Department of Clinical and Experimental Pathology, University of Udine School of Medicine, Udine, Italy.
Clin Gastroenterol Hepatol. 2010 Jul;8(7):591-9.e1; quiz e78-9. doi: 10.1016/j.cgh.2010.01.016. Epub 2010 Feb 4.
BACKGROUND & AIMS: Infliximab might prevent postsurgical recurrence of Crohn's disease. However, it is unclear whether long-term therapy is necessary and whether alternative strategies could be applied to minimize potential side effects and reduce the costs of treatment.
We performed a prospective cohort study in 12 consecutive patients, treated immediately after surgery with maintenance infliximab (5 mg/kg), who did not have clinical or endoscopic evidence of disease recurrence after 24 months; they were followed up for an additional year. Infliximab treatment was then discontinued; patients with disease recurrence, based on endoscopy (Rutgeerts score, >or=2), were given lower doses of infliximab (starting with 1 mg/kg) to re-establish mucosal integrity. Surrogate markers of disease activity (fecal calprotectin [FC], C-reactive protein, and erythrocyte sedimentation rate) were assessed after each infliximab dose.
None of the patients had clinical or endoscopic recurrence of Crohn's disease 3 years after surgery. However, discontinuation of infliximab caused endoscopic recurrence after 4 months in 10 of 12 patients (83%). All 10 patients then were treated again with infliximab, which, at a dose of 3 mg/kg every 8 weeks, restored and maintained mucosal integrity for 1 year. Among the surrogate markers, FC levels correlated with endoscopic scores (Wald test, P < .0001).
Long-term maintenance therapy with infliximab is required to maintain mucosal integrity in patients after surgery for Crohn's disease. However, a dose of 3 mg/kg (a 40% reduction from the standard dose) was sufficient to avoid disease recurrence, determined by endoscopy, in all patients at 1 year. FC levels correlate with mucosal status at different infliximab doses.
英夫利昔单抗可能预防克罗恩病术后复发。然而，尚不清楚是否需要长期治疗，以及是否可以采用替代策略来最小化潜在的副作用并降低治疗成本。
我们对 12 例连续患者进行了前瞻性队列研究，这些患者在手术后立即接受英夫利昔单抗（5mg/kg）维持治疗，在 24 个月后没有疾病复发的临床或内镜证据；他们又随访了一年。然后停止英夫利昔单抗治疗；对于内镜（Rutgeerts 评分>或=2）显示疾病复发的患者，给予较低剂量的英夫利昔单抗（起始剂量为 1mg/kg）以重建黏膜完整性。在每次给予英夫利昔单抗后，评估疾病活动的替代标志物（粪便钙卫蛋白[FC]、C 反应蛋白和红细胞沉降率）。
手术后 3 年，所有患者均无克罗恩病的临床或内镜复发。然而，在 12 例患者中的 10 例（83%）中，英夫利昔单抗停药 4 个月后导致内镜复发。这 10 例患者随后再次接受英夫利昔单抗治疗，剂量为每 8 周 3mg/kg，1 年内恢复并维持了黏膜完整性。在替代标志物中，FC 水平与内镜评分相关（Wald 检验，P<0.0001）。
克罗恩病手术后患者需要长期维持英夫利昔单抗治疗以维持黏膜完整性。然而，在所有患者中，剂量为 3mg/kg（标准剂量的 40%减少）足以避免内镜确定的疾病复发，在 1 年内。FC 水平与不同英夫利昔单抗剂量的黏膜状态相关。
