Itch relief in patients with psoriasis: effectiveness of calcipotriol plus betamethasone dipropionate foam

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 lg/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. ResultsOf 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. are employees of LEO Pharma A/S. Funding sourceThis study was sponsored by LEO Pharma.This manuscript contains original unpublished work and has not been submitted for publication elsewhere. Some of these data have previously been presented in poster format at the 27th European Academy of Dermatology and Venereology Congress 2018 (P2016).JEADV 2019, 33, 709-717 710 Jalili et al.

Fixed‐dose combination calcipotriol/betamethasone dipropionate foam provides a rapid onset of action, effective itch relief and improves patient quality of life

“…This difference reached statistical significance by Day 5 (57.5% vs. 40.2%; P < 0.01) and continued to increase through to Week 4 (83.0% vs. 45.8%; P < 0.001). 12 Similarly, a higher proportion of patients receiving Cal/BD foam achieved itch relief ≥70% VAS from baseline compared with vehicle foam (Fig. 1b).…”

“…A separate pool of patients from just the two Phase III studies was used to analyse itch relief results recorded earlier than Week 1, as the Phase II study did not record results at these early time points. 12 Over 4 weeks, a greater proportion of patients receiving Cal/ BD foam achieved an absolute itch reduction (itch VAS improvement >40 from baseline) compared with vehicle foam (Fig. 1a).…”

“…Regardless of disease severity, itch is commonly reported in psoriasis and often regarded by patients as the most burdensome symptom: 64%-97% of patients with psoriasis suffer from itch [9][10][11][12] and around 75% regard freedom from itch as a primary need. 12,13 This is unsurprising, as psoriasis-related itch negatively impacts sleep and stress, and increases feelings of stigmatisation and depression. 14,15 Itch and itch-related sleep loss, in particular, have been shown to decrease HRQoL and work productivity, 16,17 while sleep deprivation impacts psychological well-being through increased stress, anxiety and depression.…”

Rapid onset of action of calcipotriol/betamethasone dipropionate cutaneous foam in psoriasis, even in patients with more severe disease

“…In addition, efficacy was not evaluated by study investigators earlier than week 1, so the earliest onset of action in terms of PGA or mPASI is unknown. However, in terms of itch as a key symptom of psoriasis, a companion article on the efficacy of Cal/BD foam on itch relief in patients with psoriasis found significant improvements in itch‐related variables from day 3 onwards . Furthermore, this pooled analysis was not designed to evaluate the individual Cal and BD monocomponents of the fixed combination Cal/BD cutaneous foam.…”

“…However, in terms of itch as a key symptom of psoriasis, a companion article on the efficacy of Cal/BD foam on itch relief in patients with psoriasis found significant improvements in itch- related variables from day 3 onwards. 24 Furthermore, this pooled analysis was not designed to evaluate the individual Cal and BD monocomponents of the fixed combination Cal/BD cutaneous foam. However, as previously demonstrated, 11 the Cal/BD cutaneous foam shows superior clinical efficacy vs. Cal or BD alone with regard to PGA, mPASI/PASI 75 and itch.…”