PURPOSE To determine the incidence and prevalence of uveitis and its effect on multiple sclerosis (MS) disease activity and outcomes in patients with MS who participated in the fingolimod clinical trial program. DESIGN Analysis of pooled data (N = 27 528) from patients enrolled in fingolimod clinical studies and their extensions. Patients were stratified into 4 cohorts based on the history of uveitis at baseline and uveitis events during the observation period: no history and no uveitis events ("no uveitis"); history and no uveitis events ("history"); no history and uveitis events ("first event"); history and uveitis events ("recurrent event"). PARTICIPANTS Adult patients diagnosed with relapsing or primary progressive MS. INTERVENTION Patients received fingolimod (0.5, 1.25, or 5 mg/day), placebo, or intramuscular interferon beta-1a (IFNβ-1a IM) during the core studies; patients receiving placebo or IFNβ-1a IM were switched to fingolimod 0.5 mg therapy for study extensions. MAIN OUTCOME MEASURES Incidence and prevalence of uveitis, and MS outcome measures, including annualized relapse rate (ARR), time to first relapse, change in Expanded Disability Status Scale (EDSS) score from baseline, and proportion of patients with 6-month confirmed disability progression. RESULTS A total of 189 patients in the analysis population had uveitis. Of these, 162 patients had a history of uveitis (prevalence, 0.59%). Uveitis occurred as a first event in 27 patients (incidence, 0.1 per 100 patient-years) and as a recurrent event in 10 of 162 patients (prevalence, 6.17%). Patients with uveitis had a significantly shorter time to first relapse (mean, 2.11 vs. 8.12 years; P = 0.047) and a significantly higher ARR (0.31 vs. 0.21; P = 0.025) than those without uveitis. Mean increase in EDSS score at month 120 and the proportions of patients with 6-month confirmed disability progression, and with EDSS score ≥4 during follow-up, were similar in patients with uveitis compared with those without uveitis. CONCLUSIONS This pooled analysis involving a large patient cohort showed that patients with MS and uveitis had increased MS relapse activity compared with those without uveitis.

中文翻译：

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芬戈莫德临床试验中的多发性硬化症患者的葡萄膜炎：发病率，患病率及其对病程的影响。

目的确定参与芬戈莫德临床试验计划的MS患者葡萄膜炎的发病率和患病率及其对多发性硬化症（MS）疾病活动和预后的影响。设计分析芬戈莫德临床研究及其扩展患者的汇总数据（N = 27528）。根据基线时的葡萄膜炎病史和观察期内的葡萄膜炎事件将患者分为4组：无病史和无葡萄膜炎事件（“无葡萄膜炎”）；无病史和无葡萄膜炎事件（“无葡萄膜炎”）。病史，无葡萄膜炎事件（“病史”）；没有病史和葡萄膜炎事件（“第一事件”）；病史和葡萄膜炎事件（“复发事件”）。参与者被诊断患有复发性或原发性进行性MS的成年患者。干预措施：患者接受芬戈莫德（0.5、1.25或5 mg /天），安慰剂，核心研究期间使用肌内干扰素beta-1a（IFNβ-1aIM）；接受安慰剂或IFNβ-1aIM的患者改用芬戈莫德0.5 mg治疗以扩大研究范围。主要观察指标葡萄膜炎的发生率和患病率，以及MS的结果指标，包括年复发率（ARR），至首次复发的时间，从基线开始的扩展残疾状况量表（EDSS）得分的变化以及6个月确诊残疾的患者比例进展。结果分析人群中总共有189例患者患有葡萄膜炎。在这些患者中，有162例有葡萄膜炎病史（患病率为0.59％）。葡萄膜炎首先发生在27例患者中（发病率，每100名患者-年0.1例），而复发性事件在162例患者中的10例中发生（患病率，6.17％）。葡萄膜炎患者的首次复发时间明显缩短（平均值为2.11 vs. 8.12年；P = 0.047）和显着高于无葡萄膜炎的ARR（0.31比0.21； P = 0.025）。葡萄膜炎患者与没有葡萄膜炎的患者相比，在120个月时EDSS评分的平均增加以及在6个月内确认为残疾发展的患者以及EDSS评分≥4的患者比例相似。结论这项涉及大量患者队列的汇总分析表明，与无葡萄膜炎的患者相比，患有MS和葡萄膜炎的患者的MS复发活动增加。与没有葡萄膜炎的患者相比，葡萄膜炎的患者相似。结论这项涉及大量患者队列的汇总分析表明，与无葡萄膜炎的患者相比，患有MS和葡萄膜炎的患者的MS复发活动增加。与没有葡萄膜炎的患者相比，葡萄膜炎的患者相似。结论这项涉及大量患者队列的汇总分析表明，与无葡萄膜炎的患者相比，患有MS和葡萄膜炎的患者的MS复发活动增加。