Objective:

To assess the proportion of early responders to CAL/BDP PAD-cream based on achievement of Physician Global Assessment (PGA) controlled disease at Week 4 and compare results with patient-reported outcomes (PROs).

Approach:

• Study Design: Post-hoc pooled analysis of two phase III trials (MC2-01-C7 and MC2-01-C2) involving adults with mild-to-moderate psoriasis, randomized to receive CAL/BDP PAD-cream, vehicle, or CAL/BDP gel.
• Outcomes: Assessment of PGA and SGA at baseline, Week 1, and Week 4 to evaluate controlled disease and treatment success.
• Statistical Analysis: Rates of PGA and SGA outcomes compared using logistic regression models; concordance evaluated by percent agreement.

Key Findings:

• CAL/BDP PAD-cream showed significantly higher early response rates at Week 4 compared to CAL/BDP gel and vehicle.
• Approximately 70% of patients treated with CAL/BDP PAD-cream demonstrated concordance between their assessments and the physician’s assessment of controlled disease.

Interpretation:

The findings support the clinical relevance of early treatment response and the complementary value of PROs in psoriasis management.

Limitations:

• The study was a post-hoc analysis and may be subject to biases inherent in such analyses.
• P values were not adjusted for multiplicity, which may affect the interpretation of statistical significance.

Conclusion:

The study highlights the importance of early response in treatment adherence and the value of aligning patient and physician assessments.