February 08, 2019

There was no correlation between itch visual analogue scale score and modified Psoriasis Area and Severity Index at baseline,

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.

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Reference

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