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TOPLINE:

Axial spondyloarthritis (axSpA) clinical trials showed improved diversity, with increased representation of Asian and Hispanic/Latino participants. However, Black and Native Hawaiian/Pacific Islander groups remained underrepresented, and the geographic diversity of participants was limited.

METHODOLOGY:

• Researchers conducted a descriptive epidemiologic study using data from completed phase 2, 3, and 4 drug trials for axSpA from 2000 to 2023.
• A total of 59 trials with 16,162 participants were analyzed, including 40 trials on radiographic axSpA, 9 trials on nonradiographic axSpA, and 10 trials in which the type of axSpA was not distinguished.
• Data on age, sex, race, ethnicity, trial characteristics, and trial locations were extracted and analyzed, with sex reported as a binary variable and race and ethnicity categorized using the 1997 US Office of Management and Budget minimum standards.
• The geographic distribution of trial sites was assessed, with participants enrolled from 53 countries and the sites grouped into nine major regions on the basis of Global Health Data Exchange and World Bank classification systems.
• Trials were classified by period — 2000-2010, 2011-2015, and 2016-2020 — to assess time trends in reporting and site selection.

TAKEAWAY:

• Female participants constituted 31% of the total, with varying representation across different types of axSpA trials. Race reporting increased over time, from 9% in 2000-2010 to 100% in 2016-2020, and ethnicity reporting rose from 5% in 2000-2010 to 50% in 2016-2020.
• White participants represented 82%, and the Native Hawaiian/Pacific Islander participants represented 0.02% of the total participants. From 2011-2015 to 2016-2020, Asian participant representation increased from 4% to 19%, and Hispanic/Latino participant representation rose from 1% to 14%. However, Black participant representation remained at 1%.
• Geographic diversity was reflected in the enrollment, with the highest representation from Western Europe (80%), Eastern Europe (63%), and North America (61%), but minimal representation from South/Central Asia and no participants from sub-Saharan Africa.
• Enrollment activity increased notably in Eastern Europe, North America, Western Europe, and East/Southeast Asia between 2000-2010 and 2011-2015 but remained low in South/Central Asia and sub-Saharan Africa.

IN PRACTICE:

“Although this study highlights progress in the diversity of individuals enrolled in axSpA drug trials, significant gaps remain, particularly in the underrepresentation of Black and Native Hawaiian/Pacific Islander participants and the limited geographic diversity of trial sites globally. Enhancing trial diversity is crucial for ensuring the generalizability and broad impact of study results,” authors of the study wrote.

SOURCE:

This study was led by Mathieu Choufani, MD, Brigham and Women’s Hospital, Boston. It was published online on April 1, 2025, in The Journal of Rheumatology.

LIMITATIONS:

The study relied on data from ClinicalTrials.gov, which may not have covered all trials. Earlier studies had less stringent reporting requirements, which may have led to incomplete race, ethnicity, and location data. The methods for collecting race and ethnicity data were not always specified, and the categories used were inconsistent.

DISCLOSURES:

One author reported receiving support from the National Institutes of Health, a Rheumatology Research Foundation R Bridge Award, and the Doris Duke Charitable Foundation. No relevant conflicts of interest were declared by the authors.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.