Finckh Axel, Ciurea Adrian, Brulhart Laure, Kyburz Diego, Möller Burkhard, Dehler Silvia, Revaz Sylvie, Dudler Jean, Gabay Cem
University Hospital of Geneva, Geneva, Switzerland.
Arthritis Rheum. 2007 May;56(5):1417-23. doi: 10.1002/art.22520.
Patients with rheumatoid arthritis (RA) in whom the response to anti-tumor necrosis factor (anti-TNF) therapy is inadequate have several therapeutic options, such as switching to an alternative anti-TNF agent or initiating B cell-depleting therapy with rituximab (RTX). Although both therapeutic options have been proven effective in trials, no head-to-head comparisons are available. The aim of this study was to compare the effectiveness of RTX with that of an alternative anti-TNF agent in the management of patients with RA who had an inadequate response to anti-TNF therapy.
This prospective cohort study was nested within the Swiss Clinical Quality Management RA cohort and included all patients who had an inadequate response to at least 1 anti-TNF agent and subsequently received either 1 cycle of RTX or an alternative anti-TNF agent. The primary outcome was the evolution of RA disease activity (as measured on the Disease Activity Score in 28 joints [DAS28]), which was analyzed using multivariate regression models for longitudinal data.
One hundred sixteen patients with RA were included; 50 patients received 1 cycle of RTX, and 66 patients were treated with a second or a third alternative anti-TNF agent. At baseline, there were no significant differences between the 2 groups in age, sex, disease duration, and disease activity. Evolution of the DAS28 was more favorable in the group that received RTX compared with the group that received an alternative anti-TNF agent (P = 0.01). At 6 months, the mean decrease in the DAS28 was -1.61 (95% confidence interval [95% CI] -1.97, -1.25) among patients receiving RTX and -0.98 (95% CI -1.33, -0.62) among those receiving subsequent anti-TNF therapy.
The results of this observational study suggest that treatment with RTX may be more effective than switching to an alternative anti-TNF agent in patients with RA in whom active disease persists despite anti-TNF therapy.
对抗肿瘤坏死因子（抗TNF）治疗反应不足的类风湿关节炎（RA）患者有多种治疗选择，如换用另一种抗TNF药物或开始使用利妥昔单抗（RTX）进行B细胞清除治疗。尽管这两种治疗选择在试验中均已被证明有效，但尚无直接比较。本研究的目的是比较RTX与另一种抗TNF药物在治疗对抗TNF治疗反应不足的RA患者中的有效性。
这项前瞻性队列研究嵌套于瑞士临床质量管理RA队列中，纳入了所有对至少1种抗TNF药物反应不足且随后接受1个周期RTX或另一种抗TNF药物治疗的患者。主要结局是RA疾病活动度的变化（采用28个关节疾病活动评分[DAS28]衡量），使用纵向数据的多变量回归模型进行分析。
纳入116例RA患者；50例患者接受1个周期的RTX治疗，66例患者接受第二种或第三种抗TNF药物治疗。在基线时，两组在年龄、性别、病程和疾病活动度方面无显著差异。与接受另一种抗TNF药物治疗的组相比，接受RTX治疗的组DAS28的变化更有利（P = 0.01）。在6个月时，接受RTX治疗的患者中DAS28的平均下降值为-1.61（95%置信区间[95%CI]-1.97，-1.25），接受后续抗TNF治疗的患者中为-0.98（95%CI -1.33，-0.62）。
这项观察性研究的结果表明，对于尽管接受抗TNF治疗但仍有活动性疾病的RA患者，RTX治疗可能比换用另一种抗TNF药物更有效。
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