摘要

背景：大多数RA患者使用RTX治疗一疗程后，需要6-12月的再次治疗。但一些患者出现更长时间对药物的反应而无需再次治疗。队列研究可以提供此类患者的信息。

目的：描述具有长效应答RA患者的特征，即进行第一年RTX治疗后无需进行再次治疗的患者，汇总来自10个欧洲注册中心的数据。

方法：来源于10个欧洲注册中心匿名的于基线，3，6，9，12个月的使用RTX的患者的数据。这些数据经国汇总和分析。如果患者超过12个月未接受再次治疗，仍“未治疗”（即未开始其他治疗）并有12个月数据可供使用即被定义为“长效应答者”。长效应答者与在12月内接受RTX再次治疗的患者基线特征通过适当的数据测试相比较。药效的预测使用Logistic回归分析测算。

结果：在194名“长效应答者”中DAS28评分6个月时从基线时的6.0±1.3为4.2±1.3，12个月时为4.5±1.5。HAQ6个月时从1.7±0.6的基线水平降至1.2±0.6，12个月时降至1.3±0.8。6个月时，24%的患者达到EULAR“良好反应”的标准，44%达到“中度反应”。12个月时反应率分别为18%和32%。与需要接受再次治疗的患者相比，“长效应答者”年龄较大（53.2±12.9 vs. 50.0±12.7; p<0 .0001），应用的dmards药物数量较少（2.7±1.6 vs. 2.9 ± 1.6; p="0.03），基线时DAS28评分较低（(6.0±1.2" vs. 6.4±1.1; p<0.0001），且rf阳性率较高（85.8% vs. 79.7%; p="0.01)）。

结论：本研究表明年龄较大、以前用DMARDS少、治疗前DAS28评分低及RF阳性均可增加RTX一个疗程后1年内无需再次治疗并保持长期稳定的可能性。对这些患者的进一步随访将有助于明确接受一个RTX疗程即可获得长期疗效患者的特征。

附原文：Background: Most RA patients treated with Rituximab (RTX) require retreatment between 6 to 12 months after the first treatment course. In some patients longer responses not requiring retreatment are seen. Cohort studies may provide information on such patients.Objectives: To characterize RA patients with longer-term response, ie not requiring retreatment with RTX in the first year of treatment, in pooled data from 10 European registries.Methods: Ten European registries submitted anonymized baseline, 3, 6, 9 and 12 month data of patients who had started RTX. These data were pooled and analysed. Patients were defined as 'longer-term responders' if they had not received retreatment for 12 months, remained 'on treatment' (ie, no other treatment was initiated) and for whom 12-month data were available. Baseline characteristics were compared by appropriate statistical tests between these 'longer-term responders' and patients who received RTX retreatment during the first 12 months. Predictors of response were investigated by logistic regression analysis.Results: DAS28 in 194 'longer-term responders' decreased from 6.0±1.3 at baseline to 4.2±1.3 at 6 months and 4.5±1.5 at 12 months. HAQ decreased from 1.7±0.6 at baseline to 1.2±0.6 at 6 months and to 1.3±0.8 at 12 months. At 6 months, 24% had achieved EULAR Good Response and 44% EULAR Moderate Response. At 12 months the corresponding percentages were 18% and 32%, respectively.The 'longer-term responders' were older (53.2±12.9 vs. 50.0±12.7; p<0 .0001), had a lower number of previous dmards (2.7±1.6 vs. 2.9 ± 1.6; p="0.03)," lower das28 at baseline (6.0±1.2 vs. 6.4±1.1; p<0.0001) and a higher proportion of rf-positivity (85.8% vs. 79.7%; p="0.01)" compared to patients who were re-treated. conclusion: this study shows that older age, fewer prior dmards, lower baseline das28, and rf-positivity increase the likelihood of achieving a sustained clinical response without need for retreatment in the first year following the first treatment course of rtx. further follow-up of these patients will allow us to identify characteristics of those with even more prolonged responses following a single course of rtx.

引自：R.F. van Vollenhoven, K. Chatzidionysiou, E. Nasonov, et al. CHARACTERISATION OF RA PATIENTS NOT REQUIRING RETREATMENT WITH RITUXIMAB WITHIN 12 MONTHS AFTER THE FIRST COURSE - A CERERRA STUDY. Ann Rheum Dis 2010;69(Suppl3):380