Department of Gastroenterology, Saint Antoine Hospital, APHP and Paris VI University, Paris, France.
Aliment Pharmacol Ther. 2016 Nov;44(10):1102-1113. doi: 10.1111/apt.13808. Epub 2016 Sep 26.
The comparative efficacy of adalimumab (ADA) and infliximab (IFX) in Crohn's disease, and the benefit of initial combotherapy with an immunomodulator, are debated.
To assess the best anti-TNF treatment regimens in Crohn's disease.
We included 906 biologic-naïve Crohn's disease patients [median age, 31 years (24-41)] and performed a retrospective analysis of 1284 therapeutic exposures to ADA (n = 521) or IFX (n = 763) between 2006 and 2015. An immunomodulator was associated during the first 4-6 months (initial combotherapy) during 706 therapeutic exposures (55%). Median duration of anti-TNF therapy was 39 months (IQR 17-67). Primary outcomes were 6-month and 2-year response rates and drug survival. Logistic regression with propensity scoring and Cox proportional hazard analysis determined variables associated with outcomes.
The response rates at 6 months and 2 years were 64% and 44% on ADA mono, 86% and 70% on ADA combo, 72% and 45% on IFX mono, and 84% and 68% on IFX combotherapy, respectively. Differences between ADA and IFX were not significant, whereas combotherapy was superior to monotherapy (P < 0.001). Drug survival was longer with combotherapy vs. monotherapy [adjusted hazard ratio 2.17 (1.72-2.70)] and not significantly different between ADA and IFX. During subsequent anti-TNF exposures, IFX combotherapy fared better than other groups regarding response rates, drug survival, disease activity, hospitalisations and abdominal surgery.
In this retrospective analysis of a large tertiary centre cohort of Crohn's disease patients, ADA and IFX had similar efficacy as first line treatment, while initial combotherapy with an immunomodulator improved all outcome measures.
阿达木单抗(ADA)和英夫利昔单抗(IFX)在克罗恩病中的疗效比较,以及初始联合免疫调节剂治疗的益处,仍存在争议。
评估克罗恩病中最佳的抗 TNF 治疗方案。
我们纳入了 906 例初治的克罗恩病患者[中位年龄 31 岁(24-41)],并对 2006 年至 2015 年期间的 ADA(n=521)或 IFX(n=763)的 1284 次治疗暴露进行了回顾性分析。706 次治疗暴露(55%)在最初的 4-6 个月期间联合使用了免疫调节剂(初始联合治疗)。抗 TNF 治疗的中位持续时间为 39 个月(IQR 17-67)。主要结局为 6 个月和 2 年的应答率和药物存活率。采用倾向评分和 Cox 比例风险分析的 logistic 回归确定与结局相关的变量。
ADA 单药组的 6 个月和 2 年应答率分别为 64%和 44%,ADA 联合组为 86%和 70%,IFX 单药组为 72%和 45%,IFX 联合组为 84%和 68%。ADA 和 IFX 之间的差异无统计学意义,而联合治疗优于单药治疗(P<0.001)。与单药治疗相比,联合治疗的药物存活率更长[校正风险比 2.17(1.72-2.70)],ADA 和 IFX 之间无显著差异。在随后的抗 TNF 暴露中,IFX 联合治疗在应答率、药物存活率、疾病活动度、住院和腹部手术方面优于其他组。
在这项对大型三级中心队列的克罗恩病患者的回顾性分析中,ADA 和 IFX 作为一线治疗具有相似的疗效,而初始联合免疫调节剂治疗可改善所有结局指标。