Zhang Rui, Jia Ziran, Piao Yingshi
Yanbian University Medical College, Yanji, Jilin, China.
Yanbian University Medical College, No. 977 Gongyuan Road, Yanji, Jilin 133002, China.
Therap Adv Gastroenterol. 2024 Jun 7;17:17562848241253685. doi: 10.1177/17562848241253685. eCollection 2024.
The existing body of scientific literature offers inconclusive findings on the safety and therapeutic effectiveness of etrolizumab (ETR) for the treatment of ulcerative colitis (UC).
The goal of this meta-analysis is to furnish a comprehensive synthesis of evidence that evaluates the safety and therapeutic effects of ETR in the management of UC.
Meta-analysis.
PubMed, Embase, and Web of science were searched to collect relevant English studies, and the reference lists of eligible studies were manually searched to avoid missing any eligible studies. Outcome measures encompassed clinical response, incidence of adverse events, histological remission, endoscopic remission, endoscopic improvement, and antidrug antibodies. Relevant data were extracted by two independent investigators.
The meta-analysis incorporated five eligible studies, involving a total of 1528 patients, with 1015 treated with ETR and 513 with placebo. The pooled analysis indicates that ETR is both effective and safe. The adverse event rates, endoscopic and histological response, as well as overall remission were comparable between the two groups. The monoclonal antibody group had a lower incidence rate of adverse reactions than the placebo group [odds ratio (OR): 0.81; 95% confidence interval (CI): 0.63-1.03; = 0.09)]. Clinical response was higher in the ETR group than in the placebo group (OR: 1.56; 95% CI: 1.20-2.02; = 0.0009), and endoscopic improvement was more favorable in the ETR group (OR: 1.88; 95% CI: 1.45-2,45; < 0.00001). A higher rate of endoscopic remission was found in the ETR group than in the placebo group (OR: 2.48; 95% CI: 1.75-3.50; < 0.00001); histological remission was significantly higher in the ETR group than in the placebo group (OR: 2.11; 95% CI: 1.55-2.86; < 0.00001). The placebo group had a lower rate of positive antidrug antibodies (OR: 1.31; 95% CI: 0.79-2.17; < 0.29), and the incidence of complications was significantly higher in the ETR group compared with the placebo group (OR: 2.05; 95% CI: 1.48-2.83; < 0.0001).
Given the heterogeneity and potential biases in the included studies, gastroenterologists should cautiously tailor drug delivery strategies based on their clinical experience and the unique needs of individual patients.
CRD42023396100.
现有科学文献对依法珠单抗（ETR）治疗溃疡性结肠炎（UC）的安全性和治疗效果尚无定论。
本荟萃分析的目的是全面综合评估ETR治疗UC的安全性和治疗效果的证据。
荟萃分析。
检索PubMed、Embase和Web of science以收集相关英文研究，并手动检索符合条件研究的参考文献列表，以避免遗漏任何符合条件的研究。结局指标包括临床缓解、不良事件发生率、组织学缓解、内镜缓解、内镜改善和抗药抗体。由两名独立研究人员提取相关数据。
该荟萃分析纳入了五项符合条件的研究，共涉及1528例患者，其中1015例接受ETR治疗，513例接受安慰剂治疗。汇总分析表明ETR既有效又安全。两组的不良事件发生率、内镜和组织学反应以及总体缓解情况相当。单克隆抗体组的不良反应发生率低于安慰剂组[比值比（OR）：0.81；95%置信区间（CI）：0.63 - 1.03；P = 0.09]。ETR组的临床缓解率高于安慰剂组（OR：1.56；95% CI：1.20 - 2.02；P = 0.0009），且ETR组的内镜改善情况更优（OR：1.88；95% CI：1.45 - 2.45；P < 0.00001）。ETR组的内镜缓解率高于安慰剂组（OR：2.48；95% CI：1.75 - 3.50；P < 0.00001）；ETR组的组织学缓解率显著高于安慰剂组（OR：2.11；95% CI：1.55 - 2.86；P < 0.00001）。安慰剂组的抗药抗体阳性率较低（OR：1.31；95% CI：0.79 - 2.17；P < 0.29），且ETR组的并发症发生率显著高于安慰剂组（OR：2.05；95% CI：1.48 - 2.83；P < 0.0001）。
鉴于纳入研究存在异质性和潜在偏倚，胃肠病学家应根据临床经验和患者个体的独特需求谨慎制定给药策略。
PROSPERO注册号：CRD42023396100。
