Calcipotriene (CAL) and betamethasone (BDP) PAD-cream met safety and efficacy endpoints for the treatment of adults with plaque psoriasis, according to study results published in the Journal of the European Academy of Dermatology and Venerology.
Investigators conducted a phase 3, multicenter, randomized, investigator-blind, vehicle- and comparator-controlled trial in Germany, Poland, and the Czech Republic that enrolled 490 patients aged 18 years and older with mild to moderate plaque psoriasis. The investigators sought to evaluate the efficacy and safety of CAL/BDP PAD-cream compared with CAL/BDP gel and PAD-cream vehicle. Patients were randomly assigned in a 3:1:3 ratio to receive treatment with CAL/BPD PAD-cream, PAD-cream vehicle, or CAL/BDP gel. The products were applied once daily for 8 weeks. The primary efficacy endpoint was the percentage change in modified Psoriasis Area and Severity Index (mPASI) on the trunk and/or limbs from baseline to week 8. Secondary efficacy endpoints included achievement of Physician Global Assessment (PGA) treatment success (at least 2-step improvement to clear or almost clear skin), patient-reported psoriasis treatment convenience score (PTCS) at week 8, and change in the Dermatology Life Quality Index (DLQI) scores from baseline to week 8.
Patient characteristics were similar between the treatment groups. Most patients were men (60.2%); mean age was 50.2 years (range, 19-83 years); 98.2% of patients were White; mean (SD) time since diagnosis was 19.1 (13.9) years, mean (SD) baseline percentage of affected body surface area (BSA; SD) was 9.5% (6.8%), and baseline mean (SD) mPASI was 19.1 (13.9).
Efficacy assessments were conducted at baseline and after 1, 4, 6, and 8 weeks of treatment. After the 8-week treatment period, patients were evaluated during a 2-week follow-up period.
From baseline to week 8, the mPASI percentage mean change was 67.5% for patients randomly assigned to treatment with CAL/BDP PAD-cream, 11.7% for those randomly assigned to treatment with PAD-cream vehicle (P <.0001), and 63.5% with CAL/BDP gel (mean difference vs CAL/BDP PDA-cream, −4.2%; 95% CI, −9.6% to 1.2%; P =.1287), respectively.
At week 8, the proportion of patients achieving mPASI 75 was 47.6% in the CAL/BPD PAD-cream group vs 5.1% in the PAD-cream vehicle group (P <.0001) and 40.9% in the CAL/BDP gel group (40.9%; P =.1218).
After 8 weeks, the proportion of patients who achieved PGA treatment success was 50.7% with CAL/BDP PAD-cream, 6.1% with PAD-cream vehicle (P <.0001), and 42.7% with CAL/BDP gel (P =.0442). Treatment with CAL/BDP PAD-cream was also associated with a higher PTCS at week 8 (38.6) than treatment with CAL/BDP gel (36.1; P <.0001). Additionally, the mean change in DLQI scores from baseline to week 8 improved statistically significantly more for those receiving CAL/BDP PAD-cream (−6.4), compared with that of those receiving the PAD-cream vehicle (−2.5; P <.0001) and the CAL/BDP gel (−5.3; P =.0110).
Safety assessments during the trial showed that CAL/BDP PAD-cream was well-tolerated, with treatment-emergent adverse events (TEAEs) occurring in approximately 25% of all participants, with comparable TEAE frequencies between treatment groups. Most TEAEs were mild to moderate in severity. Only 3 events (1 in each treatment group) were of severe intensity. The investigators also noted that, “Despite the enrolled patients having approximately 10% of the BSA involved, there [were] no signs of calcipotriol-mediated changes in calcium metabolism.”
The investigators concluded, “In combination with a greater convenience, treatment with CAL/BDP PAD-cream may lead to better adherence and consequently better outcomes in the real world.”
Disclosure: This research was supported by MC2 Therapeutics, and some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
This article originally appeared on Dermatology Advisor
Pinter A, Reich A, Arenberger P, et al. 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