Six separate projects related to outcomes of patients with rheumatic diseases are included in this report. The first project, Genetic determinants of ankylosing spondylitis severity, is a prospective observational study of 600 subjects with ankylosing spondylitis (AS) that seeks to identify genetic determinants of ankylosing spondylitis severity. The severity of AS varies widely among patients, but the reasons for this variation are unknown. Because the susceptibility to AS is largely genetically determined, it is possible that the severity of AS may also be largely genetically determined. This project will test genotype-phenotype correlations in a large sample, stratified by duration of AS to capture inflammatory signs in early duration subjects and the degree of fusion and functional impairment in late duration subjects. Over 650 subjects have been enrolled, and genetic testing and data analysis has begun. Radiographic data and HLA data have been finalized on 402 patients with long-standing AS, and this work is in progress for 228 subjects with early AS. Initial clinical predictors of functional and radiographic severity have been identified. Collaborators include Drs. J. Reveille, M. Weisman, J Davis, T. Learch, and J. Malley. In a related case-control study, we recently identified ARTS1 and IL23R as genes important in the susceptibility to AS. The second project, Progression of spinal fusion in ankylosing spondylitis, is a feasibility study with a goal to develop and test a measure of spinal fusion in AS based on quantification of calcification of the lumbar intervertebral discs by computed tomography. Twenty-three subjects have been enrolled, and 13 have completed follow-up scans at 1 and 2 years. The collaborators on this project are Drs. J. Flynn, L. Yao, Y. Yao, and S. Tan.? ? The third project, Clinically important changes in rheumatoid arthritis, is a prospective observational study of clinically important changes in rheumatoid arthritis (RA) activity. Current criteria for improvement in RA have not emphasized the patients perspective. It is also not known if patients rate changes in their symptoms and signs of RA similarly as their physicians, or if different patients are concordant in their judgments of how much of an improvement in symptoms represents an important improvement. The goals of this project are to identify benchmarks of important improvement in pain, functioning, and global arthritis status in RA based on the self-assessment by patients of changes in their symptoms. A secondary goal is to examine the measurement properties of preference measures. To date, 165 patients have been assessed before and after escalation of their anti-rheumatic treatment. The fourth project, Measurement of functioning in rheumatoid arthritis, uses secondary analysis of clinical trial data to deconstruct measures of functional limitation into reversible components related to active synovitis and irreversible components related to joint damage. This work has recently been published, and several additional analyses suggested by this work have been developed, including testing this concept in osteoarthritis and ankylosing spondylitis. The fifth project, Malignancy in patients with rheumatoid arthritis, uses the Medicare-SEER database to compare the incidence and survival from cancer between patients with RA and those without RA. Rheumatoid arthritis may modify the risk of malignancy, increasing the risk of certain types of cancer (lymphoma, lung) and decreasing the risk of other types of cancer (colorectal). However, risks of malignancy are not well defined in patients with RA, nor is it known if the outcomes of cancer are similar between patients with RA and those without RA. The Medicare-SEER database is a large population-based linked database that combines clinical information from Medicare billing records with cancer data from SEER locations. SEER is the nations primary cancer epidemiology program, operated by the National Cancer Institute. Patients with RA are identified from Medicare records, while cancer incidence is obtained from SEER. Data analysis is currently underway. The goals of the sixth project, Clinical epidemiology of systemic lupus erythematosus, are to better estimate the prevalence of systemic lupus erythematosus (SLE), to investigate health disparities among patients with SLE, and to identify clinical features and health care practices that are associated with mortality. With this project, we recently published data on the prevalence of SLE. Administrative data have been used to identify socioeconomic differences in the incidence of end-stage renal disease due to lupus nephritis, and racial differences in laboratory tests at the start of dialysis, which suggest disparities in care. We are beginning a study of quality of care indicators for hospitalized patients with systemic lupus erythematosus.
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