[关键词]
[摘要]
目的 对我国上市的9种白细胞介素(IL)类生物制剂治疗银屑病进行临床综合评价,为医疗机构药品目录的动态调整及临床合理用药决策提供科学依据。方法 采用《中国医疗机构药品评价与遴选快速指南(第三版)》,由2名药师独立对我国批准上市的9种IL类生物制剂进行评分,交由高级职称药师审核裁定最终得分。结果 9种药物均证实对中重度斑块型银屑病有效,乌司奴单抗(81.7分)、古塞奇尤单抗(79.7分)与司库奇尤单抗(79.5分)位列前3。疗效方面,依奇珠单抗、古塞奇尤单抗等银屑病面积或严重程度指数较基线下降90%(PASI 90)应答率占优,但真实世界中古塞奇尤单抗与替瑞奇珠单抗的药物留存率最优。安全性方面,IL-23及IL-12/23抑制剂的长期安全性优于IL-17抑制剂,后者需警惕念珠菌感染与炎症性肠病风险。药学特性方面,IL-23和IL-12/23抑制剂年注射频次仅6~7次,且部分药物配备的隐针等智能装置显著提升了用药便捷性。经济性方面,匹康奇拜单抗首年治疗费用显著高于其他药物。结论 不同作用机制的IL类生物制剂临床特征差异化显著,临床选药应向整合患者特征、合并症及真实世界留存率的多维度“达标治疗”策略转变。
[Key word]
[Abstract]
Objective To conduct a comprehensive clinical evaluation of nine interleukin biologics marketed in China, aiming to provide a scientific basis for the dynamic adjustment of drug catalogs in medical institutions and rational clinical decision-making. Methods Based on the Rapid Guideline for Drug Evaluation and Selection in Chinese Medical Institutions (3rd Edition), two pharmacists independently scored nine interleukin biologics approved for marketing in China. The final scores were reviewed and arbitrated by a pharmacist with a senior professional title. Results All nine biologics demonstrated efficacy in treating moderate-tosevere plaque psoriasis, with ustekinumab (81.7 points), guselkumab (79.7 points), and secukinumab (79.5 points) ranking as the top three. In terms of efficacy, ixekizumab and guselkumab showed superior PASI 90 response rates; however, guselkumab and tildrakizumab exhibited optimal drug retention rates in real-world settings. Regarding safety, IL-23 and IL-12/23 inhibitors demonstrated better long-term safety profiles than IL-17 inhibitors, with the latter carrying risks of candidiasis and inflammatory bowel disease exacerbation. For pharmaceutical characteristics, IL-23 and IL-12/23 inhibitors required only 6–7 injections annually, and certain agents equipped with hidden-needle devices significantly improved administration convenience. Economically, the first-year treatment cost of pikankibart was significantly higher than that of the other agents. Conclusion Interleukin biologics with different mechanisms of action exhibit significantly differentiated clinical characteristics. Clinical drug selection should shift toward a multi-dimensional “treat-to-target” strategy that integrates patient characteristics, comorbidities, and real-world drug retention rates.
[中图分类号]
R965
[基金项目]
国家药品临床综合评价项目(国卫药政目录便函[2025]56号-NO.258);河北省医研企联合创新专项课题(LH20250182)