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有既往 TNF 抑制剂暴露史的强直性脊柱炎患者中司库奇尤单抗与 TNF 抑制剂的保留率和疗效。

Retention rate and effectiveness of secukinumab vs TNF inhibitor in ankylosing spondylitis patients with prior TNF inhibitor exposure.

机构信息

Division of Rheumatology, Department of Internal Medicine.

Division of Rheumatology, Department of Internal Medicine, Research Institute of Medical Science, Konkuk University Medical Center, Konkuk University School of Medicine, Gwangjin-gu.

出版信息

Rheumatology (Oxford). 2021 Dec 1;60(12):5743-5752. doi: 10.1093/rheumatology/keab245.

Abstract

OBJECTIVES

The choice of second-line biologics for AS patients previously treated with a TNF inhibitor (TNFi) remains unclear. Here, we compared drug retention and clinical efficacy between AS patients who switched biologics to secukinumab and those who switched to a different TNFi.

METHODS

AS patients enrolled in the Korean College of Rheumatology BIOlogics registry were included, and patients with non-radiographic axial spondyloarthritis were excluded. Patients with previous TNFi exposure were divided into the secukinumab group and the TNFi switching group. Drug retention and clinical efficacy [BASDAI50, Assessment of Spondylo-Arthritis International Society (ASAS)20, ASAS40, AS disease activity score (ASDAS) <2.1, ASDAS clinically important improvement and ASDAS major improvement] were assessed at the 1 year follow-up. Propensity score (PS)-matched and covariate-adjusted logistic regression analyses were performed.

RESULTS

Two hundred and forty-six had available 1 year follow-up data. Secukinumab as third- or later-line biologic was more frequent than alternative TNFi (54% vs 14%). PS-matched and multiple covariate-adjusted analyses showed that the odds ratio (OR) for drug discontinuation was comparable between the secukinumab and TNFi switching groups [OR 1.136 (95% CI 0.843, 1.531) and 1.000 (95% CI 0.433-2.308), respectively]. The proportion of patients who achieved BASDAI50 was also comparable between the two groups [OR 0.833 (95% CI 0.481, 1.441) in PS-matched analysis]. Other clinical efficacy parameters were also comparable. In the subgroup analysis of AS patients with previous TNFi discontinuation due to ineffectiveness, all clinical efficacy parameters were comparable between the two groups.

CONCLUSION

In AS patients with previous exposure to a TNFi, switching biologics to secukinumab and switching to an alternative TNFi resulted in comparable drug retention and clinical efficacy.

摘要

目的

对于先前接受 TNF 抑制剂 (TNFi) 治疗的 AS 患者,二线生物制剂的选择仍不明确。本研究比较了将生物制剂转换为司库奴单抗和转换为其他 TNFi 的 AS 患者的药物保留率和临床疗效。

方法

纳入韩国风湿病学会 BIOlogics 注册研究中的 AS 患者,并排除非放射学中轴型脊柱关节炎患者。将有先前 TNFi 暴露史的患者分为司库奴单抗组和 TNFi 转换组。在 1 年随访时评估药物保留率和临床疗效[BASDAI50、AS 国际协会评估(ASAS)20、ASAS40、AS 疾病活动评分(ASDAS)<2.1、ASDAS 临床重要改善和 ASDAS 主要改善]。进行倾向评分(PS)匹配和协变量调整的 logistic 回归分析。

结果

246 例患者有可用的 1 年随访数据。第三或更后线生物制剂使用司库奴单抗的频率高于其他 TNFi(54% vs 14%)。PS 匹配和多变量协变量调整分析显示,司库奴单抗和 TNFi 转换组停药的比值比(OR)相似[OR 1.136(95% CI 0.843,1.531)和 1.000(95% CI 0.433-2.308)]。两组患者达到 BASDAI50 的比例也相似[PS 匹配分析中 OR 0.833(95% CI 0.481,1.441)]。其他临床疗效参数也相似。在先前因无效而停止使用 TNFi 的 AS 患者亚组分析中,两组间所有临床疗效参数均相似。

结论

对于先前接受 TNFi 治疗的 AS 患者,将生物制剂转换为司库奴单抗和转换为其他 TNFi 的药物保留率和临床疗效相当。

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