TY - T1的横断面研究评估长期安全interferon-β-1b复发缓和摩根富林明女士——神经学乔-神经病学SP - 1877 LP - 1885 - 10.1212 / WNL。首页0 b013e3181e240d0六世- 74 - 23盟A.T.红盟G.C.埃伯斯盟——a . Traboulsee AU - d·李盟- d·兰登盟-科学博士Goodin AU - t . Bogumil AU - k·贝克曼非盟- a . Konieczny A2 - Y1 - 2010/06/08 UR - //www.ez-admanager.com/content/74/23/1877.abstract N2 -目的首页:16年的长期随访(LTF)关键interferon-β-1b (IFNβ-1b)试验探索临床、核磁共振、认知、和patient-reported结果。在这里,我们报告的安全评估。方法:在关键的研究中,372名患者被随机的安慰剂(n = 123), IFNβ-1b 50μg (n = 125),或250 IFNβ-1bμg (n = 124)皮下注射每隔一天长达5年。十六年后,病人被要求参与这个横断面随访研究。没有规定在随访中特定的治疗。记录不良事件以来最关键的审判。中和抗体(小伙子)IFNβ-1b测量使用myxovirus蛋白诱导试验。统计分析是描述性的。结果:总体而言,88.2%的患者(328/372)被确定。 Some centers achieved 100% ascertainment, obviating selection bias. Treatment-related adverse events (e.g., leukopenia and liver and thyroid dysfunction) reported by LTF participants were in keeping with those previously established. Based on a follow-up period that includes 2,000 patient-years of IFNβ-1b treatment, no new adverse events were observed that were associated with long-term IFNβ-1b exposure. By LTF, NAbs to IFNβ-1b disappeared in the majority (76%) of NAb-positive patients. NAb status during the pivotal study appeared to have no impact on long-term clinical and MRI outcomes. There were more deaths among patients assigned to placebo in the pivotal study (20/109 [18.3%]) compared with patients who received IFNβ-1b 50 μg (9/108 [8.3%]) or IFNβ-1b 250 μg (6/111 [5.4%]). Conclusion: The results from the 16-Year Long-Term Follow-Up study support the long-term safety of interferon-β-1b therapy in multiple sclerosis. Classification of evidence: This study provides Class III evidence that patients with relapsing-remitting MS taking IFNβ-1b 50 μg or 250 μg subcutaneously every other day for up to 5 years, with subsequent unspecified treatment, have fewer deaths after 16 years of follow-up than similar patients on placebo for up to 5 years, with subsequent unspecified treatment (risk difference 11.5%, 95% confidence interval 4–19). AE=adverse event; BOD=burden of disease; CI=confidence interval; EDSS=Expanded Disability Status Scale; EQ-5D=European Quality of Life–5-Dimensional questionnaire; IFN=interferon; LTF=Long-Term Follow-Up; MS=multiple sclerosis; MSFC=Multiple Sclerosis Functional Composite; MSSS=Multiple Sclerosis Severity Score; NAbs=neutralizing antibodies; RRMS=relapsing-remitting multiple sclerosis; SPMS=secondary progressive multiple sclerosis. ER -