托珠单抗治疗风湿性疾病超说明书用药中国专家共识

Chinese expert consensus on off-label use of Tocilizumab in rheumatic diseases

白细胞介素-6(IL-6)通路参与多种风湿性疾病,靶向IL-6受体的生物制剂托珠单抗临床使用广泛,但在国内仅获批3种适应证。为规范临床托珠单抗超说明书用药治疗风湿性疾病,中国初级卫生保健基金会风湿免疫学专业委员会组织国内相关专业的专家就调研的12个临床问题,检索国内外药品说明书、风湿性疾病指南共识及临床研究等证据,采用牛津大学循证医学中心分级系统进行证据评价和推荐强度分级,并经共识专家组讨论、投票,最终形成10条推荐意见,涉及巨细胞动脉炎、风湿性多肌痛、大动脉炎、系统性硬化病、成人斯蒂尔病、类风湿关节炎和幼年特发性关节炎,旨在为临床医师提供合理用药依据并为药学部门管理提供参考。

The interleukin-6(IL-6)pathway plays a crucial role in various rheumatic diseases.Tocilizumab,a biologic targeting IL-6 receptor,has been widely used in clinical practice,though it′s officially approved in China for only three indications.To address clinical challenges associated with the off-label use of tocilizumab in treating rheumatic diseases,the Committee of Chinese Primary Health Care Foundation for Rheumatologists and Immunologists engaged multidisciplinary experts and highlight 12 related clinical issues.We aggregated the drug specifications,the guidelines for clinical management of rheumatic diseases and the evidence from clinical research.Recommendations were formed through voting with the consensus conference method incorporating the Oxford evidence-based medicine criteria to evaluate the strength of evidence and recommendations.We have formulated 10 recommendations for off-label use of tocilizumab related to giant cell arteritis,polymyalgia rheumatica,Takayasu arteritis,systemic sclerosis,adult-onset Still′s disease,rheumatoid arthritis,and juvenile idiopathic arthritis.This consensus aims to provide references for the rational use of tocilizumab in clinical practice and enhance pharmacovigilance monitoring.