Background/Purpose: To assess how and to what extent race, ethnicity, sex, gender and socioeconomic status of participants are reported in ANCA-associated vasculitis (AAV) randomized controlled trials (RCTs), and to estimate the representativeness of different ethnic/racial groups in AAV-RCTs.

Methods: We searched all published AAV-RCTs indexed in PubMed and Embase since 2000. We retrieved information on main features of RCTs published from 2000 to 2022 and recorded for each study whether participant race/ethnicity, socioeconomic status (SES) and sex/gender were reported; how ethnicity/race was defined and assigned; the number of patients included for each racial/ethnic group. Descriptive statistics was used to summarize the main study results.

Results: We included 45 studies enrolling a total of 5053 patients (42% recruiting in more than one country), mostly published between 2011 – 2022 (62%), including patients with mainly granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) (68%), and mainly investigating pharmacologic interventions (98%). Information on race/ethnicity was available in 9 (20%) studies, 7 of which published ≥ 2011, including a total of 1445 (28%) patients. Figure 1 (left panel) shows the number of studies reporting race/ethnicity over time. Sex and/or gender of participants was reported in all but one study, but in 33 (73%) studies the authors clearly specified whether they reported the sex or the gender. In univariate analysis, we found a better reporting of race/ethnicity for larger studies including patients from different continents, funded by industry, and being published in higher impact factor journals. In studies where race/ethnicity was reported, White patients were the most represented (90%), followed by Asian (3%) and African American (2%). Figure 1 (right panel)presents temporal trends in the proportion of included participants across racial/ethnic groups in the overall sample of studies. Studies never reported the reasons for collecting race/ethnicity or subgroup analyses focusing on race/ethnicity. Only one study provided the definitions used to identify different patient’s origin. Only one paper reported patient SES.

Conclusion: Reporting of race/ethnicity and socioeconomic status deserves to be improved in AAV-RCTs. The non-White patients are underrepresented in AAV-RCTs reporting race/ethnicity of participants.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/reporting-of-race-ethnicity-sex-gender-socioeconomic-status-and-representativeness-of-race-and-ethnicity-in-anca-associated-vasculitis-randomized-trials/