Lessons learned: Ofatumumab infusion reactions can be diminished by escalating the dose rate in individual patients in sequential infusions.
Background: Ofatumumab (OFA) is a fully humanized, anti-CD20 antibody approved for use in chronic lymphocytic leukemia (CLL). The recommended administration requires long infusion times. We evaluated an accelerated infusion regimen of 2 hours.
Methods: The first dose of OFA (300 mg) was given on week 1 day 1 starting at 3.6 mg/hour and doubling every 30 minutes until a rate of 240 mg/hour was reached. If tolerated, the second dose (1,000 mg) was given on week 1 day 3 starting at 50 mg/hour and doubling every 30 minutes until a rate of 800 mg/hour was reached. If tolerated, the third dose (2,000 mg) was given on week 2 day 1 at 800 mg/hour over the first 30 minutes and, if tolerated, at 1,068 mg/hour over the next 90 minutes (goal infusion time: 120 minutes). Subsequent OFA infusions were administered weekly in the same manner for 8 weeks, and then monthly for 4 months.
Results: Thirty-four patients were treated. Most infusion-related reactions occurred during the first and second infusion. Eighty-seven percent (87%) of patients finished the third infusion within 15 minutes of the planned 2 hours and only one had an infusion reaction.
Conclusion: Using this stepped-up dosing regimen, a rapid infusion of OFA is safe and well tolerated.
经验总结
• 通过逐步升高个体患者每次输注的剂量速率可降低Ofatumumab的输注反应。
摘要
背景. Ofatumumab（OFA）是被批准用于治疗慢性淋巴细胞白血病（CLL）的完全人源化抗CD20抗体。推荐的给药量所需的输注时间较长。研究对2小时的加速输注方案进行了评估。
方法. 在第1周第1天给予第一剂OFA（300mg）, 起始输注速率为3.6 mg/小时, 每30分钟翻一倍, 直到输注速率达到240 mg/小时。如果可耐受, 则在第1周第3天给予第二剂药物（1 000 mg）, 起始输注速率为50 mg/小时, 每30分钟翻一倍, 直到输注速率达到800 mg/小时。如果可耐受, 在第2周第1天给予第三剂药物（2 000 mg）, 输注的前30分钟内速率为800 mg/小时, 如果仍能耐受, 则在接下来的90分钟内以1 068 mg/小时的速率给药（目标输注时间：120分钟）。随后以相同的方式每周进行OFA输注给药, 持续8周, 然后每月以相同的方式给药, 持续4个月。
结果. 34名患者接受治疗。大多数输注相关反应在首次或第二次输注时出现。87%的患者在15分钟内完成了原计划持续2小时的第三次输注, 仅1名患者出现输注反应。
结论. 使用这种加速给药方案快速输注OFA是安全和可良好耐受的。
Trial registration: ClinicalTrials.gov NCT01848145.
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