Racial minorities are under-represented in SLE clinical trials: A systematic review and meta-analysis

With numerous emerging treatments for systemic lupus erythematosus (SLE), it is imperative that clinical trials include diverse populations reflective of those with SLE, especially active disease. Epidemiological data from North America and Europe indicate that the prevalence of SLE is disproportionately higher among Black populations compared to White populations, relative to their distribution in the general population. The objectives of this study were to examine the racial composition of randomized controlled trials (RCTs) in SLE from 2014 to 2024, assessing whether these trials accurately represent the diversity of SLE populations.

A systematic review of the literature was conducted using EMBASE, PUBMED, Web of Science, and Cochrane CENTRAL from Jan 1, 2014 - May 14, 2024. RCTs of pharmaceutical interventions in SLE patients were included. Studies were excluded if they had less than 50 participants, were not in English, or did not report on race/ethnicity. Revman 5.4 and SPSS were used for statistical analysis.

Of 2505 studies identified, 63 were included. The pooled proportion of women was 91%. Among studies reporting these categories, White participants represented 61% of trial participants, Black participants 14%, Asian participants 14%, and Indigenous (including Native American) participants 8%, whereas fewer than 1% were Pacific Islanders. Hispanic/Latino ethnicity, which was variably reported across studies and may overlap with racial categories, was reported in 37% of participants.

Racial and ethnic minority groups appear under-represented in recent SLE RCTs, particularly Black participants. Interpretation of Hispanic/Latino representation is limited by inconsistent reporting of race and ethnicity across trials. Greater effort is needed to ensure that SLE research trials are generalizable to patients and equitable with respect to patient diversity.