生物制剂治疗类风湿关节炎合理用药中国专家共识

Chinese expert consensus on rational use of biological agents in the treatment of rheumatoid arthritis

生物制剂在类风湿关节炎(RA)治疗中的应用越来越广泛。生物改善病情抗风湿药物(bDMARDs)为传统合成改善病情抗风湿药物(csDMARDs)疗效不佳或不耐受的RA患者提供了新的治疗选择。在我国获批上市治疗RA的bDMARDs包括肿瘤坏死因子-α抑制剂、白细胞介素-6受体抑制剂、选择性T细胞共刺激调节剂和其他生物制剂。如何安全合理地使用生物制剂是临床工作中备受关注的问题。目前国内外已有一些生物制剂治疗RA相关的诊治指南或专家共识。但是,尚无从药学角度出发,针对生物制剂治疗RA的临床实际问题,比较全面系统的合理用药专家共识。为此,我国RA诊疗及相关领域专家依据国内外研究证据和临床实践经验,结合中国患者的特点,在深入研讨的基础上制订了本共识。从生物制剂的合理选药、给药、转换用药,以及联合用药、合并疾病患者和特殊人群用药的注意事项等方面,为广大医务人员和患者合理使用生物制剂治疗RA提供参考。

Biologics are increasingly used in the treatment of rheumatoid arthritis(RA). Biological disease modifying anti-rheumatic drugs(bDMARDs) provide new treatment options for RA patients with poor response or intolerance to conventional synthetic disease modifying anti-rheumatic drugs(csDMARDs). bDMARDs approved for the treatment of RA in China include tumor necrosis factor-α inhibitors, interleukin-6 receptor inhibitors, selective T cell costimulation modulators and other biologic agents. How to use biologic agents safely and rationally is a matter of great concern in clinical. At present, there are some domestic and international guidelines or expert consensus on diagnosis and treatment related to biologic treatment of RA. However, from the perspective of pharmacy, there is no comprehensive and systematic expert consensus on the rational drug use for the clinical problems of biologic agents in the treatment of RA. Therefore, Chinese experts in RA diagnosis and treatment and related fields formulated this consensus under in-depth discussion based on domestic and foreign research evidence and clinical practice experience, combing the characteristics of Chinese patients. We provide a reference for medical staff and patients on how to rationally use biologic agents for the treatment of RA from the aspects of rational drug selection, administration, and conversion of biologic agents, as well as precautions for combination drugs, patients with concomitant diseases, and medication in special populations.