Connecticut Children's Medical Center, Hartford, Connecticut 06106, USA.
Am J Gastroenterol. 2010 Jun;105(6):1430-6. doi: 10.1038/ajg.2009.759. Epub 2010 Jan 26.
Infliximab is effective in treating moderate/severe ulcerative colitis (UC) in adults. The aim of this study was to determine the outcome after treatment with infliximab in pediatric UC.
We performed a multicenter cohort study of 332 pediatric patients with UC enrolled in the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry. Children<or=16 years of age and newly diagnosed with UC are enrolled in the registry. Disease and medication information are collected prospectively from the treating physician at diagnosis, 30 days, and quarterly thereafter. No interventions were specified, per protocol.
Of 332 patients, 52 (16%) received infliximab (23%<3 months from diagnosis, 38% 3-12 months, 38% >12 months). Mean age at infliximab initiation was 13.3+/-2.6 (range 6-17) years; 87% of patients had pancolitis. Median follow-up was 30 months. Continuous maintenance (CM) therapy was given in 65%, episodic in 21%, episodic converted to CM in 6%, and insufficient data in 8% of patients. Sixty-three percent of patients were corticosteroid refractory, and 35% were corticosteroid dependent. Concomitant medications at first infliximab infusion included corticosteroids (87%), thiopurines (63%), and 5-aminosalicylates (51%). Corticosteroid-free inactive disease by physician global assessment was noted in 12/44 (27%), 15/39 (38%), and 6/28 (21%) patients at 6, 12, and 24 months, respectively. Kaplan-Meier analysis showed that the likelihood of remaining colectomy free after treatment with infliximab was 75% at 6 months, 72% at 12 months, and 61% at 2 years.
In this cohort of children with UC receiving infliximab, corticosteroid-free inactive disease was observed in 38 and 21% of patients at 12 and 24 months, respectively. By 24 months, 61% of patients had avoided colectomy.
英夫利昔单抗治疗成人中重度溃疡性结肠炎（UC）有效。本研究旨在确定英夫利昔单抗治疗小儿 UC 的结果。
我们对小儿炎症性肠病协作研究组登记处登记的 332 例新诊断为 UC 的儿科患者进行了一项多中心队列研究。登记处招募年龄<或=16 岁且新诊断为 UC 的儿童。疾病和药物信息由治疗医生在诊断时、30 天时以及此后每季度前瞻性收集。根据方案，未指定任何干预措施。
在 332 例患者中，52 例（16%）接受了英夫利昔单抗治疗（23%在诊断后<3 个月，38%在 3-12 个月，38%>12 个月）。英夫利昔单抗起始时的平均年龄为 13.3+/-2.6（范围 6-17）岁；87%的患者有全结肠炎。中位随访时间为 30 个月。65%的患者接受了持续维持（CM）治疗，21%接受了间歇性治疗，6%接受了间歇性转换为 CM 治疗，8%的患者数据不足。63%的患者对皮质类固醇耐药，35%的患者对皮质类固醇依赖。首次英夫利昔单抗输注时的伴随药物包括皮质类固醇（87%）、硫嘌呤（63%）和 5-氨基水杨酸（51%）。根据医生的总体评估，6 个月、12 个月和 24 个月时，分别有 12/44（27%）、15/39（38%）和 6/28（21%）例患者达到皮质类固醇无活性疾病。Kaplan-Meier 分析显示，接受英夫利昔单抗治疗后，6 个月时无结肠切除术的可能性为 75%，12 个月时为 72%，2 年时为 61%。
在本队列中，接受英夫利昔单抗治疗的儿童 UC 患者中，分别有 38%和 21%的患者在 12 个月和 24 个月时达到皮质类固醇无活性疾病。到 24 个月时，61%的患者避免了结肠切除术。
