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阿达木单抗在风湿性和自身免疫性疾病中的作用:与其他生物制剂的比较。

The role of adalimumab in rheumatic and autoimmune disorders: comparison with other biologic agents.

作者信息

Reimold Andreas M

机构信息

Dallas Veterans Affairs Medical Center and Rheumatic Diseases Division, University of Texas Southwestern Medical Center, Dallas, TX, USA.

出版信息

Open Access Rheumatol. 2012 May 3;4:33-47. doi: 10.2147/OARRR.S14569. eCollection 2012.

Abstract

Adalimumab (ADA) is a biologic medication that dampens inflammatory pathways by binding to the cytokine tumor necrosis factor alpha. The US Food and Drug Administration has approved ADA as a medication for use in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, psoriasis, and juvenile idiopathic arthritis. This year marks 10 years of clinical experience with ADA. Long-term extension studies of some of the initial clinical trials, as well as data from large patient registries, are demonstrating ongoing benefit for responders. Potential side effects such as increased risk of infection, lymphoma, congestive heart failure, and demyelination continue to be examined, as the available data are not unanimous in showing an increase in incidence. In balancing both the advantages and the disadvantages of using ADA, the drug's overall effectiveness and its availability for use in patients with hepatic or renal comorbidities are weighed against the high cost. ADA is expected to have a leading role in the treatment of rheumatoid arthritis and other inflammatory conditions for years to come. Future studies will need to address the optimal sequence of disease-modifying antirheumatic drugs and biologics to use, combinations of disease-modifying antirheumatic drugs and biologics, and head-to-head comparisons of biologics in clinical trials. For those who go into clinical remission on an anti-tumor necrosis factor medication, unanswered questions remain about identifying the patients who can maintain the remission off all drugs, or at least off injected medication. Given the cost of biologic drugs, even studies that increase the interval between drug doses in well-controlled patients could provide financial benefits.

摘要

阿达木单抗(ADA)是一种生物药物,通过与细胞因子肿瘤坏死因子α结合来抑制炎症途径。美国食品药品监督管理局已批准ADA用于治疗类风湿性关节炎、银屑病关节炎、强直性脊柱炎、克罗恩病、银屑病和青少年特发性关节炎。今年是ADA临床应用10周年。一些初始临床试验的长期扩展研究以及大型患者登记处的数据表明,ADA对有反应者持续有效。潜在的副作用,如感染风险增加、淋巴瘤、充血性心力衰竭和脱髓鞘,仍在研究中,因为现有数据在显示发病率增加方面并不一致。在权衡使用ADA的利弊时,要将该药物的总体有效性及其在有肝或肾合并症患者中的可用性与高成本进行权衡。预计在未来几年,ADA在类风湿性关节炎和其他炎症性疾病的治疗中仍将发挥主导作用。未来的研究需要解决改善病情抗风湿药物和生物制剂的最佳使用顺序、改善病情抗风湿药物与生物制剂的联合使用,以及生物制剂在临床试验中的直接比较等问题。对于那些使用抗肿瘤坏死因子药物后进入临床缓解期的患者,关于如何识别那些可以在停用所有药物或者至少停用注射药物后仍能维持缓解的患者,问题仍然没有答案。考虑到生物药物的成本,即使是那些增加病情控制良好患者用药间隔时间的研究也可能带来经济效益。

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