Hu Qiong, Tang Xing-Zhou, Liu Fang, Liu De-Wu, Cao Bo
AnoRectal Surgery, Guizhou University of Traditional Chinese Medicine, Guizhou, Guiyang, China.
AnoRectal Surgery, Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, Guizhou, Guiyang, China.
Therap Adv Gastroenterol. 2023 Apr 27;16:17562848231166227. doi: 10.1177/17562848231166227. eCollection 2023.
The application of vedolizumab (VDZ) subcutaneous (SC) formulation has brought more convenience and hope to patients with moderate-to-severe inflammatory bowel diseases (IBDs) in the coronavirus disease 2019 context.
This study aimed to systematically evaluate all previous studies that used VDZ SC formulation for maintenance therapy in patients with IBD.
Systematic review and meta-analysis.
The search was conducted using the subject and free terms related to 'Vedolizumab', 'Subcutaneous', and 'IBD', in Embase, PubMed, Web of Science, Cochrane, and at ClinicalTrials.gov databases between 2008 and 2022. The methodological quality of randomized controlled trials (RCTs) and cohort studies was assessed using the Cochrane Handbook of Systematic Reviews and the Newcastle-Ottawa Scale, respectively. The endpoints included efficacy, safety, and immunogenicity.
A total of 60 studies and 2 completed clinical registry trials were retrieved, of which 3 RCTs with high methodological quality, and 3 cohort studies with large heterogeneity were included in the meta-analysis. In the RCT study design, patients with ulcerative colitis (UC) under different conditions after treated with VDZ SC were significantly distinct than those for placebo (PBO) in clinical remission, endoscopic remission, and biochemical remission. In Crohn's disease (CD), the aforementioned parameters were slightly higher than those for PBO, but there was not statistically significant in endoscopic remission and the efficacy of anti-tumor necrosis factor-naive patients. The clinical remission, endoscopic remission, and biochemical remission in patients with UC after VDZ SC treatment were similar to those after intravenous (IV) treatment. The risk ratios in patients experiencing adverse events (AEs) and serious AEs after VDZ SC and PBO treatments were 86% and 89% in UC, and 96% and 80% in CD, respectively. Compared with IV, safety was not statistically different. The risk of developing anti-VDZ antibody after VDZ SC treatment was only 20% of that after PBO in patients with UC, but it was 9.38 times in CD.
VDZ SC treatment maintained the clinical efficacy of IV induction in patients with IBD without increasing the safety risk, and the efficacy was more pronounced in patients with UC. Immunogenicity might be a potential factor for the decrease in efficacy rate in patients with IBD.
INPLASY 2022120115.
在2019冠状病毒病背景下，维多珠单抗（VDZ）皮下（SC）制剂的应用给中重度炎症性肠病（IBD）患者带来了更多便利和希望。
本研究旨在系统评价既往所有使用VDZ SC制剂对IBD患者进行维持治疗的研究。
系统评价和荟萃分析。
于2008年至2022年期间，在Embase、PubMed、Web of Science、Cochrane以及ClinicalTrials.gov数据库中，使用与“维多珠单抗”、“皮下”和“IBD”相关的主题词和自由词进行检索。分别采用Cochrane系统评价手册和纽卡斯尔-渥太华量表评估随机对照试验（RCT）和队列研究的方法学质量。终点指标包括疗效、安全性和免疫原性。
共检索到60项研究和2项完成的临床注册试验，其中3项方法学质量高的RCT和3项异质性大的队列研究纳入荟萃分析。在RCT研究设计中，VDZ SC治疗后不同条件下的溃疡性结肠炎（UC）患者在临床缓解、内镜缓解和生化缓解方面与安慰剂（PBO）组相比有显著差异。在克罗恩病（CD）中，上述参数略高于PBO组，但在内镜缓解和未使用过抗肿瘤坏死因子的患者疗效方面无统计学意义。VDZ SC治疗后UC患者的临床缓解、内镜缓解和生化缓解与静脉注射（IV）治疗后相似。VDZ SC和PBO治疗后UC患者发生不良事件（AE）和严重AE的风险比分别为86%和89%，CD患者分别为96%和80%。与IV相比，安全性无统计学差异。VDZ SC治疗后UC患者产生抗VDZ抗体的风险仅为PBO治疗后的20%，但在CD患者中为9.38倍。
VDZ SC治疗维持了IBD患者IV诱导的临床疗效，且未增加安全风险，在UC患者中疗效更显著。免疫原性可能是IBD患者疗效降低的一个潜在因素。
INPLASY 2022120115
