The use of calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g cutaneous (Cal/BD) foam in patients with psoriasis provides quicker, more effective relief of itch compared with foam vehicle, with significant improvements in sleep and Dermatology Life Quality Index (DLQI) scores, according to a study published in the Journal of the European Academy of Dermatology and Venereology.
Investigators pooled data from 3 multicenter, randomized, parallel-group, blinded trials (ClinicalTrials.gov identifiers: NCT01536886 [phase 2], NCT01866163 [phase3], and NCT02132936 [phase 3]) and sought to assess the efficacy of topical fixed-dose combination therapy with Cal/BD on itch, itch-associated loss of sleep, and health-related quality of life vs foam vehicle among adults with mild to severe psoriasis.
Patients with visual analogue scale (VAS) scores >40 (range, 1-100) were evaluated. Study outcomes included the following: itch VAS score reduction >40, ≥70% improvement in itch (Itch70) or itch-related loss of sleep, 75% improvement in modified Psoriasis Area and Severity Index (excluding the head; mPASI75), and DLQI scores 0/1 through 4 weeks.
Among a total of 837 patients with itch measurements available, 37 had baseline itch VAS=0 and were excluded from the analysis. Of the remaining 800 patients (Cal/BD foam: n=610; foam vehicle: n=190), 484 had baseline itch VAS >40. No association was reported between itch VAS score and mPASI at baseline. In patients with baseline itch VAS >40, significantly more individuals attained itch VAS reduction >40 in the active treatment vs vehicle treatment group from day 5 on (day 5: 57.5% vs 40.2% [P <.05]; and week 4: 83.0% vs 45.8% [P <.001]).
Furthermore, significantly more Cal/BD foam-treated patients compared with foam vehicle-treated patients achieved Itch70 at day 3 (34.2% vs 22.5%; P <.05) through week 4 (79.3% vs 38.1%; P <.001). Among patients with baseline itch VAS >40 and sleep loss >20, improvements in itch-associated sleep loss were seen at week 1 and continued through 4 weeks, with itch-related improvements occurring before mPASI75 improvements.
Moreover, significant differences were observed in the proportion of Cal/BD foam-treated patients vs foam vehicle-treated patients with baseline DLQI >10 (n=172 vs n=50) attaining DLQI ≤1 (25.0% vs 4.0%; P =.001) and DLQI 0 (17.4% vs 2.0%, respectively; P =.006) at week 4.
Limitations of the current study include the lack of validated itch-related sleep loss measurement tools, as well as the need for different patient pools, the lower patient numbers available for the earlier times (ie, days 3 and 5), and the lack of pooled efficacy data that compared Cal/BD foam and its monocomponents.
The investigators concluded that this pooled analysis of patients with psoriasis demonstrated that Cal/BD foam provides more rapid, effective relief from itch than foam vehicle, and is linked to significant improvements in DLQI and sleep among this population.
Disclosures: LEO Pharma sponsored this study. Multiple authors disclosed affiliations with pharmaceutical companies. See the reference for complete disclosure information.
Jalili A, Lebwohl M, Gold LS, et al. Itch relief in patients with psoriasis: effectiveness of calcipotriol plus betamethasone dipropionate foam [published December 6, 2018]. J Eur Acad Dermatol Venereol. doi: 10.1111/jdv.15393