阿达木单克隆抗体生物类似药治疗克罗恩病的真实世界疗效分析  

Real world efficacy analysis of adalimumab biosimilar in the treatment of Crohn′s disease

作　　者：黄钊鹏 吴锐彬 唐健[1,2] 晁康 林敏芝[1,2] 高翔 Huang Zhaopeng;Wu Ruibin;Tang Jian;Chao Kang;Lin Minzhi;Gao Xiang(Department of Gastroenterology,the Sixth Affiliated Hospital,Sun Yat-sen University,Guangzhou 510655,China;Guangdong Provincial Key Laboratory of Colorectal and Pelvic Floor Diseases,Guangzhou 510655,China)

机构地区：[1]中山大学附属第六医院消化内科,广州510655 [2]广东省结直肠盆底疾病研究重点实验室,广州510655

出　　处：《中华炎性肠病杂志（中英文）》2023年第1期43-47,共5页Chinese Journal of Inflammatory Bowel Diseases

摘　　要：目的评估阿达木单克隆抗体(ADA)生物类似药治疗克罗恩病(CD)的疗效及安全性。方法采用回顾性队列研究方法,纳入2019年1月到2022年3月在中山大学附属第六医院接受ADA生物类似药治疗且资料齐全的CD患者。采用哈维-布拉德肖指数(HBI)评估CD患者基线疾病活动性,并根据疾病活动情况将患者分为活动组和缓解组。主要终点为活动期CD患者治疗后12周临床应答率及缓解率;次要终点为活动期CD患者治疗后26周临床应答率及缓解率,缓解期CD患者治疗后12、26周的维持缓解率及安全性报告。结果共纳入48例患者,其中活动期20例,HBI评分7(6,8)分;缓解期28例,HBI评分3(2,4)分。活动期CD患者治疗后12周临床应答率为70.0%(14/20),临床缓解率为60.0%(12/20),治疗后26周临床应答率及临床缓解率均为61.5%(8/13)。缓解期CD患者治疗后12周维持缓解率为96.4%(27/28),治疗后26周维持缓解率为92.3%(12/13)。随访期间,共发生2例不良反应(4.2%),未见严重不良反应。结论 ADA生物类似药在短期诱导中国轻中度活动期CD患者缓解及维持临床缓解方面具有良好的疗效及安全性。Objectives To evaluate the efficacy and safety of adalimumab(ADA)biosimilar in the treatment of Crohn′s disease(CD).Methods A retrospective cohort study was conducted.The patients with CD treated with ADA biosimilar in the Sixth Affiliated Hospital of Sun Yat-sen University from January 2019 to March 2022 with complete data were enrolled.The disease activity of patients at baseline was evaluated by Harvey-Bradshaw index(HBI).The patients were divided into active group and remission group according to the activity.The primary endpoints were clinical response rate and remission rate at the 12th week in patients with active CD.The secondary endpoints included the clinical response rate and the remission rate in patients with active CD at the 26th week,maintenance remission rate at the 12th and the 26th weeks in patients with remission CD,and safety report.Results Forty-eight patients were included.There were 20 patients whose HBI was 7(6,8)points in active group and 28 whose HBI was 3(2,4)points in remission group.In patients with active CD,the clinical response rate was 70.0%(14/20)and clinical remission rate was 60.0%(12/20)at the 12th week.The clinical response rate and clinical remission rate were both 61.5%(8/13)at the 26th week.The maintain remission rate of patients with remission CD was 96.4%(27/28)and 92.3%(12/13)at the 12th and the 26th weeks respectively.During the follow-up period,adverse reactions occurred in 2 patients(4.2%)and no serious adverse reaction was found.Conclusion ADA biosimilar has good efficacy and safety in short-term induction and maintenance of clinical remission in Chinese patients with mild to moderate active CD.

关 键 词：克罗恩病 阿达木单克隆抗体 生物类似药 疗效 安全性 

分 类 号：R574.62[医药卫生—消化系统]