Pan-JAK inhibition with delgocitinib met its primary endpoint in the DELTA 1 trial for the treatment of chronic hand eczema (CHE). At week 16, significantly more patients presented clear or almost clear skin in the Investigator’s Global Assessment (IGA) at week 16.
Robert Bissonnette, MD, FRCPC, presented these findings at the 2023 American Academy of Dermatology annual meeting.1
After promising results on the use of topical delgocitinib for CHE from phase 2b, the DELTA 1 trial advanced to phase 3. Adults with moderate-to-severe CHE, represented by an IGA score of 3 or 4, were included in the trial. Patients having had CHE more than 3 months and who experienced contraindications for topical steroids, met the inclusion criteria.
A total of 487 patients were randomized 2:1 to delogocitinib cream (20 mg/g; twice daily) or a cream vehicle. The primary endpoint, which was considered a “very high bar” according to Dr. Bissonnette, consisted of an IGA 0/1 at week 16, together with an improvement of at least two steps.
The mean age of the DELTA 1 cohort was 44, with a median age of 32 at disease onset. Severe CHE was observed in one-third of the participants and the median Dermatology Life Quality Index (DLQI) was 12.0, which represents a high impact of disease on QOL.
At week 16, 19.7% of the 325 participants in the active-treatment arm reached the IGA-CHE score of clear or almost clear, considerably more than in the vehicle arm (9.9%; P=0.006). In the hand eczema severity index (HECSI), a 75% improvement was achieved by 49.2% versus 23.5% and a 90% improvement in HECSI by 29.5% versus 12.3%, for delogocitinib and vehicle cream, respectively (P<0.001 for both comparisons, in favor of delgocitinib). In 74.4% in the delogocitinib arm versus 50.0% in the vehicle arm, the results for a 4-point or greater improvement in DLQI were observed (P<0.001).
The safety assessment revealed numerically higher rates of adverse events in the vehicle arm (50.6% vs 45.2%) with very similar proportions of serious adverse events (1.9% vs 1.8%).
Dr. Bissonnette emphasized that delgocitinib cream “significantly improved patient- and clinician-reported efficacy outcomes compared with vehicle treatment in this difficult to treat patient population.”
Copyright ©2023 Medicom Medical Publishers
Leave a Reply