Characteristics of race/ethnicity in trials leading to anti-rheumatic drug approval for inflammatory arthritis by the US Food and Drug Administration

Abstract

Objective: Presenting the racial/ethnic representation in clinical trials leading to new approvals of inflammatory arthritis (IA) by the US Food and Drug Administration (FDA) to determine the extent of racial/ethnic disparities.

Methods: Pivotal trials supporting the approval of new indications from July 2012 to June 2022 were collected from Drugs@FDA, the FDA-approved drugs database. More details were then identified by searching Pubmed and the National Institutes of Health trials registry. General characteristics of the approved drugs and demographic data for each pivotal trial, especially the race/ethnicity data, were collected. The enrollment profiles of each race/ethnicity were analyzed and then compared with the 2020 US census data.

Results: From 2012 to 2022, 34 new approvals were identified based on 59 clinical trials. The Black was consistently underrepresented in all subtypes of IA and drugs, while the White was overrepresented compared to the 2020 US census data. For Asian and Hispanic participants, these pivotal trials presented relatively heterogeneities in enrollments. As for the trends over time, increased involvements of White were still observed in rheumatoid arthritis (RA), psoriatic arthritis, and spondyloarthritis, while increased involvements of Black and decreased enrollments of Asian and Hispanic were only observed in RA.

Conclusions: Despite many efforts to eliminate racial/ethnic disparities, the Black was consistently underrepresented in pivotal clinical trials compared to the 2020 US national race/ethnicity distribution data. The White was consistently overrepresented, and the Hispanic presented heterogeneous results. No evident time trend was observed.

Keywords: FDA; anti-rheumatic drug; clinical trials; inflammatory arthritis; race/ethnicity distribution.