Favalli Ennio Giulio, Selmi Carlo, Becciolini Andrea, Biggioggero Martina, Ariani Alarico, Santilli Daniele, Fusaro Enrico, Parisi Simone, Massarotti Marco, Marchesoni Antonio, Meroni Pier Luigi
Gaetano Pini Institute, Milan, Italy.
Humanitas Research Hospital, Rozzano, and University of Milan, Milan, Italy.
Arthritis Care Res (Hoboken). 2017 Jun;69(6):867-874. doi: 10.1002/acr.23090.
To evaluate the 8-year survival of the first tumor necrosis factor inhibitor (TNFi) in patients with axial spondyloarthritis (SpA) or psoriatic arthritis (PsA), identify the predictive factors for withdrawal, and compare the discontinuation rates for infliximab, etanercept, and adalimumab.
We evaluated PsA and axial SpA patients treated with a first-line TNFi between 2005 and 2015 at 4 Italian tertiary centers. Eight-year drug survival was calculated by the Kaplan-Meier method, and risk for discontinuation among treatment groups compared by stratified log-rank test. Univariate and multivariate Cox proportional hazard models were developed to examine predictors of withdrawal.
Of 614 patients (316 axial with SpA, 298 with PsA), 203 received adalimumab, 131 etanercept, and 280 infliximab, with similar frequencies in axial SpA and PsA subgroups. The cumulative 8-year retention rate in the whole population was 55.1% (57.2% and 51.9% for axial SpA and PsA, respectively; P = not significant). No significant differences were observed in drug persistence among individual TNFi in either group. Male sex (hazard ratio [HR] 0.595 [95% confidence interval (95% CI) 0.405-0.875]; P = 0.008) and concomitant methotrexate use (HR 0.648 [95% CI 0.426-0.985]; P = 0.042) were associated with a lower risk of withdrawal in PsA. High baseline Bath Ankylosing Spondylitis Disease Activity Index (HR 0.9842 [95% CI 0.9708-0.9980]; P = 0.028) was associated with a lower risk of withdrawal in axial SpA. No difference was found in the comparative analysis of reasons for discontinuation between PsA and axial SpA.
We reported that the real-life 8-year retention rate of the first TNFi in axial SpA and PsA is greater than 50%, with no significant differences between axial SpA and PsA, irrespective of the individual TNFi.
评估首批肿瘤坏死因子抑制剂（TNFi）在轴性脊柱关节炎（SpA）或银屑病关节炎（PsA）患者中的8年生存率，确定停药的预测因素，并比较英夫利昔单抗、依那西普和阿达木单抗的停药率。
我们评估了2005年至2015年间在4家意大利三级中心接受一线TNFi治疗的PsA和轴性SpA患者。采用Kaplan-Meier方法计算8年药物生存率，并通过分层对数秩检验比较各治疗组之间的停药风险。建立单因素和多因素Cox比例风险模型来研究停药的预测因素。
614例患者（316例轴性SpA，298例PsA）中，203例接受阿达木单抗治疗，131例接受依那西普治疗，280例接受英夫利昔单抗治疗，在轴性SpA和PsA亚组中的频率相似。总体人群中8年累积保留率为55.1%（轴性SpA和PsA分别为57.2%和51.9%；P=无显著性差异）。两组中各TNFi之间的药物持久性均未观察到显著差异。在PsA中，男性（风险比[HR]0.595[95%置信区间（95%CI）0.405-0.875]；P=0.008）和同时使用甲氨蝶呤（HR0.648[95%CI0.426-0.985]；P=0.042）与较低的停药风险相关。高基线巴斯强直性脊柱炎疾病活动指数（HR0.9842[95%CI0.9708-0.9980]；P=0.028）与轴性SpA中较低的停药风险相关。在PsA和轴性SpA之间停药原因的比较分析中未发现差异。
我们报告称，首批TNFi在轴性SpA和PsA中的实际8年保留率大于50%，轴性SpA和PsA之间无显著差异，与具体的TNFi无关。
