Park Jun Won, Yoon Young Im, Lee Jae Hyun, Park Jin Kyun, Lee Eun Bong, Song Yeong Wook, Lee Eun Young
Division of Rheumatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Clin Exp Rheumatol. 2016 Jul-Aug;34(4):592-9. Epub 2016 Mar 25.
To investigate the efficacy and safety of low-dose etanercept treatment after clinical remission of ankylosing spondylitis (AS) in the real world.
Data on 134 AS patients who were treated with etanercept for more than 12 months and achieved clinical remission (BASDAI<4 and CRP<0.5 mg/dL) were extracted from a large single centre registry. Drug survival and incidence of adverse events in 100 patients who reduced the dose during follow up (low-dose group) were compared with 34 patients who maintained the initial dose (standard-dose group). For minimisation of selection bias between the two groups, the same analyses were performed in a propensity score-matched population.
Both groups showed similar BASDAI score and CRP levels during the follow-up. Drug survivals between the two groups were also comparable up to 4 years (vs. standard-dose group, adjusted HR=0.472, 95% CI 0.155-1.435). The same analysis performed after propensity score-matching showed concordant result. The incidence of injection site reactions in the low-dose group was significantly lower, and the incidence of other adverse events showed no differences between the two groups. In the low-dose group, dose reduction after more than 24 weeks of standard-dose treatment was associated with longer drug survival (adjusted HR=0.261, 95% CI 0.084-0.809).
Low-dose etanercept treatment after achieving clinical remission can be an alternative treatment option in terms of its comparable long-term efficacy and favourable safety in AS. More than 24 weeks of standard-dose treatment before dose reduction may be beneficial for longer drug survival in this strategy.
在现实世界中研究低剂量依那西普治疗强直性脊柱炎（AS）临床缓解后的疗效和安全性。
从一个大型单中心登记处提取了134例接受依那西普治疗超过12个月并达到临床缓解（BASDAI<4且CRP<0.5mg/dL）的AS患者的数据。将100例在随访期间降低剂量的患者（低剂量组）与34例维持初始剂量的患者（标准剂量组）的药物生存率和不良事件发生率进行比较。为尽量减少两组之间的选择偏倚，在倾向评分匹配人群中进行了相同的分析。
两组在随访期间的BASDAI评分和CRP水平相似。两组的药物生存率在4年内也相当（与标准剂量组相比，调整后HR=0.472，95%CI 0.155-1.435）。倾向评分匹配后进行的相同分析显示结果一致。低剂量组注射部位反应的发生率显著较低，两组之间其他不良事件的发生率无差异。在低剂量组中，标准剂量治疗超过24周后降低剂量与更长的药物生存时间相关（调整后HR=0.261，95%CI 0.084-0.809）。
临床缓解后采用低剂量依那西普治疗，就其在AS中的可比长期疗效和良好安全性而言，可作为一种替代治疗选择。在该策略中，剂量降低前进行超过24周的标准剂量治疗可能有利于延长药物生存时间。
