Abstract：
A 52-week postmarketing surveillance study was initiated to evaluate the safety and effectiveness of guselkumab, a human anti-interleukin 23 subunit p19 monoclonal antibody, in Japanese patients with psoriasis vulgaris, psoriatic arthritis, generalized pustular psoriasis, and erythrodermic psoriasis in real-world practice. Here, we report results of the 20-week interim analysis of the ongoing postmarketing surveillance study. Patients who received guselkumab between May 2018 (the date of commercial launch in Japan) and October 2020 were registered in this study. In total, 411 and 245 patients were included in the safety and effectiveness analysis sets, respectively. Adverse drug reactions (ADRs) occurred in 6.6% (27 of 411) and serious ADRs in 2.2% (nine of 411) of patients. The most frequent ADRs by System Organ Class were \"Infections and infestations\" (2.4%), with nasopharyngitis being the most frequently observed ADR (0.7%). The mean Psoriasis Area Severity Index score decreased from 11.6 at baseline to 6.5 at week 4 and 2.2 at week 20, with improvements achieving statistical significance at each time point. Clinical Global Impression, Dermatology Life Quality Index, and Nail Psoriasis Severity Index outcomesalso showed substantial improvements. Our findings demonstrate that guselkumab is well tolerated and effective in Japanese patients with psoriasis through 20 weeks of treatment in real-world clinical practice, showing significant effectiveness observed as early as 4 weeks. The study was officially registered with the University Hospital Medical Information Network Clinical Trials Registry with the identifier UMIN000032969.
摘要：
开始了为期52周的上市后监测研究，以评估guselkumab的安全性和有效性。人抗白细胞介素23亚基p19单克隆抗体，在日本寻常型牛皮癣患者中，银屑病关节炎,全身性脓疱型银屑病，和红皮病型银屑病在现实世界的实践。这里,我们报告了正在进行的上市后监测研究的20周中期分析结果.在2018年5月（日本商业推出之日）至2020年10月期间接受guselkumab的患者在本研究中注册。总的来说,411名和245名患者被纳入安全性和有效性分析集，分别。6.6%（411个中的27个）发生药物不良反应（ADR），2.2%（411个中的9个）发生严重ADR。按系统器官类别划分的最常见不良反应是“感染和感染”(2.4%)，鼻咽炎是最常见的ADR（0.7％）。平均银屑病面积严重度指数评分从基线时的11.6下降至第4周的6.5和第20周的2.2,改善在每个时间点达到统计学显著性。临床总体印象，皮肤病生活质量指数，和指甲牛皮癣严重程度指数结果也显示出实质性的改善。我们的研究结果表明，guselkumab在现实世界临床实践中通过20周的治疗对日本牛皮癣患者具有良好的耐受性和有效性。早在4周就观察到了显著的有效性。该研究已在大学医院医学信息网络临床试验注册中心正式注册，标识符为UMIN000032969。
