Stein Gold Linda, Pinter Andreas, Armstrong April, Augustin Matthias, Arenberger Petr, Bhatia Neil, Praestegaard Morten, Iversen Lars, Reich Adam
Dermatology Clinical Research, Henry Ford Health System, Detroit, MI, USA.
Department of Dermatology, University Hospital Frankfurt am Main, Frankfurt am Main, Germany.
Dermatol Ther (Heidelb). 2023 Sep;13(9):2031-2044. doi: 10.1007/s13555-023-00979-z. Epub 2023 Jul 25.
Psoriasis ranges from mild to severe with the majority of patients having mild disease. Mild to moderate disease is often treated with topical therapies while photo-, oral, and biologic therapies are generally reserved for moderate-to-severe disease. There is a strong scientific rationale for the combination of calcipotriene (CAL) and betamethasone dipropionate (BDP) with respect to mode of action, efficacy, and safety and CAL/BDP has shown an inhibitory effect on key pathogenic cytokines in psoriasis including tumor necrosis factor-α, interleukin (IL)-17, and IL-23.
The objective of this pooled post hoc analysis is to investigate the efficacy of CAL/BDP polyaphron dispersion (PAD)-cream in subgroups of patients with moderate-to-severe psoriasis from two completed phase 3 studies conducted in the USA and Europe.
The proportion of patients achieving Physician Global Assessment (PGA) treatment success as well as a modified Psoriasis Area and Severity Index (mPASI)75 response was higher in the subgroup with a body surface area > 10% and mPASI > 10 and Dermatology Life Quality Index > 10 at baseline compared to the overall patient population. Furthermore, the numerical difference in treatment efficacy between CAL/BDP PAD-cream and CAL/BDP topical suspension/gel increased in patient subgroups with higher baseline severity. Similar patterns were shown for the patient-reported outcomes.
In this subgroup analysis, patients who had higher disease severity at baseline achieved greater efficacy than the total patient population when treated with 8 weeks of CAL/BDP PAD-cream as compared to a currently marketed active comparator. Additionally, as indicated by this analysis, CAL/BDP PAD-cream treatment may also be more convenient and less greasy, which may reduce the burden of daily treatment and improve adherence to therapy.
NCT03308799 and NCT03802344.
银屑病病情轻重不一，大多数患者病情较轻。轻至中度银屑病通常采用局部治疗，而光疗、口服治疗和生物治疗一般用于中至重度银屑病。就作用方式、疗效和安全性而言，卡泊三醇（CAL）和二丙酸倍他米松（BDP）联合使用具有充分的科学依据，且CAL/BDP已显示出对银屑病关键致病细胞因子（包括肿瘤坏死因子-α、白细胞介素（IL）-17和IL-23）的抑制作用。
本汇总事后分析的目的是，在美国和欧洲进行的两项已完成的3期研究中，调查CAL/BDP多泡分散体（PAD）乳膏在中至重度银屑病患者亚组中的疗效。
与总体患者人群相比，基线时体表面积>10%、改良银屑病面积和严重程度指数（mPASI）>10且皮肤病生活质量指数>10的亚组患者，达到医生整体评估（PGA）治疗成功以及改良银屑病面积和严重程度指数（mPASI）改善75%的比例更高。此外，基线严重程度较高的患者亚组中，CAL/BDP PAD乳膏与CAL/BDP局部混悬液/凝胶之间的治疗疗效数值差异增大。患者报告的结局也呈现类似模式。
在该亚组分析中，与目前上市的活性对照药相比，基线疾病严重程度较高的患者接受8周CAL/BDP PAD乳膏治疗时，疗效优于总体患者人群。此外，如该分析所示，CAL/BDP PAD乳膏治疗可能也更方便且油腻感更低，这可能减轻日常治疗负担并提高治疗依从性。
NCT03308799和NCT03802344。
