Gastroenterology Department, Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Spain.
Aliment Pharmacol Ther. 2010 Mar;31(5):553-60. doi: 10.1111/j.1365-2036.2009.04206.x. Epub 2009 Nov 30.
Most available data on infliximab therapy come from large, short-term, pivotal RCTs and concerns about long-term safety profile still remain.
To evaluate the long-term safety profile of infliximab in inflammatory bowel disease (IBD) in a clinical practice setting.
Since 1999, all IBD patients treated with infliximab were registered and clinical outcomes prospectively recorded up to March 2008, loss of follow-up or patient's death. Infliximab regimens and preventive measures were in accordance with the prevalent guidelines or with the manufacturer's recommendations.
One hundred fifty-two patients were included (121 Crohn's disease, 24 ulcerative colitis, 7 indeterminate colitis), with a median of 5 infliximab infusions (IQR 3-8) and 87% of patients received at least three infusions. Seventy-nine per cent of them received concomitant immunomodulators and 70% were pre-medicated with hydrocortisone from the first infusion. After a median follow-up of 142 weeks, 13% presented infusion reactions, 13% viral or bacterial infections and two patients developed neoplasia. The mortality rate was 2.6% (four patients).
Infliximab therapy is safe when the recommended preventive measures are implemented, with a rate of serious adverse events less than 10%. No new safety signals were found.
大多数关于英夫利昔单抗治疗的可用数据来自大型短期关键随机对照试验，关于长期安全性仍存在担忧。
在临床实践环境中评估英夫利昔单抗治疗炎症性肠病（IBD）的长期安全性。
自 1999 年以来，所有接受英夫利昔单抗治疗的 IBD 患者均进行了登记，并前瞻性地记录了截至 2008 年 3 月的临床结果、随访丢失或患者死亡。英夫利昔单抗方案和预防措施均符合现行指南或制造商的建议。
共纳入 152 例患者（121 例克罗恩病，24 例溃疡性结肠炎，7 例未定型结肠炎），中位接受英夫利昔单抗输注 5 次（IQR 3-8），87%的患者接受至少 3 次输注。其中 79%的患者同时接受免疫调节剂治疗，70%的患者从第一次输注开始接受氢化可的松预处理。中位随访 142 周后，13%的患者出现输注反应，13%的患者发生病毒或细菌感染，2 例患者发生肿瘤。死亡率为 2.6%（4 例）。
当实施推荐的预防措施时，英夫利昔单抗治疗是安全的，严重不良事件发生率低于 10%。未发现新的安全信号。
