654 - Delgocitinib cream reduces itch and pain in adults with moderate to severe chronic hand eczema: pooled analyses of the phase 3 DELTA-1 and -2 trials

Abstract Introduction/Background Itch and pain are two of the most common and burdensome symptoms of Chronic Hand Eczema. Delgocitinib cream, a topical pan-Janus kinase inhibitor, was well tolerated and demonstrated significant improvement in primary and all secondary efficacy endpoints in DELTA-1 (NCT04871711) and DELTA-2 (NCT04872101). Objectives The objectives of this analysis were to assess the effect on itch and pain of twice-daily applications of delgocitinib cream 20 mg/g, including early onset of reductions, compared with cream vehicle in the treatment of adults with moderate to severe CHE in a pooled analysis of the pivotal Phase 3 DELTA-1 and DELTA-2 trials. Methods This analysis includes pooled data from DELTA-1 and -2 (delgocitinib cream 20 mg/g n=639; cream vehicle n=321; twice-daily). The Hand Eczema Symptom eDiary (HESD) captured patient-reported worst severity of itch and pain over the past 24 hours on an 11-point numeric rating scale (0=no itch/pain to 10=severe itch/pain). Changes in itch and pain from baseline were assessed daily during Week (W)1 and weekly from W1-16. Results For itch, a significant least square (LS) mean reduction from baseline was detected 1 day after patients first applied delgocitinib 20 mg/g (0.75) versus the cream vehicle group (0.32, P0.001). For pain, a significant LS mean reduction was detected 3 days after the first application of delgocitinib cream (0.98) versus cream vehicle (0.58, P0.001). The LS mean itch and pain reductions continued for delgocitinib cream-treated patients up to W16 (P0.001). A clinically meaningful ≥4-point reduction in itch was achieved by significantly more patients applying delgocitinib cream from W2 (14.2%) versus cream vehicle (6.3%, P0.001) and onwards to W16 (delgocitinib cream: 47.2%; cream vehicle: 21.5%; P0.001). Similar results for a ≥4-point reduction in pain were observed. Conclusions Early onset of itch and pain reduction was observed within W1 for delgocitinib-treated patients, with reductions remaining significantly greater versus cream vehicle-treated patients from W1 to W16.