Delgocitinib cream outperforms oral alitretinoin in chronic hand eczema

The phase 3 DELTA FORCE trial, directly comparing topical delgocitinib with systemic alitretinoin for chronic hand eczema (CHE), showed superior benefit for the pan-JAK inhibitor. These favourable results of the recently EMA-approved delgocitinib cream were detected in both primary and secondary endpoints.

“CHE is a very prevalent disease that affects hands and wrists and impacts patients’ daily quality-of-life as well as their occupational setting,” Prof. Ana Giménez-Arnau (Pompeu Fabra University; Autonomous University of Barcelona, Spain) stated [1]. She presented a head-to-head comparison of topical delgocitinib with the, until recently, only approved drug for severe CHE, oral alitretinoin. The phase 3 DELTA FORCE trial (NCT05259722) randomised 513 adult participants to twice-daily treatment with delgocitinib cream (20 mg/g) over 16 weeks, or oral alitretinoin at a daily dose of 30 mg over 12 weeks. This discrepancy in duration was decided due to the drug labelling of alitretinoin.

The mean age at baseline was 45 years, 65.1% of participants were women, the disease duration was 4 years, and the median Hand Eczema Severity Index (HECSI) score was 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 squares mean HECSI (-67.6 vs -51.5; P<0.001) and all secondary endpoints were significantly in favour of delgocitinib (see Figure). Secondary endpoints included HECSI-90 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 week 1 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).

Figure: Change in the HECSI score (WOCF) in the DELTA FORCE trial [1]



CI, confidence incidence; LS, least squares; WOCF, worst observation carried forward.*P≤0.001 versus alitretinoin.

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 very soon,” Prof. Giménez-Arnau concluded.

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   1. Giménez-Arnau A, et al. DELTA FORCE trial: A 24-week head-to-head phase 3 trial comparing the efficacy and safety of topical delgocitinib cream with oral alitretinoin capsules in adults with severe chronic hand eczema. D1T01.1F, EADV Congress 2024, 25–28 September, Amsterdam, the Netherlands.

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Posted on 6 November 20246 November 2024