Incidence and Management of Infusion Reactions to Infliximab in a Prospective Real-world Community Registry
Incidence and Management of Infusion Reactions to Infliximab in a Prospective Real-world Community Registry
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DOI：
10.3899/jrheum.140538
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发表时间：
2015-07-01
影响因子：
3.9
通讯作者：
Nantel, Francois
中科院分区：
文献类型：
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作者：
Choquette, Denis;Faraawi, Rafat;Nantel, Francois
objective.英夫利昔单抗（IFX）是一种靶向肿瘤坏死因子-α的治疗性单克隆抗体，适用于治疗慢性炎症性疾病。IFX通过静脉输注给药，可能与不同类型的输注反应有关。RemiTRAC输注（NCT 00723905）是一项加拿大观察性登记研究，对接受IFX的患者进行前瞻性随访，以记录术前用药、不良事件、输注反应和输注反应的管理。主要终点是评估与输液反应相关的因素。入组了1632例患者，记录了24，852次输注。大多数患者（63.1%）接受了风湿性疾病治疗，如类风湿性关节炎、强直性脊柱炎或银屑病关节炎。在1632例患者中，201例（12.3%）报告了至少1例输注反应。322例输注与输注反应相关（1.3%），大多数严重程度为轻度至中度（95%）。最常见的输注反应为瘙痒（19.9%）、潮红（9.9%）或呼吸困难（6.2%）。多变量分析显示，术前抗组胺药、既往输液反应次数和女性与输液反应发生率增加显著相关（p <0.0011）。任何免疫抑制剂或皮质类固醇的伴随使用均不影响输注反应的发生率。术前使用抗组胺药与输液反应发生率增加相关（OR 1.58，p = 0.0007）。该登记研究表明，在社区输液诊所，IFX的输液反应并不常见，性质为轻度至中度。抗组胺药、静脉注射类固醇和对乙酰氨基酚被广泛用作预防性术前用药，尽管这项研究显示使用它们没有益处。
Objective. Infliximab (IFX) is a therapeutic monoclonal antibody targeting tumor necrosis factor-a indicated in the treatment of chronic inflammatory diseases. IFX is administered by intravenous infusion and may be associated with different types of infusion reactions.Methods. RemiTRAC Infusion (NCT00723905) is a Canadian observational registry in which patients receiving IFX are followed prospectively to document premedication use, adverse events, infusion reactions, and the management of infusion reactions. The primary endpoint was to assess factors associated with infusion reactions.Results. There were 1632 patients enrolled and 24,852 infusions recorded. Most patients (63.1%) were treated for rheumatologic conditions such as rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis. Of the 1632 patients, 201 (12.3%) reported at least 1 infusion reaction. Three hundred twenty-two infusions were associated with an infusion reaction (1.3%), and most were mild to moderate in severity (95%). The most common infusion reactions were pruritus (19.9%), flushing (9.9%), or dyspnea (6.2%). Multivariate analysis showed that antihistamines premedication, number of previous infusion reactions, and female sex were significantly associated with an increased incidence of infusion reactions (p < 0.0011). The use of any concomitant immunosuppressant or corticosteroids did not influence the incidence of infusion reactions. Antihistamine premedication was associated with an increased incidence of infusion reactions (OR 1.58, p = 0.0007).Conclusion. This registry shows that in community-based infusion clinics, infusion reactions to IFX are uncommon and mild to moderate in nature. Antihistamines, intravenous steroids, and acetaminophen are widely used as preventative premedication, although this study showed an absence of benefit with their use.