Bermejo Fernando, López San Román Antonio, Algaba Alicia, van Domselaar Manuel, Carneros José A, Rivero Miguel, Piqueras Belén, Valer M Paz
Servicio de Aparato Digestivo, Hospital Universitario de Fuenlabrada, Madrid, Spain.
Gastroenterol Hepatol. 2008 Dec;31(10):629-32. doi: 10.1016/S0210-5705(08)75809-6. Epub 2009 Jan 7.
Infliximab can provoke acute or delayed infusion reactions (IR) leading to treatment withdrawal. Our aim was to determine the frequency of IR in patients with inflammatory bowel disease receiving intravenous infliximab and premedicated with steroids and antihistaminics.
We prospectively studied 100 consecutive patients (74 with Crohn's disease, 26 with ulcerative colitis) treated with infliximab induction therapy (3 doses: weeks 0-2-6), followed or not by maintenance every 8 weeks. All patients were premedicated with 100 mg i.v. hydrocortisone and 5 mg i.v. dexchlorpheniramine 30 min before each infusion.
The mean age was 40.9+/-13 years (51% females, and 38% smokers). Ninety-two percent of the patients were under immunomodulator therapy (azathioprine/ mercaptopurine 85% or methotrexate 7%). A total of 560 infusions were administered, with a mean of 5.6 per patient (range, 1-21). Fifty-six percent of the patients received maintenance therapy. The mean length of follow-up was 17+/-16 months. IR occurred in 6 patients (6%) and in 1.4% of all infusions (8/560). All reactions were mild or moderate. Five IR were immediate, occurring in the second infusion. One IR was delayed (exanthema 5 days after the second infusion). Infliximab therapy was discontinued in only 3 patients (in the patient with the delayed IR and in 2 patients with immediate IR that reappeared during the third infusion).
In patients with inflammatory bowel disease treated with infliximab and under immunomodulator therapy, premedication with steroids and antihistaminics was associated with a low prevalence of IR. Moreover, after close follow-up, infliximab had to be discontinued in only 3% of the patients.
英夫利昔单抗可引发急性或迟发性输注反应(IR),导致治疗中断。我们的目的是确定接受静脉注射英夫利昔单抗并预先使用类固醇和抗组胺药治疗的炎症性肠病患者中IR的发生率。
我们前瞻性地研究了100例连续接受英夫利昔单抗诱导治疗(3剂:第0、2、6周)的患者(74例克罗恩病患者,26例溃疡性结肠炎患者),随后每8周进行或不进行维持治疗。所有患者在每次输注前30分钟静脉注射100毫克氢化可的松和5毫克右氯苯那敏进行预处理。
平均年龄为40.9±13岁(51%为女性,38%为吸烟者)。92%的患者接受免疫调节剂治疗(85%使用硫唑嘌呤/巯嘌呤或7%使用甲氨蝶呤)。共进行了560次输注,平均每位患者5.6次(范围为1 - 21次)。56%的患者接受维持治疗。平均随访时间为17±16个月。6例患者(6%)出现IR,占所有输注的1.4%(8/560)。所有反应均为轻度或中度。5例IR为即刻反应,发生在第二次输注时。1例IR为迟发性反应(第二次输注后5天出现皮疹)。仅3例患者停用英夫利昔单抗治疗(迟发性IR患者以及2例在第三次输注时再次出现即刻IR的患者)。
在接受英夫利昔单抗治疗且接受免疫调节剂治疗的炎症性肠病患者中,预先使用类固醇和抗组胺药与IR的低发生率相关。此外,经过密切随访,仅3%的患者不得不停用英夫利昔单抗。