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The U.S. Food and Drug Administration (FDA) initiated this study in the Sentinel System to estimate the prevalence of cutaneous lupus erythematosus (CLE) and its subtypes. Existing prevalence estimates were limited, and CLE includes several subtypes that differ significantly, making it challenging to understand the true burden of disease.
This analysis assessed the prevalence of CLE subtypes overall, by diagnosing physician specialty, and across demographic groups, including sex, race, ethnicity, and insurance type.
Results showed that CLE subtypes are rare (less than 100 per 100,000 eligible members) with an overall low prevalence in the Sentinel Distributed Database (SDD). Among dermatologist- or rheumatologist-confirmed cases, the prevalence of discoid lupus erythematosus (DLE) was 27.77 per 100,000 eligible members and 9.28 per 100,000 eligible member-years (95% Confidence interval [CI]: 9.21, 9.35). Subacute CLE (SCLE) was 9.81 per 100,000 eligible members and 3.28 per 100,000 eligible member-years (95% CI: 3.24, 3.32). Other subtypes included: other cutaneous lupus erythematosus (OLE) at 11.71 per 100,000 members and 3.91 per 100,000 member-years (95% CI: 3.87, 3.96); systemic lupus erythematosus without systemic manifestations at 14.38 per 100,000 members and 4.81 per 100,000 member-years (95% CI: 4.76, 4.85); DLE preceding systemic lupus erythematosus at 11.22 per 100,000 members and 3.75 per 100,000 member-years (95% CI: 3.71, 3.79); mixed CLE at 11.40 per 100,000 members and 3.81 per 100,000 member-years (95% CI: 3.77, 3.85); and Chilblains with evidence of systemic lupus erythematosus at 0.67 per 100,000 members and 0.22 per 100,000 member-years (95% CI: 0.21, 0.23).Prevalence of all CLE subtypes was higher among women than men, and greatest in adults aged 45 to 64 years with an extremely low prevalence in patients younger than 18 years of age. Black and White patients had the highest prevalence, and non-Hispanic individuals had higher prevalence than Hispanic individuals. Prevalence of CLE subtypes differed between publicly and commercially insured patients, and differences persisted across race and sex strata.
These findings will support ongoing FDA reviews. Based on the study findings, no immediate regulatory actions were required, but the results fill critical knowledge gaps and strengthen the scientific foundation for future decision making.