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Introduction:Immune tolerance induction (ITI) is the only treatment to eradicate inhibitors in people with severe hemophilia A with inhibitors (PwSHAi). An earlier study reported lower receipt of ITI treatment in non-Hispanic (NH) Black and Hispanic compared to NH White PwSHAi (Kempton CL, 2022). Since risk of inhibitor development is greater among Black and Hispanic persons with hemophilia, it has been hypothesized that race and ethnicity may impact the success of ITI. Limited studies have evaluated this hypothesis. This study examined the success of ITI by race and ethnicity among PwSHAi in the Community Counts (CC) Registry between 2013-2017 in the United States (US).

Background: Racial and ethnic representativeness in clinical trials is a crucial step to mitigate disparities in outcomes. In 2017, the United States (US) Food and Drug Administration (FDA) issued a final ruling requiring trial sponsors to report race/ethnicity data to the clinicaltrials.gov registry. Black and Hispanic persons are underrepresented in clinical trials for several diseases, including hematologic malignancies (Hantel, Luskin et al. 2021). However, the reporting and representation of race and ethnicity for hemophilia interventional trials is unknown. Congenital Hemophilia is a rare bleeding disorder for which there have been significant treatment advances leading to substantial gains in life expectancy and improvements in quality of life for those with access to treatment. The aims of the current study are to assess 1) the frequency of race and ethnicity reporting; and 2) the racial and ethnic distribution of participants in interventional clinical trials enrolling persons with hemophilia (PwH).