Prof. Ana Giménez-Arnau (Pompeu Fabra University; Autonomous University of Barcelona, Spain) and colleagues compared topical delgocitinib head-to-head with the, until recently, only approved drug for severe CHE, oral alitretinoin1. The phase 3 DELTA FORCE trial (NCT05259722) randomised 513 adult participants to twice-daily treatment with delgocitinib cream (20 mg/g) or oral alitretinoin at a daily dose of 30 mg.
The mean age was 45 years at baseline, 65.1% of the participants were women and the disease duration was 4 years. Disease characteristics comprised a median Hand Eczema Severity Index (HECSI) score of 80.0. In both arms, participants with an Investigator Global Assessment (IGA-CHE) of 0/1 were allowed to discontinue and restart treatment later if needed up to week 24.
At week 12, both the primary endpoint of change in the least square mean HECSI (-67.6 vs -51.5; P<0.001), and all secondary endpoints were significantly in favour of delgocitinib. Secondary endpoints included HECSI90 at week 12 (38.6 vs 26%; P=0.003), treatment success with IGA-CHE 0/1 (27.2% vs 16.6%; P=0.004), change in Hand Eczema Symptom Diary (HESD) itch (-3.0 vs -2.4; P=0.005) and HESD pain (-2.0 vs -2.3; P=0.018). Prof. Giménez-Arnau added that the HECSI improved from the first week and the effect was maintained through week 24. Furthermore, significantly more topically treated participants achieved a reduction in Dermatology Life Quality Index (DLQI) score ≥4 points (P≤0.001 at weeks 12 and 24).
Study drug-related adverse events (AEs) occurred in 9.5% of the delgocitinib arm and 54.3% of alitretinoin the arm; serious AEs in 2% and 4.9%, respectively. The most common AEs in the delgocitinib versus the alitretinoin arm were headache (4.0% vs 32.4%) and nasopharyngitis (11.9% vs 13.8%).
“Last Friday, it [delgocitinib] was approved by the EMA and approved to be assessed in the FDA; we will then probably have the opportunity to use it in our daily practice,” Prof. Giménez-Arnau concluded.
Medical writing support was provided by Karin Drooff MPH