Rapid and effective itch relief using calcipotriol plus betamethasone dipropionate foam in patients with psoriasis

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J Clin Aesthet Dermatol


Background/Objective: Itch is common in psoriasis, regardless of disease severity, and is bothersome to many patients, adversely affecting health-related quality of life (HRQoL) and sleep. Topical fixed-dose combination calcipotriol 50μg/g plus betamethasone dipropionate 0.5mg/g cutaneous foam (Cal/BD foam) has demonstrated superior efficacy and favorable tolerability versus Cal or BD alone and versus Cal/BD in gel and ointment formulations in patients with psoriasis. Recently, Cal/BD foam demonstrated good itch relief, comparable to BD foam alone and superior to Cal foam alone. Steroid monotherapy is perceived as the gold standard in itch relief. This pooled analysis evaluated the efficacy of Cal/BD foam on itch and itch-related sleep loss, as well as Dermatology Life Quality Index (DLQI), and timing relative to effect on visible symptoms, versus foam vehicle (FV), through four weeks of treatment. Methods: Data from three Phase II/III trials (NCT01536886, NCT01866163, NCT02132936) of Cal/ BD foam versus FV and active comparators in patients with psoriasis aged 18 years or older with mild-to-severe disease were pooled. For itch-related analyses, only patients with baseline (BL) itch Visual Analog Scale (VAS) greater than 40 were analyzed. For endpoints at Days 3 and 5, only Phase III studies provided patient data. Efficacy endpoints included proportion of patients achieving itch reduction greater than 40 (according to VAS, range 1-100) or 70-percent-or-greater improvement in itch/itch-related sleep loss at Day 3, Day 5, Weeks 1, 2, and 4, or 75-percent improvement in the (excluding head) modified Psoriasis Area Severity Index (mPASI75) from BL at Weeks 1, 2, and 4. Results: Overall, 837 patients were included in the pooled analysis; 37 patients had BL itch VAS=0 (mean mPASI'±SD: 5.76'±3.06) and were subsequently excluded (Cal/BD foam, n=610; FV, n=190). Of that, 776 patients (97.0%) had data available at Week 4; there were no systematic reasons for discontinuation. Additionally, 484 had BL itch VAS greater than 40 (mean mPASI'±SD: 7.83'±5.32). We found no correlation between itch VAS score and mPASI at BL (R2=0.021). In patients with a BL itch VAS greater than 40, the proportion of patients achieving itch VAS reduction greater than 40 increased through four weeks with active treatment versus FV (Cal/ BD foam: Day 3: 41.3% [p=0.05], Day 5: 57.5% [p=0.005], Week 1: 60.1%, Week 2: 70.1%, Week 4: 83.0% [p<0.001]; FV: Day 3: 29.2%, Day 5: 40.2%, Week 1: 35.5%, Week 2: 42.5%, Week 4: 45.8%). In patients with BL itch VAS greater than 40, 34.2 percent of Cal/BD-foam-treated patients achieved a 70-percent-or-greater improvement in itch (Itch70) at Day 3, versus 22.5 percent of patients receiving FV (p<0.05); the proportion of patients achieving Itch70 continued to improve through four weeks with active treatment (Cal/BD foam: Day 5: 51.2%, Week 1: 54.4%, Week 2: 68.9%, Week 4: 79.3%; FV: Day 5: 28.7%, Week 1: 26.5%, Week 2: 36.7%, Week 4: 38.1; p<0.001). In patients with BL itch VAS greater than 40/sleep loss greater than 20, improvements in itch-related sleep loss occurred at Week 1 and continued to improve through four weeks. These improvements occurred before significant improvements in mPASI75 were observed. Data for DLQI are provided for Phase III data only (Cal/BD foam: n=178; FV: n=52); at baseline, all patients had a DLQI score greater than five. An improvement in DLQI was observed in both treatment groups: 44.2 percent of Cal/BD foam-treated patients and 18.3 percent of FV-treated patients achieved DLQI 0/1 at Week 4. Significant differences between Cal/ BD foam- versus FV-treated patients were observed in those with BL DLQI greater than 10 (n=172 vs. n=50) who achieved a DLQI score of one or less (25.0 vs. 4.0%; p=0.001) and DLQI 0 (17.4 vs. 2.0%; p=0.006) at Week 4. Conclusion: Cal/BD foam offers more rapid and effective relief from itch than FV; itch reduction is associated with significant improvements in sleep and DLQI. Cal/BD foam has a direct impact on itch relief observed before improvements in visible disease severity (mPASI).





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