a Department of Clinical Medicine and Surgery - Section of Infectious Diseases , University of Naples "Federico II" , Naples , Italy.
Expert Opin Drug Saf. 2018 Jul;17(7):709-717. doi: 10.1080/14740338.2018.1483330. Epub 2018 Jun 11.
Alemtuzumab is a monoclonal anti CD-52 antibody recently approved for use in relapsing-remitting multiple sclerosis(MS). Given that the targeted antigen is primarily expressed on B and T lymphocytes, the administration of this biological drug is associated with rapid but protracted peripheral lymphopenia.
The impact on infective risk of this immune impairment is still to be fully understood. In this review, we attempt to summarize all the available literature concerning opportunistic infections occurring in patients with MS receiving alemtuzumab. Infective adverse events were observed in more than 70% of patients in phase 2/3 RCTs, mainly of mild-to-moderate severity. Nevertheless, several post-marketing reports documented cases of serious, rare, and unexpected infections.
Predictive risk factors and prognostic features of opportunistic infections in this setting still need to be exactly assessed. At present, the only recommended preventive measures consist in anti-herpetic prophylaxis, Listeria-free diet, Tuberculosis prophylaxis and annual Papillomavirus screening. Given the non-negligible risk of unpredicted infective events, we advise physicians to take into account patients' history of infectious diseases and vaccine status and to consider supplementary prophylactic strategies, including screening for Toxoplasma gondii and viral hepatitis serostatus as well as pre-emptive approaches to avert CMV reactivation and Pneumocystosis.
阿仑单抗是一种单克隆抗 CD-52 抗体,最近被批准用于治疗复发缓解型多发性硬化症(MS)。鉴于其靶向抗原主要表达于 B 和 T 淋巴细胞,这种生物药物的给药与快速但持久的外周血淋巴细胞减少有关。
这种免疫损伤对感染风险的影响仍有待充分了解。在这篇综述中,我们试图总结所有关于接受阿仑单抗治疗的 MS 患者发生机会性感染的现有文献。在 2/3 期 RCT 中,超过 70%的患者观察到感染不良事件,主要为轻至中度严重程度。然而,一些上市后报告记录了一些严重、罕见和意外的感染病例。
在这种情况下,机会性感染的预测风险因素和预后特征仍需要准确评估。目前,唯一推荐的预防措施包括抗疱疹预防、李斯特菌饮食、结核病预防和年度人乳头瘤病毒筛查。鉴于不可预测的感染事件的风险不可忽视,我们建议医生考虑患者的传染病史和疫苗接种状况,并考虑补充预防策略,包括弓形体和病毒性肝炎血清学筛查,以及抢先预防 CMV 再激活和肺囊虫病。