Real world efficacy analysis of adalimumab biosimilar in the treatment of Crohn′s disease
10.3760/cma.j.cn101480-20220622-00095
- VernacularTitle: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
- Author:
Zhaopeng HUANG
1
;
Ruibin WU
;
Jian TANG
;
Kang CHAO
;
Minzhi LIN
;
Xiang GAO
Author Information
1. 中山大学附属第六医院消化内科，广州 510655
- Publication Type:Journal Article
- Keywords:
Crohn′s disease;
Adalimumab;
Biosimilar;
Efficacy;
Safety
- From:
Chinese Journal of Inflammatory Bowel Diseases
2023;07(1):43-47
- CountryChina
- Language:Chinese
-
Abstract:
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.
