Kaiser Permanente Autoimmune Disease Registry

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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.