Itch relief in patients with psoriasis: effectiveness of calcipotriol plus betamethasone dipropionate foam

Abstract

Itch is common in psoriasis, adversely affecting health-related quality of life (HRQoL) and sleep. We evaluated the efficacy of topical fixed-dose combination calcipotriol 50μg/g plus betamethasone dipropionate 0.5mg/g cutaneous foam (Cal/BD foam) on itch, itch-related sleep loss and HRQoL vs. foam vehicle. We pooled data from three Phase II/III trials (NCT01536886/NCT01866163/NCT02132936) of Cal/BD foam vs. foam vehicle in adults with mild-severe psoriasis. For itch-related analyses, patients with baseline itch visual analogue scale (VAS) >40 (range 0-100) were analysed. Outcomes included the following: itch VAS reduction >40, ≥70% improvement in itch (Itch70) or itch-related sleep loss, 75% improvement in modified Psoriasis Area and Severity Index (excluding head; mPASI75) and Dermatology Life Quality Index (DLQI) scores 0/1 through 4weeks. Of 837 patients, 800 had baseline itch VAS >0 (Cal/BD foam, n=610; foam vehicle, n=190); 484 had baseline itch VAS >40. There was no correlation between itch VAS score and mPASI at baseline (R2 =0.021). In patients with baseline itch VAS >40, more patients achieved itch VAS reduction >40 in the active vs. vehicle group from Day 5 onwards (Day 5: 57.5% vs. 40.2% [P<0.05]; Week 4: 83.0% vs. 45.8% [P<0.001]). More Cal/BD-foam-treated patients achieved Itch70 at Day 3 (34.2% vs. 22.5%; P<0.05) through to Week 4 (79.3% vs. 38.1%; P<0.001). In patients with baseline itch VAS >40 and sleep loss >20, improvements in itch-related sleep loss occurred at Week 1 and continued through 4weeks. Itch-related improvements occurred before improvements in mPASI75. There were significant differences in the proportion of Cal/BD-foam- vs. foam-vehicle-treated patients with baseline DLQI >10 (n=172 vs. n=50) achieving DLQI ≤1 (25.0% vs. 4.0%; P=0.001) and DLQI 0 (17.4% vs. 2.0%; P=0.006) at Week 4. Compared with foam vehicle, Cal/BD foam offers more rapid and effective itch relief, with associated significant improvements in sleep and DLQI.