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强直性脊柱炎患者停用肿瘤坏死因子抑制剂:一项基于美国Corrona注册中心的观察性研究

Tumor Necrosis Factor Inhibitor Discontinuation in Patients with Ankylosing Spondylitis: An Observational Study From the US-Based Corrona Registry.

作者信息

Mease Philip J, van der Heijde Désirée, Karki Chitra, Liu Mei, Park Yujin, Greenberg Jeffrey D

机构信息

Swedish Medical Center and University of Washington, Seattle, WA, USA.

Leiden University Medical Center, Leiden, The Netherlands.

出版信息

Rheumatol Ther. 2018 Dec;5(2):537-550. doi: 10.1007/s40744-018-0129-z. Epub 2018 Oct 23.

DOI:10.1007/s40744-018-0129-z
PMID:30353387
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6251840/
Abstract

INTRODUCTION

Tumor necrosis factor inhibitors (TNFis) have shown efficacy for the treatment of ankylosing spondylitis (AS). However, many patients may discontinue or switch TNFis due to lack of effect or adverse events. As biologics with alternative mechanisms of action become available for the treatment of AS, it is important to better understand the characteristics of patients who discontinue or have an inadequate response to TNFis to help inform treatment choices regarding initiating or switching to a biologic therapy. This study compared demographic and clinical characteristics of patients with AS who discontinued vs. continued a TNFi by their second follow-up visit in the US-based Corrona Psoriatic Arthritis and Spondyloarthritis (PsA/SpA) Registry.

METHODS

All patients aged ≥ 18 years with AS enrolled in the Corrona PsA/SpA Registry between April 2013 and January 2015 who were receiving or had initiated a TNFi (index therapy) at the time of registry enrollment (baseline) and had ≥ 2 follow-up visits were included. Patient demographics, clinical characteristics, and patient-reported outcome scores at baseline were compared between cohorts of patients who discontinued or continued their TNFi by the second follow-up visit.

RESULTS

Of the 155 included patients, 37 (23.9%) discontinued their index TNFi therapy by the second follow-up visit (mean follow-up, 17.8 months). Patients who discontinued their TNFi were older (mean age, 52.1 vs. 46.6 years; P = 0.04), were more likely to be obese (59.5% vs. 34.2%; P < 0.01), and had worse mean Bath Ankylosing Spondylitis Disease Activity Index and Bath Ankylosing Spondylitis Functional Index scores (4.8 vs. 3.5 and 4.2 vs. 2.8, respectively; P = 0.01 for both) at baseline than those who continued their TNFi.

CONCLUSIONS

The results of this real-world study provide insight into the demographic and clinical characteristics of patients with AS who discontinue vs. continue TNFi therapy in US clinical practice.

FUNDING

Corrona, LLC. Plain language summary available for this article.

摘要

引言

肿瘤坏死因子抑制剂(TNFis)已显示出对强直性脊柱炎(AS)的治疗效果。然而,许多患者可能因疗效不佳或出现不良事件而停用或更换TNFis。随着具有替代作用机制的生物制剂可用于治疗AS,更好地了解停用或对TNFis反应不足的患者特征,有助于为启动或转换生物治疗的治疗选择提供参考。本研究在美国Corrona银屑病关节炎和脊柱关节炎(PsA/SpA)注册中心,比较了强直性脊柱炎患者在第二次随访时停用与继续使用TNFis的人口统计学和临床特征。

方法

纳入2013年4月至2015年1月在Corrona PsA/SpA注册中心登记的所有年龄≥18岁的AS患者,这些患者在登记时(基线)正在接受或已开始使用TNFis(索引治疗),且有≥2次随访。比较第二次随访时停用或继续使用TNFis的患者队列在基线时的人口统计学、临床特征和患者报告的结局评分。

结果

在纳入的155例患者中,37例(23.9%)在第二次随访时停用了索引TNFis治疗(平均随访17.8个月)。停用TNFis的患者年龄更大(平均年龄52.1岁对46.6岁;P = 0.04),更可能肥胖(59.5%对34.2%;P < 0.01),且在基线时的平均巴斯强直性脊柱炎疾病活动指数和巴斯强直性脊柱炎功能指数评分比继续使用TNFis的患者更差(分别为4.8对3.5和4.2对2.8;两者P = 0.01)。

结论

这项真实世界研究的结果为美国临床实践中强直性脊柱炎患者停用与继续使用TNFis治疗的人口统计学和临床特征提供了见解。

资助

Corrona有限责任公司。本文提供通俗易懂的总结。

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