Pinter Andreas, Galván Jordi, Freischläger Frank
Department of Dermatology, University Hospital Frankfurt am Main, Frankfurt, Germany.
Global Medical Affairs Department, Almirall S.A., Barcelona, Spain.
Dermatol Ther (Heidelb). 2025 Jun;15(6):1441-1453. doi: 10.1007/s13555-025-01418-x. Epub 2025 Apr 24.
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).
与卡泊三醇/倍他米松二丙酸酯（CAL/BDP）凝胶相比，基于多泡囊分散体（PAD）技术的CAL/BDP乳膏在3期试验中的个体终点显示出高效性和便利性。目的是评估在第4周和第8周时对CAL/BDP PAD乳膏最佳反应者的比例，并通过与最佳反应相关的患者关键基线特征来识别超级反应者。
这是一项对来自两项3期试验（MC2-01-C2，NCT03308799；和MC2-01-C7，NCT03802344）的轻度至中度银屑病成年患者进行的事后汇总分析。患者被随机分配（3:1:3），每天一次使用CAL/BDP PAD乳膏、PAD乳膏赋形剂或CAL/BDP凝胶。第4周和第8周的最佳反应者定义为达到包括医师整体评估（PGA）疾病得到控制、改良银屑病面积和严重程度指数（mPASI）改善以及皮肤病生活质量指数（DLQI）满意在内的限制性终点的患者。使用多重填补法通过逻辑回归比较各治疗组之间的最佳反应率。基于观察病例的分类回归树（CART）通过CAL/BDP PAD乳膏使用者中与最佳反应相关的关键基线特征识别超级反应者。所有分析均基于改良意向性治疗（mITT）人群。
mITT人群包括551例使用CAL/BDP PAD乳膏的患者、542例使用CAL/BDP凝胶的患者和178例使用赋形剂的患者。与CAL/BDP凝胶相比，CAL/BDP PAD乳膏组在第4周（10.7%对6.1%；p = 0.0048）和第8周（27.4%对16.1%；p < 0.0001）的最佳反应率具有统计学显著更高，与赋形剂相比也是如此。在CAL/BDP PAD乳膏使用者中，基线DLQI < 7且mPASI < 4.0的患者中有63.6%在第8周达到最佳反应并被视为超级反应者。
与CAL/BDP凝胶和赋形剂相比，CAL/BDP PAD乳膏在轻度至中度银屑病成人患者中显示出更高的最佳反应率。基线DLQI和mPASI评分可能预测哪些患者最有可能对CAL/BDP PAD乳膏获得最佳反应。
ClinicalTrials.gov标识符，NCT03308799（MC2-01-C2）和NCT03802344（MC2-01-C7）。
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