The State of Lupus Clinical Trials: Minority Participation Needed.

Saira Z Sheikh,Kristen D Holtz,Nicole I Wanty,Sheryl Mccalla,Joncel Stephens

doi:10.3390/jcm8081245

Abstract

In the United States, the reported prevalence of lupus is 100,000 to 500,000 patients. Lupus disproportionately affects minority populations, including African Americans and Latinos, and the associated health disparities are substantial. Women are at a higher risk of lupus than men and lupus prevalence is the highest in African Americans and Latinos compared to non-Hispanic whites. African Americans and Latinos also have increased disease symptom severity, experience more lupus-related complications, and have a two- to three-fold mortality rate compared to non-Hispanic Whites. Lupus clinical trials offer opportunities for quality care and can result in new treatment options, but African Americans and Latinos are underrepresented in clinical trials because of substantial patient- and provider-side barriers. In conjunction with the limited knowledge of clinical trials that potential participants may have, the healthcare staff approaching participants have limited time to adequately educate and explain the aspects of clinical trials. Indeed, ninety percent of clinical trials fail to meet their recruitment goals on time, so a multi-faceted approach is necessary to address the issue of low minority participation in clinical trials.

Highlights

Lupus disproportionately affects minority populations, including African Americans and Latinos
There is no cure for lupus [9] and cutaneous lupus can result in permanent and disfiguring effects or irreversible damage to the skin
Clinical trials offer promise and potentially new therapeutic options for patients living with aggressive dermatologic involvement in lupus

Summary

Introduction

Lupus disproportionately affects minority populations, including African Americans and Latinos. African Americans represent approximately 12 percent of the U.S population, but only 5 percent of clinical trial participants [12]. Low minority participation in lupus clinical trials results in a lack of data on the effectiveness, safety, and side effects of treatment within populations with the highest incidence, prevalence, morbidity, and mortality [13]. Human Genome Sciences and GlaxoSmithKline conducted an international belimumab Phase IV clinical trial with African Americans and other patients of Black race [14,16]. Researchers noted that the inclusion of Latinos in RCTs has increased over time to 16 percent of lupus cases and 21 percent of RCT enrollees, but new sites in Latin American countries may have contributed to this increase [17]. Diverse study populations for clinical trials can improve the generalization of findings on the efficacy, side effects, and risk of medications, helping patients make better treatment decisions with their provider and improving health outcomes overall

Addressing the Problem by Increasing Minority Participation

Findings

Future Directions