Vermeire Severine, Louis Edouard, Carbonez An, Van Assche Gert, Noman Maja, Belaiche Jacques, De Vos Martine, Van Gossum Andre, Pescatore Paul, Fiasse Rene, Pelckmans Paul, Reynaert Hendrik, D'Haens Geert, Rutgeerts Paul
Department of Gastroenterology, University Hospital Gasthuisberg, Leuven, Belgium.
Am J Gastroenterol. 2002 Sep;97(9):2357-63. doi: 10.1111/j.1572-0241.2002.05991.x.
Infliximab is an effective treatment for refractory or fistulizing Crohn's disease (CD). However, about 30% of patients do not respond to infliximab for unknown reasons. Identifying predictive factors of response is important for optimizing clinical management and for better understanding infliximab's mechanisms of action. The aim of this study was to assess whether demographic or clinical parameters influence short-term response to infliximab.
The first 240 CD patients of the Belgian Infliximab Expanded Access Program were studied for response to infliximab treatment and assessed at 4 (refractory luminal CD) or 10 wk (fistulizing CD) after the first infusion. Detailed demographic and clinical information on age, sex, type of disease (fistulizing or refractory), Crohn's Disease Activity Index score, C-reactive protein (CRP), smoking habits, disease duration, localization of disease, concomitant medication, and previous surgery were obtained from all patients. Logistic regression and decision tree analysis were performed.
There were 73.5% responders and 26.5% nonresponders to treatment. Stepwise logistic regression identified age (OR = 0.971, 95% CI = 0.947-0.995, p = 0.018), isolated ileitis (OR = 0.359, 95% CI = 0.177-0.728, p = 0.004), and previous surgery (OR = 0.429, 95% CI = 0.233-0.787, p = 0.006) as inversely correlated with response, whereas isolated colitis (OR = 1.905, 95% CI = 1.010-3.597, p = 0.046) and concomitant immunosuppressive treatment (OR = 2.670, 95% CI = 1.430-5.016, p = 0.0022) were positively correlated with response to infliximab. Surprisingly, smoking habits were not retained as predictors for response. Decision tree analysis provided a working algorithm based on age and immunosuppressive treatment that warrants further exploration.
In this large cohort of infliximab-treated CD patients, young age, Crohn's colitis, and concomitant immunosuppressive treatment were identified as independent variables favoring short-term response to infliximab.
英夫利昔单抗是治疗难治性或瘘管性克罗恩病（CD）的有效药物。然而，约30%的患者对英夫利昔单抗无反应，原因不明。确定反应的预测因素对于优化临床管理和更好地理解英夫利昔单抗的作用机制很重要。本研究的目的是评估人口统计学或临床参数是否会影响对英夫利昔单抗的短期反应。
对比利时英夫利昔单抗扩大使用计划的首批240例CD患者进行了英夫利昔单抗治疗反应的研究，并在首次输注后4周（难治性肠腔CD）或10周（瘘管性CD）进行评估。从所有患者处获取了关于年龄、性别、疾病类型（瘘管性或难治性）、克罗恩病活动指数评分、C反应蛋白（CRP）、吸烟习惯、疾病持续时间、疾病部位、合并用药以及既往手术等详细的人口统计学和临床信息。进行了逻辑回归和决策树分析。
治疗的反应者为73.5%，无反应者为26.5%。逐步逻辑回归确定年龄（比值比[OR]=0.971，95%置信区间[CI]=0.947-0.995，p=0.018）、孤立性回肠炎（OR=0.359，95%CI=0.177-0.728，p=0.004）和既往手术（OR=0.429，95%CI=0.233-0.787，p=0.006）与反应呈负相关，而孤立性结肠炎（OR=1.905，95%CI=1.010-3.597，p=0.046）和合并免疫抑制治疗（OR=2.670，95%CI=1.430-5.016，p=0.0022）与对英夫利昔单抗的反应呈正相关。令人惊讶的是，吸烟习惯未被保留作为反应的预测因素。决策树分析提供了一种基于年龄和免疫抑制治疗的实用算法，值得进一步探索。
在这个接受英夫利昔单抗治疗的大量CD患者队列中，年轻、克罗恩结肠炎和合并免疫抑制治疗被确定为有利于对英夫利昔单抗短期反应的独立变量。
