Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: findings from an open-label treatment extension
Long-term efficacy and safety of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis: findings from an open-label treatment extension
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DOI：
10.1136/ard.2009.100354
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发表时间：
2010-04-01
影响因子：
27.4
通讯作者：
Giannini, Edward H.
中科院分区：
文献类型：
--
作者：
Ruperto, Nicolino;Lovell, Daniel J.;Giannini, Edward H.
目的评价英夫利西单抗联合甲氨蝶呤治疗幼年类风湿关节炎（JRA）的长期疗效和安全性。（OLE，第52-204周）接受英夫利昔单抗3-6 mg/kg，每8周加甲氨蝶呤。最常见的原因是撤回知情同意（11例患者）、缺乏疗效（8例患者）或患者/医生/申办者要求（8例患者）。英夫利西单抗（平均剂量4.4 mg/kg/输注）通常耐受良好。32%（25/78）的患者发生输注反应，英夫利西单抗抗体阳性患者的发生率更高（58%，15/26）。在第204周，达到ACR-Pedi-30/50/70/90反应标准和非活动性疾病状态的患者比例分别为44%，40%，33%，24%和13%，respectively.Conclusions在有限的人群中，JRA患者在4年的研究中，英夫利西单抗是安全有效的，但与高患者停药率。
Objective To assess the long-term efficacy and safety of infliximab plus methotrexate in juvenile rheumatoid arthritis (JRA).Methods Patients eligible for the open-label extension (OLE, weeks 52-204) received infliximab 3-6 mg/kg every 8 weeks plus methotrexate.Results Of the 78/122 (64%) children entering the OLE, 42 discontinued infliximab, most commonly due to consent withdrawal (11 patients), lack of efficacy (eight patients) or patient/physician/sponsor requirement (eight patients). Infliximab (mean dose 4.4 mg/kg per infusion) was generally well tolerated. Infusion reactions occurred in 32% (25/78) of patients, with a higher incidence in patients positive for antibodies to infliximab (58%, 15/26). At week 204, the proportions of patients achieving ACR-Pedi-30/50/70/90 response criteria and inactive disease status were 44%, 40%, 33%, 24% and 13%, respectively.Conclusions In the limited population of JRA patients remaining in the study at 4 years, infliximab was safe and effective but associated with a high patient discontinuation rate.