Lin Chien-Hung, Liu Wen-Sheng, Wan Chuan, Wang Hsin-Hui
Division of Pediatric Immunology and Nephrology, Department of Pediatrics, Taipei Veterans General Hospital, Taipei, Taiwan.
School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.
BMJ Open Gastroenterol. 2024 Dec 12;11(1):e001347. doi: 10.1136/bmjgast-2024-001347.
This study aimed to evaluate the real-world effectiveness of tofacitinib for treating moderate-to-severe ulcerative colitis (UC).
Systematic review and meta-analysis.
PubMed, EMBASE and Cochrane CENTRAL databases were searched from inception up to 18 July 2023. Reference lists of included studies were manually searched to identify potentially relevant studies not found in the databases.
Eligible studies included real-world observational studies, reported in English, on patients with moderate-to-severe UC treated with tofacitinib, defined by the Partial Mayo Score. Excluded were clinical trials, reviews, letters, conference abstracts, case reports and studies involving patients with mixed Crohn's disease.
Two independent reviewers extracted data and recorded it in Excel. Quality assessment was performed using the Newcastle-Ottawa scale. Meta-analysis was performed using random-effects models due to high heterogeneity across studies.
19 studies containing a total of 2612 patients were included. Meta-analysis revealed that clinical response rates were 58% at week 8, 61% at weeks 12-16, 51% at weeks 24-26 and 51% at week 52. Clinical remission rates were 39% at week 8, 43% at weeks 12-16, 40% at weeks 24-26 and 43% at week 52. Corticosteroid-free clinical remission rates were 33% at week 8, 37% at weeks 12-16, 32% at weeks 24-26 and 40% at week 52.
This meta-analysis of real-world studies indicates that treatment of UC with tofacitinib is associated with favourable clinical response and remission rates in the induction and maintenance phases.
本研究旨在评估托法替布治疗中重度溃疡性结肠炎（UC）的真实疗效。
系统评价和荟萃分析。
检索PubMed、EMBASE和Cochrane CENTRAL数据库，检索时间从建库至2023年7月18日。对纳入研究的参考文献列表进行人工检索，以识别数据库中未找到的潜在相关研究。
纳入的研究包括以英文报道的、关于接受托法替布治疗的中重度UC患者的真实世界观察性研究，中重度UC由梅奥分项评分定义。排除临床试验、综述、信函、会议摘要、病例报告以及涉及克罗恩病混合型患者的研究。
两名独立审阅者提取数据并记录在Excel中。使用纽卡斯尔-渥太华量表进行质量评估。由于各研究间异质性较高，采用随机效应模型进行荟萃分析。
纳入19项研究，共2612例患者。荟萃分析显示，第8周时临床缓解率为58%，第12 - 16周时为61%，第24 - 26周时为51%，第52周时为51%。临床缓解率在第8周时为39%，第12 - 16周时为43%，第24 - 26周时为40%，第52周时为43%。无皮质类固醇临床缓解率在第8周时为33%，第12 - 16周时为37%，第[此处原文有误，推测应为24 - 26周]时为32%，第52周时为40%。
这项对真实世界研究的荟萃分析表明，托法替布治疗UC在诱导期和维持期均具有良好的临床缓解率和缓解反应。
