Best Responders and Super-Responders to Calcipotriol and Betamethasone Dipropionate PAD-Cream: A Post Hoc Pooled Analysis of Two Phase 3 Trials.

IF 3.5 3区医学 Q1 DERMATOLOGY

Dermatology and Therapy Pub Date : 2025-06-01 Epub Date: 2025-04-24 DOI:10.1007/s13555-025-01418-x

Andreas Pinter, Jordi Galván, Frank Freischläger

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引用次数: 0

Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Trials registration: ClinicalTrials.gov identifiers, NCT03308799 (MC2-01-C2) and NCT03802344 (MC2-01-C7).

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钙三醇和二丙酸倍他米松pad霜的最佳反应者和超级反应者：两项3期试验的事后汇总分析。

来自3期试验的个体终点表明，与CAL/BDP凝胶相比，基于多aphron分散体（PAD）技术的钙三醇/倍他米松二丙酸（CAL/BDP）乳膏具有更高的疗效和便利性。目的是在第4周和第8周评估CAL/BDP PAD-cream的最佳应答者比例，并通过与最佳应答相关的患者关键基线特征确定超级应答者。方法：这是一项针对MC2-01-C2 （NCT03308799）和MC2-01-C7 （NCT03802344）两项3期试验中轻中度牛皮癣成年患者的事后汇总分析。患者被随机分配（3:1:3）至CAL/BDP PAD-cream， PAD-cream载体，或CAL/BDP凝胶每日一次。在第4周和第8周，最佳反应者被定义为达到限制性终点的患者，包括医师总体评估（PGA）控制的疾病、改良的牛皮癣面积和严重程度指数（mPASI）成功和皮肤病生活质量指数（DLQI）满意度的组合。采用多重归因的逻辑回归方法比较不同治疗间的最佳有效率。基于观察病例的分类和回归树（CART）通过CAL/BDP PAD-cream使用者中与最佳反应相关的关键基线特征确定了超级应答者。所有分析均基于改良意向治疗（mITT）人群。结果：mITT包括551例CAL/BDP PAD-cream， 542例CAL/BDP gel， 178例vehicle。与CAL/BDP凝胶相比，CAL/BDP PAD-cream组在第4周的最佳缓解率具有统计学意义(10.7% vs 6.1%；P = 0.0048)和第8周(27.4% vs 16.1%；结论：与CAL/BDP凝胶和载体相比，CAL/BDP PAD-cream在轻度至中度牛皮癣成人患者中表现出更高的最佳缓解率。基线DLQI和mPASI评分可以预测哪些患者最有可能对CAL/BDP PAD-cream获得最佳反应。试验注册：ClinicalTrials.gov标识符NCT03308799 （MC2-01-C2）和NCT03802344 （MC2-01-C7）。

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来源期刊

Dermatology and Therapy Medicine-Dermatology

CiteScore

6.00

自引率

8.80%

发文量

187

审稿时长

6 weeks

期刊介绍： Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers. The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.