Race, Ethnicity, and Geographic Diversity in Pivotal Psoriatic Arthritis Clinical Trials: Further Progress Is Needed.

Abstract

Objective: We assessed race, ethnicity, and geographic diversity in pivotal trials of biologic and targeted synthetic disease-modifying antirheumatic drugs approved for psoriatic arthritis (PsA) in the United States.

Methods: We conducted a descriptive epidemiological study, examining the reporting and representation of race, ethnicity, and geographic distribution of trial sites in pivotal PsA trials using data from journal publications, the Drugs@FDA database, and ClinicalTrials.gov.

Results: We identified 29 pivotal PsA trials for 16 targeted therapies with start dates between 2000 and 2019. Race data were reported in 93% of trials. Race reporting was highest in journal publications (86%); however, among these, 46% reported only the proportion of White participants. Ethnicity data were available for 41% of trials, primarily from ClinicalTrials.gov, with improved reporting in recent years. Among 14,165 participants in 27 trials with race data, 92% were White, 7% Asian, and fewer than 1% were Black, American Indian/Alaska Native, or Native Hawaiian/Pacific Islander. Among 8,105 participants in 12 trials with ethnicity data, 11% were Hispanic or Latino individuals. Location data were available for 26 trials. In the U.S., trial activity was highest in Texas (24 trials), Florida and Pennsylvania (22 each), and California (20), strongly correlating with state population size (r = 0.78, p < 0.0001). Globally, trial sites were identified in 55 countries, primarily in North America and Europe, with fewer sites in Asia, Africa, and Latin America.

Conclusion: Racial and ethnic diversity in pivotal PsA trials remains limited. Tailored and multifaceted strategies are needed to improve participant representativeness in future trials.