Long term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4 year extended study
Long term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4 year extended study
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DOI：
10.1136/ard.2005.044404
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发表时间：
2006-06-01
影响因子：
27.4
通讯作者：
Segurado, O. G.
中科院分区：
文献类型：
--
作者：
Weinblatt, M. E.;Keystone, E. C.;Segurado, O. G.
目的：评价阿达木单抗加甲氨蝶呤（MTX）的有效性和安全性，给予长达4年的活动性，长期类风湿arthritis.Methods：MTX反应不充分的患者进入一个24周的对照研究（阿尔马达）阿达木单抗加MTX或安慰剂加MTX，有些人参加了随后的开放标签扩展。评价治疗的有效性和安全性。额外的分析，对那些患者的皮质类固醇和/或MTX剂量进行了调整，在extension.Results：在原来的阿尔马达试验中的271例患者，262接受了至少一个剂量的阿达木单抗，并进行了评估。在分析时，162/262（62%）例患者仍留在研究中，平均接受治疗3.4年。退出的原因包括缺乏疗效（8%）、不良事件（12%）和其他原因（18%）。在完成4年治疗的147例患者中，6个月时达到的疗效得以维持。4年时，78%、57%和31%的患者达到ACR 20/50/70; 43%的患者达到临床缓解（DAS 28，2.6）; 22%的患者无身体功能异常（HAQ = 0）。196例接受2-4年治疗的患者的结果相似。当剂量降低时，许多患者的疗效得以维持（皮质类固醇（51/81（63%）例患者）、MTX（92/217（42%））或两者（25/217（12%）。开放标签治疗期间和对照阶段的严重不良事件相当。在开放标签治疗和盲期发生的严重感染是相似的（2.03 v 2.30事件每100患者年，分别）。结论：阿达木单抗加MTX持续的临床反应和缓解RA患者在4年。前6个月的安全性特征与4年随访后相似。减少皮质类固醇和/或MTX剂量对长期疗效无不良影响。
Objective: To evaluate the efficacy and safety of adalimumab plus methotrexate (MTX) given for up to 4 years in patients with active, longstanding rheumatoid arthritis.Methods: Patients responding inadequately to MTX were entered into a 24 week, controlled study (ARMADA) with adalimumab plus MTX or placebo plus MTX, and some were enrolled in a subsequent open label extension. The efficacy and safety of treatment were evaluated. Additional analyses were made for those patients whose corticosteroid and/or MTX dosages were adjusted during the extension.Results: Of 271 patients in the original ARMADA trial, 262 received at least one dose of adalimumab and were evaluated. At the time of analysis, 162/262 (62%) patients had remained in the study and received treatment for a mean of 3.4 years. Withdrawals were for lack of efficacy (8%), adverse events (12%), and other reasons (18%). In 147 patients who completed 4 years' treatment, efficacy achieved at 6 months was maintained. At 4 years, 78%, 57%, and 31% had achieved ACR20/50/70; 43% achieved clinical remission (DAS28,2.6); and 22% had no physical function abnormalities (HAQ = 0). Results were similar for 196 patients who received treatment for 2-4 years. Efficacy was maintained in many patients when dosages were decreased (corticosteroids (51/81 (63%) patients), MTX (92/217 (42%)), or both (25/217 ( 12%))). Serious adverse events were comparable during open label treatment and the controlled phase. Serious infections occurring during open label treatment and the blinded period were similar (2.03 v 2.30 events per 100 patient-years, respectively).Conclusions: Adalimumab plus MTX sustained clinical response and remission in patients with RA during 4 years. The safety profile during the first 6 months was similar to that after 4 years' follow up. Reduction of corticosteroid and/or MTX dosages did not adversely affect long term efficacy.