Changsheng Wang, Hanbiao Wu, Yeqing Huang, Aiqun Liu, Sha Lai
{"title":"健康技术评估：单克隆抗体治疗视谱神经脊髓炎的评价","authors":"Changsheng Wang, Hanbiao Wu, Yeqing Huang, Aiqun Liu, Sha Lai","doi":"10.2147/DDDT.S535347","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>The comprehensive evaluation scores, with a maximum of 100 points, were as follows: eculizumab (70.43), satralizumab (69.33), and inebilizumab (68).</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":11290,"journal":{"name":"Drug Design, Development and Therapy","volume":"19 ","pages":"7909-7927"},"PeriodicalIF":5.1000,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12432095/pdf/","citationCount":"0","resultStr":"{\"title\":\"Health Technology Assessment: Evaluation of Monoclonal Antibodies for the Treatment of Neuromyelitis Optica Spectrum Disorders.\",\"authors\":\"Changsheng Wang, Hanbiao Wu, Yeqing Huang, Aiqun Liu, Sha Lai\",\"doi\":\"10.2147/DDDT.S535347\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>The comprehensive evaluation scores, with a maximum of 100 points, were as follows: eculizumab (70.43), satralizumab (69.33), and inebilizumab (68).</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":11290,\"journal\":{\"name\":\"Drug Design, Development and Therapy\",\"volume\":\"19 \",\"pages\":\"7909-7927\"},\"PeriodicalIF\":5.1000,\"publicationDate\":\"2025-09-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12432095/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Drug Design, Development and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/DDDT.S535347\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, MEDICINAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug Design, Development and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/DDDT.S535347","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"CHEMISTRY, MEDICINAL","Score":null,"Total":0}
Health Technology Assessment: Evaluation of Monoclonal Antibodies for the Treatment of Neuromyelitis Optica Spectrum Disorders.
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.
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.
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