Kremer Joel M, Weinblatt Michael E, Bankhurst Arthur D, Bulpitt Ken J, Fleischmann Roy M, Jackson Christopher G, Atkins Kelly M, Feng Anyang, Burge Daniel J
The Center for Rheumatology, Albany, New York 12206, USA.
Arthritis Rheum. 2003 Jun;48(6):1493-9. doi: 10.1002/art.11142.
To observe the long-term safety and efficacy of combination therapy with etanercept and methotrexate in patients with rheumatoid arthritis (RA), and to determine whether the addition of etanercept allowed reductions in methotrexate or corticosteroid dosages while maintaining a clinical response.
Patients with RA who received methotrexate plus etanercept in a previous randomized, placebo-controlled trial were offered the opportunity to enroll in an open-label extension study for further evaluation of treatment with etanercept and methotrexate.
Seventy-nine of the 89 patients in the original blinded study enrolled in the extension study, and 65 of these patients continue in the study. Patients have received etanercept therapy for up to 47 months (median 44 months). The types and rate of adverse events noted during the extension trial were similar to those observed in the controlled trial. At the 3-year assessment, 77% of the 57 patients available for evaluation met American College of Rheumatology 20% (ACR20) criteria for improvement in RA, 47% met the ACR50 criteria, and 23% met the ACR70 criteria. Of the 36 patients assessed at 3 years in the extension study, 30 (83%) were able to decrease their dosages of corticosteroids, and 20 (56%) were able to discontinue corticosteroid therapy. At 3 years, the dosage of methotrexate was decreased in 41 of 66 patients (62%), and methotrexate therapy was discontinued in 19 patients (29%).
In this observational continuation study, the addition of etanercept to background methotrexate provided sustained clinical benefit over a median period of 44 months. With etanercept therapy, there were trends toward dosage reduction or discontinuation of methotrexate and corticosteroids, without apparent worsening of ACR response rates. Compared with the controlled trial, no increases in the rate of adverse events were observed.
观察依那西普与甲氨蝶呤联合治疗类风湿关节炎（RA）患者的长期安全性和疗效，并确定添加依那西普是否能在维持临床反应的同时减少甲氨蝶呤或皮质类固醇的剂量。
在先前一项随机、安慰剂对照试验中接受甲氨蝶呤加依那西普治疗的RA患者有机会参加一项开放标签的延长期研究，以进一步评估依那西普和甲氨蝶呤的治疗效果。
原盲法研究中的89例患者中有79例参加了延长期研究，其中65例继续参与该研究。患者接受依那西普治疗长达47个月（中位时间44个月）。延长期试验中观察到的不良事件类型和发生率与对照试验中观察到的相似。在3年评估时，57例可评估患者中有77%达到美国风湿病学会（ACR）类风湿关节炎改善20%（ACR20）标准，47%达到ACR50标准，23%达到ACR70标准。在延长期研究中3年评估的36例患者中，30例（83%）能够减少皮质类固醇剂量，20例（56%）能够停用皮质类固醇治疗。3年时66例患者中有41例（62%）甲氨蝶呤剂量减少，19例（29%）停用甲氨蝶呤治疗。
在这项观察性延续研究中，在甲氨蝶呤基础上加用依那西普在中位44个月的时间里提供了持续的临床益处。使用依那西普治疗时，有减少甲氨蝶呤和皮质类固醇剂量或停药的趋势，且ACR反应率无明显恶化。与对照试验相比，未观察到不良事件发生率增加。
