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戈利木单抗用于影像学阳性和阴性轴向型脊柱关节炎:临床试验综述

Golimumab in radiographic and nonradiographic axial spondyloarthritis: a review of clinical trials.

作者信息

Toussirot Eric, Vauchy Charline, Binda Delphine, Michel Fabrice

机构信息

Clinical Investigation Center in Biotherapy, Intitut National de la Santé et de la Recherche Médicale CIC-1431; Fédération Hospitalo-Universitaire Integrated Center for Research in inflammatory Diseases; Department of Rheumatology, University Hospital of Besançon, Besançon, France; Department of Therapeutics; Equipe d'accueil EA 4266: "Pathogenic Agents and Inflammation", University of Franche-Comté

Clinical Investigation Center in Biotherapy, Intitut National de la Santé et de la Recherche Médicale CIC-1431.

出版信息

Drug Des Devel Ther. 2016 Jul 1;10:2087-94. doi: 10.2147/DDDT.S107587. eCollection 2016.

DOI:10.2147/DDDT.S107587
PMID:27445459
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4936813/
Abstract

Axial spondyloarthritis (Ax SpA) refers to chronic inflammatory rheumatic diseases that mainly affect the axial skeleton, leading to erosions and new bone formation in the sacroiliac joints and/or the spine. Ax SpA includes the radiographic form of the disease, ie, ankylosing spondylitis (AS), and the nonradiographic Ax SpA (non-Rx Ax SpA) forms. Anti-tumor necrosis factor alpha (TNFα) agents are used in the treatment of Ax SpA in patients who do not respond to or are intolerant to nonsteroidal anti-inflammatory drugs. In these patients, anti-TNFα agents show promising results by targeting the inflammatory process and providing symptomatic relief. Golimumab is a fully human anti-TNFα agent that is currently approved for the treatment of both AS and non-Rx Ax SpA in Europe. This review focuses on the results of clinical trials with golimumab for the treatment of AS (GO-RAISE studies) and non-Rx Ax SpA (GO-AHEAD study) and on the effects of this agent on imaging findings (radiographic progression, magnetic resonance imaging inflammation) as well as on biological parameters. Overall, golimumab is a valid therapeutic option in patients with AS and non-Rx Ax SpA in Europe.

摘要

轴性脊柱关节炎(Ax SpA)是指主要影响中轴骨骼的慢性炎症性风湿性疾病,可导致骶髂关节和/或脊柱出现侵蚀及新骨形成。Ax SpA包括疾病的影像学形式,即强直性脊柱炎(AS),以及非影像学Ax SpA(非放射学Ax SpA)形式。抗肿瘤坏死因子α(TNFα)药物用于治疗对非甾体抗炎药无反应或不耐受的Ax SpA患者。在这些患者中,抗TNFα药物通过针对炎症过程并提供症状缓解显示出有前景的结果。戈利木单抗是一种全人源抗TNFα药物,目前在欧洲已获批用于治疗AS和非放射学Ax SpA。本综述重点关注戈利木单抗治疗AS(GO-RAISE研究)和非放射学Ax SpA(GO-AHEAD研究)的临床试验结果,以及该药物对影像学表现(放射学进展、磁共振成像炎症)和生物学参数的影响。总体而言,在欧洲,戈利木单抗是AS和非放射学Ax SpA患者的一种有效治疗选择。

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本文引用的文献

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Immunotherapy. 2016 Feb;8(2):107-15. doi: 10.2217/imt.15.112. Epub 2016 Jan 22.
2
Golimumab for the treatment of axial spondyloarthritis.戈利木单抗治疗中轴型脊柱关节炎。
Expert Rev Clin Immunol. 2016;12(1):9-18. doi: 10.1586/1744666X.2016.1106941. Epub 2015 Nov 2.
3
Immunogenicity, drug trough levels and therapeutic response in patients with rheumatoid arthritis or ankylosing spondylitis after 24-week golimumab treatment.类风湿关节炎或强直性脊柱炎患者接受戈利木单抗治疗24周后的免疫原性、药物谷浓度及治疗反应
Ann Rheum Dis. 2015 Dec;74(12):2261-4. doi: 10.1136/annrheumdis-2015-207978. Epub 2015 Oct 6.
4
Effect of golimumab and pamidronate on clinical efficacy and MRI inflammation in axial spondyloarthritis: a 48-week open randomized trial.戈利木单抗和帕米膦酸对中轴型脊柱关节炎临床疗效及MRI炎症的影响:一项48周开放随机试验
Scand J Rheumatol. 2015;44(6):480-6. doi: 10.3109/03009742.2015.1038300. Epub 2015 Aug 14.
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Immunogenicity of biologic agents in rheumatoid arthritis patients: lessons for clinical practice.生物制剂在类风湿关节炎患者中的免疫原性:临床实践的经验教训。
Rheumatology (Oxford). 2016 Feb;55(2):210-20. doi: 10.1093/rheumatology/kev277. Epub 2015 Aug 12.
6
A randomized, double-blind, placebo-controlled, sixteen-week study of subcutaneous golimumab in patients with active nonradiographic axial spondyloarthritis.一项评估皮下注射戈利木单抗治疗活动性非放射学中轴型脊柱关节炎患者的随机、双盲、安慰剂对照、十六周研究。
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