Background Itch is common in psoriasis, adversely affecting health?related quality of life (HRQoL) and sleep.
Objective We evaluated the efficacy of topical fixed?dose combination calcipotriol 50 ?g/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) on itch, itch?related sleep loss and HRQoL versus foam vehicle.
Methods We pooled data from three Phase II/III trials (NCT01536886/NCT01866163/NCT02132936) of Cal/BD foam versus foam vehicle in adults with mild–severe psoriasis. For itch?related analyses, patients with baseline itch VAS >40 (range 1–100) were analysed. Outcomes included: itch VAS reduction >40, ?70% improvement in itch (Itch70) or itch?related sleep loss, 75% improvement in modified PASI (excluding head) (mPASI75), and Dermatology Life Quality Index (DLQI) scores 0/1 through 4 weeks.
Results 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 versus 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 foam4?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 4 weeks. Itch?related improvements occurred before improvements in mPASI75. There were significant differences in the proportion of Cal/BD?foam? versus 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.
Conclusion Compared with foam vehicle, Cal/BD foam offers more rapid and effective itch relief, with associated significant improvements in sleep and DLQI.