Moreland L W, Cohen S B, Baumgartner S W, Tindall E A, Bulpitt K, Martin R, Weinblatt M, Taborn J, Weaver A, Burge D J, Schiff M H
Arthritis Clinical Intervention Program, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, 1717-6th Avenue South, Room 068, Birmingham, AL 35294-7201, USA.
J Rheumatol. 2001 Jun;28(6):1238-44.
Patients with rheumatoid arthritis (RA) treated with etanercept (Enbrel) in controlled studies of 3 to 6 months' duration had rapid and sustained improvement of their disease, with minimal safety issues. In this study, we examine safety and clinical benefit after longer term treatment with etanercept.
All adult patients with RA with a previously inadequate response to one or more disease modifying antirheumatic drugs, and who received at least one dose of etanercept as monotherapy in controlled or open label clinical trials were evaluated for safety and clinical benefit. Adverse event rates were compared as was evidence of continued benefit over time.
Etanercept continued to be safe and well tolerated in 628 adult patients treated for a median of 25 mo (maximum 43 mo; 1109 patient-years). Nine percent of patients withdrew due to lack of efficacy and 7% due to adverse events. Most adverse events were mild, and no statistically significant increases in frequency of events were seen when patients received etanercept over longer periods of time. Clinical benefit was maintained with longterm therapy. A 100% improvement in individual disease activity measures was achieved by 17% to 28% of the patients. Fifty-five percent of patients who were taking corticosteroids (mean dose at baseline 6.6 mg/day) decreased or discontinued corticosteroid therapy while maintaining control of their arthritis symptoms.
Etanercept continued to be safe and well tolerated, and its clinical benefit was sustained for a median of 25 mo and for as long as 43 mo in patients with RA.
在为期3至6个月的对照研究中，接受依那西普（恩利）治疗的类风湿关节炎（RA）患者病情迅速且持续改善，安全性问题极少。在本研究中，我们考察依那西普长期治疗后的安全性和临床获益情况。
对所有之前使用一种或多种改善病情抗风湿药物疗效不佳、且在对照或开放标签临床试验中接受至少一剂依那西普单药治疗的成年RA患者进行安全性和临床获益评估。比较不良事件发生率以及随时间推移持续获益的证据。
628例成年患者接受依那西普治疗，中位治疗时间为25个月（最长43个月；1109患者年），依那西普继续显示出安全性良好且耐受性佳。9%的患者因疗效不佳退出，7%因不良事件退出。多数不良事件为轻度，患者长期接受依那西普治疗时，事件发生频率未见统计学显著增加。长期治疗可维持临床获益。17%至28%的患者在个体疾病活动指标上实现了100%的改善。正在服用皮质类固醇的患者（基线平均剂量6.6毫克/天）中有55%减少或停用了皮质类固醇治疗，同时维持对关节炎症状的控制。
依那西普继续显示出安全性良好且耐受性佳，在RA患者中其临床获益持续中位时间达25个月，最长达43个月。
