Adalimumab Is More Effective Than Azathioprine and Mesalamine at Preventing Postoperative Recurrence of Crohn's Disease: A Randomized Controlled Trial
Adalimumab Is More Effective Than Azathioprine and Mesalamine at Preventing Postoperative Recurrence of Crohn's Disease: A Randomized Controlled Trial
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DOI：
10.1038/ajg.2013.287
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发表时间：
2013-11-01
影响因子：
9.8
通讯作者：
Savarino, Vincenzo
中科院分区：
文献类型：
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作者：
Savarino, Edoardo;Bodini, Giorgia;Savarino, Vincenzo
目的：克罗恩病 (CD) 术后复发非常频繁，迄今为止，只有英夫利昔单抗被证明可有效预防复发。阿达木单抗 (ADA) 的功效鲜为人知。我们评估了肠道切除术后给予ADA是否可以减少术后CD复发。 方法：我们随机分配51名接受回结肠切除的CD患者，术后2周接受ADA，剂量为每两周160/80/40 mg，硫唑嘌呤（AZA）2 mg/kg/天，或美沙拉嗪3 g/天，并随访2年。主要终点是内镜和临床复发的患者比例。次要终点是通过先前验证的问卷评估生活质量。 结果：与 AZA 组（64.7%；比值比 (OR)=0.036（95% 置信区间 (CI) 0.004-0.347））和美沙拉嗪组（83.3%；OR=0.013（95% CI）相比，ADA 组的内镜复发率显着较低（6.3%）。 0.001-0.143))。与 AZA 组 (64.7%; OR=0.078 (95% CI 0.013-0.464)) 和美沙拉嗪组 (50%; (OR=0.143 (95% CI 0.025-0.819)) 相比，ADA 组临床复发的患者比例 (12.5%) 显着较低。ADA (202) 组的生活质量高于 ADA 组 (202)。 AZA组（90；OR=0.028（95% CI 0.004-0.196））和美沙拉嗪组（98；OR=0.015（95% CI 0.002-0.134））。结论：肠道切除手术后给予ADA对于预防CD的内镜和临床复发非常有效，需要进一步更大规模的研究来证实其治疗优势并显示其经济意义。该领域的生物治疗。
OBJECTIVES: Postsurgical recurrence of Crohn's disease (CD) is very frequent and, to date, only infliximab has been shown to be useful in preventing it. The efficacy of adalimumab (ADA) is poorly known. We evaluated whether the administration of ADA after resective intestinal surgery reduces postoperative CD recurrence.METHODS: We randomly assigned 51 patients with CD who had undergone ileocolonic resection to receive after 2 weeks from surgery ADA at the dose of 160/80/40 mg every two weeks, azathioprine (AZA) at 2 mg/kg/day, or mesalamine at 3 g/day, and they were followed up for 2 years. The primary end point was the proportion of patients with endoscopic and clinical recurrence. Secondary end point was the assessment of quality of life by means of a previously validated questionnaire.RESULTS: The rate of endoscopic recurrence was significantly lower in ADA (6.3%) compared with the AZA (64.7%; odds ratio (OR)=0.036 (95% confidence interval (CI) 0.004-0.347)) and mesalamine groups (83.3%; OR=0.013 (95% CI 0.001-0.143)). There was a significantly lower proportion of patients in clinical recurrence in the ADA group (12.5%) compared with the AZA (64.7%; OR=0.078 (95% CI 0.013-0.464)) and mesalamine groups (50%; (OR=0.143 (95% CI 0.025-0.819)). The quality of life was higher in the ADA (202) than in the AZA (90; OR=0.028 (95% CI 0.004-0.196)) and mesalamine groups (98; OR=0.015 (95% CI 0.002-0.134)).CONCLUSIONS: The administration of ADA after intestinal resective surgery was greatly effective in preventing endoscopic and clinical recurrence of CD. Further larger studies are necessary to confirm the therapeutic advantage and to show the economic implications of biologic therapy in this field.