Tsoi Man Fung, Kearsley-Fleet Lianne, Azadbakht Narges, Watson Kath, Hyrich Kimme L, Bluett James
Versus Arthritis Centre for Epidemiology, Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.
NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
Rheumatology (Oxford). 2025 Feb 1;64(2):477-483. doi: 10.1093/rheumatology/keae500.
Tocilizumab is an IL-6 receptor humanized monoclonal antibody for the treatment of rheumatoid arthritis (RA) with intravenous (IV) and subcutaneous (SC) preparations available. Only IV tocilizumab is dosed adjusting for weight. Therefore, we aimed to study the association between body weight and the effectiveness of tocilizumab by the route of administration.
Patients with RA-administered tocilizumab in the BSRBR-RA were included in the analysis and stratified by route of administration. Outcomes included the 6-month change in DAS28, the proportion of patients achieving DAS28 remission, 6-month EULAR response and persistence of the first route of tocilizumab administration. The exposure was every increase in 10 kg of body weight. Adjusted regression models appropriate to outcome were used to study the associations between body weight and outcomes. Multiple imputations accounted for missing data.
A total of 2612 patients were included. Body weight was associated with reduced response to SC tocilizumab measured by change in DAS28: adjusted regression coefficient (95% CI) all patients 0.01 (-0.04, 0.07); IV: -0.03, (-0.1, 0.5); SC: 0.1 (0.02, 0.2) but not odds in achieving DAS28 remission or EULAR response. There was no significant association between body weight and the persistence of IV or SC tocilizumab.
Body weight was associated with the initial response to SC tocilizumab, although the difference in response was small, but not drug persistence. Physicians should monitor the body weight of patients and consider interventions to promote maintenance of a healthy weight.
托珠单抗是一种用于治疗类风湿性关节炎（RA）的白细胞介素-6受体人源化单克隆抗体，有静脉注射（IV）和皮下注射（SC）两种制剂。只有静脉注射托珠单抗的剂量会根据体重进行调整。因此，我们旨在按给药途径研究体重与托珠单抗疗效之间的关联。
纳入在英国风湿病学会生物制剂注册数据库（BSRBR-RA）中接受托珠单抗治疗的类风湿性关节炎患者，并按给药途径进行分层。观察指标包括疾病活动度评分28（DAS28）的6个月变化、达到DAS28缓解的患者比例、欧洲抗风湿病联盟（EULAR）6个月反应以及首次托珠单抗给药途径的持续时间。暴露因素为体重每增加10千克。采用适合观察指标的校正回归模型研究体重与观察指标之间的关联。多重填补法处理缺失数据。
共纳入2612例患者。根据DAS28变化衡量，体重与皮下注射托珠单抗的反应降低相关：校正回归系数（95%置信区间），所有患者为0.01（-0.04，0.07）；静脉注射为-0.03（-0.1，0.5）；皮下注射为0.1（0.02，0.2），但与达到DAS28缓解或EULAR反应的几率无关。体重与静脉注射或皮下注射托珠单抗的持续时间之间无显著关联。
体重与皮下注射托珠单抗的初始反应相关，尽管反应差异较小，但与药物持续时间无关。医生应监测患者体重，并考虑采取干预措施以促进维持健康体重。
