Adalimumab effectiveness for the treatment of ankylosing spondylitis is maintained for up to 2 years: long-term results from the ATLAS trial
Adalimumab effectiveness for the treatment of ankylosing spondylitis is maintained for up to 2 years: long-term results from the ATLAS trial
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DOI：
10.1136/ard.2007.087270
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发表时间：
2009-06-01
影响因子：
27.4
通讯作者：
Davis, J. C., Jr.
中科院分区：
文献类型：
--
作者：
van der Heijde, D.;Schiff, M. H.;Davis, J. C., Jr.
目的：确定阿达木单抗对强直性脊柱炎（AS）患者的长期疗效，这些患者参加了阿达木单抗试验评估AS的长期疗效和安全性（ATLAS），这是一项随机、双盲、安慰剂对照、24周的试验。第24周时，患者转换为开放标签阿达木单抗40 mg eow。疗效指标包括国际脊柱关节炎协会（ASAS）标准（ASAS 20）改善20%、ASAS 40和ASAS部分缓解反应以及ASAS 20反应评价的单个组分的变化，例如Bath AS功能指数（BASFI）和Bath AS疾病活动指数（BASDAI）。根据阿达木单抗暴露的总持续时间，对两年的中期数据进行分析，无论治疗随机分组group.Results：在2年，255（82.0%）的原始311 ATLAS患者继续接受阿达木单抗治疗。ATLAS中观察到的ASAS缓解改善在长期治疗期间持续; 64.5%（200/310）为ASAS 20缓解者，50.6%（157/310）为ASAS 40缓解者，33.5%（104/310）维持ASAS定义的部分缓解。阿达木单抗长期治疗期间，个体ASAS应答组分的变化持续或改善。从ATLAS基线至阿达木单抗暴露2年，BASDAI从6.3（SD 1.7）改善至2.4（SD 2.3），BASFI从5.2（SD 2.4）改善至2.9（SD 2.5）。阿达木单抗耐受性良好。没有结核病，充血性心力衰竭，狼疮样症状，或脱髓鞘疾病的病例reported.Conclusions：阿达木单抗减少AS的体征和症状，并诱导部分缓解长达2年。长期安全性特征与短期安全性特征相似。试验注册信息：NCT 00085644
Objective: To determine the long-term effect of adalimumab on patients with ankylosing spondylitis (AS) who participated in the Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS (ATLAS), a randomised, double-blind, placebo controlled, 24-week trial.Methods: Patients received adalimumab 40 mg every other week (eow) or placebo for 24 weeks in ATLAS. At week 24, patients were switched to open-label adalimumab 40 mg eow. Efficacy measures included 20% improvement in the Assessment in SpondyloArthritis International Society (ASAS) criteria (ASAS20), ASAS40 and ASAS partial remission responses and changes in individual components of the ASAS20 response evaluations, for example, Bath AS Functional Index (BASFI) and Bath AS Disease Activity Index (BASDAI). Two-year interim data were analysed based on the total duration of adalimumab exposure, irrespective of the treatment randomisation group.Results: At 2 years, 255 (82.0%) of the original 311 ATLAS patients continued receiving adalimumab treatment. Improvements in ASAS responses observed in ATLAS were sustained during long-term treatment; 64.5% (200/310) were ASAS20 responders, 50.6% (157/310) were ASAS40 responders and 33.5% (104/310) had maintained ASAS-defined partial remission. Changes in individual ASAS response components were sustained or improved during long-term adalimumab treatment. From ATLAS baseline to 2 years of adalimumab exposure, respectively, BASDAI improved from 6.3 (SD 1.7) to 2.4 (SD 2.3) and BASFI improved from 5.2 (SD 2.4) to 2.9 (SD 2.5). Adalimumab was well tolerated. No cases of tuberculosis, congestive heart failure, lupus-like symptoms, or demyelinating disease were reported.Conclusions: Adalimumab reduced the signs and symptoms of AS and induced partial remission for up to 2 years. The long-term safety profile was similar to the short-term safety profile.Trial registration information: NCT00085644