0673: Reporting of Race, Ethnicity, Sex, Gender, Socioeconomic Status and Representativeness of Race and Ethnicity in ANCA-associated Vasculitis Randomized Trials

Michele Iudici¹, Juan C. Rueda² and Xavier Puéchal³, ¹Division of Rheumatology, Department of Internal Medicine Specialties, Geneva University Hospitals, Geneva, Switzerland, ²Universidad de La Sabana, Chía, Colombia, Chia, Colombia, ³National Referral Center for Rare Systemic Autoimmune Diseases, Paris, France

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.




M. Iudici: Boehringer-Ingelheim, 1; J. Rueda: None; X. Puéchal: None.