北美地区早期和长期类风湿性关节炎患者应用依那西普10年以上的安全性和有效性

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Arthritis Care Res (Hoboken). 2010 Oct 18. [Epub ahead of print] Safety and efficacy of etanercept beyond 10 years of therapy in North American patients with early and long-standing rheumatoid arthritis. Weinblatt ME, Bathon JM, Kremer JM, Fleischmann RM, Schiff MH, Martin RW, Baumgartner SW, Park GS, Mancini EL, Genovese MC. Harvard Medical School, Brigham and Women's Hospital, Boston, MA. Abstract OBJECTIVE.: To evaluate long-term safety and efficacy of etanercept therapy in rheumatoid arthritis (RA) patients. METHODS.: Adult patients with early RA (ERA) or long-standing RA (LRA) received etanercept in open-label extension studies following initial double-blind trials of etanercept. RESULTS.: Of 558 ERA and 714 LRA patients who received at least 1 dose of etanercept, a total of 194 ERA and 217 LRA patients were treated with 25 mg etanercept twice weekly through 10 years. Five opportunistic infections were reported: in ERA, 1 Candida septicemia; in LRA, 1 herpes zoster, 1 atypical mycobacterium infection, 1 meningoencephalitis (unspecified), and 1 fungal sepsis (unspecified). Twenty-nine cases of sepsis occurred (10, ERA; 19, LRA). Occurrence of all malignancies was similar to that expected in the general population, but the occurrence of lymphomas was higher than expected in the general population. Fourteen lymphomas (7, ERA; 7, LRA) and 2 cases of demyelinating disease (1, ERA; 1, LRA) were reported. Deaths occurred in 18 ERA patients and 43 LRA patients. Both patient groups showed sustained improvement in American College of Rheumatology responses, swollen joint counts, Health Assessment Questionnaire scores, and C-reactive protein levels. CONCLUSION.: Etanercept maintained therapeutic benefits beyond 10 years of therapy in both ERA and LRA patients, suggesting that etanercept is well tolerated and effective as a long-term, continuous therapy for the treatment of RA with a favorable risk-benefit ratio.

北美地区早期和长期类风湿性关节炎患者应用依那西普10年以上的安全性和有效性   目的: 评价依那西普治疗类风湿性关节炎(RA)患者的长期安全性和有效性。方法: 早期RA(ERA)或长期(LRA)的成人患者在完成最初依那西普的双盲试验后接受依那西普治疗的开放期延长试验。结果: 558例ERA和714例LRA患者接受至少1剂量的依那西普,其中194例ERA和217例LRA患者接受25mg依那西普每周两次治疗长达10年。共报道有5次机会菌感染:ERA患者中，1例念珠菌败血症；LRA患者中：1例带状疱疹、1例非典型分枝杆菌感染,1例脑膜脑炎（未分类）,和1例真菌败血症(未分类)。29例患者发生败血症 (10例ERA，19例LRA)。总的恶性肿瘤的发生率与一般人群相似,但淋巴瘤的发生高于预期。14例淋巴瘤(7例ERA;7例LRA)和2例中枢系统脱髓鞘病变(1例ERA;1例LRA)被报道。死亡病例中18例为ERA，43例LRA。两组患者的美国风湿病协会疗效、肿胀关节计数,健康评估问卷积分,和C反应蛋白水平都有持续的改善。结论:依那西普对ERA和LRA患者都能维持10年以上的治疗效果，提示依那西普长期持续应用治疗RA有良好的耐受性和疗效,具有较好的风险效益比。