Best Responders and Super-Responders to Calcipotriol and Betamethasone Dipropionate PAD-Cream: A Post Hoc Pooled Analysis of Two Phase 3 Trials
Year: 2025
Type: article
Abstract: Individual endpoints from phase 3 trials demonstrated high efficacy and convenience for the calcipotriol/betamethasone dipropionate (CAL/BDP) cream based on polyaphron dispersion (PAD) technology compared to CAL/BDP gel. The objectives are to assess the proportion of best responders to CAL/BDP PAD-cream at weeks 4 and 8 and to identify the super-responders through the patients’ key baseline characteristics associated with best response. This was a post hoc pooled analysis of adult patients with mild-to-moderate psoriasis from two phase 3 trials: MC2-01-C2 (NCT03308799) and MC2-01-C7 (NCT03802344). Patients were randomly assigned (3:1:3) to CAL/BDP PAD-cream, PAD-cream vehicle, or CAL/BDP gel once daily. Best responders at weeks 4 and 8 were defined as patients achieving a restrictive endpoint comprising the combination of Physician’s Global Assessment (PGA) controlled disease, modified Psoriasis Area and Severity Index (mPASI) success, and Dermatology Life Quality Index (DLQI) satisfaction. Best response rates were compared between treatments by logistic regression using multiple imputation. A classification and regression tree (CART) based on observed cases identified super-responders through the key baseline characteristics associated with best response among CAL/BDP PAD-cream users. All analyses were based on the modified intention-to-treat (mITT) population. The mITT included 551 patients on CAL/BDP PAD-cream, 542 on CAL/BDP gel, and 178 on vehicle. The CAL/BDP PAD-cream group showed a statistically significant higher best response rate compared to CAL/BDP gel at week 4 (10.7% vs 6.1%; p = 0.0048) and week 8 (27.4% vs 16.1%; p < 0.0001), and also compared to vehicle. Among CAL/BDP PAD-cream users, 63.6% of patients with a baseline DLQI < 7 and mPASI < 4.0 achieved best response at week 8 and were considered super-responders. CAL/BDP PAD-cream demonstrated higher best response rates compared to CAL/BDP gel and vehicle in adults with mild-to-moderate psoriasis. Baseline DLQI and mPASI scores may predict which patients are most likely to achieve best response to CAL/BDP PAD-cream. ClinicalTrials.gov identifiers, NCT03308799 (MC2-01-C2) and NCT03802344 (MC2-01-C7). This study evaluated a new calcipotriol and betamethasone dipropionate (CAL/BDP) cream with polyaphron dispersion (PAD) technology, designed to provide efficacy and safety with greater comfort for patients with mild-to-moderate psoriasis. The study compared the new cream to CAL/BDP gel and a dermatological vehicle to identify patients who responded best and which patient characteristics predicted best outcomes. Data from 1271 adult patients with mild-to-moderate psoriasis who participated in two trials were analyzed. Patients applied CAL/BDP PAD-cream, CAL/BDP gel, or vehicle once daily. Researchers defined “best responders” as patients achieving three key goals after 8 weeks of treatment: (1) clear or almost clear skin, (2) very low psoriasis severity, and (3) no significant impact on quality of life. They also identified “super-responders” as those most likely to achieve best outcomes, based on patient characteristics at the start of the study. CAL/BDP PAD-cream resulted in significantly more best responders compared to gel or vehicle. By week 4, 10.7% of cream users achieved best response compared to 6.1% of gel users. By week 8, these numbers rose to 27.4% for the cream and 16.1% for the gel. Among cream users, patients without an important affection of their quality of life and less severity at the start of the study had the highest likelihood of being super-responders. Overall, CAL/BDP PAD-cream was more effective than gel or vehicle in treating mild-to-moderate psoriasis. Patients with lower baseline disease severity were more likely to benefit the most.
Source: Dermatology and Therapy
Institutions: University Hospital Frankfurt, Almirall (Spain)
Language: English
Subfield: Immunology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $7,400
Funder: Almirall
OpenAlex ID: W4409739505