Department of Rheumatology, Institute of Medicine, University of Debrecen Medical and Health Science Center, Nagyerdei krt. 98, 4032, Debrecen, Hungary.
Eur J Health Econ. 2014 May;15 Suppl 1:S93-100. doi: 10.1007/s10198-014-0598-0. Epub 2014 May 16.
The aim of this study was to evaluate the efficacy, reasons for switching and drug survival of TNF-α inhibitors (TNFis) used as first- and second-line drugs in ankylosing spondylitis (AS).
Data on patients suffering from AS and treated with at least one TNFi between November 2005 and 2013 were extracted retrospectively from the database of a single clinical centre. Beside demographic data, the disease activity measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), the response rates (BASDAI50), reasons for switching and survival curves of TNFis were analysed in general and in subgroups of patients treated with each of the available TNFis. The reasons for switching were defined as inefficacy, side effects of the given drug, patient's request and occurrence of extra-articular manifestations.
Altogether, 175 patients were on TNFis and 77 of them received at least two TNFis. The patients' age at the initiation of the first TNFi was higher among switchers compared to non-switchers (42.5 ± 12.6 vs. 38.8 ± 11.2 years, p = 0.049); otherwise, gender, disease duration and initial disease activity had no influence on the risk of switching. The decrease of the BASDAI was similar among non-switchers and switchers using either the first or second TNFi, but the response rates to the first and second TNFi were worse in switchers than in non-switchers. Following the failure of the first TNFi, the retention on therapy was unfavourable, especially in patients on infliximab after 1 year of treatment. The main reason for switching from the first drug was inefficacy. The frequency of side effects that led to switching was higher in the infliximab group than in patients treated with other agents.
Although the retention rate to a second-line TNFi was somewhat worse than that to the first-line TNFi, the switching of TNFis is a good therapeutic option in AS patients who failed to respond to the first TNFi.
本研究旨在评估 TNF-α 抑制剂（TNFis）作为强直性脊柱炎（AS）一线和二线药物的疗效、转换原因和药物生存率。
回顾性地从单一临床中心的数据库中提取了 2005 年 11 月至 2013 年间接受至少一种 TNFis 治疗的 AS 患者的数据。除了人口统计学数据外，还分析了 Bath 强直性脊柱炎疾病活动指数（BASDAI）测量的疾病活动度、反应率（BASDAI50）、转换原因和 TNFis 的生存曲线，总体上和每种可用的 TNFis 治疗的患者亚组中进行分析。转换的原因定义为无效、药物的副作用、患者的要求和出现关节外表现。
共有 175 名患者接受 TNFis 治疗，其中 77 名患者至少接受了两种 TNFis。与非转换者相比，首次接受 TNFis 的患者年龄更高（42.5 ± 12.6 岁 vs. 38.8 ± 11.2 岁，p = 0.049）；否则，性别、疾病持续时间和初始疾病活动度对转换风险没有影响。非转换者和使用一线或二线 TNFis 的转换者的 BASDAI 降低相似，但转换者对一线和二线 TNFis 的反应率较差。一线 TNFis 失败后，治疗保留率不利，尤其是在接受英夫利昔单抗治疗 1 年后的患者。从第一种药物转换的主要原因是无效。导致转换的副作用频率在英夫利昔单抗组中高于其他药物治疗的患者。
尽管二线 TNFis 的保留率略低于一线 TNFis，但对于对一线 TNFis 反应不佳的 AS 患者，转换 TNFis 是一种很好的治疗选择。
