Dignass Axel U, Siegmund Britta, Goertz Ralf, Schneidewind Gundula, Fanter Lena
a Department of Medicine I , Agaplesion Markus Hospital, Goethe-University , Frankfurt am Main , Germany.
b Department of Medicine(Gastroenterology, Infectious Diseases, Rheumatology) , Charité-Universitätsmedizin Berlin , Berlin , Germany.
Scand J Gastroenterol. 2019 Feb;54(2):178-187. doi: 10.1080/00365521.2019.1569124. Epub 2019 Feb 8.
Indirect comparison of efficacy and safety of vedolizumab with adalimumab in biologic-naïve patients with moderate to severe ulcerative colitis (UC).
Vedolizumab is a gut-selective medication for moderate to severe UC. Since no comparative trials are available for direct comparison of vedolizumab vs adalimumab in UC, a systematic review of literature databases was conducted to identify randomized, placebo-controlled trials of the two drugs in patients with moderate to severe UC after failure of conventional treatment. Studies were screened for eligibility by two reviewers based on predefined inclusion criteria. Bucher's adjusted indirect comparison was used to compare vedolizumab and adalimumab indirectly through placebo as common comparator.
One vedolizumab study (GEMINI 1) and three adalimumab studies (ULTRA 1, ULTRA 2 and M10-447) met the eligibility criteria. Baseline characteristics of the included populations were similar in biologic-naïve UC patients across study arms. Although no statistically significant differences between treatments were found for induction efficacy endpoints, there was a trend toward a benefit of vedolizumab over adalimumab. There were also no significant differences between treatments for any maintenance efficacy endpoints, with no clear trend favoring either agent. Vedolizumab exhibited statistically superior maintenance safety compared with adalimumab, with significant reductions in risks of adverse events (relative risk 0.67 [95% confidence interval 0.57-0.80]; p < .0001), serious adverse events (0.20 [0.09-0.42]; p < .0001) and adverse events leading to discontinuation (0.14 [0.05-0.43]; p = .0006).
This analysis indicates that vedolizumab has comparable efficacy to adalimumab with improved safety in biologic-naïve patients with moderate to severe UC.
在初治的中重度溃疡性结肠炎（UC）患者中，间接比较维多珠单抗与阿达木单抗的疗效和安全性。
维多珠单抗是一种用于中重度UC的肠道选择性药物。由于尚无比较维多珠单抗与阿达木单抗治疗UC的直接对比试验，因此对文献数据库进行了系统回顾，以确定这两种药物在常规治疗失败后的中重度UC患者中的随机、安慰剂对照试验。两名研究者根据预先定义的纳入标准对研究进行筛选，以确定其是否符合要求。采用布赫尔校正间接比较法，通过安慰剂作为共同对照，间接比较维多珠单抗和阿达木单抗。
一项维多珠单抗研究（GEMINI 1）和三项阿达木单抗研究（ULTRA 1、ULTRA 2和M10 - 447）符合纳入标准。各研究组中初治UC患者的基线特征相似。虽然诱导疗效终点在治疗组间未发现统计学显著差异，但维多珠单抗有优于阿达木单抗的趋势。在任何维持疗效终点方面，治疗组间也无显著差异，没有明显倾向于任何一种药物的趋势。与阿达木单抗相比，维多珠单抗在维持治疗安全性方面具有统计学优势，不良事件风险显著降低（相对风险0.67[95%置信区间0.57 - 0.80]；p < 0.0001），严重不良事件（0.20[0.09 - 0.42]；p < 0.0001）以及导致停药的不良事件（0.14[0.05 - 0.43]；p = 0.0006）。
该分析表明，在初治的中重度UC患者中，维多珠单抗与阿达木单抗疗效相当，但安全性更佳。
