5PSQ-168健康危机期间达拉单抗快速输注的兴趣和实施

C. Séréni, L. Maljean, F. Morey, S. Dupire, B. Mauguen
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引用次数: 0

摘要

背景和重要性Daratumumab是一种抗cd38单克隆抗体,目前广泛用于多发性骨髓瘤。由于输注相关反应(IRRs)的高风险,给药时间为4小时。作为COVID-19的一部分,法国骨髓瘤Intergroup已授权在临床试验(CT)中输注超过1.5小时的daratumumab,研究显示其安全性与长时间输注相当。目的和目的本研究的目的是评估在现实生活人群中快速注射达拉图单抗相关的IRRs。材料和方法2020年6月至7月,经医学批准,以标准输注速率给予两剂或两剂以上剂量daratumumab的患者被授权接受“快速数据”(输注1.5小时)。药房为护理团队组织了一个小组,向他们介绍新的输液速度,并提醒他们IRRs的风险。收集患者特征(年龄、性别、合并症)、既往达拉单抗输注(包括患者是否经历过IRRs)和方案类型。irr直接记录在验证管理软件中。结果23例患者在研究期间接受了“快速数据”,无IRRs报告。平均年龄69.5岁;5/23的患者年龄在45 ~ 65岁之间,13/23的患者年龄在65 ~ 75岁之间,5/23的患者年龄>75岁。15/23为女性,8/23为男性。15/23例患者至少有一种合并症;13/23有至少一种心血管合并症,3/23有一种肺病合并症,6/23有肾脏损害。在治疗方面,21/23的患者接受了多药治疗(相比之下,2/23的患者接受了单抗治疗)。6/23之前收到了3到10个INJ, 14/23收到了11到20个INJ, 3/23收到了>20个INJ。结论和相关性我们的研究结果表明,在现实生活中的患者中,“快速数据”在irr方面是安全的。这些结果与以前的CT表现一致。在2019冠状病毒病危机的背景下,减少输液时间可以减少接触时间,减少住院治疗,并优化护理时间。在等待皮下达拉图单抗时,快速达拉图单抗似乎是一种安全和经济的选择。参考文献和/或致谢利益冲突无利益冲突
本文章由计算机程序翻译,如有差异,请以英文原文为准。
5PSQ-168 Interest and implementation of rapid daratumumab infusion during the health crisis
Background and importance Daratumumab is an anti-CD38 monoclonal antibody now extensively used for multiple myeloma. Due to the high risk of infusion related reactions (IRRs), it is administered over a period of 4 hours. The French Myeloma Intergroup, as part of COVID-19, has authorised infusions of daratumumab over 1.5 hours in clinical trials (CT) based on studies showing a safety profile comparable with long infusions. Aim and objectives The aim of this study was to evaluate IRRs associated with rapid injection of daratumumab in a real life population. Material and methods From June to July 2020, after medical approval, patients who were given two or more doses of daratumumab with standard infusion rates were authorised to receive ‘rapid dara’ (infusion 1.5 hours). A group was organised by the pharmacy for the nursing team to present the new infusion rate and to remind them of the risks of IRRs. Patient characteristics (age, sex, comorbidities), previous daratumumab infusions (including if patients experienced IRRs) and type of protocols were collected. IRRs were directly recorded in validation administration software. Results 23 patients received ‘rapid dara’ during the study period and no IRRs were reported. Mean age was 69.5 years; 5/23 patients were between 45 and 65 years old, 13/23 between 65 and 75 years old and 5/23 were >75 years old. 15/23 were women and 8/23 were men. 15/23 patients had at least one comorbidity; 13/23 had at least one cardiovascular comorbidity, 3/23 had one pneumological comorbidity and 6/23 had renal impairment. In terms of treatment, 21/23 patients were receiving multidrug therapy (compared with 2/23 on daratumumab monotherapy). 6/23 had previously received between 3 and 10 INJ, 14/23 between 11 and 20 INJ and 3/23 had received >20 INJ. Conclusion and relevance Our findings suggest that in real life patients, ‘rapid dara’ is safe in terms of IRRs. These results are in agreement with those presented in previous CT. In the context of the COVID-19 crisis, decreased infusion time allows a reduction in contact time, decreased hospitalisations, and optimises nurse timing. Rapid daratumumab appears to be a safe and economic alternative while waiting for subcutaneous daratumumab. References and/or acknowledgements Conflict of interest No conflict of interest
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