Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, National Key Clinical Specialty, Tianjin Institute of Digestive Diseases, Tianjin Key Laboratory of Digestive Diseases, Tianjin, China; Department of Gastroenterology, Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, National Key Clinical Specialty, Tianjin Institute of Digestive Diseases, Tianjin Key Laboratory of Digestive Diseases, Tianjin, China.
Pharmacol Res. 2024 Apr;202:107108. doi: 10.1016/j.phrs.2024.107108. Epub 2024 Feb 24.
BACKGROUND: Optimizing second-line biologic therapies for adult ulcerative colitis (UC) post first-line failure is essential. OBJECTIVE: Compare second-line biologic therapy efficacy in adult UC patients with prior treatment failure. METHODS: A comprehensive search of electronic databases up to May 2023 was conducted to assess second-line biologic therapy efficacy using a random effects model. Parameters analyzed included clinical remission rate, clinical response rate, mucosal healing rate, annual discontinuation rate, and colectomy rates. RESULTS: Forty-three research papers were analyzed. Clinical remission rates for second-line biologics were ranked at 6-14 weeks: Infliximab (30%) was followed by Vedolizumab (29%), Ustekinumab (27%), and Adalimumab (19%). At 52-54 weeks, the order shifted, with Vedolizumab (35%) followed by Infliximab (32%), Ustekinumab (31%), and Adalimumab (26%). The mucosal healing rate was 21%, ranked as: Infliximab (31%), Vedolizumab (21%), Adalimumab (21%), and Ustekinumab (14%). The annual discontinuation rate stood at 20%, with Adalimumab (25%), Vedolizumab (18%), Infliximab (17%), and Ustekinumab (16%). Discontinuation rates due to primary failure (PF), secondary failure (SF), and adverse events (AE) were 6%, 12%, and 3%, respectively. The annual colectomy rate was 9%, with Adalimumab (15%) followed by Vedolizumab (10%), Ustekinumab (9%), and Infliximab (5%), and colectomy rates of 10% due to PF, 12% due to SF, and 4% due to AE. CONCLUSION: For UC patients with first-line treatment failure, it is recommended to prioritize infliximab or vedolizumab as second-line biologic therapies, while avoiding adalimumab as the primary choice. Further clinical trials are necessary to assess ustekinumab efficacy accurately.
背景：优化成人溃疡性结肠炎（UC）一线治疗失败后的二线生物治疗至关重要。
目的：比较既往治疗失败的成人 UC 患者二线生物治疗的疗效。
方法：全面检索电子数据库至 2023 年 5 月，采用随机效应模型评估二线生物治疗的疗效。分析的参数包括临床缓解率、临床反应率、黏膜愈合率、年停药率和结肠切除术率。
结果：分析了 43 篇研究论文。二线生物制剂的临床缓解率在 6-14 周排名如下：英夫利昔单抗（30%），紧随其后的是维得利珠单抗（29%）、乌司奴单抗（27%）和阿达木单抗（19%）。在 52-54 周时，顺序发生变化，维得利珠单抗（35%）紧随其后的是英夫利昔单抗（32%）、乌司奴单抗（31%）和阿达木单抗（26%）。黏膜愈合率为 21%，排名如下：英夫利昔单抗（31%）、维得利珠单抗（21%）、阿达木单抗（21%）和乌司奴单抗（14%）。年停药率为 20%，阿达木单抗（25%）、维得利珠单抗（18%）、英夫利昔单抗（17%）和乌司奴单抗（16%）。因原发性失败（PF）、继发性失败（SF）和不良反应（AE）而停药的比例分别为 6%、12%和 3%。年结肠切除术率为 9%，阿达木单抗（15%），其次是维得利珠单抗（10%）、乌司奴单抗（9%）和英夫利昔单抗（5%），因 PF 而行结肠切除术的比例为 10%，因 SF 而行结肠切除术的比例为 12%，因 AE 而行结肠切除术的比例为 4%。
结论：对于一线治疗失败的 UC 患者，建议将英夫利昔单抗或维得利珠单抗作为二线生物治疗的首选，而避免将阿达木单抗作为首选。需要进一步的临床试验来准确评估乌司奴单抗的疗效。
United European Gastroenterol J. 2019-8-20
Lancet Gastroenterol Hepatol. 2021-12
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