Calcipotriol/Betamethasone Dipropionate Cutaneous Foam Treatment for Psoriasis in Patients With BSA 5–15% and PGA ≥ 3: Post-Hoc Analysis From Three Randomized Controlled Trials

Abstract

Introduction: Psoriasis is a chronic, inflammatory disease, which ranges in severity from mild to severe. Although topical therapies are frequently used to treat mild disease, they are not routinely used to treat patients with moderateto-severe disease who have a larger proportion of their body surface area (BSA) affected (C 5% BSA). Based on well-controlled trials in adults with mild-to-severe disease, fixed-dose combination calcipotriol 50 lg/g ? betamethasone dipropionate 0.5 mg/g (Cal/BD) cutaneous foam has been approved (EnstilarÒ, LEO Pharma) in the USA and EU for the treatment of psoriasis vulgaris for up to 4 weeks in adults. In this post-hoc subgroup analysis, we used pooled data from phase II/III trials to investigate the efficacy and safety of Cal/BD cutaneous foam in patients with moderate-to-severe psoriasis. Methods: Patients included in this analysis had psoriasis affecting 5-15% BSA and a physician's global assessment (PGA) C 3. Endpoints included: treatment success by PGA (rating: clear/almost clear), patient's global assessment (PaGA) at week 4 (rating: clear/very mild) and safety. Results: A total of 340 patients in the three randomized trials met the BSA/PGA inclusion criteria, of whom 254 were treated with Cal/BD foam and 86 with vehicle foam. Treatment success by PGA and PaGA at week 4 was achieved in 143 (58.1%) and 138 (56.1%) patients receiving Cal/BD foam, respectively, versus three (3.6%) and 14 (16.7%) patients receiving vehicle foam. Sixty-six adverse events (AEs) occurred in 47 (18.5%) patients receiving Cal/BD foam and 11 AEs occurred in 11 (12.8%) patients receiving vehicle foam. Three severe AEs and 15 non-serious treatment-related AEs occurred in patients receiving Cal/BD foam. Conclusion: The results from three clinical trials analyzed together show that topical Cal/BD foam is well tolerated and efficacious for treating patients with moderate-to-severe disease. Data support Cal/BD foam as a potential topical therapy for moderate-to-severe psoriasis.

Efficacy and safety of apremilast in patients with mild-to-moderate plaque psoriasis: Results of a phase 3, multicenter, randomized, double-blind, placebo-controlled trial

“…Topical treatments are commonly used to treat mild-to-moderate psoriasis and have demonstrated efficacy and tolerability in randomized clinical trials. 6,7 However, guidelines suggest that systemic treatment should be considered for patients with mild-to-moderate skin involvement who experience high disease burden or inadequate disease control with topical therapies, including patients with psoriasis in special areas.…”

“…1 Several classes of topical treatments are available, including topical corticosteroids, retinoids, vitamin D analogs, calcineurin inhibitors, dithranol, tar-based preparations, and combination treatments. 4,5 Topical treatments have demonstrated efficacy and tolerability for mildto-moderate psoriasis [6][7][8][9] and are the initial treatment for patients with mild-to-moderate psoriasis. 10 However, for some patients, topical treatments may not achieve sufficient disease control or may be impractical to apply.…”

Calcipotriene and Betamethasone Dipropionate PAD-Cream Demonstrates Greater Treatment Efficacy in Patients with Moderate-to-Severe Psoriasis Compared to Topical Suspension/Gel: A Subgroup Analysis of Two Phase 3 Studies

“…Topical therapies can be used as a treatment option for moderate-to-severe psoriasis as indicated by previous studies [ 37 , 38 ]. In a post hoc subgroup analysis of a phase 3 study, patients with baseline severity according to the rule of tens achieved numerically or statistically significant improvements with CAL/BDP foam compared to CAL/BDP TS/gel in PGA treatment success, mPASI75, and DLQI [ 39 ]; however, this was mainly at similar treatment success rates (32.0% for CAL/BDP foam) relative to the total mild-to-severe population (38.3%) [ 39 , 40 ] in contrast to what we have shown here.…”