Early Response to Calcipotriol and Betamethasone Dipropionate PAD-Cream at Week 4 in Patients with Mild-to-Moderate Plaque Psoriasis: A Post-Hoc Pooled Analysis of Two Phase III Trials.
Topical therapy plays an essential role in psoriasis management. However, lack of rapid improvement may negatively impact adherence. The calcipotriol and betamethasone dipropionate (CAL/BDP) cream based on polyaphron dispersion (PAD) technology has demonstrated high efficacy, favorable safety, and convenience compared with CAL/BDP gel in phase III trials. This post-hoc analysis aims to assess early treatment response to CAL/BDP PAD-cream at Week (W) 4.
Methods
This was a post-hoc pooled analysis of adults with mild-to-moderate psoriasis from two multicenter, investigator-blind, phase III trials (MC2-01-C2 and MC2-01-C7). Patients were randomized 3:1:3 to CAL/BDP PAD-cream (N = 551), PAD-cream vehicle (N = 178), or CAL/BDP gel (N = 542) once daily for 8 weeks. Physician's Global Assessment (PGA) and Subject's Global Assessment (SGA) were assessed at W1 and W4. At W4, early responders were defined as patients achieving PGA controlled disease (i.e., any improvement from baseline to a PGA score of 0-1), while PGA success was defined as a PGA score of 0-1 combined with a minimum 2-point improvement from baseline. SGA controlled disease and SGA success were also assessed. Comparisons between groups were performed by logistic regression models using multiple imputation. Rates of PGA/SGA concordance were assessed by simple percent agreement.
Results
At W4, CAL/BDP PAD-cream was associated with a significantly higher proportion of patients achieving early response compared with CAL/BDP gel (32.1% vs 21.4%, P < 0.0001). Differences were already significant at W1 (7.8% vs 4.8%, P = 0.0410). PGA success at W4 was also higher with CAL/BDP PAD-cream than with CAL/BDP gel (23.6% vs 14.8%, P < 0.0001). Rates of SGA controlled disease and success were also statistically significantly higher for CAL/BDP PAD-cream at W4. Concordance between PGA/SGA assessments at W4 was observed in 65.5% (controlled disease) and 69.5% (success) of patients treated with CAL/BDP PAD-cream.
Conclusion
CAL/BDP PAD-cream was associated with significantly higher early response rates at W4 than CAL/BDP gel, suggesting earlier clinical improvements.
