University of Colorado School of Medicine, 5400 South Monaco Street, Greenwood Village, CO 80111, USA.
Clin Rheumatol. 2010 Jun;29(6):583-91. doi: 10.1007/s10067-009-1363-0. Epub 2010 Jan 23.
This article reviews the efficacy, safety, and tolerability of abatacept plus methotrexate in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate who are naïve to biologic disease-modifying antirheumatic drugs (DMARDs). Data from the randomized, double-blind, placebo-controlled Abatacept in Inadequate Responders to Methotrexate, Abatacept or Infliximab vs Placebo, a Trial for Tolerability, Efficacy, and Safety in Treating Rheumatoid Arthritis, and phase IIb dose-finding trials and their long-term extensions are reviewed. Abatacept plus methotrexate significantly improved clinical responses, physical function, and health-related quality of life compared with methotrexate alone. More patients receiving abatacept plus methotrexate than methotrexate monotherapy achieved a low disease activity state or remission. Radiographic progression of the disease was significantly slowed in the abatacept plus methotrexate arms. Abatacept plus methotrexate was generally well tolerated with no clinically significant safety issues identified. The beneficial effects of abatacept plus methotrexate were sustained long term in extension studies, and no new tolerability or safety issues were evident. Abatacept in combination with methotrexate is an effective, safe, and well-tolerated long-term therapy in biologic-naïve patients with active RA and an inadequate response to methotrexate. Abatacept could be considered as a first-line biologic DMARD in the treatment of RA.
这篇文章回顾了阿巴西普联合甲氨蝶呤在生物 DMARD 治疗初治、对甲氨蝶呤应答不足的活动性类风湿关节炎（RA）患者中的疗效、安全性和耐受性。来自随机、双盲、安慰剂对照的 Abatacept 在对甲氨蝶呤、阿巴西普或英夫利昔单抗应答不足的患者中的疗效、安全性和耐受性试验，以及 IIb 期剂量发现试验及其长期扩展的数据进行了回顾。与甲氨蝶呤单药治疗相比，阿巴西普联合甲氨蝶呤显著改善了临床应答、身体功能和健康相关生活质量。与甲氨蝶呤单药治疗相比，更多接受阿巴西普联合甲氨蝶呤治疗的患者达到了低疾病活动状态或缓解。疾病的放射学进展在阿巴西普联合甲氨蝶呤组显著减缓。阿巴西普联合甲氨蝶呤通常具有良好的耐受性，未发现有临床意义的安全性问题。在扩展研究中，阿巴西普联合甲氨蝶呤的有益效果持续长期存在，并且没有出现新的耐受性或安全性问题。在对甲氨蝶呤应答不足的生物 DMARD 初治、活动性 RA 患者中，阿巴西普联合甲氨蝶呤是一种有效、安全且耐受良好的长期治疗方法。阿巴西普可被考虑作为 RA 治疗的一线生物 DMARD。
