Background/Purpose: Black, Indigenous, and people of color (BIPOC) experience greater morbidity and mortality from autoimmune connective tissue diseases (AICTDs); thus, equitable access to randomized controlled trials (RCTs) on AICTDs is a scientific and ethical imperative. Drug safety and efficacy may not be optimized until participants reflect the disease epidemiology. We aimed to examine race and ethnicity in RCTs investigating biologic and small molecule agents for AICTDs.

Methods: A search was executed on August 5th, 2022 across MEDLINE, Embase, Web of Science, Cochrane Library, Global Index Medicus, ClinicalTrials.gov, and International Clinical Trials Registry Platform for English-language studies involving biologics or new small molecule drugs for lupus erythematosus (LE), dermatomyositis, systemic sclerosis (SSc), or morphea. Three independent reviewers performed screening followed by eligibility assessment, with inclusion dependent on consensus by two reviewers. Duplicate study reports were removed, and data was summarized with descriptive statistics and chi-squared analyses.

Results: Ninety-two RCTs were included. The most common reason for exclusion was a lack of participant race or ethnicity data; around three-fourths (74.5%) of otherwise eligible RCTs were excluded for this reason. Of the 92 included studies, 75 (81.5%) involved LE, 6 (6.5%) dermatomyositis, 14 (15.2%) SSc, and 0 (0.0%) morphea (Table 1). Across all AICTDs, when analyzing baseline demographics, patients who identified as White were the most frequently included (55.7%), followed by Asian (18.9%), Hispanic (16.3%), and Black/African American (12.0%). Those who identified as American Indian/Alaskan Native and Native Hawaiian/Other Pacific Islander were the least represented (6.2% and 0.1%, respectively). Chi-squared analysis revealed significant underrepresentation of patients who identify as BIPOC in United States (US)-based LE and SSc trials compared to United States epidemiological estimates (p< 0.0001 and p=0.0014, respectively; Fig 1, Table 2A). BIPOC were also underrepresented in US-based DM trials, but not significantly (p = 0.2758; Fig 1, Table 2A). World-wide, despite efforts for improved diversity in clinical trials, the inclusion of BIPOC in RCTs on AITCDs has not changed significantly in the last five years (X2 = 3.26, p = 0.07; Table 2B). When examining by race, inclusion of patients who identify as American Indian/Alaskan Native and Hispanic decreased (p< 0.0001). However, patients who identify as Black/African American increased (p< 0.0001), likely in part attributable to the EMBRACE study, a belimumab RCT which enrolled participants with African ancestry.

Conclusion: Our data show that inclusivity in RCTs for AICTDs remains problematic. This comes despite the recent push for greater diversity in clinical trial participants, with the understanding that race is a social construct, and that many differences in treatment response are driven by social, political, and environmental factors rather than biological factors. The lack of diversity in trials serves to exacerbate disparities in outcomes for patients who identify as BIPOC and are diagnosed with AICTDs.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/ethnic-and-racial-minorities-in-clinical-trials-for-autoimmune-connective-tissue-disease-therapeutic-agents/