P854 Race and ethnicity in ulcerative colitis clinical trial enrolment: a post hoc analysis of patient demographics and clinical characteristics from GEMINI 1, VARSITY, and VISIBLE 1

Abstract

Background The incidence of inflammatory bowel disease (IBD) has risen among Black individuals and Hispanic or Latino individuals in the USA in recent decades; however, these patients are underrepresented in clinical trials of IBD therapies. We aimed to perform a post hoc analysis of the baseline demographics and clinical characteristics in three phase 3 clinical trials of vedolizumab for ulcerative colitis (UC) to identify differences between racial and ethnic groups. Methods The baseline demographics and clinical characteristics of patients with UC who were enrolled in GEMINI 1, VARSITY, and VISIBLE 1 were pooled and stratified by race and ethnicity, which were self-reported. The inclusion criteria for these trials included adult patients with moderately to severely active UC who had a prior inadequate treatment response, loss of response, or intolerance to conventional therapies or anti-tumour necrosis factor α treatment. Data were analysed using descriptive statistics, with mean or median values calculated for continuous variables, and the number and proportion of patients reported for categorical variables. T-tests and exact tests were used to compare continuous and categorical variables, respectively, between Black and White patients and between Hispanic or Latino patients and those who were not Hispanic or Latino. Results We included 1,358 patients, of whom 1,171 (86.2%) were White, 148 (10.9%) were Asian, 14 (1.0%) were Black, and 25 (1.8%) were of multiple or unspecified racial groups (Table 1). Black patients had significantly higher mean weight (87.9 kg vs 74.8 kg, p < 0.01) and body mass index (30.5 kg/m2 vs 25.2 kg/m2, p < 0.01), but lower albumin (38.5 g/L vs 41.2 g/L, p < 0.05) and haemoglobin levels (115.5 g/L vs 126.1 g/L, p < 0.05) than White patients (Table 1). Ethnicity data were recorded for 465 patients (34.2%). Hispanic or Latino patients were shorter in height (166.6 cm vs 171.0 cm, p < 0.01) and had shorter mean disease duration (4.6 years vs 7.6 years, p < 0.01) than those who were not Hispanic or Latino (Table 2). A non-significant, but numerically greater proportion of Hispanic or Latino patients had pancolitis than those who were not Hispanic or Latino (50.0% vs 35.8%). Conclusion In this post hoc analysis of vedolizumab clinical trials, Black patients and Hispanic or Latino patients with UC had differences in certain demographic and disease characteristics versus White patients and patients who were not Hispanic or Latino, respectively. These differences may have implications for therapy. Thus, inclusion of a more diverse patient population that reflects the demographics of the general population is warranted to adequately ascertain drug efficacy across racial and ethnic groups.