Health Technology Assessment: Evaluation of Monoclonal Antibodies for the Treatment of Neuromyelitis Optica Spectrum Disorders.

IF 5.1 2区医学 Q1 CHEMISTRY, MEDICINAL

Drug Design, Development and Therapy Pub Date : 2025-09-08 eCollection Date: 2025-01-01 DOI:10.2147/DDDT.S535347

Changsheng Wang, Hanbiao Wu, Yeqing Huang, Aiqun Liu, Sha Lai

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引用次数: 0

Abstract

Objective: 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.

Methods: 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).

Results: The comprehensive evaluation scores, with a maximum of 100 points, were as follows: eculizumab (70.43), satralizumab (69.33), and inebilizumab (68).

Conclusion: 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.

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健康技术评估：单克隆抗体治疗视谱神经脊髓炎的评价

目的：为系统评价单克隆抗体治疗视神经脊髓炎谱系障碍（NMOSD）的临床价值，采用更新后的《中国医疗机构药物评价与选择快速指南（第二版）》的药物评价框架，对eculizumab、inebilizumab和satralizumab三种单克隆抗体疗法进行多维度评价。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。方法：在5个不同的领域采用定量评分系统：药理学（28分）、疗效（27分）、安全性（25分）、经济性（10分）和其他属性（10分）。结果：综合评价得分为eculizumab（70.43分）、satralizumab（69.33分）、inebilizumab（68分），满分为100分。结论：Eculizumab因其最佳的获益-风险概况而被强烈认可为一线治疗选择。Satralizumab和inebilizumab可被视为有条件的替代方案，取决于机构资源和个体患者因素。这一分级推荐框架促进了适应性处方管理，使其与不断变化的治疗环境和社会经济条件相一致，从而为全球卫生保健系统提供了可复制的模式。

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来源期刊

Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

9.00

自引率

0.00%

发文量

382

审稿时长

>12 weeks

期刊介绍： Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications. The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas. Specific topics covered by the journal include: Drug target identification and validation Phenotypic screening and target deconvolution Biochemical analyses of drug targets and their pathways New methods or relevant applications in molecular/drug design and computer-aided drug discovery* Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes) Structural or molecular biological studies elucidating molecular recognition processes Fragment-based drug discovery Pharmaceutical/red biotechnology Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products** Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing) Preclinical development studies Translational animal models Mechanisms of action and signalling pathways Toxicology Gene therapy, cell therapy and immunotherapy Personalized medicine and pharmacogenomics Clinical drug evaluation Patient safety and sustained use of medicines.