Black, Hispanic patients underrepresented in PsA clinical trials
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PHILADELPHIA — Non-Hispanic white patients are overrepresented while Black and Hispanic patients are underrepresented in pivotal psoriatic arthritic clinical trials, according to data presented at ACR Convergence 2022.
“Understanding participant diversity and enrolling patients of diverse backgrounds in clinical trials is important to better understand whether or not the therapies we offer our patients work as well in people of color or people of different ethnicities than they do in the white population,” Niti Goel, MD, FACR, senior vice president and therapeutic area head of rheumatology at TrialSpark, Inc. and adjunct assistant professor of medicine at Duke University School of Medicine, said during a presentation. “Especially since psoriatic arthritis is present in about half the prevalence rate in Blacks and Hispanics than it is in whites.”
There are currently 36 approved targeted therapies for PsA in the United States, according to the poster. Therefore, the analysis included 36 trials that were identified from package inserts as well as ClinicalTrials.gov. Goel reviewed primary endpoint data, where available, and race and ethnicity data were pulled from the published data or from summary basis of approval documents posted on FDA.gov and/or from CT.gov.
Of the 36 phase III randomized control trials, 35 were published from 2004 to 2022 and 27 reported race data in a publication. A total of 15 publications reported details of "non-white” race, with 14 reporting data on Black race, and 15 reporting on Asian and other races. Goel was able to obtain data on white race for five of the nine studies missing data and “non-white” race for 15 of 21 studies missing data. Furthermore, Hispanic and Latinx ethnicity data were not reported in any publications, but were found in government sources for 12 studies, according to the poster.
“In general, race and ethnicity are underreported in publications of psoriatic arthritis randomized clinical trials,” Goel said. “However, additional data can be obtained from government sources. However, in order for individuals to do analyses, or meta-analyses for how therapeutics may work across diverse individuals, these data should be provided in the publications of the trials.”
For all 36 studies, 17,632 individuals were studied, but for the 29 trials where data was available for white, Black, Asian or other categories, 15,323 individuals were studied.
Of the known studied populations, 0.6% (n = 89) were Black, 4.6% (n = 706) were Asian, and 2.5% (n = 388) were “other.” Of the 12 trials with available ethnicity data, 13.2% was Hispanic/Latinx.
Among the 29 trials that had available data on Black race, Black individuals comprised less than 1% of the enrolled population, with nine trials reporting no Black individuals enrolled. According to the poster, only one trial reported Black individuals at 2.7% of the enrolled population. Data on Asian race was reported in 30 trials, with Asian individuals comprising less than 5% of the enrolled individuals, and two studies reporting enrolling no participants of Asian race.
Data was also analyzed to determine any improvement in reporting or recruitment of diverse individuals in later studies, conducted from 2017 to 2022, compared with earlier studies, conducted from 2004 to 2016. Goel found that later studies reported “non-white race” data with 60% frequency compared with 56% in earlier studies. However, reporting of white race data showed a potential improvement, from 20% in early studies compared with 31% in later studies.
When assessing reporting on Hispanic and Latinx ethnicity data, Goel found an improvement from 13% in earlier studies to 50% in later studies. However, the percentage of “non-white race” individuals who were enrolled in clinical trials from 2017 to 2022 did not “noticeably improve,” according to the poster.
Goel also highlighted that of the 11 articles published in U.S.-based journals, two reported no racial data and only two published details on “non-white race” data. There were 24 articles published in journals outside of the U.S. and while six reported no racial data, 12 reported details on “non-white race” data.
“Even when the data have been reported ... whites were overrepresented in phase 3 clinical trials of psoriatic arthritis when compared to trials that were the basis of approvals of all new therapeutics approved in 2020 in the United States,” Goel said. “This overrepresentation is notable and efforts to increase the reporting of race and ethnicity, as well as adequate representation of racial and ethnic minorities in psoriatic arthritis clinical trials are needed.”
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Goel N. Abstract 0090. Presented at: ACR Convergence 2022; November 11-14, 2022; Philadelphia (hybrid meeting).
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