Division of Infectious Diseases, University of Genoa and Ospedale Policlinico San Martino, Genova, Italy.
Department of Epidemiology and Preclinical Research, National Institute for Infectious Diseases "Lazzaro Spallanzani", Rome, Italy.
Clin Microbiol Infect. 2018 Jun;24 Suppl 2:S71-S82. doi: 10.1016/j.cmi.2018.02.003. Epub 2018 Feb 12.
The present review is part of the ESCMID Study Group for Infections in Compromised Hosts (ESGICH) Consensus Document on the safety of targeted and biological therapies.
To review, from an Infectious Diseases perspective, the safety profile of agents targeting CD19, CD20 and CD52 and to suggest preventive recommendations.
Computer-based MEDLINE searches with MeSH terms pertaining to each agent or therapeutic family.
Although CD19-targeted agents (blinatumomab or inebilizumab) are not associated with an increased risk of infection, they may cause IgG hypogammaglobulinaemia and neutropenia. The requirement for prolonged intravenous infusion of blinatumomab may increase the risk of catheter-associated bloodstream infections. Infection remains the most common non-haematological adverse effect of anti-CD20 monoclonal antibodies, including severe respiratory tract infection, hepatitis B virus (HBV) reactivation and varicella-zoster virus infection. Screening for chronic or resolved HBV infection is recommended for patients receiving anti-CD20 monoclonal antibodies. Antiviral prophylaxis should be offered for 12-18 months to hepatitis B surface antigen (HBsAg)-positive and HBsAg-negative/anti-hepatitis B core antibody (HBc)-positive patients. Anti-Pneumocystis prophylaxis should be considered in patients receiving concomitant chemotherapy, particularly steroids. Alemtuzumab (anti-CD52) increases the risk of infections, in particular among leukaemia and solid organ transplant patients. These populations benefit from anti-Pneumocystis prophylaxis, prevention strategies for cytomegalovirus infection, and screening for HBV, hepatitis C virus and tuberculosis. Antiviral prophylaxis for at least 6-12 months should be provided for HBsAg-positive patients.
As there are limited clinical data for many of the reviewed agents, special attention must be given to promptly detect and report emerging infectious complications.
本综述是 ESCMID 研究组（ESGICH）有关靶向和生物治疗安全性的共识文件的一部分。
从传染病学的角度，审查靶向 CD19、CD20 和 CD52 的药物的安全性概况，并提出预防建议。
使用与每种药物或治疗药物家族相关的 MeSH 术语进行基于计算机的 MEDLINE 搜索。
虽然靶向 CD19 的药物（blinatumomab 或 inebilizumab）与感染风险增加无关，但它们可能导致 IgG 低丙种球蛋白血症和中性粒细胞减少症。blinatumomab 需长期静脉输注，这可能会增加导管相关血流感染的风险。感染仍然是抗 CD20 单克隆抗体最常见的非血液学不良事件，包括严重呼吸道感染、乙型肝炎病毒（HBV）再激活和水痘带状疱疹病毒感染。建议接受抗 CD20 单克隆抗体治疗的患者进行慢性或已解决的 HBV 感染筛查。对于 HBsAg 阳性和 HBsAg 阴性/抗乙型肝炎核心抗体（HBc）阳性的患者，应提供抗病毒预防治疗 12-18 个月。对于同时接受化疗，特别是接受皮质类固醇治疗的患者，应考虑预防性抗肺孢子虫治疗。阿仑单抗（抗 CD52）会增加感染风险，特别是在白血病和实体器官移植患者中。这些人群受益于抗肺孢子虫预防、巨细胞病毒感染预防策略以及 HBV、丙型肝炎病毒和结核病筛查。对于 HBsAg 阳性的患者，应至少提供 6-12 个月的抗病毒预防治疗。
由于许多被审查的药物的临床数据有限，因此必须特别注意及时发现和报告新出现的感染并发症。
