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SPECTREM 3b期临床试验结果至第16周:古塞尔库马布治疗低体表面积,中度牛皮与高影响部位的疗效和安全性

Linda Stein Gold ¹, Alice B Gottlieb ², April W Armstrong ³

¹Department of Dermatology, Henry Ford Medical Center, West Bloomfield, Michigan, USA.
²Department of Dermatology, UT Southwestern Medical Center, Dallas, TX, USA.
³Department of Dermatology, University of California Los Angeles, Los Angeles, CA, USA.
⁴Johnson & Johnson, Horsham and Spring House, PA, USA.
⁵Innovaderm Research, Montreal, QC, Canada.
⁶Division of Dermatology, Department of Medicine, Dalhousie University, Halifax, NS, Canada.
⁷Laboratory for Investigative Dermatology, The Rockefeller University, New York, NY, USA.
⁸Alliance Clinical Trials and Probity Medical Research, Waterloo, ON, Canada.
⁹Division of Dermatology, Temetry Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
¹⁰Johnson & Johnson, Toronto, Ontario, Canada.
¹¹Department of Dermatology, Medical College of Wisconsin, Milwaukee, WI, USA.
¹²Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
¹³Department of Dermatology, Yale University School of Medicine, New Haven, CT, USA.
¹⁴Central Connecticut Dermatology Research, Cromwell, CT, USA.

⁰Department of Dermatology, Henry Ford Medical Center, West Bloomfield, Michigan, USA.

The British Journal of Dermatology +

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2025年八月28日

在PubMed上查看摘要

概括

在身体表面积 (BSA) 影响较小的患者中,Guselkumab有效治疗影响高影响区域的中度斑块牛皮. 该研究显示皮肤清除显著改善,耐受性良好,没有出现新的安全问题.

科学领域

皮肤病学
免疫学
临床试验

背景情况

在临床研究中,患有低身体表面积 (BSA) 的牛皮患者往往代表性不足.
这些患者可能会出现严重的疾病负担,特别是当高影响部位受到影响时.

研究的目的

评估高影响部位的低BSA,中度斑块性牛皮的参与者的guselkumab的疗效和安全性.
这项研究旨在评估guselkumab在改善皮肤清除和患者报告的结果方面的有效性.

主要方法

一个3b期,随机,安慰剂控制的研究 (SPECTREM) 涉及338名参与者.
参与者接受了guselkumab或安慰剂,在第16周通过研究人员的整体评估 (IGA) 和牛皮区域和严重程度指数 (PASI) 评价疗效.

主要成果

在所有主要和次要终点上,Guselkumab在统计学上显著优于安慰剂 (p< 0. 001).
在第16周,74. 2%的古塞尔库马布治疗患者达到IGA0/ 1,而安慰剂患者为12. 4%.
在头皮,面部,生殖器和三角体之间有显著改善,没有发现新的安全信号.

结论

在低BSA患者中,Guselkumab对中度斑块性牛皮治疗有效且耐受良好.
这些发现支持guselkumab在广泛的患者中的疗效,无论基线BSA如何.

相关概念视频

Clinical Trials

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