类风湿关节炎患者接受利妥昔单抗治疗后生物疗法的安全性。
Safety of biological therapies following rituximab treatment in rheumatoid arthritis patients.
作者信息
Genovese M C, Breedveld F C, Emery P, Cohen S, Keystone E, Matteson E L, Baptiste Y, Chai A, Burke L, Reiss W, Sweetser M, Shaw T M
机构信息
Stanford University School of Medicine, Palo Alto, California, USA.
出版信息
Ann Rheum Dis. 2009 Dec;68(12):1894-7. doi: 10.1136/ard.2008.101675. Epub 2009 Jan 20.
OBJECTIVE
To assess the safety of biological disease-modifying antirheumatic drugs (DMARD) in rheumatoid arthritis (RA) patients following rituximab.
METHODS
RA patients who participated in an international rituximab clinical trial programme were included. Patients who had received one or more rituximab courses and entered safety follow-up (SFU) were permitted additional biological DMARD. Serious infection events (SIE) were collected.
RESULTS
Of 185 of 2578 patients who entered SFU and received another biological DMARD, 88.6% had peripheral B-cell depletion at the time of initiation of another biological agent. Thirteen SIE (6.99 events/100 patient-years) occurred following rituximab but before another biological DMARD and 10 SIE (5.49 events/100 patient-years) occurred following another biological DMARD. SIE were of typical type and severity for RA patients. 153 had received one or more tumour necrosis factor inhibitor(s). No fatal or opportunistic infections occurred.
CONCLUSIONS
In this analysis, treatment with biological DMARD after rituximab was not associated with an increased serious infection rate. Sample size with limited follow-up restricts definitive conclusions.
目的
评估类风湿关节炎（RA）患者在接受利妥昔单抗治疗后使用生物改善病情抗风湿药（DMARD）的安全性。
方法
纳入参与一项国际利妥昔单抗临床试验项目的RA患者。已接受一个或多个利妥昔单抗疗程并进入安全性随访（SFU）的患者可加用生物DMARD。收集严重感染事件（SIE）。
结果
在2578例进入SFU并接受另一种生物DMARD的患者中，185例（88.6%）在开始使用另一种生物制剂时外周血B细胞耗竭。13例SIE（6.99例/100患者年）发生在利妥昔单抗治疗后但在使用另一种生物DMARD之前，10例SIE（5.49例/100患者年）发生在使用另一种生物DMARD之后。SIE的类型和严重程度在RA患者中较为典型。153例患者接受过一种或多种肿瘤坏死因子抑制剂治疗。未发生致命或机会性感染。
结论
在本分析中，利妥昔单抗治疗后使用生物DMARD与严重感染率增加无关。样本量和随访时间有限限制了得出确定性结论。
Zotero 插件