E0395 - Racial and Ethnic Diversity in Inflammatory Bowel Disease Randomized Clinical Trials

Tuesday, October 25, 2022

3:00 PM – 5:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

Matt Pelton, MD

Rutgers Robert Wood Johnson University Hospital
Wayne, PA

Matt Pelton, MD¹, Paddy Ssentongo, MD², Kofi Clarke, MD³
¹Rutgers Robert Wood Johnson University Hospital, New Brunswick, NJ; ²Penn State Heatlh, Hershey, PA; ³Penn State Health, Hershey, PA

Introduction: The prevalence of Inflammatory Bowel Disease (IBD) in non-White populations may be higher than previously thought. However, inclusion of patients from underrepresented backgrounds in IBD randomized clinical trials (RCTs) is not well characterized. To address this, we conducted a systematic review of inclusions of race and ethnicity in Phase 2, 3 and 4 RCTs investigating biologic treatments in IBD.

Methods: National and international trials were included if they investigated a biological treatment against at least one other unique treatment arm in patients with Crohn’s Disease (CD), Ulcerative Colitis (UC) or both. Studies with less than fifty patients with IBD were excluded.

Results: Of 111 RCTs that met inclusion criteria, 48.6% of studies did not include information on the racial breakdown of participants and 29.7% included demographics for one race (28 trials reported only White patients, 5 only Asian patients). Multiple racial groups were represented in 22.1% of RCTs. Of these 24 studies, 100% reported White patients, 83.3% reported Black patients, 83.3% reported Asian patients, 16.6% reported Native or Pacific Island patients and 70.8% included patients defined as “Other” (most cases concurrent with reporting of Asian and Black patients).

Across studies with reported racial demographics, participants were 89.1% White, 2.6% Black, 7.6% Asian, 0.7% Native or Pacific Islander (NA/PI) and 2.0% “Other”. Ethnicity was reported in 4.5% of RCTs, in which 1.3% of participants identified as Hispanic or Latino. There was a significant temporal decrease in the proportion of White participants (RR: 0.96 CI 0.92 - 0.99). There were no significant temporal trends in the participation of Black, Asian, NA/PI, “Other” and Hispanic or Latino patients.

Discussion: There is limited inclusion of race and ethnicity in RCTs. When documentation is present, it shows marginalized groups are underrepresented. Ongoing and future RCTs have an opportunity to 1) characterize the racial and ethnic demographics of participants and 2) increase recruitment of participants from underrepresented backgrounds to enhance the generalizability of RCT findings.

Races Reported	Percent of Studies (n=111)	Percent Pre-2010 (n=61)	Percent Post-2010 (n=50)	Crohn’s Disease (n=67)	Ulcerative Colitis (n=45)
None	48.6 (54)	54.1 (33)	42.0 (21)	53.7 (36)	40.0 (18)
One	29.7 (33)	27.9 (17)	32.0 (16)	23.9 (16)	37.8 (17)
Asian Only	4.5 (5)	1.6 (1)	8.0 (4)	1.5 (1)	8.9 (4)
White Only	26.2 (29)	22.8 (14)	30.6 (15)	22.4 (15)	28.9 (13)
Multiple Races	21.7 (24)	18.0 (11)	26.0 (13)	22.4 (15)	37.8 (17)
Two	3.6 (4)	6.6 (4)	0 (0)	1.5 (1)	6.7 (3)
Three	3.6 (4)	3.3 (2)	4.0 (2)	4.5 (3)	2.2 (1)
Four	13.5 (15)	8.2 (5)	20.0 (10)	13.4 (9)	13.3 (6)
Five	0.9 (1)	0 (0)	2.0 (1)	3.0 (2)	0 (0)
Average Racial Breakdown
White	89.1	90.6	87.6	90.3	86.6
Black	2.6	2.7	2.4	5.2	2.1
Asian	7.6	8.4	7.0	5.6	9.9
NA/PI	0.7	0	0.6	0.5	0.6
Other	2.0	2.3	1.8	1.6	2.6
Reports Ethnicity	4.5 (5)	4.9 (3)	4.0 (2)	4.5 (3)	4.4 (2)
Average Hispanic/Latino	1.3	0.5	3.4	1.1	1.7

Table: Table 1: Percent and number of studies reporting racial and ethnic demographics, split by time period and IBD subtype.

Disclosures:

Matt Pelton indicated no relevant financial relationships.

Paddy Ssentongo indicated no relevant financial relationships.

Kofi Clarke: ABBVie – Speakers Bureau. BMS – Advisory Committee/Board Member. Janssen – Consultant, Speakers Bureau. Pfizer – Research grant Review. Takeda – Speakers Bureau.

Matt Pelton, MD¹, Paddy Ssentongo, MD², Kofi Clarke, MD³. E0395 - Racial and Ethnic Diversity in Inflammatory Bowel Disease Randomized Clinical Trials, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.