Low Geographic, Racial Diversity Persists in Myositis Trials

TOPLINE:

A systematic review of randomized clinical trials (RCTs) on idiopathic inflammatory myopathies (IIMs) found that race was not appropriately reported in nearly half of the studies. A geographic analysis showed no trial sites in Africa or South/Central America, with most trials conducted in North America.

METHODOLOGY:

• Researchers conducted a systematic literature review of 19 phase 2, 2b/3, and 3 IIM RCTs published between 2010 and 2023 to assess reporting of race, ethnicity, and sex, as well as geographic disparities in enrolling sites worldwide.
• A total of 1223 participants were included across all RCTs, with a mean of 64.4 participants per trial and a mean age of 53.4 years.
• Trial characteristics included sponsor category, recruitment period (mean, 1336.2 days), number of trial arms, intervention type, and IIM subtype.
• Demographic information (sex, race, and ethnicity), geographical representation in RCTs, and site locations (multicentric trials defined as those having more than one enrolling center) were reported.

TAKEAWAY:

• The distribution of IIM subtypes showed dermatomyositis as the most common (78.9%), followed by polymyositis (57.9%), inclusion body myositis (15.8%), and immune-mediated necrotizing myopathy (5.3%).
• Race was appropriately reported in 11 studies (57.9%), with White participants comprising 75.9%, Black participants 7.1%, Asian participants 18.7%, and multiracial participants 0.2%.
• Reporting practices improved over time, with a higher proportion of RCTs conducted in or after 2020 fully reporting race than those conducted in or before 2019 (72.7% vs 33%), while ethnicity reporting increased from none to 45.5%. Female representation exceeded 45% in 89.5% of trials.
• Overall, 73.7% of the trials were multicentric, with 1-47 centers per trial. Trials were conducted in North America (10 trials), Europe (9 trials), Asia (5 trials), and Australasia (1 trial), but none were conducted in Africa or South/Central America.

IN PRACTICE:

“This study highlights the pressing need to augment collaborative efforts between researchers, patients, and sponsors to repair the current racial, ethnic, and geographic inequity in IIM RCTs,” the authors wrote.

SOURCE:

The study was led by Didem Saygin, MD, Rush University Medical Center, Chicago. It was published online on March 18, 2025, in Arthritis Care & Research.

LIMITATIONS:

The study included a small number of existing RCTs, which may have underpowered the results. The study focused only on pharmaco-intervention trials, potentially not representing non-interventional trials. Additionally, the comparison of race, ethnicity, and sex representation with US census data may not be generalizable to disease and population demographics in other countries.

DISCLOSURES:

This project did not receive dedicated funding support. Some authors disclosed financial relationships with various pharmaceutical companies, including GlaxoSmithKline, Amgen, Sanofi, Fresenius Kabi, and Eli Lilly and Company, as well as organizations such as the Rheumatology Research Foundation, the Vasculitis Foundation, the National Institute for Health and Care Research, and others.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.