The Lupus Center at JHH is uniquely situated to address clinical research issues through prospective follow-up of a large number of SLE patients. During Dr. Petri's FIRST award, issues addressed included the risk of future thrombosis and coronary artery disease associated with antiphospholipid antibodies, routine cardiovascular risk factors, and prednisone use. The Lupus Cohort has now been refunded by the NIH.
The specific aims of the RO-1, although a continuation of the FIRST award work, now include an emphasis on disease activity and disability. Ongoing disease activity exposes patients to the side effects of corticosteroids. Over one-half of patients sustain permanent organ damage. Determination of predictors of disease activity should help to reduce unneeded corticosteroid treatment and allow institution of earlier treatment when it is needed. Whenever a patient has a scheduled visit, three to ten extra tablespoons of blood are drawn to test for disease activity and clotting. A record of tender muscles (fibromyalgia) is also completed. In addition, several times a year, patients are contacted so that we can determine other risk factors for organ damage and disability (through the use of questionnaires).
Specific Aim One : Prediction of Activity/Flare We are continuing our work on predicting the probability of disease flares, using a definition of an increase of 1 or more points on a 0 to 3 visual analog scale. The probability of a flare in a 6 month period is 0.20. Women are more likely to flare than men, and younger patients are more likely to flare than older patients. Flares are equally likely in those recently diagnosed (within 5 years) and those with established (>5 years) disease. We have begun a study of predictors of flare when patients are seen on a monthly basis (the cohort protocol consists of quarterly visits). This study completed enrollment of 50 patients in December 1997, and will take 12 months to complete. It is a supplemental study funded by the Outpatient Clinical Research Center.
Specific Aim Two : Predictors of Morbidity (Damage) Our most recent analysis of predictors of atherosclerosis (measured by carotid duplex, partially funded by the American Heart Association grant-in-aid) found that antiphospholipid antibodies, duration of SLE, race, and hypertension are prospective predictors. Surprisingly, only 8% of the cohort have had atherosclerosis detected by carotid duplex.
Specific Aim Three : Quality of Life Our most recent analyses have examined the relationship of fibromyalgia and health status in SLE. We found a strong association of fibromyalgia tender points with coping scales, such as the Health Related Hardiness scale and the Mishel Uncertainty-in-Illness scale. SLE patients with fibromyalgia had poorer health status on multiple measures of health status, including physical measures (HAQ), fatigue (Fatigue Severity Scale), depression (CES-D), and anxiety/depression (Health Anxiety Depression Scale). Research in all of these specific aim areas is currently ongoing. The Hopkins Lupus Pregnancy Center RPN was terminated on August 27, 1997. This RPN became part of the Cohort RPN, and now all of the procedures listed under the Pregnancy Center consent form (monthly visits, ultrasounds, biophysical monitoring, and measurement of antiphospholipid antibodies) are part of routine care under the Cohort (where outcomes are monitored as stated above).
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