect of delgocitinib 8 mg/g and 20 mg/g was already noticed at week 2 (P<0.05).
The majority of adverse events were non-serious, mild, or moderate, and not considered treatment related. The most frequently reported adverse events were nasopharyngitis, eczema, and headache. As Prof. Worm mentioned in the discussion, the number of patients in the different treatment groups was too small to discriminate between different subgroups of hand eczema and their response. “We have to wait for phase 3 data, but delgocitinib is definitely interesting in a disease where we have hardly any options,” Prof. Worm concluded.
- Worm M. The topical pan-JAK inhibitor delgocitinib cream demonstrates dose response in a 16-week phase 2b trial in chronic hand eczema. Late-breaker D1T03.4A, EADV Virtual, 29-31 October 2020.
© 2023 The Author(s). Published by Medicom Medical Publishers.
User license: Creative Commons Attribution – NonCommercial (CC BY-NC 4.0)
Posted on
site created by:
© 2023 Medicom Medical Publishers. All rights reserved. Terms and Conditions | Privacy Policy