Division of Gastroenterology, Center of Excellence for Gastrointestinal Inflammation and Immunity Research (CEGIIR), University of Alberta, Edmonton, AB, Canada.
Aliment Pharmacol Ther. 2011 Jul;34(2):181-7. doi: 10.1111/j.1365-2036.2011.04699.x. Epub 2011 May 25.
Infliximab is a chimeric monoclonal antibody to tumour necrosis factor alpha (TNFα) with efficacy in inducing and maintaining remission of inflammatory bowel disease, rheumatoid arthritis, ankylosing spondylitis and psoriasis. Infliximab is generally administered over 2h with a further 1-h postinfusion observation. This time interval has substantial impact on healthcare resources and is costly in terms of patient's time away from work.
To examine the safety and tolerability of a 1-h, relative to a 2-h maintenance of infusion of infliximab, and to determine the effect of corticosteroid premedication and concurrent immunosuppressor use on infusion reaction rates.
A prospective cohort study with variable follow-up duration of 2165 consecutive infliximab infusions in 415 patients during 2009 was conducted. Diagnosis, infusion episode number, infusion rate, premedication, concurrent immunosuppressor therapy, the nature and the outcome of infusion reactions were examined.
The majority of infusions (74%) were for management of inflammatory bowel disease. Infusion reactions clustered within the first eight infusions with subsequent sporadic reactions. The infusion reaction incidence rate per 1000 person days in 274 1-h infusions from 54 patients and 1356 2-h infusions from 256 patients were 0.08 and 0.28 respectively (P=0.07). Poisson regression model confirmed that the concurrent use of immunosuppressor therapy was associated with a lower infusion reaction rate, whereas corticosteroid premedication was not.
During maintenance therapy, infliximab infusion can be safely administered over 1h in patients with no past history of significant infliximab infusion reaction. Corticosteroid premedication had no impact on the infusion reaction rates.
英夫利昔单抗是一种针对肿瘤坏死因子-α（TNF-α）的嵌合单克隆抗体，在诱导和维持炎症性肠病、类风湿关节炎、强直性脊柱炎和银屑病的缓解方面具有疗效。英夫利昔单抗通常在 2 小时内输注，然后再进行 1 小时的输注后观察。这个时间间隔对医疗资源有很大的影响，并且患者离开工作岗位的时间成本也很高。
检查英夫利昔单抗维持输注 1 小时相对于 2 小时的安全性和耐受性，并确定皮质类固醇预用药和同时使用免疫抑制剂对输注反应率的影响。
在 2009 年期间，对 415 例患者的 2165 次连续英夫利昔单抗输注进行了前瞻性队列研究，随访时间长短不一。检查了诊断、输注次数、输注速度、预用药、同时使用免疫抑制剂治疗、输注反应的性质和结果。
大多数输注（74%）用于治疗炎症性肠病。输注反应集中在前 8 次输注中，随后出现散发性反应。54 例患者的 274 次 1 小时输注和 256 例患者的 1356 次 2 小时输注的每 1000 人天输注反应发生率分别为 0.08 和 0.28（P=0.07）。泊松回归模型证实，同时使用免疫抑制剂治疗与较低的输注反应率相关，而皮质类固醇预用药则没有。
在维持治疗期间，在没有既往严重英夫利昔单抗输注反应史的患者中，英夫利昔单抗输注可以安全地在 1 小时内完成。皮质类固醇预用药对输注反应率没有影响。
