Novel Calcipotriene and Betamethasone Dipropionate PAD cream effective and safe treatment of Psoriasis
New research revealed that a fixed-dose combination of the novel calcipotriene (CAL) and betamethasone dipropionate PAD cream is highly efficacious and safe with a superior patient-reported treatment outcome in psoriasispatients. The study was published in the Journal of the European Academy of Dermatology & Venereology.
Plaque psoriasis is a common, chronic, and relapsing inflammatory skin disorder. Topical steroid-based therapies still play a vital role in the management of psoriasis. A well-established topical treatment option for psoriasis is the fixed-dose combination of calcipotriene (CAL) and betamethasone dipropionate (BDP), which is supported by solid scientific evidence supporting the individual medicines' complimentary efficacy and safety. The revolutionary formulation and drug delivery method known as PAD TechnologyTM is the foundation of the CAL/BDP PAD cream, an easily spreadable cream. Hence Andreas Pinter, MD, from Goethe-Universität Frankfurt am Main in Germany et al conducted a study in a phase III trial to evaluate the efficacy and safety of CAL/BDP PAD-cream compared to CAL/BDP gel and PAD-cream vehicle.
A Phase 3, multicentre, randomized, investigator-blind, active, and vehicle-controlled trial was carried out enrolling 490 patients with mild to moderate psoriasis according to the Physician Global Assessment (PGA) scale in 3 European countries. Products were applied once daily for 8 weeks. The primary endpoint was the percentage change in modified Psoriasis Area and Severity Index (mPASI) from baseline to week 8.
Findings:
- CAL/BDP PAD-cream (67.5%) showed a superior percentage mean change from baseline to week 8 in mPASI compared to PAD-cream vehicle (11.7%) and non-inferior to CAL/BDP gel (63.5%).
- CAL/BDP PAD-cream (50.7%) was superior in at least 2-step improvement to clear or almost clear in achieving PGA treatment success after eight weeks compared to PAD-cream vehicle (6.1%, p<0.0001) and statistically significantly greater than CAL/BDP gel (42.7%, p=0.0442).
- Patient-reported psoriasis treatment convenience score (PTCS) for CAL/BDP PAD cream was rated superior to CAL/BDP gel at week 8 (p<0.0001).
- The mean change in DLQI from baseline to week 8 improved statistically significantly more in the CAL/BDP PAD-cream group compared to both the PAD-cream vehicle (p<0.0001) and CAL/BDP gel (p=0.0110).
- Safety assessments during the trial demonstrated that CAL/BDP PAD cream was well-tolerated.
Thus, CAL/BDP PAD cream is a novel topical treatment of psoriasis having high efficacy, a favorable safety profile, and excellent patient acceptability.
Further reading: Pinter A et al. Randomized Phase 3 trial demonstrating high efficacy, favorable safety, and convenience of a novel calcipotriol and betamethasone dipropionate cream for the treatment of psoriasis. https://doi.org/10.1111/jdv.19330
