Disease Progression and Activity in Patients With Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a severe, chronic, disabling autoimmune disease that
significantly affects health status and quality of life. Since the disease occurs most often
in young to middle-aged adults, SLE can also affect work and disability. However, there is
currently little information on work-related disability from longitudinal, population-based
studies of SLE.

The Carolina Lupus Study is a large (265 cases, 355 controls) case-control study of SLE in
eastern North Carolina and South Carolina. Patients were recently diagnosed (median time
from diagnosis to enrollment was 13 months) and were referred from university and community
rheumatologists (approximately 50% from each source). Controls were selected using a
population-based sampling method (state driver's license registries). A standardized
in-person interview was conducted that included demographic, reproductive, and occupational
histories, and a blood sample was collected from 92% of cases and 85% of controls.
Approximately 60% of the study patients (n=150) are African-Americans. The Carolina Lupus
Study cohort provides an opportunity to examine disability and disease severity measures in
a population-based sample of SLE patients diagnosed within a relatively short period
(1995-1999).

Participants were enrolled into the Carolina Lupus Study between February, 1997 and July,
1999. We conducted two telephone contacts with patients and one telephone contact with
controls in a follow-up study completed in 2001. Funding for the proposed follow-up is
provided by The National Institute of Arthritis and Musculoskeletal Diseases (NIAMS), NIH
Multidisciplinary Clinical Research Center for Rheumatologic Diseases in African Americans
(Project C - Genetic and environmental influences on the development and progression of
lupus nephritis). Patient contact will follow an introductory letter that describes the
proposed follow-up study interviews which are planned to begin in late 2003. This letter
provides participants the opportunity (via a toll-free phone number) to decline further
contact about this study. The 30-minute telephone interview will cover hospitalizations,
current health status, work and disability issues, and changes in exposures since the 2001
follow-up interview.

Controls will not be contacted for this year's follow-up but may be contacted during
subsequent years. A total of 101 cases from the UNC Lupus Nephritis Study will also be
included in this follow-up. Disease damage will be assessed using the Systemic Lupus
International Collaborating Clinics (SLICC) American College of Rheumatology (ACR) Damage
Index, a standardized and validated instrument that is completed by the patient's physician.
Written consent will be obtained before any information is obtained from the patient's
physician or medical record. We will seek death certificates for patients and controls who
have died in order to obtain cause of death information.

- ELIGIBILITY CRITERIA:

Participants to be contacted for this follow-up study are enrolled as part of the Disease
Progression and Activity in the Carolina Lupus Study (Protocol Number OH97-E-N002) and the
UNC Nephritis Study (Lupus Nephritis: Role of Environmental and Occupational Exposures,
Protocol Number 01-E-N154). There will be no new subject enrollment. Participants were
initially recruited from collaborating hospitals and physicians in North and South
Carolina. Recruitment ended in July, 1999.

Lupus most often affects young women and this is shown by the makeup of study
participants. The demographics of the study participants is described in Table 2. Most CLU
participants were born in North or South Carolina. More than half of CLU patients are
African Americans. There is no involvement of special classes of subjects.