Systematic Review of Inequitable Population Representation in Systemic Lupus Erythematosus Clinical Trials.

Objective: This systematic review and meta-analysis aims to evaluate the participation of historically marginalized populations in systemic lupus erythematosus (SLE) clinical trials conducted in the US.

Background: SLE, a complex autoimmune disease characterized by a dysregulated immune response leading to inflammation and tissue damage in multiple organ systems, exhibits a mortality rate four times higher in historically marginalized populations compared to the general population. It is essential for clinical trials to accurately represent the disease population to effectively evaluate treatment modalities. However, the current trial design lacks appropriate representation of historically marginalized populations, limiting the generalizability of results. Our study addresses this research gap by evaluating the participant demographics in SLE clinical trials.

Methods: Relevant clinical trials were obtained in a comprehensive search of MEDLINE (PubMed) and Embase (Elsevier) in May of 2024. Included trials were published in the United States between January 1, 2018, and December 31, 2023. Two reviewers independently performed screening and data extraction via a standardized Google Form.

Results: Having met our inclusion criteria, 18 U.S. SLE clinical trials were evaluated for participant sex, age, racial, and ethnic data. Analysis of sex/gender revealed that the included population accurately represented the disease population. Regarding race/ethnicity participation, 11/18 (61.1%) received an overall Poor rating, and none received a Good rating. Analysis revealed that 14/18 (77.8%) of studies demonstrated statistically insignificant underrepresentation of Black, Asian, and Hispanic populations. No studies reported the inclusion of older adults in their sample, suggesting a significant need for better age representation.

Conclusion: The results of this study reveal disparities in the representation of the SLE disease population in clinical trials, emphasizing insufficient inclusion of Black, Asian, and Hispanic/Latinx participants and the disproportionate overrepresentation of white participants. Our study highlights the need for the initiation of effective strategies to engage historically marginalized populations in SLE clinical trials. Addressing these gaps is necessary to prioritize the participation of inequitable populations, increase standardization of SLE treatments, and improve the relevance of SLE research.