AB0953 Lack of Racial Diversity in Clinical Trials of Psoriatic Arthritis

Conference Paper

BackgroundParticipant diversity in clinical trials of therapeutics in rheumatology is important to understand how persons of different races and ethnicities might respond differently to therapeutics. Specifically, for psoriatic arthritis (PsA), although people of color (POC) have lower disease prevalence, prevalence still ranges from 0.04-0.19% in Blacks, 0.13-0.19% in Asians, and 0.09-0.30% in Hispanics versus 0.19-0.34% in Whites in the insured population of the US1. Literature on the diversity of PsA clinical trials remains limited, though data suggest that minorities are underrepresented in clinical trials2. This analysis aims to evaluate the diversity of participants in randomized clinical trials (RCTs) of US Food and Drug Administration approved targeted therapies for PsA.ObjectivesTo evaluate the reporting of race and ethnicity in published RCTs of targeted therapeutics approved for the treatment of PsA in the US.MethodsTargeted therapies approved for use in the treatment of PsA in the US were identified. Package inserts and ClinicalTrials.gov (CT.gov) were used to identify the pivotal double blind, RCTs in PsA which supported the approval of the identified therapeutics in the US. The articles reporting the primary endpoint data were obtained. Race and ethnicity data were extracted from the published data. Countries in which the studies were conducted were identified from the publications or CT.gov. Descriptive analyses were performed.ResultsTwenty-nine pivotal RCTs in PsA evaluating targeted therapeutics, published from 2002 – 2022, were identified; 24 reported race; non-White race was reported in only 13 (45%) (Table 1 and Figure 1). In the latter, people of Black race comprised <1% of the overall population in 12 RCTs and 2.7% in the remaining RCT. People of Asian race comprised 6.1% of the overall population reflecting <10% of the population in 11 studies and 11.3% and 19.0% in the remaining 2 studies. Overall, 19 (65.6%) trials recruited participants from Asia Pacific countries. Hispanic/Latinx ethnicity was not reported in any study. Studies published from 2017-2022 reported non-White race (n=7 of 15 [47%]) no more frequently than studies published from 2004-2016 (n=6 of 14 [43%]). Although the 13 RCTs reporting non-White race may not reflect unique individuals, the total number of people included across these RCTs was 7261, of which 48 (0.7%), 441 (6.1%), and 6598 (90.9%) were Black, Asian, and White, respectively.Table 1.Race Reporting in Psoriatic Arthritis Pivotal Clinical Trials of Targeted TherapeuticsRace Reporting StatusTotal Trials (N)Trials which recruited in AP countries(n [% of N])Total Participants (N)White (n [% of N])Black (n [% of N])Asian (n [% of N])Other* (n [% of N])Not reported51 (20.0)1572----Non-White race reported1313 (44.8)72616598 (90.9)48 (0.7)441 (6.1)172 (2.4)Non-White race not reported115 (45.5)65885803 (88.1)---Total (N)2919 (65.5)15421----Abbreviations: AP, Asia Pacific; N and n, number.*Other also includes American Indian/Alaskan Native, mixed race, unknown raceNote: Numbers across rows may not add up to 0, and the total number of individuals reported in any one group may not be unique. Dashes reflect data not provided or able to be calculated.ConclusionOur data show under-reporting of race and ethnicity in publications of pivotal PsA RCTs, and no evidence of improved reporting over time. Whites were overrepresented in pivotal trials of PsA, especially when considering 72 and 62% of the US population was White in 2010 and 2020 (US Census data), respectively, and the reported prevalence of PsA by race in the insured population of the US1. Improved reporting of race/ethnicity and increased representation of racial/ethnic minorities in PsA RCTs are needed.References[1]Ogdie A, et al. Rheumatol Ther. 2021;8(4):1725-39.[2]https://trialfacts.com/diversity-inclusion/ accessed 22 Aug 2021Disclosure of InterestsNiti Goel Shareholder of: UCB, Abcuro, Employee of: Abcuro

Full Text

Duke Authors

Cited Authors

  • Goel, N

Published Date

  • June 2022

Published In

Volume / Issue

  • 81 / Suppl 1

Start / End Page

  • 1604.2 - 1605

Published By

Electronic International Standard Serial Number (EISSN)

  • 1468-2060

International Standard Serial Number (ISSN)

  • 0003-4967

Digital Object Identifier (DOI)

  • 10.1136/annrheumdis-2022-eular.4524