Diversity Gap Persists in Key Trials for Psoriatic Arthritis
An analysis of 29 pivotal drug trials for psoriatic arthritis revealed significant racial disparities, with White individuals making up the majority of trial participants, whereas Asian, Black, and other racial groups remained underrepresented. Geographic disparities in participant inclusion were also observed, with trial sites primarily located in North America and Europe.
METHODOLOGY:
Researchers conducted a descriptive epidemiologic study to assess the gaps in reporting of racial, ethnic, and geographic data of participants enrolled in pivotal US clinical trials of biologic and targeted synthetic disease-modifying antirheumatic drugs for psoriatic arthritis.
They collected data on 14,845 participants enrolled in 29 trials with start dates from April 2000 to April 2019, using three primary public sources: Journal publications, the Drugs@FDA database, and ClinicalTrials.gov.
Overall, 16 drugs with varying mechanisms were assessed in these trials: Seven trials each of TNF inhibitors and interleukin 17A or 17A/F inhibitors, four trials each of JAK inhibitors and interleukin 23 inhibitors, three trials of phosphodiesterase 4 inhibitors, and two trials each of cytotoxic T-lymphocyte antigen immunoglobulin and interleukin 12/23 inhibitors.
TAKEAWAY:
Data on race were reported in 93% of trials, with the most frequent reporting in journal publications (86%), although 46% of them reported the proportion of only White participants.
Among participants for whom data on race were available, 92% were White, 5% were Asian, 0.6% were Black, 0.3% were American Indian/Alaska Native, and 0.1% were Native Hawaiian/Pacific Islander individuals.
Ethnicity was formally reported in only 41% of trials. The reporting of both race and ethnicity improved over time, reaching full coverage (eight of eight trials) on ClinicalTrials.gov between 2016 and 2020. Among participants for whom data on ethnicity were available, 11% were Hispanic or Latino individuals.
Within the US, the highest participation was reported from Texas (24 trials), Florida and Pennsylvania (22 each), California (20), and Alabama (18), with participation in clinical trials strongly correlated with state population size (correlation coefficient, 0.78; P < .0001). Trial sites were primarily located in North America and Europe, with limited representation in Asia, Africa, and Latin America.
IN PRACTICE:
'Standardizing and mandating race and ethnicity reporting across data sources is crucial to ensure transparency and equity. Tailored and multifaceted recruitment strategies are essential to increase diversity and ensure the generalizability of trial results, ultimately aiding clinicians to provide the most effective and informed treatment options for all patients,' the authors wrote.
SOURCE:
This study was led by Mathieu Choufani, MD, Brigham and Women's Hospital, Boston. It was published online on May 19, 2025, in Arthritis Care & Research .
LIMITATIONS:
This study relied on the US-centric Office of Management and Budget categories for data on race and ethnicity, which may not have represented international populations. Definitions of categories were inconsistent across data sources. Site-level enrollment details were lacking. The analysis was focused solely on pivotal trials for FDA-approved drugs.
DISCLOSURES:
This study had no specific outside funding source. One author reported receiving consulting fees and grants from various pharmaceutical organizations and being a member of the board of directors for the Spondyloarthritis Research and Treatment Network. Another author reported owning stocks in UCB and Abcuro.
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