Systematic lupus erythematosus (SLE) is a disease that is more prevalent in people of Black African ancestry and Hispanic/Latino ethnicity than in other populations, yet significant gaps in representation continue to exist in lupus clinical trials. Now, a new article published by the American College of Rheumatology highlights the importance of addressing these gaps and recommends strategies to help improve diversity in lupus research moving forward.
The researchers report:
- White patients constitute 33% of SLE cases but are overrepresented in SLE randomized controlled trials (RCTs), representing 51% of participants in these types of studies.
- Black/African American patients make up 43% of SLE cases but are underrepresented in clinical trials, comprising only 14% of RCT participants.
Clinical trials investigating the lupus medication belimumab offer a telling example. While belimumab was found to be effective in the first phases of clinical trials in the general population, it yielded inconsistent results for people of Black African ancestry. Due to these mixed findings, the FDA requested a product label advising healthcare providers to practice caution when prescribing belimumab to people of Black/African American race.
To better understand these discrepancies, the Food and Drug Administration conducted a new study: the Efficacy and Safety of Belimumab in Black Race Patients with SLE (EMBRACE) study. The EMBRACE study specifically assessed the efficacy and safety of belimumab in self-identified Black population and found the drug was actually effective enough to warrant removing the cautionary statement from the product label. The EMBRACE study is important because it showcases the challenges and consequences of underrepresentation in clinical trial recruitment – without enough people of diverse racial and ethnic backgrounds enrolled in a clinical trial, it’s difficult to determine how safe and effective a treatment is for those populations.
To overcome these issues moving forward, the researchers recommend strategies for conducting well-designed clinical trials, calling for further guidance, transparency and pretrial discussions and consensus with regulatory agencies to ensure future lupus studies reflect the true population living with the disease. The Lupus Foundation of America (LFA) has long been committed to helping improve representation in lupus clinical trials. More than a decade ago, the LFA and lupus advocates worked with Congress to secure funding for the Office on Minority Health (OMH) where the National Lupus Outreach and Clinical Trial Education Program was established. Since that time, Congress has provided more than $20 million in funding to support minority participation in lupus clinical trials. And just last year, the LFA worked with the OMH to launch an updated program called Improving Minority Participation and Awareness in Clinical Trials (IMPACT+). The LFA also has an online lupus data platform called “Research Accelerated by You” (RAY), where people with lupus and caregivers share information about their lupus experience to increase the understanding of lupus and help drug developers enhance clinical trials, accelerating the potential for new lupus therapies.
Learn more about RAY’s patient-powered approach to research.
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