Long-term safety of infliximab for the treatment of inflammatory bowel disease: a single-centre cohort study
Long-term safety of infliximab for the treatment of inflammatory bowel disease: a single-centre cohort study
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DOI：
10.1136/gut.2008.163642
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发表时间：
2009-04-01
期刊：
影响因子：
24.5
通讯作者：
Rutgeerts, P.
中科院分区：
文献类型：
--
作者：
Fidder, H.;Schnitzler, F.;Rutgeerts, P.
背景和目的：本研究评估英夫利昔单抗治疗炎症性肠病（IBD）患者14年的长期安全性。方法：回顾性分析734例接受英夫利昔单抗治疗的IBD患者和666例未接受英夫利昔单抗治疗的对照患者的不良事件。记录发病时间、转归、严重程度及伴随用药情况。结果：对患者和对照组进行严重不良事件随访，中位时间分别为58个月（IQR 33-88）和144个月（IQR 83-163）。英夫利昔单抗组93例（13%）患者发生112例严重不良事件，对照组126例（19%）患者发生157例严重不良事件(OR 1.33 （95% CI 0.56 ~ 3.00, p = 0.45）。两组在死亡率、恶性肿瘤和感染率方面没有差异。两名接受英夫利昔单抗的患者在基线时皮肤试验呈阴性，被诊断为结核病，而接受预防性治疗的16名皮肤试验呈阳性的患者中没有人患结核病。合并类固醇治疗是英夫利昔单抗治疗患者感染的唯一独立危险因素（OR 2.69 (95% CI 1.18 ~ 6.12), p = 0.018）。最常见的全身性副作用是150例（20%）患者的皮肤出疹，包括牛皮癣样出疹。结论：在研究的患者队列中，长期英夫利昔单抗治疗具有良好的总体安全性。
Background and aims: This study evaluates the long-term safety of infliximab in patients with inflammatory bowel disease (IBD) treated with the drug over a 14-year period.Methods: The medical records of 734 patients with IBD treated with infliximab and 666 control patients not treated with infliximab were reviewed for adverse events. The time of onset and outcome, severity and concomitant medication were recorded.Results: Patients and controls were followed up for serious adverse events for a median time of 58 months (IQR 33-88) and 144 months (IQR 83-163), respectively. 112 severe adverse events occurred in 93 patients (13%) treated with infliximab and 157 occurred in 126 (19%) control patients (OR 1.33 (95% CI 0.56 to 3.00, p = 0.45). There was no difference between the two groups in mortality, malignancies and infection rate. Tuberculosis was diagnosed in two patients receiving infliximab who had negative skin tests at baseline whereas none of 16 patients with positive skin tests who received prophylaxis developed tuberculosis. Concomitant treatment with steroids was the only independent risk factor for infections in patients treated with infliximab (OR 2.69 (95% CI 1.18 to 6.12), p = 0.018). The most commonly observed systemic side effects were skin eruptions including psoriasiform eruptions in 150 patients (20%).Conclusions: Long-term infliximab treatment had a good overall safety profile in the patient cohort studied.