EMBRACE: One Small Story in Lupus-One Giant Challenge in Clinical Trials.

ABSTRACT: Clinical trials of novel therapeutics in the United States have not been adequately representative of diverse populations, particularly racial and ethnic minorities. The challenges and consequences of underrepresentation in clinical trial recruitment are exemplified by the case of belimumab, a biologic treatment for systemic lupus erythematosus (SLE), a disease that is more prevalent in patients of Black African ancestry and of Hispanic/Latino ethnicity than in other patient populations. Although belimumab was found to be effective in phase 2 and 3 clinical trials in the general population, post hoc analyses of efficacy data in patients of Black African ancestry showed inconsistent results. Consequently, a cautionary statement regarding belimumab use in this population was added to the pro

SUBMITTER: Sheikh SZ 

PROVIDER: S-EPMC9469483 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature