Wang Changsheng, Wu Hanbiao, Huang Yeqing, Liu Aiqun, Lai Sha
Key Specialty of Clinical Pharmacy, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, People's Republic of China.
Department of Neurology, The First Affiliated Hospital of Guangdong Pharmaceutical University, Guangzhou, People's Republic of China.
Drug Des Devel Ther. 2025 Sep 8;19:7909-7927. doi: 10.2147/DDDT.S535347. eCollection 2025.
To systematically evaluate the clinical value of monoclonal antibodies for neuromyelitis optica spectrum disorders (NMOSD), a multidimensional assessment of three monoclonal antibody therapies (eculizumab, inebilizumab, and satralizumab) was conducted using the updated drug evaluation framework from the Rapid Guide for Drug Evaluation and Selection in Chinese Medical Institutions (2nd Edition). This study aims to provide evidence-based guidance for optimizing monoclonal antibody selection in clinical practice.
A quantitative scoring system was employed across five distinct domains: pharmacological properties (28 points), efficacy (27 points), safety (25 points), economics (10 points), and other attributes (10 points).
The comprehensive evaluation scores, with a maximum of 100 points, were as follows: eculizumab (70.43), satralizumab (69.33), and inebilizumab (68).
Eculizumab is strongly endorsed as the first-line therapeutic option due to its optimal benefit-risk profile. Satralizumab and inebilizumab may be considered as conditional alternatives, contingent upon institutional resources and individual patient factors. This tiered recommendation framework facilitates adaptive formulary management that aligns with the evolving therapeutic landscape and socioeconomic conditions, thereby providing a replicable model for healthcare systems worldwide.
为系统评估单克隆抗体治疗视神经脊髓炎谱系障碍（NMOSD）的临床价值，使用《中国医疗机构药品评价与遴选快速指南（第2版）》更新的药物评价框架，对三种单克隆抗体疗法（依库珠单抗、inebilizumab和萨特利珠单抗）进行多维度评估。本研究旨在为临床实践中优化单克隆抗体选择提供循证指导。
采用定量评分系统，涵盖五个不同领域：药理学特性（28分）、疗效（27分）、安全性（25分）、经济学（10分）和其他属性（10分）。
综合评价得分满分为100分，结果如下：依库珠单抗（70.43分）、萨特利珠单抗（69.33分）和inebilizumab（68分）。
依库珠单抗因其最佳的效益风险比，被强烈推荐为一线治疗选择。萨特利珠单抗和inebilizumab可根据机构资源和个体患者因素，被视为有条件的替代方案。这种分层推荐框架有助于进行适应性处方管理，以适应不断变化的治疗格局和社会经济状况，从而为全球医疗系统提供一个可复制的模式。
