Spondyloarthritis & psoriatic arthritis

Diversity in Axial Spondyloarthritis Drug Trials: Enrollment by Sex, Race, Ethnicity, and Geographic Region

J RheumatolPublished Descriptive epidemiological study

Authors' conclusion

The proportion of women enrolled in axSpA drug trials largely reflects disease demographics. Race and ethnicity reporting has improved over time. Whereas participation of Asian, American Indian/Alaska Native and Hispanic/Latino patients has increased, Black and Native Hawaiian/Pacific Islander representation has remained low.

Study context

Population
Completed phase II–IV drug trials in adults with axial spondyloarthritis (axSpA), 2000–2023, with results posted on ClinicalTrials.gov
Participants
16,162 participants59 trials
Outcome
Demographic (sex, race, ethnicity) and geographic diversity of enrollment in axSpA drug trials
Methodological detailsClinicalTrials.gov data, completed phase II-IV drug trials, 2000–2023, with results posted
  • ClinicalTrials.gov data
  • Completed phase II-IV drug trials, 2000–2023, with results posted

Main finding

As reported in the abstract

Enrollment by sex, race, ethnicity and region
Female participants, overall
30%
Female participants, r-axSpA trials
25%
Female participants, axSpA trials
34%
Female participants, nr-axSpA trials
48%
Trials reporting race
31 (53%)
Trials reporting both race and ethnicity
12 (20%)
Trials reporting race, 2000-2010 / 2011-2015 / 2016-2020
9% / 53% / 100%
White (of 10,037 with race data)
82%
Asian
15%
American Indian/Alaska Native
2%
Black
1%
Native Hawaiian/Pacific Islander
0.02%
Asian representation, 2011-2015 to 2016-2020
4% to 19%
American Indian/Alaska Native representation, 2011-2015 to 2016-2020
1% to 3%
Black representation, consistently low
1%
Hispanic/Latino (of 3577 with ethnicity data)
14%
Hispanic/Latino, 2011-2015 to 2016-2020
1% to 14%
Countries enrolling participants (51 trials with location data)
53
Sub-Saharan Africa share of enrollment sites (lowest)
0%
South/Central Asia share of enrollment sites
2%

Original publication

Diversity in Axial Spondyloarthritis Drug Trials: Enrollment by Sex, Race, Ethnicity, and Geographic Region. J Rheumatol. Published 15 March 2025. doi:10.3899/jrheum.2024-1013

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