银屑病关节炎患者持续使用抗肿瘤坏死因子疗法：来自英国风湿病学会生物制剂登记处的观察性研究
Persistence with anti-tumour necrosis factor therapies in patients with psoriatic arthritis: observational study from the British Society of Rheumatology Biologics Register.
作者信息
Saad Amr A, Ashcroft Darren M, Watson Kath D, Hyrich Kimme L, Noyce Peter R, Symmons Deborah P M
机构信息
School of Pharmacy and Pharmaceutical Sciences, University of Manchester, Oxford Road, Manchester, UK.
出版信息
Arthritis Res Ther. 2009;11(2):R52. doi: 10.1186/ar2670. Epub 2009 Apr 8.
INTRODUCTION
Anti-TNF therapies represent a breakthrough in the treatment of severe psoriatic arthritis. However, little is known about long-term drug persistence with these treatments in patients with psoriatic arthritis in routine clinical practice. The aim of this study was to assess persistence with first-course and second-course treatment with anti-TNF agents in a prospective cohort of psoriatic arthritis patients and to identify factors associated with and reasons for drug discontinuation.
METHODS
A total of 566 patients with psoriatic arthritis were registered with the British Society for Rheumatology Biologics Register (first anti-TNF agent: etanercept, n = 316; infliximab, n = 162; and adalimumab, n = 88). Treating physicians completed 6-monthly follow-up questionnaires detailing changes to anti-TNF therapies. Persistence with treatment was examined using Kaplan-Meier survival analysis. Reasons for withdrawal were classified as due to inefficacy, adverse events or other reasons. Univariate and multivariate Cox proportional hazard models were developed to examine potential predictors of withdrawals due to inefficacy or adverse events, using a range of demographic, baseline disease-specific and therapeutic variables.
RESULTS
At baseline, the mean (standard deviation) age of patients was 45.7 (11.1) years, 53% were female and the mean disease duration was 12.4 (8.7) years. Persistence data were available for a mean (standard deviation) follow-up of 2.3 (0.9) person-years. In total, 422 patients had completed at least 12 months of follow-up, 75.5% of whom remained on their first anti-TNF drug while 9.5% discontinued due to inefficacy, 10.0% due to adverse events and 5.0% due to other reasons. During the period of follow-up, 178 patients received a second anti-TNF therapy. The survivor function on second anti-TNF for switchers was 74% at 12 months.
CONCLUSIONS
Psoriatic arthritis patients show high persistence rates with both initial and second anti-TNF therapies.
引言
抗TNF疗法是重度银屑病关节炎治疗的一项突破。然而，在常规临床实践中，对于银屑病关节炎患者使用这些疗法的长期药物持续性了解甚少。本研究的目的是评估银屑病关节炎患者前瞻性队列中抗TNF药物首疗程和次疗程治疗的持续性，并确定与药物停用相关的因素及停药原因。
方法
共有566例银屑病关节炎患者在英国风湿病学会生物制剂登记处登记（首种抗TNF药物：依那西普，n = 316；英夫利昔单抗，n = 162；阿达木单抗，n = 88）。治疗医生每6个月填写一次随访问卷，详细说明抗TNF疗法的变化。使用Kaplan-Meier生存分析来检查治疗的持续性。停药原因分为无效、不良事件或其他原因。采用一系列人口统计学、基线疾病特异性和治疗变量，建立单因素和多因素Cox比例风险模型，以检查因无效或不良事件而停药的潜在预测因素。
结果
基线时，患者的平均（标准差）年龄为45.7（11.1）岁，53%为女性，平均病程为12.4（8.7）年。持续性数据的平均（标准差）随访时间为2.3（0.9）人年。共有422例患者完成了至少12个月的随访，其中75.5%的患者仍在使用首种抗TNF药物，9.5%因无效停药，10.0%因不良事件停药，5.0%因其他原因停药。在随访期间，178例患者接受了第二种抗TNF疗法。转换者使用第二种抗TNF疗法的12个月生存函数为74%。
结论
银屑病关节炎患者在初始和第二种抗TNF疗法中均显示出较高的持续性。
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