Itch relief in patients with psoriasis: effectiveness of calcipotriol plus betamethasone dipropionate foam. (28th March 2019)

• Record Type: Journal Article
• Authors: Jalili, A.; Lebwohl, M.; Stein Gold, L.; Andersen, S.B.; Jensen, K.L.; Pink, A.E.; Segaert, S.; Berg, P.; Calzavara‐Pinton, P.G.; de la Cueva Dobao, P.; Thaçi, D.
• Is Part Of: Journal of the European Academy of Dermatology and Venereology. Volume 33:Number 4(2019)
• Page Start: 709
• Page End: 717
• Publication Date: 2019-03-28
• Subjects: Dermatology -- Periodicals; Sexually transmitted diseases -- Periodicals; 616.5
• DOI: 10.1111/jdv.15393
• Languages: English
• ISSNs: 0926-9959

Abstract

Abstract: 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 μg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam (Cal/BD foam) on itch, itch‐related sleep loss and HRQoL vs. foam vehicle. Methods: 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 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 ( R 2 = 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 4 weeks. 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. Conclusion: Compared with foam vehicle, Cal/BD foam offers more rapid and effective itch relief, with associated significant improvements in sleep and DLQI.