An evaluation of ravulizumab for the treatment of neuromyelitis optica spectrum disorder.

IF 3.6 3区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Expert Opinion on Biological Therapy Pub Date : 2024-10-26 DOI:10.1080/14712598.2024.2423002
Denis T Balaban, Michael Levy, Ray Borrow, Monique R Anderson
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Abstract

Introduction: Following the CHAMPION-NMOSD trial, the FDA recently granted approval for ravulizumab, a humanized monoclonal antibody against complement C5 protein in AQP-4 seropositive neuromyelitis optica spectrum disorder (NMOSD). Similar to eculizumab, ravulizumab offers near complete prevention of NMOSD relapses, but has a longer half-life, providing decreased infusion frequency and increased convenience for patients. While targeting the complement pathway has clear advantages, patients are at risk for infection with encapsulated organisms, in particular Neisseria meningitidis.

Areas covered: In this paper, we discuss the details of the CHAMPION-NMOSD trial and discuss challenges in meningitis prevention and strategies for switching therapies.

Expert opinion: Ravulizumab improves on eculizumab's success as a highly effective NMOSD therapy by decreasing infusion frequency, thereby increasing patient convenience. We predict ravulizumab will eventually replace eculizumab, but may not have a similar impact on inebelizumab or satralizumab. Patients taking C5 complement inhibitors have an increased risk of serious meningococcal infections, such as invasive meningococcal disease (IMD), and have incomplete protection against IMD despite immunization. Thus, we recommend that in addition to standard pre-immunizations against Neisseria meningitidis, patients should also be assessed for starting on appropriate antibiotic prophylaxis against IMD, based on local resistance patterns.

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评估雷珠单抗治疗神经脊髓炎视网膜频谱紊乱症的效果。
前言继CHAMPION-NMOSD试验之后,美国食品药品管理局最近批准了针对AQP-4血清阳性神经脊髓炎视网膜频谱病变(NMOSD)的补体C5蛋白人源化单克隆抗体ravulizumab。与 eculizumab 相似,ravulizumab 几乎能完全预防 NMOSD 复发,但其半衰期更长,可减少输液次数,为患者提供更多便利。虽然以补体途径为靶点具有明显的优势,但患者仍有可能感染包膜生物,尤其是脑膜炎奈瑟菌:在本文中,我们讨论了CHAMPION-NMOSD试验的细节,并讨论了脑膜炎预防的挑战和转换疗法的策略:Ravulizumab通过减少输液次数,提高了eculizumab作为高效NMOSD疗法的成功率,从而为患者提供了更多便利。我们预测雷珠单抗最终将取代依库珠单抗,但可能不会对伊奈珠单抗或萨曲珠单抗产生类似的影响。服用 C5 补体结合抑制剂的患者发生严重脑膜炎球菌感染(如侵袭性脑膜炎球菌病 (IMD))的风险会增加,而且尽管进行了免疫接种,但对 IMD 的保护仍不完全。因此,我们建议除了对奈瑟氏脑膜炎球菌进行标准的预免疫接种外,还应根据当地的耐药模式对患者进行评估,以便开始使用适当的抗生素预防侵袭性脑膜炎球菌病(IMD)。
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来源期刊
Expert Opinion on Biological Therapy
Expert Opinion on Biological Therapy 医学-生物工程与应用微生物
CiteScore
8.60
自引率
0.00%
发文量
96
审稿时长
3-8 weeks
期刊介绍: Expert Opinion on Biological Therapy (1471-2598; 1744-7682) is a MEDLINE-indexed, international journal publishing peer-reviewed research across all aspects of biological therapy. Each article is structured to incorporate the author’s own expert opinion on the impact of the topic on research and clinical practice and the scope for future development. The audience consists of scientists and managers in the healthcare and biopharmaceutical industries and others closely involved in the development and application of biological therapies for the treatment of human disease. The journal welcomes: Reviews covering therapeutic antibodies and vaccines, peptides and proteins, gene therapies and gene transfer technologies, cell-based therapies and regenerative medicine Drug evaluations reviewing the clinical data on a particular biological agent Original research papers reporting the results of clinical investigations on biological agents and biotherapeutic-based studies with a strong link to clinical practice Comprehensive coverage in each review is complemented by the unique Expert Collection format and includes the following sections: Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results; Article Highlights – an executive summary of the author’s most critical points.
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