Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam in Patients with Moderate-to-Severe Psoriasis: Sub-Group Analysis of the PSO-ABLE Study

Abstract

BackgroundFixed-combination calcipotriol 50 μg/g plus betamethasone 0.5 mg/g (Cal/BD) aerosol foam is a new topical treatment for psoriasis. Although moderate-to-severe psoriasis is typically treated with systemic/biologic therapies, a topical treatment that is efficacious in these patients may be a significant cost-saving alternative to systemic therapy.ObjectiveThe objective of this study was to assess the response to Cal/BD foam and gel in patients with moderate-to-severe psoriasis enrolled in the phase III, 12-week PSO-ABLE study.MethodsPatients eligible for this analysis had moderate-to-severe psoriasis, defined by the ‘Rule of Tens’: body surface area ≥10% or Psoriasis Area and Severity Index (PASI) [excluding head; modified PASI (mPASI)] >10 or Dermatology Life-Quality Index >10. Endpoints included: proportion of patients achieving mPASI75 or mPASI90; change in body surface area; proportion of patients clear/almost clear with a ≥2 grade improvement (i.e., treatment success); change in Dermatology Life-Quality Index.ResultsSeventy-seven Cal/BD foam patients and 82 gel patients had moderate-to-severe psoriasis. A greater proportion achieved mPASI75 and mPASI90 with Cal/BD foam than gel at weeks 4, 8, and 12 (57.1 vs. 35.4%; p = 0.006 and 15.6 vs. 12.2% at week 12, respectively); overall reduction in mPASI from baseline to week 12 was 64% with the foam vs. 51% with the gel. Overall reduction in body surface area at week 12 was 50% with the foam and 39% with the gel. Treatment success rates were higher with the Cal/BD foam than the gel at weeks 1, 2, 4, 8 (p = 0.0089), and 12, and a greater proportion of foam patients achieved a Dermatology Life-Quality Index score of 0/1 at weeks 4 (p = 0.004), 8, and 12 (p = 0.001).ConclusionCal/BD foam can be considered as a treatment option in some patients with moderate-to-severe psoriasis who are potential candidates for systemic therapy.Clinicaltrials.gov identifierNCT02132936.

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

“…DLQI data to assess the impact of onset of action on HRQoL were from two Phase III trials; therefore, it was a smaller sample size than other data analysed in this study. Nevertheless, together with previously published data, our analysis suggests a potential impact of rapid onset of action on DLQI . 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.…”

New Calcipotriol/Betamethasone Dipropionate Foam Formulation for the Treatment of Psoriasis: An Overview

“…39 Clinical trials involving Cal/BD aerosol foam have demonstrated that this formulation is safe and well tolerated. Once that the application frequency is reduced by the combination treatment foam, a significant reduction of both active ingredients monotherapies-related adverse events (AEs) is also observed.…”

“…Once that the application frequency is reduced by the combination treatment foam, a significant reduction of both active ingredients monotherapies-related adverse events (AEs) is also observed. 13 AEs were generally of mild or moderate severity, 2,3,25,[37][38][39]43 mostly lesional or perilesional, rarely leading to treatment discontinuation. 3,25,38,39 Skin atrophy, adrenal suppression based on ACTH stimulating test, clinically relevant changes to HPA axis or calcium homeostasis were rarely reported (Table 1).…”

“…13 AEs were generally of mild or moderate severity, 2,3,25,[37][38][39]43 mostly lesional or perilesional, rarely leading to treatment discontinuation. 3,25,38,39 Skin atrophy, adrenal suppression based on ACTH stimulating test, clinically relevant changes to HPA axis or calcium homeostasis were rarely reported (Table 1). 3,25,38,39,43 In a pooled safety analysis set including PSO-FAST patients 25 and from two other trials of 4 weeks' duration, 38,39 (N = 1099) at least one treatment-related AE was reported in 2.7% of Cal/BD foam recipients, 3.0% of Cal/BD ointment recipients, 6.1% of calcipotriol foam recipients and 7.1% of betamethasone foam recipients.…”

“…3,25,38,39 Skin atrophy, adrenal suppression based on ACTH stimulating test, clinically relevant changes to HPA axis or calcium homeostasis were rarely reported (Table 1). 3,25,38,39,43 In a pooled safety analysis set including PSO-FAST patients 25 and from two other trials of 4 weeks' duration, 38,39 (N = 1099) at least one treatment-related AE was reported in 2.7% of Cal/BD foam recipients, 3.0% of Cal/BD ointment recipients, 6.1% of calcipotriol foam recipients and 7.1% of betamethasone foam recipients. 3 In patients receiving Cal/BD foam, the most common treatment-related AEs (occurring in at least two patients) were application-site pruritus and pain (0.4% and 0.5%, respectively).…”