Evidence-based expert consensus on the clinical application and pharmaceutical management of antibody-based drugs for the treatment of myasthenia gravis
- VernacularTitle:治疗重症肌无力的抗体类药物临床应用与药学管理循证专家共识
- Author:
Rong DUAN
1
;
Zhengxiang LI
1
;
Xiaocong ZUO
2
;
Rongsheng ZHAO
3
;
Ruigang HOU
4
;
Chunsheng YANG
5
;
Guoyan QI
6
Author Information
1. Dept. of Pharmacy，Tianjin Medical University General Hospital，Tianjin 300052，China;Drug Clinical Evaluation Working Committee of Chinese Pharmacists Association，Tianjin 300052;Tianjin Center for Drug Use Monitoring and Clinical Comprehensive Evaluation，Tianjin 300052，China
2. the Third Xiangya Hospital，Central South University，Changsha 410013，China
3. Dept. of Pharmacy，Peking University Third Hospital，Beijing 100191，China
4. Dept. of Pharmacy，the Second Hospital of Shanxi Medical University，Taiyuan 030001，China
5. Dept. of Pharmacy，Tianjin Medical University General Hospital，Tianjin 300052，China
6. Hebei Myasthenia Gravis Diagnosis and Treatment Center，Shijiazhuang People’s Hospital，Shijiazhuang 050020，China
- Publication Type:Journal Article
- Keywords:
myasthenia gravis;
antibody-based drugs;
expert consensus;
evidence-based evaluation;
clinical application
- From:
China Pharmacy
2026;37(9):1113-1121
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To provide standardized guidance for the rational clinical use of antibody-based drugs for the treatment of myasthenia gravis， and to enhance the evidence-based system of guidelines and consensus in this field. METHODS The consensus expert team consisted of 71 multidisciplinary experts from 28 provinces/autonomous regions/municipalities directly under the Central Government. Evidence was systematically retrieved through multiple databases， drug package inserts， and official websites of international and national health administrative authorities， drug regulatory agencies， healthcare security departments， and related industry associations， up to April 30， 2025. Evidence was graded according to the 2014 version of JBI pre-grading system for evidence from intervention studies. Based on full consideration of the current best evidence and multidisciplinary expert experience， the expert consensus recommendations were formulated using a modified Delphi method. RESULTS The Evidence-based expert consensus on the clinical application and pharmaceutical management of antibody-based drugs for the treatment of myasthenia gravis standardized the key points of whole-process pharmaceutical management for four antibody-based drugs approved for marketing in the mainland of China for the treatment of myasthenia gravis （efgartigimod alfa， efgartigimod alfa/hyaluronidase， eculizumab， and rozanolixizumab）. It formulated 37 expert consensus recommendations covering nine pharmaceutical management aspects： drug suitability selection， medication in special populations， administration methods， drug storage， therapeutic drug monitoring and pharmacogenetic testing， immunization management， drug interactions， pharmaceutical care， and off-label drug use. CONCLUSIONS Based on the current best evidence and multidisciplinary expert experience， this consensus establishes a whole-process management framework for antibody-based drugs for the treatment of myasthenia gravis， from clinical application to pharmaceutical management. It provides a scientific basis for the rational and precise use of these drugs in clinical practice， effectively promotes the enhancement of pharmaceutical management efficiency， and helps improve the overall therapeutic benefits for patients.
