Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris – A randomized phase II study

Abstract

Background: An aerosol foam formulation of fixed combination calcipotriene 0.005% (as hydrate; Cal) plus betamethasone dipropionate 0.064% (BD) was developed to improve psoriasis treatment. Objectives: To compare the efficacy and safety of Cal/BD aerosol foam with Cal/BD ointment after 4 weeks. Methods: In this Phase II, multicenter, investigator-blind, 4-week trial, adult patients with psoriasis vulgaris were randomized to Cal/BD aerosol foam, Cal/BD ointment, aerosol foam vehicle or ointment vehicle (3:3:1:1). The primary efficacy endpoint was the proportion of patients at week 4 who achieved treatment success (clear or almost clear with at least a two-step improvement) according to the physician’s global assessment of disease severity. Results: In total, 376 patients were randomized. At week 4, significantly more patients using Cal/BD aerosol foam achieved treatment success (54.6% versus 43.0% [ointment]; p = 0.025); mean modified (excluding the head, which was not treated) psoriasis area and severity index score was significantly different between Cal/BD aerosol foam and Cal/BD ointment (mean difference –0.6; p = 0.005). Rapid, continuous itch relief occurred with both active treatments. One adverse drug reaction was reported with Cal/BD aerosol foam (application site itch). Conclusions: Cal/BD aerosol foam demonstrates significantly greater efficacy and similar tolerability compared with Cal/BD ointment for psoriasis treatment.

Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO‐ABLE study

“…This may also explain why the treatment success rates at week 4 were lower in patients with mild disease compared to those with moderate and severe disease (18.9% vs. 44.8% and 50.0%, respectively). Importantly, the proportion of patients achieving mPASI75 at week 4 in PSO‐ABLE (52%) was comparable to that observed in previous studies (53% in PSO‐FAST,23 49% in one Phase II study24 and 50% in another Phase II study25). Based on the study protocol, patients who achieved treatment success were allowed to discontinue treatment, but were required to attend all scheduled visits until study end.…”

“…The safety profile of Cal/BD aerosol foam was similar to previous studies23, 24, 25 and was consistent with the fixed combination gel and ointment formulations 27, 28, 29. The rates of AEs and ADRs with Cal/BD aerosol foam in PSO‐ABLE cannot be compared to previous studies due to the longer observation period (12 vs. 4 weeks).…”

“…The treatment success rate with Cal/BD aerosol foam at week 4 was slightly lower in PSO‐ABLE than in previous studies; the same was true for Cal/BD gel. One possible explanation for this could be that a greater proportion of patients with mild disease were enrolled (30% compared with 16% in PSO‐FAST,23 9% in one Phase II study24 and 16% in another Phase II study25). Whereas moderate and severe patients are considered to achieve treatment success if they are ‘clear’ or ‘almost clear’, mild patients need to be completely clear of psoriasis to be considered as such; this makes it more difficult for mild patients to achieve treatment success according to the predefined treatment success rule using PGA.…”

“…An aerosol foam formulation of the fixed Cal/BD combination has been developed to enhance adherence and increase therapeutic options available. Previous Cal/BD aerosol foam studies have shown greater in vitro skin penetration compared with other formulations,21 and a significantly greater antipsoriasis effect over 4 weeks of treatment than Cal/BD ointment,22 vehicle23 and individual active ingredients,24 with a comparable tolerability profile 24, 25. The primary hypothesis of the PSO‐ABLE study was that 4 weeks of Cal/BD aerosol foam has superior efficacy compared with 8 weeks of Cal/BD gel.…”

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

“…34,32 Psoriasis' impact on HR-QoL was also assessed. Baseline Dermatology Life-Quality Index (DLQI) 33 for Cal/BD aerosol foam and vehicle groups were ACTH -Adrenocorticotropic hormone; ADRs -Adverse reactions; AEs -Adverse events; AUC -Area under the curve; DLQI -Dermatology Life-Quality Index; DTT -Difficult to treat; HR-QOL -Health-related quality of life; MDR -maximal dermal response; MCII -mean cumulative irritation index; mPASI -modified psoriasis area and severity index; pts -Patients; SAES -Serious adverse events; SD -Standard deviation; TCS -Total clinical score; y -Years 9.9 and 10.3, respectively, indicating a substantial impact on HR-QoL. 25 Mean baseline EQ-5D utility index scores indicated that the impaired QoL in these patients was due to significantly pain/discomfort and anxiety/depression compared with general population.…”