Lapadula G, Ferraccioli G, Ferri C, Punzi L, Trotta F
Rheumatology Unit, Dept. Internal and Public Medicina (DiMIMP), Università degli Studi Aldo Moro - 70124 Bari, c/o Az. Universitario-Ospedaliera Policlinico, P.za Giulio Cesare, 11 - 70124 Bari.
Reumatismo. 2011 Nov 9;63(3):155-64. doi: 10.4081/reumatismo.2011.155.
The GISEA registry is an independent database that was established by the Italian Group for the Study of Early Arthritis (GISEA) in 2008, funded by the Italian Association of Rheumatic Patients (ANMAR - ONLUS). In line with the network's epidemiological strategy, the initial protocol was designed to collect long-term follow-up data concerning patients with rheumatic diseases treated with biological agents in order to investigate the realworld characteristics in terms of disease activity, comorbidities and survival on treatment. We here describe the design and methodology used to collect patient data. Information concerning demographics, disease activity, treatment changes (including the reasons for changing and the duration of each therapy), concomitant therapies and adverse events is available to all the members of the study groups by means of a web-based interface that allows queries and the presentation of numerical data, as well as graphics to illustrate trends. Fourteen Italian rheumatology centres have contributed patients to the database which, at the time writing, includes 5145 patients (72% women) with a mean age of 53 years (range 16-88). The initial diagnoses were rheumatoid arthritis (3494 patients, 67.9%), psoriatic arthritis (833, 16.2%), ankylosing spondylitis (493, 9.6%), undifferentiated spondylo-arthritides (307, 5.9%), enteropathic arthritis (14, 0.3%) and spondylitis following reactive arthritis (4, 0.1%). These patients have been followed for up to 10 years, and 1927 (35.8%) have been treated for at least three years. The biological treatments received include etanercept, infliximab, anakinra, adalimumab, abatacept, rituximab and tocilizumab. A total of 2926 adverse events have been observed, with 1171 patients (22%) reporting at least one. Analysis of the accumulated data will provide insights into the critical early phase of the studied arthritides, and enable us to identify the clinical and laboratory profiles that may predict responsiveness to a specific therapy.
GISEA注册库是一个独立数据库，由意大利早期关节炎研究小组（GISEA）于2008年建立，由意大利风湿病患者协会（ANMAR - ONLUS）资助。根据该网络的流行病学策略，最初的方案旨在收集有关接受生物制剂治疗的风湿病患者的长期随访数据，以便研究疾病活动、合并症和治疗生存率方面的真实世界特征。我们在此描述用于收集患者数据的设计和方法。通过基于网络的界面，研究小组的所有成员都可以获取有关人口统计学、疾病活动、治疗变化（包括变化原因和每种治疗的持续时间）、伴随治疗和不良事件的信息，该界面允许查询并呈现数值数据以及用于说明趋势的图形。14个意大利风湿病中心为该数据库提供了患者数据，在撰写本文时，该数据库包括5145名患者（72%为女性），平均年龄为53岁（范围16 - 88岁）。初始诊断为类风湿关节炎（3494例患者，67.9%）、银屑病关节炎（833例，16.2%）、强直性脊柱炎（493例，9.6%）、未分化脊柱关节炎（307例，5.9%）、肠病性关节炎（14例，0.3%）和反应性关节炎后脊柱炎（4例，0.1%）。这些患者已被随访长达10年，1927例（35.8%）接受治疗至少三年。接受的生物治疗包括依那西普、英夫利昔单抗、阿那白滞素、阿达木单抗、阿巴西普、利妥昔单抗和托珠单抗。共观察到2926例不良事件，1171例患者（22%）报告至少发生过一次。对累积数据的分析将为所研究关节炎的关键早期阶段提供见解，并使我们能够识别可能预测对特定治疗反应性的临床和实验室特征。
