612 Racial and Ethnic Disparities in Patients with Incomplete Lupus Erythematosus

Patients with incomplete lupus erythematosus (ILE) have features of systemic lupus erythematosus (SLE) but do not satisfy classification criteria for this condition. Some of these ILE patients are at risk for development of SLE. An ongoing multicenter, double-blind, placebo- controlled, NIH-sponsored project, the Study of Anti-Malarials in Incomplete Lupus Erythematosus, the SMILE trial, is investigating whether treatment of ILE patients with hydroxychloroquine slows accumulation of SLE criteria. Although SLE is a condition that disproportionately affects non-White individuals, including Blacks and Hispanics, these groups were under-represented in the SMILE participants. For example, the SMILE site with highest Black enrollment (47%) was Medical University of South Carolina, but this was significantly less than the proportion of Black patients in their SLE cohort (78%; p<0.0001). One possible explanation is that the accumulation of SLE criteria is a slower process in Whites than in the other groups, so that an extended ILE stage where individuals could be identified and recruited is more likely. Alternatively, lack of access to health care or decreased acceptability of clinical trials may contribute to lower numbers of Blacks and Hispanics in SMILE. To examine this further, the composition of previously reported ILE cohorts at two SMILE sites, Hershey Medical Center (HMC) and Oklahoma Medical Research Foundation (OMRF) were compared to the SMILE enrollees at those sites. As previously reported, SLE and ILE cohorts at these sites were not significantly different in proportions of White patients. However, HMC enrollment in SMILE was more than 97% White, which was significantly greater than in the HMC ILE cohort, which was 79% White; P=0044. The proportion of Hispanics was also greater in the HMC ILE cohort (15%) than in SMILE (8%), but this difference was not statistically significant in this small sample (P=0.25). The previously reported OMRF cohort of ILE patients was 57% European-American, while OMRF enrollment of White participants in SMILE was 29/37 (78%) which is significantly greater (P=0.0115). These findings suggest that recruitment to SMILE was less successful for non-White candidates, possibly reflecting differences in interest or abilities to participate in a clinical trial. To further understand these differences, a subgroup of the SMILE investigators is now engaged in a followup NIH-sponsored study, Mechanisms of New-Onset Autoimmunity/Longitudinal Immune Systems Analysis, MONA-LISA, directed by Dr. Karp. One aim of MONA-LISA is to enroll ILE patients who were under-represented in SMILE and to investigate other factors such as ancestry-specific variations that might explain risks of autoimmunity progression and observed differences in SLE epidemiology.