Kaiser Permanente Autoimmune Disease Registry

凯撒永久自身免疫性疾病登记处

• 批准号: 7937015
• 负责人: LISA J HERRINTON
• 金额: $ 49.96万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-28 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7937015
• 关键词: Accounting; Address; Adolescent; Adult; Adverse event; Alabama; Ankylosing spondylitis; Area; Autoimmune Diseases; Autoimmune Process; Biological Assay; Biological Response Modifier Therapy; Blood; California; Child; Chronic Childhood Arthritis; Clinical; Collaborations; DNA; Databases; Dermatology; Disease; Effectiveness; Epidemiology; Etanercept; Foundations; Future; Genotype; Health Status; Health system; Immunology; Individual; Inflammatory Bowel Diseases; Letters; Link; Longevity; Massachusetts; Measures; Methods; Outcome; Patients; Persons; Pharmaceutical Preparations; Population; Population Heterogeneity; Psoriasis; Psoriatic Arthritis; Registries; Reporting; Research; Rheumatoid Arthritis; Rheumatology; Risk; Saliva; Sampling; Severities; Societies; Spondylarthritis; Surveys; Telephone; Training; Universities; Vulnerable Populations; Work; adalimumab; comparative effectiveness; computer program; disability; disease registry; economic cost; effectiveness measure; effectiveness research; functional status; genetic epidemiology; genetic profiling; global health; improved; infliximab; member; preference; skin disorder; tool

DESCRIPTION (provided by applicant): This application responds to broad Challenge Area (05): Comparative Effectiveness Research (CER), and specific Challenge Topic 05-AR-101: Comparative Effectiveness of Biologics in Autoimmune Rheumatic and Skin Diseases, with emphasis on five diseases: rheumatoid arthritis (RA), juvenile inflammatory arthritis (JIA), psoriatic arthritis (PsA), psoriasis (PsO), and ankylosing spondylitis (AS). We propose to establish the Kaiser Permanente (KP) Autoimmune Disease Registry, containing comprehensive clinical information for a large, diverse population with access to DNA for future genotyping and functional assays. This registry will be invaluable for understanding the effectiveness and comparative effectiveness of biologic therapies at the level of the individual. We propose the following Specific Aims: Aim #1: Link clinical databases covering the 15-year period 1996-2010 to expand and reframe the existing KP Inflammatory Bowel Disease (IBD) Registry into an Autoimmune Disease Registry by adding RA, JIA, PsO, PsA, and AS using the tools and methods developed and proven for our IBD Registry. Aim #2: Perform chart review on a random sample of 1000 patients, including 200 each with RA, JIA, PsO, PsA, and AS to confirm disease extent and severity using the tools and methods proven for our IBD work. Aim #3: For a stratified random sample of 600 adult RA patients initiating etanercept, infliximab, or adalimumab treatment, determine preference for therapy and investigate differences in effectiveness across drugs in patient-reported disease activity, functional status, global health, and work disability using telephone surveys at baseline and 6 months later. Aim #4: Measure the effectiveness of biologics for improving clinical outcomes during the 15-year period 1996-2010 at the population-level among persons with RA and psoriasis and in vulnerable populations with RA, again using methods and computer programs developed and proven for IBD. The Autoimmune Disease Registry will include all members of KP Northern California with prevalent RA, JIA, PsO, PsA, and AS during the 15-year period 1996-2010. Currently, information is available for more than 26,000 patients with these diseases, of which 4393 are biologics users (3063 with RA, 79 with JIA, 665 with psoriasis, 214 with AS, and 372 with multiple indications). The proposed Registry will provide the foundation for: (1) Measuring the many domains of effectiveness across a wide range of endpoints and throughout the patient's lifespan, (2) individualizing the determination of effectiveness to account for the patient's genetic profile, baseline risk for adverse events, and preferences, (3) elucidating and addressing special problems in children and other vulnerable populations, (4) identifying barriers to effectiveness that can be mitigated at the level of the health system, and (5) estimating and comparing economic costs to the individual and society. The Kaiser Permanente (KP) Autoimmune Disease Registry will include all members of KP Northern California with prevalent rheumatoid arthritis, juvenile rheumatoid arthritis, psoriasis, psoriatic arthritis, and ankylosing spondylitis during the 15-year period 1996-2010. Currently, information is available for more than 26 thousand patients with these five diseases, including 4393 biologics users.

描述(申请人提供)：此申请响应广泛的挑战领域(05)：比较有效性研究(CER)，和特定挑战主题05-AR-101：生物制剂在自身免疫性风湿和皮肤病中的比较有效性，重点是五种疾病：类风湿性关节炎(RA)、青少年炎症性关节炎(JIA)、牛皮癣(PSA)、牛皮癣(PSO)和强直性脊柱炎(AS)。我们建议建立Kaiser Permanente(KP)自身免疫性疾病注册中心，为大量、多样化的人群提供全面的临床信息，并为未来的基因分型和功能分析提供DNA。这一登记对于在个人层面上理解生物疗法的有效性和相对有效性将是无价的。我们提出了以下具体目标：目标1：通过添加RA、JIA、PSO、PSA并使用为我们的IBD注册开发和验证的工具和方法，将覆盖1996-2010年15年期间的临床数据库链接到现有的KP炎症性肠病(IBD)注册中心，并将其重组为自身免疫性疾病注册中心。目的#2：对随机抽样的1000名患者进行图表回顾，其中包括200名RA、JIA、PSO、PSA和AS患者，使用为我们的IBD工作证明的工具和方法来确认疾病的范围和严重性。目的#3：对600名开始依那西普、英夫利昔单抗或阿达单抗治疗的成年RA患者进行分层随机抽样，确定治疗偏好，并在基线和6个月后通过电话调查，调查不同药物在患者报告的疾病活动、功能状态、全球健康和工作残疾方面的有效性差异。目的#4：再次使用为IBD开发和验证的方法和计算机程序，在人群水平上评估在1996-2010年间，在RA和牛皮癣患者以及易患RA的人群中，生物制剂改善临床结果的有效性。自身免疫性疾病登记处将包括1996-2010年15年期间患有RA、JIA、PSO、PSA和AS的北加州KP的所有成员。目前，有26,000多名患有这些疾病的患者可以获得信息，其中4393人是生物制剂使用者(3063人患有类风湿关节炎，79人患有JIA，665人患有牛皮癣，214人患有强直性脊柱炎，372人有多种适应症)。拟议的登记系统将为以下方面提供基础：(1)衡量跨越广泛终点和患者整个生命周期的多个有效性领域；(2)根据患者的遗传特征、不良事件的基线风险和偏好对有效性的确定进行个人化；(3)阐明和解决儿童和其他脆弱人群中的特殊问题；(4)确定可在卫生系统层面上缓解的有效性障碍；以及(5)估计和比较个人和社会的经济成本。Kaiser Permanente(KP)自身免疫疾病登记处将包括1996-2010年15年间患有风湿性关节炎、幼年类风湿性关节炎、牛皮癣、牛皮癣关节炎和强直性脊柱炎的北加州KP的所有成员。目前，超过2.6万名患有这五种疾病的患者可以获得信息，其中包括4393名生物制剂使用者。