January 28, 2019

Investigators noted that itch-related improvements occurred before treatment efficacy was observed using modified PASI scores.

Topical calcipotriol/betamethasone dipropionate foam (Cal/BD foam) offers more effective and rapid itch relief in people with moderate to severe psoriasis compared with foam vehicle delivery of corticosteroids, according to study results published in the Journal of the European Academy of Dermatology and Venereology.

The investigators sought to examine the efficacy of topical fixed-dose combination calcipotriol 50 µg/g plus betamethasone dipropionate 0.5 mg/g cutaneous foam vs foam vehicle on symptoms of itch, itch-related sleep loss, and quality of life in patients with moderate to severe psoriasis.

The investigators pooled data from 3 Phase II/III trials comparing the effectiveness of Cal/BD foam vs foam vehicle in a cohort of 837 adults with mild to severe psoriasis over a 4-week treatment period. Participants demonstrated the presence of itch as a key symptom with a baseline itch visual analogue scale (VAS) score of >0 or >40.

Outcomes of interest were the absolute itch reduction of VAS >40 and achieving ≥70% improvement in itch relief and itch-related sleep loss. Other outcomes included improvement in modified Psoriasis Area Severity Score (PASI) ≥75% and achieving a Dermatology Life Quality Index (DLQI) score of 0/1, representing no or minimal impact of psoriasis on quality of life. Itch-related outcomes were assessed at baseline, day 3, and day 5 (phase III trial pool only), and weeks 1, 2, and 4 (extended pool).

In the overall cohort, 800 participants had baseline itch VAS >0 (Cal/BD foam, n=610; foam vehicle, n=190); of these 800 participants, 484 had severe baseline itch VAS >40. At baseline, the investigators did not identify any correlation between itch VAS score >0 and modified PASI (R²=0.021), and itch severity was comparable among Cal/BD foam and vehicle foam groups. At week 4, itch VAS scores were lower in the Cal/BD foam group vs foam vehicle group (mean VAS: 9.8±19.3 vs 30.3±28.4).

More participants with baseline itch VAS >40 achieved itch VAS reduction >40 using Cal/BD foam vs foam vehicle as early as day 5 (57.5% vs 40.2%; P <.05) and through week 4 (83% vs 45.8%; P <.001). Similarly, a greater proportion of Cal/BD foam users achieved a ≥70% improvement in itch at day 3 (32.2% vs 22.5%; P <.05) and continuing through week 4 (19.3% vs 38.1%; P <.001). Improvements in itch-related sleep loss were greater in patients with baseline itch VAS >40 and sleep loss >20 in the Cal/BD foam group vs the foam vehicle group; the differences in improvement measures between groups was significant at week 4.

Investigators noted that itch-related improvements occurred before treatment efficacy was observed using modified PASI scores. As for quality of life, significantly more Cal/BD foam users vs foam vehicle users with baseline DLQI scores >10 (Cal/BD, n=172; vehicle, n=50) achieved DLQI ≤1 (25% vs 4%; P =.001) or DLQI 0 (17.4% vs 2%; P =.006).

Limitations to the study included lack of validated tools to measure itch-related sleep-loss, lower participant numbers for early time points (days 3 and 5), and missing information comparing the efficacy of Cal/BD foam with its individual components.

Compared with foam vehicle delivery of corticosteroids, Cal/BD foam is more effective and rapid to relieve itch-related symptoms in patients with moderate-to-severe psoriasis. The reduction of itch from Cal/BD foam was further associated with improvements in sleep and quality of life. The investigators recommend the increased use of itch assessment tools for outcomes in future clinical studies.

Disclosure: This study was sponsored by LEO Pharma.

Follow @DermAdvisor

Reference                    

Jalili A, Lebwohl M, Gold LS, et al. Itch relief in patients with psoriasis: Effectiveness of calcipotriol plus betamethasone dipropionate foam [published online December 6, 2018]. J Eur Acad Dermatol Venereol. doi: 10.1111/jdv.15393