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类风湿关节炎患者肿瘤坏死因子抑制剂治疗失败后生物制剂的长期疗效比较:一项前瞻性队列研究

Comparison of long-term efficacy between biological agents following tumor necrosis factor inhibitor failure in patients with rheumatoid arthritis: a prospective cohort study.

作者信息

Bogas Patricia, Plasencia-Rodriguez Chamaida, Navarro-Compán Victoria, Tornero Carolina, Novella-Navarro Marta, Nuño Laura, Martínez-Feito Ana, Hernández-Breijo Borja, Balsa Alejandro

机构信息

Department of Rheumatology, La Paz University Hospital, 28046 Madrid, Spain.

Department of Rheumatology, La Paz University Hospital, Madrid, Spain.

出版信息

Ther Adv Musculoskelet Dis. 2021 Nov 24;13:1759720X211060910. doi: 10.1177/1759720X211060910. eCollection 2021.

Abstract

BACKGROUND

Currently, there is contradictory evidence regarding the best strategy to follow after discontinuation of a first biological agent in patients with rheumatoid arthritis (RA). We aimed to compare the long-term efficacy of switching to a second tumor necrosis factor inhibitor (TNFi) biopharmaceuticals with other mechanisms of action (non-TNFi) in patients with RA who previously failed a first TNFi.

METHODS

This prospective cohort study analyzed data from 127 patients who discontinued a previous TNFi between 1999 and 2016. Disease activity was assessed at baseline and at 6, 12, and 24 months (m-6, m-12, m-24) after switching. Primary outcome was the proportion of patients achieving good/moderate EULAR response (E-resp). Factors associated with clinical outcomes were assessed using univariate and multivariate logistic regression models.

RESULTS

Seventy-seven (61%) patients received a second TNFi and 50 (39%) switched to a non-TNFi. At m-6 and m-12, no differences were observed between groups; nevertheless, at m-24, the proportion of patients with E-resp was higher in the non-TNFi group (49% TNFi group 77% non-TNFi group;  = 0.002). In regression models, switching to a non-TNFi was significantly associated with E-resp at m-24 (odds ratio = 3.21;  = 0.01). When assessing the response to the second biological agent based on the reason for discontinuation of the first TNFi, similar results were obtained; at m-24, patients who discontinued the first TNFi due to inefficacy (either primary or secondary) experienced a better E-resp if they had switched to a non-TNFi (primary inefficacy: 52% TNFi group 79% non-TNFi group,  = 0.09; secondary inefficacy: 50% 76%,  = 0.03).

CONCLUSION

In our cohort of RA patients who discontinued a first TNFi, those who switched to a non-TNFi were three times more likely to attain a sustained clinical response, regardless of whether they had discontinued the first biologic due to a primary or secondary inefficacy.

摘要

背景

目前,关于类风湿关节炎(RA)患者停用第一种生物制剂后最佳治疗策略的证据相互矛盾。我们旨在比较在先前使用第一种肿瘤坏死因子抑制剂(TNFi)治疗失败的RA患者中,换用第二种TNFi生物制剂与换用其他作用机制的生物制剂(非TNFi)的长期疗效。

方法

这项前瞻性队列研究分析了1999年至2016年间停用先前TNFi的127例患者的数据。在换药后的基线、6个月、12个月和24个月(m-6、m-12、m-24)评估疾病活动度。主要结局是达到良好/中度欧洲抗风湿病联盟反应(E-resp)的患者比例。使用单因素和多因素逻辑回归模型评估与临床结局相关的因素。

结果

77例(61%)患者接受了第二种TNFi,50例(39%)换用了非TNFi。在m-6和m-12时,两组之间未观察到差异;然而,在m-24时,非TNFi组达到E-resp的患者比例更高(TNFi组为49%,非TNFi组为77%;P = 0.002)。在回归模型中,换用非TNFi与m-24时的E-resp显著相关(比值比 = 3.21;P = 0.01)。当根据停用第一种TNFi的原因评估对第二种生物制剂的反应时,得到了类似的结果;在m-24时,因无效(原发性或继发性)而停用第一种TNFi的患者,如果换用非TNFi,其E-resp更好(原发性无效:TNFi组为52%,非TNFi组为79%,P = 0.09;继发性无效:50%对76%,P = 0.03)。

结论

在我们这个停用第一种TNFi的RA患者队列中,换用非TNFi的患者获得持续临床反应的可能性是换用TNFi患者的三倍,无论他们是因原发性还是继发性无效而停用第一种生物制剂。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/30ef/8641114/15d6419a73e3/10.1177_1759720X211060910-fig2.jpg

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