University of Alabama, Birmingham, Birmingham, AL, USA.
University of Tennessee Health Science Center, Memphis, TN, USA.
Ann Hematol. 2024 Jun;103(6):1909-1917. doi: 10.1007/s00277-024-05736-6. Epub 2024 Apr 20.
Crizanlizumab, a monoclonal antibody against P-selectin, has been shown to reduce vaso-occlusive crises (VOCs) compared to placebo in patients ≥ 16 years with sickle cell disease (SCD). However, there have been rare reports of patients experiencing severe pain and subsequent complications within 24 hours of crizanlizumab infusions. These events are defined as infusion-related reactions (IRRs). Informed by current literature and clinical experience, a group of content experts developed clinical guidelines for the management of IRRs in patients with SCD. We used the RAND/University of California, Los Angeles (UCLA) modified Delphi panel method, a valid, reproducible technique for achieving consensus. We present our recommendations for managing IRRs, which depend on patient characteristics including: prior history of IRRs to other monoclonal antibodies or medications, changes to crizanlizumab infusion rate and patient monitoring, pain severity relative to patient's typical SCD crises, and severe allergic symptoms. These recommendations outline how to evaluate and manage IRRs in patients receiving crizanlizumab. Future research should validate this guidance using clinical data and identify patients at risk for these IRRs.
Crizanlizumab,一种针对 P-选择素的单克隆抗体,与安慰剂相比,已被证明可减少≥16 岁镰状细胞病 (SCD) 患者的血管阻塞性危象 (VOCs)。然而,有罕见报告称,患者在接受 crizanlizumab 输注后 24 小时内出现严重疼痛和随后的并发症。这些事件被定义为输注相关反应 (IRR)。根据当前的文献和临床经验,一组内容专家制定了 SCD 患者 IRR 管理的临床指南。我们使用了 RAND/加利福尼亚大学洛杉矶分校 (UCLA) 改良 Delphi 小组方法,这是一种用于达成共识的有效、可重复的技术。我们提出了管理 IRR 的建议,这些建议取决于患者的特征,包括:对其他单克隆抗体或药物的 IRR 既往史、改变 crizanlizumab 输注率和患者监测、与患者典型 SCD 危象相比的疼痛严重程度,以及严重过敏症状。这些建议概述了如何在接受 crizanlizumab 治疗的患者中评估和管理 IRR。未来的研究应该使用临床数据验证这一指导,并确定有这些 IRR 风险的患者。