Scrivo R, Conti F, Spinelli F R, Truglia S, Magrini L, Di Franco M, Ceccarelli F, Valesini G
Dipartimento di Clinica e Terapia Medica, Sezione di Reumatologia, Sapienza Università di Roma, Policlinico Umberto I, 00161 Roma, Italia.
Reumatismo. 2009 Apr-Jun;61(2):107-17. doi: 10.4081/reumatismo.2009.107.
To evaluate the clinical response after switching to another TNFalpha antagonist in patients with rheumatoid arthritis (RA) and provide a review of the literature on this topic.
In this ongoing, longitudinal, observational study we have prospectively collected data of patients starting biological treatments since 2000. The present analysis is restricted to RA patients who switched to another anti-TNFalpha due to lack of efficacy (LaE), loss of efficacy (LoE), or adverse events (AEs) by the end of December 2007. Disease activity score (ESR-based DAS28) was calculated and the clinical response (none, moderate, good) was evaluated according to the European League Against Rheumatism (EULAR) criteria. Clinical remission (DAS28 <2.6) and low disease activity (DAS28 </=3.2) were also evaluated.
A total of 692 anti-TNFalpha-naïve patients has been registered, of whom 395 with a diagnosis of RA. Thirtyseven RA patients switched to another TNFalpha antagonist. Three months after switching, the proportion of patients with remission, low disease activity, good and moderate/good EULAR responses grew from 0%, 2.7%, 0%, and 5.4% (baseline before switching) to 16.2%, 35.1%, 27%, and 62.2% (p<0.05, p<0.001, p<0.001, p<0.000001, respectively). Of the patients who switched because of LaE, LoE, and AEs a moderate/good EULAR response was achieved in 38.4%, 66.6%, and 88.8% of patients, respectively. Mean treatment duration with the second anti-TNFalpha was significantly longer in patients switching for LoE and AEs than in those switching for LaE (p<0.05).
The findings of this study suggest that RA patients may be successfully treated with another TNFalpha antagonist, especially those withdrawing for LoE or AEs.
评估类风湿关节炎（RA）患者换用另一种肿瘤坏死因子α（TNFα）拮抗剂后的临床反应，并对该主题的文献进行综述。
在这项正在进行的纵向观察性研究中，我们前瞻性收集了自2000年以来开始生物治疗的患者的数据。目前的分析仅限于截至2007年12月底因疗效不佳（LaE）、疗效丧失（LoE）或不良事件（AE）而换用另一种抗TNFα药物的RA患者。计算疾病活动评分（基于血沉的DAS28），并根据欧洲抗风湿病联盟（EULAR）标准评估临床反应（无、中度、良好）。还评估了临床缓解（DAS28<2.6）和低疾病活动度（DAS28≤3.2）。
共登记了692例初治抗TNFα患者，其中395例诊断为RA。37例RA患者换用了另一种TNFα拮抗剂。换药后3个月，缓解、低疾病活动度、良好和中度/良好EULAR反应的患者比例从0%、2.7%、0%和5.4%（换药前基线）分别增至16.2%、35.1%、27%和62.2%（p<0.05、p<0.001、p<0.001、p<0.000001）。因LaE、LoE和AE换药的患者中，分别有38.4%、66.6%和88.8%实现了中度/良好的EULAR反应。因LoE和AE换药的患者使用第二种抗TNFα的平均治疗持续时间显著长于因LaE换药的患者（p<0.05）。
本研究结果表明，RA患者换用另一种TNFα拮抗剂可能得到成功治疗，尤其是那些因LoE或AE而停药的患者。
