Adalimumab for Crohn's disease: Long-term sustained benefit in a population-based cohort of 438 patients
Adalimumab for Crohn's disease: Long-term sustained benefit in a population-based cohort of 438 patients
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DOI：
10.1016/j.crohns.2014.01.012
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发表时间：
2014-08-01
影响因子：
8
通讯作者：
Ponsioen, Cyriel Y.
中科院分区：
文献类型：
--
作者：
Peters, Charlotte P.;Eshuis, Emma J.;Ponsioen, Cyriel Y.
背景和目的：阿达利马是一种有效的治疗克罗恩病的方法。然而，临床试验的结果并不一定反映日常的临床实践。因此，我们在一个基于人群的大型队列中评估了阿达利单抗的实际长期临床疗效，并确定了影响疗效的临床参数。方法：纳入2003至2011年间在北荷兰开始使用阿达利单抗的所有连续患者，并对其中的病历进行回顾。在3个月后评估诱导治疗的反应。维持治疗的持续收益是根据描述正在进行的阿达利单抗治疗的Kaplan-Meier存活率表计算出来的。结果：共有438名克罗恩患者开始使用阿达利单抗，92.5%的患者对诱导期有反应。维持性治疗1年后持续有效率为83.3%，2年后为74.0%。然而，三分之一的患者在随访结束时处于非类固醇缓解状态。较长的病程(OR1.05；p<；0.01)和狭窄(OR3.73；p=0.04)对诱导反应有负面影响。升高的CRP水平预示着较高的初始应答率(OR0.31；P<；0.01)。在阿达利玛单抗治疗的前6个月中，伴随的硫嘌呤降低了维持治疗失败的风险(HR 0.69，p=0.05)。以前的英夫利昔单抗治疗不影响阿达利单抗的疗效，但剂量递增更多地被认为是必要的(p<；0.01)。结论：阿达利昔单抗在大多数患者中是成功的，每一年有10%的反应损失。同时使用硫唑嘌呤可能会改善阿达利玛单抗的维持治疗。(C)2014年欧洲克罗恩和结肠炎组织。爱思唯尔出版，版权所有。
Background and aims: Adalimumab is an effective therapy for induction and maintenance of Crohn's disease. However, results in clinical trials don't necessarily reflect daily clinical practice. Therefore, we assessed real-life long-term clinical response to adalimumab in a large population-based cohort and identified clinical parameters affecting responseMethods: All consecutive patients in North-Holland that started adalimumab between 2003 and 2011 were included, of which medical charts were reviewed. Response to induction therapy was assessed after 3 months. Sustained benefit of maintenance therapy was calculated from Kaplan-Meier survival tables depicting ongoing adalimumab treatment. Regression analyses were performed to identify factors predicting response to adalimumab therapy.Results: In total 438 Crohn's patients started adalimumab with 92.5% response to the induction phase. After 1 year 83.3% showed sustained benefit of maintenance treatment, followed by 74.0% after 2 years. Nevertheless, one third of patients were in steroid-free remission at the end of their follow-up. Response to induction was negatively affected by longer disease duration (OR 1.05; p < 0.01) and strictures (OR 3.73; p = 0.04). Increased CRP levels predicted higher rates of initial response (OR 0.31; p < 0.01). Concomitant thiopurines in the first 6 months of adalimumab treatment decreased the risk to fail maintenance therapy (HR 0.69, p = 0.05). Previous infliximab therapy did not affect response to adalimumab, however dose escalation was more often deemed necessary (p < 0.01).Conclusion: Adalimumab was successful in the majority of patients, with 10% loss of response per subsequent year. Concomitant thiopurines might improve adalimumab maintenance treatment. (c) 2014 European Crohn's and Colitis Organisation. Published by Elsevier B.V. All rights reserved.