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在观察性队列中,在先前使用一种 TNF 抑制剂治疗失败的患者中,比较利妥昔单抗与抗 TNF。

Rituximab versus anti-TNF in patients who previously failed one TNF inhibitor in an observational cohort.

机构信息

Unit for Clinical Research Therapy, Inflammatory Diseases-ClinTRID, Karolinska Institute, Stockholm, Sweden.

出版信息

Scand J Rheumatol. 2013;42(3):190-5. doi: 10.3109/03009742.2012.729607. Epub 2013 Jan 3.

Abstract

OBJECTIVE

The purpose of this study was to characterize and compare responses in patients who had failed one tumour necrosis factor (TNF) inhibitor when switching to another TNF inhibitor or rituximab (RTX).

METHODS

The Stockholm TNF follow-up registry (STURE) was used. Treatment results at 6 months were analysed by (i) the biologic used, (ii) the type of anti-TNF switch, and (iii) the reason for discontinuation (inefficacy or intolerance).

RESULTS

A total of 328 patients who failed an anti-TNF switched to an alternative biologic, 69 to RTX, 161 to an anti-TNF monoclonal antibody (mAb), and 98 to etanercept (ETA). Significant reductions in the 28-joint Disease Activity Score (DAS28) at 6 months were observed for all groups. The mean ± SD reduction in DAS28 was 1.70 ± 1.18 for RTX, 1.40 ± 1.51 for ETA, and 0.67 ± 1.36 for mAb, the difference being statistically significant between RTX and mAb (p < 0.0001). For patients who had failed ETA, RTX led to significantly greater DAS28 reductions than mAb (p = 0.01). When the reason for discontinuation of the previous anti-TNF was intolerance or secondary inefficacy, RTX led to significantly greater DAS28 reduction compared to mAb and ETA (p = 0.01 and p = 0.03, respectively).

CONCLUSIONS

In this observational cohort, patients who failed one anti-TNF had better overall results when treated with RTX than with a subsequent anti-TNF mAb. Having failed ETA, RTX yielded greater DAS28 reductions and European League Against Rheumatism (EULAR) responses than mAb. The advantage of RTX was most clearly seen in patients who had failed anti-TNF because of intolerance or secondary inefficacy.

摘要

目的

本研究旨在描述和比较在使用一种肿瘤坏死因子(TNF)抑制剂治疗失败后转换为另一种 TNF 抑制剂或利妥昔单抗(RTX)的患者的反应。

方法

使用斯德哥尔摩 TNF 随访登记处(STURE)。通过以下方式分析 6 个月时的治疗结果:(i)使用的生物制剂,(ii)抗 TNF 转换的类型,和(iii)停药原因(无效或不耐受)。

结果

共有 328 名使用抗 TNF 治疗失败的患者转为使用另一种生物制剂,69 名患者转为 RTX,161 名患者转为抗 TNF 单克隆抗体(mAb),98 名患者转为依那西普(ETA)。所有组在 6 个月时 28 关节疾病活动度评分(DAS28)均显著降低。RTX 的 DAS28 平均降幅为 1.70 ± 1.18,ETA 为 1.40 ± 1.51,mAb 为 0.67 ± 1.36,RTX 与 mAb 之间的差异具有统计学意义(p < 0.0001)。对于使用 ETA 治疗失败的患者,RTX 导致的 DAS28 降低幅度明显大于 mAb(p = 0.01)。当停用先前抗 TNF 的原因是不耐受或继发疗效不佳时,RTX 导致的 DAS28 降低幅度明显大于 mAb 和 ETA(p = 0.01 和 p = 0.03)。

结论

在这项观察性队列研究中,与使用后续抗 TNF mAb 相比,在使用 RTX 治疗失败的一种抗 TNF 的患者总体结果更好。对于因不耐受或继发疗效不佳而使用 ETA 治疗失败的患者,RTX 导致的 DAS28 降低幅度和欧洲抗风湿病联盟(EULAR)反应大于 mAb。RTX 的优势在因不耐受或继发疗效不佳而使用抗 TNF 治疗失败的患者中最为明显。

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