Efficacy and Safety of Adalimumab by Disease Duration: Analysis of Pooled Data From Crohn's Disease Studies
Efficacy and Safety of Adalimumab by Disease Duration: Analysis of Pooled Data From Crohn's Disease Studies
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DOI：
10.1093/ecco-jcc/jjy223
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发表时间：
2019-06-01
影响因子：
8
通讯作者：
Colombel, Jean-Frederic
中科院分区：
文献类型：
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作者：
Panaccione, Remo;Lofberg, Robert;Colombel, Jean-Frederic
背景与目的克罗恩病分析[CD]抗肿瘤坏死因子药物的研究，包括阿达利单抗，报告了病程较短的患者有较高的缓解率。为了进一步探讨病程和临床疗效之间的关系，我们分析了一个更大的患者队列。方法收集了接受阿达利单抗或安慰剂治疗的中到重度CD活动患者的10项临床试验的数据。在诱导和维持治疗期间，使用克罗恩疾病活动指数[CDAI]终点[缓解，临床反应[CR]-70，CR-100，患者报告结果[PRO]缓解]或哈维-布拉德肖指数[HBI]终点[缓解/应答]进行疗效分析。使用Logistic回归分析比较阿达利单抗和安慰剂治疗。Cochran-Armitage趋势检验用于比较病程亚组之间的差异。
Background and Aims Analyses of Crohn's Disease [CD] studies of anti-TNF agents, including adalimumab, have reported higher remission rates among patients with shorter disease duration. To further explore the relationship between disease duration and clinical efficacy, we analysed a larger patient cohort.Methods Data were pooled from 10 clinical trials in patients with moderately to severely active CD who received treatment with either adalimumab or placebo. Analyses of efficacy using Crohn's Disease Activity Index [CDAI] endpoints [remission, clinical response [CR]-70, CR-100, patient-reported outcome [PRO] remission] or Harvey-Bradshaw Index [HBI] endpoints [remission/response] were conducted for induction and maintenance treatment periods. Logistic regression was used for comparisons between adalimumab and placebo treatment. Cochran-Armitage trend tests were used for comparisons between disease-duration subgroups [