A New Restrictive Composite Endpoint to Assess Best Response in Patients with Mild-to-Moderate Psoriasis Treated with CAL/BDP PAD Cream: A Case Series.

Abstract

Introduction: In the assessment of a psoriasis treatment, traditional endpoints evaluated independently may not fully capture the multidimensional nature of treatment response. Best response to calcipotriol/betamethasone dipropionate (CAL/BDP) cream based on polyaphron dispersion (PAD) technology has recently been defined as a restrictive composite endpoint comprising two efficacy outcomes (Physician's Global Assessment [PGA] 0-1 and modified Psoriasis Area and Severity Index [mPASI] <2) and one quality-of-life outcome (Dermatology Life Quality Index [DLQI] 0-1).

Case presentations: This retrospective case series aims to provide further insights into the demographics and outcomes of patients achieving best response to CAL/BDP PAD cream based on this newly defined composite endpoint. From the 213 patients with mild-to-moderate psoriasis who received CAL/BDP PAD cream in the European MC2-01-C7 phase 3 clinical trial (NCT03802344), 7 patients who achieved best response at week 4 and/or week 8 and had available clinical photographs were evaluated. The mean patient age was 55.0 years (range: 34-68), with a mean psoriasis duration of 19.9 years (range: 6.9-29.1). Results support the efficacy of CAL/BDP PAD cream in improving both clinical signs and quality of life.

Conclusion: Despite existing variability in key baseline characteristics and long disease duration, all included patients met the novel restrictive composite endpoint after 8 weeks, which reflects complete/almost complete clearance of psoriasis and no impact on patient quality of life.