Andreas Pinter, MD

Credit: International Psoriasis Council

Calcipotriene (CAL) and betamethasone dipropionate (BDP) PAD-cream has high efficacy and a strong safety profile for psoriasis when combined with a superior, patient-reported treatment convenience, according to recent findings.¹

These findings resulted from a recent study examining CAL/BDP cream formulated with PAD technology known to limit the need for surfactant, given that most prefer a topical formulation which dries on the skin quickly and without sticky or greasy properties.²

Given the proven efficacy of CAL/BDP gel on psoriasis, the study’s investigators chose to examine the innovative formulation and delivery system of the PAD technology with the cream. The research was authored by Andreas Pinter, MD, from Goethe-Universität Frankfurt am Main in Germany.

“Here we report the results of a phase III trial conducted in Europe with the objective to evaluate the efficacy and safety of CAL/BDP PAD-cream compared to CAL/BDP gel and PAD-cream vehicle,” Pinter and colleagues wrote.

Background and Findings

The phase 3 trial was an investigator-blind, multicenter study which was conducted in Germany, the Czech Republic, and Poland. The team’s trial consisted of screening, 8-week treatment, and 2-week follow-up periods.

Eligible participants for the study were adults aged 18 or older who had diagnoses of plaque psoriasis and specific criteria for Physician Global Assessment (PGA) score, body surface area (BSA) involvement, and modified psoriasis area and severity index (mPASI). They were randomly assigned to be treated with CAL/BDP PAD-cream, PAD-cream vehicle, or CAL/BDP gel in a predetermined ratio.

Blinding measures were implemented to ensure the investigators used an unbiased evaluation of subjects. They applied treatment topically once-per-day for a period of 8 weeks, and efficacy assessments were conducted at various time points.

The investigators’ primary efficacy endpoint focused on the percentage change in mPASI on the body.

Secondary and other efficacy endpoints they used included patients’ assessment of treatment convenience, PGA success, mPASI75, PGA success on the patients’ scalps, percentage change in mPASI at 4 weeks, and change in Dermatology Life Quality Index (DLQI) at Weeks 4 and 8. Additionally, post-hoc analyses were conducted by the research team to assess the proportion of participants with specific mPASI levels.

Statistical comparisons were made by the team between CAL/BDP PAD-cream and the active comparator, as well as between CAL/BDP PAD-cream and the PAD-cream vehicle. Additionally, safety assessments primarily focused on laboratory values, adverse events (AEs), and local skin reactions were used.

Overall, the investigators found that CAL/BDP PAD-cream exhibited a substantially higher mean percentage change in mPASI from baseline to week 8 (67.5%) compared to PAD-cream vehicle (11.7%; P<0.0001). They added that it was also non-inferior to CAL/BDP gel (63.5%).

Furthermore, the research team noted that a greater proportion of participants reached treatment success based on PGA, with CAL/BDP PAD-cream showing superiority (50.7%) over PAD-cream vehicle (6.1%; P<0.0001) and a statistically significant improvement compared to CAL/BDP gel (42.7%; P=0.0442).

The team also reported that participants rated the convenience of psoriasis treatment higher for CAL/BDP PAD-cream compared to CAL/BDP gel at 8 weeks (P<0.0001). Additionally, they noted that mean change in DLQI from baseline to week 8 was shown to be substantially greater in the CAL/BDP PAD-cream group compared to both PAD-cream vehicle (P<0.0001) and CAL/BDP gel (P=0.0110).

Lastly, the investigators noted that the safety assessments made during this trial demonstrated strong tolerability of CAL/BDP PAD-cream.

“The greater convenience scores of the PAD-cream formulation compared to gel was mainly driven by questions concerning greasiness. In combination with the improved efficacy and favourable safety profile, this may lead to enhanced treatment adherence and ultimately improved treatment response,” they wrote.

References

1. ^{Pinter A, Reich A, Arenberger P, Gold LS, Armstrong A, Iversen L, Praestegaard M, Augustin M. Randomised Phase 3 trial demonstrating high efficacy, favourable safety, and convenience of a novel calcipotriol and betamethasone dipropionate cream for the treatment of psoriasis. J Eur Acad Dermatol Venereol. Published online July 11, 2023. doi:10.1111/jdv.19330.}
2. ^{Eastman WJ, Malahias S, Delconte J, DiBenedetti D. Assessing attributes of topical vehicles for the treatment of acne, atopic dermatitis, and plaque psoriasis. Cutis. 2014;94(1):46-53.}