英夫利昔单抗加速输注安全性和耐受性在炎症性肠病患者中不劣于标准输注方案：一项随机对照研究
Accelerated Infliximab Infusion Safety and Tolerability Is Non-inferior to Standard Infusion Protocol in Inflammatory Bowel Disease Patients: A Randomized Controlled Study.
作者信息
Abushamma Suha, Walker Ted, Garza Kevin, Chen Ling, Nix Darren, Chen Chien-Huan
机构信息
Division of Gastroenterology, John T. Milliken Department of Medicine, Washington University School of Medicine, Saint Louis, Missouri, USA.
Division of General Medicine, John T. Milliken Department of Medicine, Washington University School of Medicine, St. Louis, Missouri, USA.
出版信息
Crohns Colitis 360. 2023 May 3;5(3):otad022. doi: 10.1093/crocol/otad022. eCollection 2023 Jul.
BACKGROUND AND AIM
Infliximab is typically given over an infusion time of 2 hours, leading to a significant burden in inflammatory bowel disease (IBD) patients. We aimed to determine the safety and cost-effectiveness of an accelerated infliximab infusion of 1 hour, compared with the standard 2-hour infusion.
METHODS
Open-label randomized trial where IBD patients receiving maintenance infliximab infusions were randomly assigned to 1- and 2-hour infusion groups, corresponding to study and control groups, respectively. The primary outcome was the rate of infusion reactions. Secondary outcomes were assessment of the effect of premedications and immunomodulators on the rate of infusion reactions, and cost-effectiveness analysis. The cost-effectiveness analysis was based on direct nursing costs for the infusion time, indirect infusion center costs, and cost of productivity loss for patients. This trial is registered with ClinicalTrials.gov, NCT05340764.
RESULTS
From November 2020 to November 2021, 96 patients were randomly assigned: 51 (53%) to the 1-hour infusion group and 45 (47%) to the 2-hour infusion group. Over a median time of 1 year, 309 infusions were administered in the control group, and 376 in the study group. Fifty-seven (18%) infusions in the control group and 45 (12%) infusions in the study group experienced an infusion reaction. The only infusion reaction was asymptomatic hypotension not requiring infusion discontinuation. No other infusion reactions (mild or moderate/severe) were seen. Diphenhydramine was associated with an increased rate of infusion reactions (OR 2.04 [95% CI 1.18-3.52], = .01). The average costs were estimated to reduce by 37% in the accelerated infusion group.
CONCLUSIONS
Accelerated 1-hour infusions are non-inferior in safety and superior in cost-effectiveness compared with standard 2-hour infusions in IBD patients receiving maintenance infliximab infusions.
TRIAL IDENTIFICATION NUMBER
Registered with ClinicalTrials.gov, NCT05340764.
背景与目的
英夫利昔单抗通常在2小时的输注时间内给药，这给炎症性肠病（IBD）患者带来了沉重负担。我们旨在确定与标准2小时输注相比，1小时加速输注英夫利昔单抗的安全性和成本效益。
方法
开放标签随机试验，接受维持性英夫利昔单抗输注的IBD患者被随机分配到1小时和2小时输注组，分别对应研究组和对照组。主要结局是输注反应发生率。次要结局是评估预处理药物和免疫调节剂对输注反应发生率的影响以及成本效益分析。成本效益分析基于输注时间的直接护理成本、间接输注中心成本以及患者的生产力损失成本。本试验已在ClinicalTrials.gov注册，注册号为NCT05340764。
结果
2020年11月至2021年11月，96例患者被随机分配：51例（53%）至1小时输注组，45例（47%）至2小时输注组。在中位时间1年期间，对照组进行了309次输注，研究组进行了376次输注。对照组57次（18%）输注和研究组45次（12%）输注发生了输注反应。唯一的输注反应是无症状性低血压，无需中断输注。未观察到其他输注反应（轻度或中/重度）。苯海拉明与输注反应发生率增加相关（比值比2.04 [95%置信区间1.18 - 3.52]，P = .01）。加速输注组的平均成本估计降低了37%。
结论
在接受维持性英夫利昔单抗输注的IBD患者中，与标准2小时输注相比，1小时加速输注在安全性上不劣且在成本效益上更优。
试验识别号
已在ClinicalTrials.gov注册，注册号为NCT05340764。
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