Cal/BD foam vs ointment in Chinese patients with plaque PsO: Phase III study results

Results from the randomized, investigator-blind, active-controlled, multicenter phase III trial (NCT05919082) evaluating calcipotriol + betamethasone dipropionate (Cal/BD) foam vs Cal/BD ointment in 604 Chinese adults with plaque psoriasis (PsO) were published in Dermatology and Therapy by Cai et al. The primary endpoint was the proportion of patients with a Physician’s Global Assessment (PGA) score of 0/1 with a ≥2-point reduction from baseline at Week 4. Secondary endpoints included the proportion of patients demonstrating a decrease in modified Psoriasis Area and Severity Index (mPASI) of ≥75% (mPASI75) and a decrease in mPASI of ≥90% (mPASI90) from baseline to Week 4. 

Key data: At Week 4, a significantly greater proportion of patients receiving Cal/BD foam vs ointment achieved a PGA score of 0/1 with a ≥2-point reduction from baseline (50.0% vs 42.4%; p = 0.044). Overall, mPASI75 and mPASI90 were achieved by 63.6% vs 53.6% (p = 0.011) and 33.1% vs 24.5% (p = 0.020) of patients receiving Cal/BD foam vs ointment, respectively. The mean change from baseline in mPASI was significantly greater with Cal/BD foam vs ointment at Week 2 (−59.87% vs −54.59%; p = 0.010) and Week 4 (−74.69% vs −70.22%; p = 0.043). Improvements in patient-reported outcomes were numerically greater with Cal/BD foam, though not statistically significant. 

Key learning: Cal/BD foam demonstrated a rapid onset of action with clinically meaningful improvements in signs, symptoms, and health-related quality of life (HRQoL) in Chinese patients with plaque PsO, with outcomes similar to or better than those achieved with Cal/BD ointment.