Emma Children's Hospital, Amsterdam UMC, Pediatric Gastroenterology, University of Amsterdam, Meibergdreef 9, 1105 AZ, Amsterdam, The Netherlands.
Emma Children's Hospital, Amsterdam UMC, Pediatric Gastroenterology, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Eur J Clin Pharmacol. 2019 Oct;75(10):1445-1450. doi: 10.1007/s00228-019-02715-z. Epub 2019 Jul 22.
Infusion reactions (IR) are commonly described side effects of infliximab (IFX) infusions, often leading to discontinuation of IFX. This study aimed to investigate the influence of steroid premedication (PM) on incidence of IR in pediatric inflammatory bowel disease (PIBD) patients receiving IFX.
A case-control study in two tertiary centers in Amsterdam, The Netherlands, including PIBD patients receiving IFX. PM with steroids was part of standard care in one center (PM+) but not in the other center (PM-). Acute IR were divided into mild/severe reactions and in grade 1/2/3/4 for detailed exploration. Differences between subgroups were assessed with the T or chi-square test. Multivariate logistic regression was used to assess associations between PM and IR incidence, correcting for co-medication usage.
We included 226 patients (91 PM+, 50% male, mean age at onset of IBD 12.7 years), receiving 3433 infusions. There was no difference between the PM+ and PM- subgroups in incidence of IR (14.3% vs. 17.0% of patients, p = 0.58) and in percentage of infusions followed by IR (1.4% in both subgroups). The OR of developing IR when using PM was 1.06 (95% CI 0.49-2.27, p = 0.89), and the OR of developing a grade 3 or 4 IR when using PM was 0.90 (95% CI 0.24-3.39, p = 0.88) when correcting for co-medication usage.
The incidence of IR was low, and premedication with steroids did not decrease the incidence of IR in this cohort of PIBD patients receiving IFX. Our results indicate that PM with steroids is not indicated in PIBD to prevent IR.
输注反应(IR)是英夫利昔单抗(IFX)输注的常见不良反应,常导致 IFX 停药。本研究旨在探讨皮质类固醇预处理(PM)对接受 IFX 治疗的小儿炎症性肠病(PIBD)患者 IR 发生率的影响。
这是在荷兰阿姆斯特丹的两个三级中心进行的病例对照研究,包括接受 IFX 治疗的 PIBD 患者。在一个中心(PM+),PM 包括皮质类固醇,而在另一个中心(PM-)则没有。急性 IR 分为轻度/重度反应,并分为 1/2/3/4 级进行详细探讨。使用 T 检验或卡方检验评估亚组之间的差异。使用多变量逻辑回归校正合并用药使用情况,评估 PM 与 IR 发生率之间的关联。
我们纳入了 226 名患者(91 名 PM+,50%为男性,IBD 发病年龄中位数为 12.7 岁),共接受了 3433 次输注。PM+和 PM-亚组的 IR 发生率(分别为 14.3%和 17.0%的患者,p=0.58)和接受 IR 治疗的输注百分比(两个亚组均为 1.4%)无差异。使用 PM 时发生 IR 的 OR 为 1.06(95%CI 0.49-2.27,p=0.89),校正合并用药使用情况后,使用 PM 时发生 3 级或 4 级 IR 的 OR 为 0.90(95%CI 0.24-3.39,p=0.88)。
IR 的发生率较低,皮质类固醇预处理并未降低本队列接受 IFX 治疗的 PIBD 患者的 IR 发生率。我们的结果表明,在 PIBD 中,皮质类固醇 PM 并不能预防 IR。