Jani Meghna, Dixon William G, Kersley-Fleet Lianne, Bruce Ian N, Chinoy Hector, Barton Anne, Lunt Mark, Watson Kath, Symmons Deborah P, Hyrich Kimme L
Arthritis Research UK Centre for Epidemiology, Institute of Inflammation and Repair, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK; Centre for Musculoskeletal Research, Institute of Inflammation and Repair, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK; National Institute of Health Research Manchester Musculoskeletal Biomedical Research Unit, Central Manchester Foundation Trust and University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
Arthritis Research UK Centre for Epidemiology, Institute of Inflammation and Repair, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK; Centre for Musculoskeletal Research, Institute of Inflammation and Repair, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
RMD Open. 2017 Jan 17;3(1):e000314. doi: 10.1136/rmdopen-2016-000314. eCollection 2017.
To compare the risk of lupus-like events (LLEs) and vasculitis-like events (VLEs) in tumour necrosis factor-α inhibitor (TNFi)-treated patients with rheumatoid arthritis (RA) to those receiving non-biological disease-modifying antirheumatic drugs (nbDMARDs).
Patients were recruited to the British Society for Rheumatology Biologics Register-RA, a national prospective cohort study. Two cohorts recruited between 2001 and 2015: (1) patients starting first TNFi (adalimumab, etanercept, infliximab and certolizumab) (n=12 937) and (2) biological-naïve comparison cohort receiving nbDMARDs (n=3673). The risk of an event was compared between the two cohorts using Cox proportional-hazard models, adjusted using propensity scores. Rates of LLE/VLE were compared between TNFi and nbDMARD patients.
The crude incidence rates for LLEs were: TNFi 10/10 000 patient-years (pyrs) (95% CI 8 to 13) and nbDMARD 2/10 000 pyrs (95% CI 1 to 6); for VLEs: TNFi 15/10 000 pyrs (95% CI 12 to 19) and nbDMARD 7/10 000 pyrs (95% CI 4 to 12). The risk of both events was highest in the first year of TNFi treatment. After adjusting for differences in baseline characteristics, there was no difference in risk of LLEs (HR 1.86; 95% CI 0.52 to 6.58) or VLEs (HR 1.27; 95% CI 0.40 to 4.04) for TNFi compared to nbDMARD-treated patients. Infliximab conferred the highest overall risk, followed by etanercept, although 95% CIs overlapped following adjustment.
In one of the largest biological registers, the absolute risk of both events is low. The addition of TNFi to nbDMARD does not alter the risk of either event in patients with RA selected for TNFi. This is the first study to assess the risk of these outcomes in a prospective, observational cohort.
比较肿瘤坏死因子-α抑制剂（TNFi）治疗的类风湿关节炎（RA）患者与接受非生物改善病情抗风湿药物（nbDMARDs）的患者发生狼疮样事件（LLEs）和血管炎样事件（VLEs）的风险。
患者被纳入英国风湿病学会生物制剂注册库-RA，这是一项全国性前瞻性队列研究。2001年至2015年招募了两个队列：（1）开始首次使用TNFi（阿达木单抗、依那西普、英夫利昔单抗和赛妥珠单抗）的患者（n = 12937），（2）接受nbDMARDs的未使用过生物制剂的对照队列（n = 3673）。使用Cox比例风险模型比较两个队列之间的事件风险，并使用倾向得分进行调整。比较TNFi组和nbDMARDs组患者的LLE/VLE发生率。
LLEs的粗发病率为：TNFi组10/10000患者年（pyrs）（95%CI 8至13），nbDMARDs组2/10000 pyrs（95%CI 1至6）；VLEs的粗发病率为：TNFi组15/10000 pyrs（95%CI 12至19），nbDMARDs组7/10000 pyrs（95%CI 4至12）。两种事件的风险在TNFi治疗的第一年最高。在调整基线特征差异后，与接受nbDMARDs治疗的患者相比，TNFi治疗患者发生LLEs（HR 1.86；95%CI 0.52至6.58）或VLEs（HR 1.27；95%CI 0.40至4.04）的风险没有差异。英夫利昔单抗带来的总体风险最高，其次是依那西普，不过调整后95%CI有重叠。
在最大的生物制剂注册库之一中，两种事件的绝对风险都很低。在nbDMARDs基础上加用TNFi不会改变选择使用TNFi的RA患者发生这两种事件的风险。这是第一项在前瞻性观察性队列中评估这些结局风险的研究。
