Department of Rheumatology, Ghent University Hospital, De Pintelaan 185, 9000 Ghent, Belgium.
Arthritis Res Ther. 2010;12(5):R169. doi: 10.1186/ar3129. Epub 2010 Sep 10.
This study describes the results of the Belgian 'MabThera In Rheumatoid Arthritis (MIRA)' registry: effectiveness, safety and evaluation of the current retreatment practice on the background of the Belgian reimbursement criteria for rituximab.
All Belgian rheumatologists had the possibility to participate in the study. Patients entered the registry in November 2006 and the entry is still open.
By mid-September 2009, 401 patients had entered the registry with a mean follow-up time of 70 weeks. Overall, DAS28-ESR decreased from 6.0 at baseline to 4.2 at week 16. Further decrease of disease activity was observed at the end of year 1 and year 2 with mean DAS28-ESR of 4.0 and 3.7 at these respective time points. More than 80% of patients showed a EULAR response at week 16. Patients could be retreated if they had DAS scores of > 3.2 at least 6 months after the previous course. Second and third courses were given in 224 and 104 patients, respectively. At month 6 after the second course, significantly lower DAS28-ESR values were observed compared to the first course. This was especially the case for patients who were retreated before they showed an obvious flare (DAS increase > 1.2).
This study describes the follow-up of a daily clinical practice cohort of 401 RA patients with long-standing refractory disease treated with rituximab. Relatively high DAS28 values at the start of each retreatment, compared to values 6 months after each treatment course, were noted. Moreover, further decrease of DAS28 scores after the second course was significantly more pronounced in those patients who didn't show an obvious flare. These two elements suggest that treatment of RA patients with rituximab could be optimized by earlier retreatment.
本研究描述了比利时“MabThera 在类风湿关节炎（MIRA）”登记处的结果：在比荷卢经济联盟（Belgian）利妥昔单抗报销标准的背景下，评估当前的再治疗实践的有效性、安全性。
所有比利时风湿病学家都有机会参与这项研究。患者于 2006 年 11 月进入登记处，登记仍在进行中。
截至 2009 年 9 月中旬，已有 401 名患者进入登记处，平均随访时间为 70 周。总体而言，DAS28-ESR 从基线时的 6.0 下降到第 16 周的 4.2。在第 1 年和第 2 年末，疾病活动进一步下降，分别在这些时间点的平均 DAS28-ESR 为 4.0 和 3.7。超过 80%的患者在第 16 周时达到 EULAR 缓解。如果患者在之前的疗程至少 6 个月后 DAS 评分>3.2，则可进行再治疗。分别有 224 名和 104 名患者接受了第二和第三次疗程。在第二次疗程后的第 6 个月，与第一次疗程相比，DAS28-ESR 值明显更低。对于在出现明显复发（DAS 增加>1.2）之前进行再治疗的患者，尤其如此。
本研究描述了利妥昔单抗治疗的长期难治性类风湿关节炎患者的日常临床实践队列的随访。与每次治疗疗程后 6 个月相比，每次再治疗开始时的 DAS28 值相对较高。此外，在第二次疗程后，在没有明显复发的患者中，DAS28 评分的进一步下降明显更为显著。这两个因素表明，通过更早地进行再治疗，可以优化利妥昔单抗治疗类风湿关节炎患者的治疗。
