P1959 - Efficacy and Safety of Prucalopride in Patients With Chronic Idiopathic Constipation From Different Racial and Ethnic Groups: A Post Hoc Analysis of Phase 3 and 4 Clinical Study Data

Anthony Lembo, MD¹, Kyle Staller, MD, MPH², Brian Terreri, PharmD, MBA³, Brooks D Cash, MD, FACG⁴, Paul Feuerstadt, MD, FACG⁵, André Gabriel, MS, MD⁶, William Spalding, MS⁷, Yaping Wan, MS⁶, Yunlong Xie, PhD⁶, Ashraf Youssef, MD, PhD, MBA⁸, Mena Boules, MD^3
1Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, OH; ²Massachusetts General Hospital, Boston, MA; ³Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA; ⁴University of Texas Health Science Center at Houston, Houston, TX; ⁵PACT Gastroenterology Center and Yale School of Medicine, Hamden, CT; ⁶Takeda Development Center Americas, Inc., Cambridge, MA; ⁷Takeda Development Center Americas, Inc., Lexington, MA; ⁸Takeda Pharmaceuticals U.S.A., Inc., Cambridge, MA

Introduction: Although racial and ethnic minority groups are disproportionately affected by constipation in the USA, they are underrepresented in clinical studies. This post hoc analysis aimed to evaluate the efficacy and safety of prucalopride in patients with chronic idiopathic constipation (CIC) stratified by different racial and ethnic groups.

Methods: Data from six key phase 3–4 randomized, double-blind, placebo-controlled studies of prucalopride (1 or 2 mg once daily) over 12 weeks were pooled. Patients with CIC were stratified by physician-reported race or ethnicity (Asian, Black or African American, Hispanic, White, other and missing information). The prespecified primary endpoint was the proportion of patients with a mean frequency of ≥3 complete spontaneous bowel movements per week over weeks 1–12. Safety data were evaluated descriptively.

Results: Of the 2484 patients included in the full analysis set (mean age, 47.4 years; 76.0% female), 478 (19.2%) were Asian, 78 (3.1%) were Black or African American, 19 (0.8%) were Hispanic and 1857 (74.8%) were White. Patient demographics and baseline characteristics are shown in the Table. A total of 34 patients (1.4%) reported their race or ethnicity as ‘other’; for 18 patients (0.7%) this information was missing. These two groups were not analyzed further. Within each racial and ethnic group, a numerically greater proportion of prucalopride-treated patients achieved the primary efficacy endpoint compared with placebo (Asian: 32.8% vs 10.5%; Black or African American: 17.4% vs 9.4%; Hispanic: 12.5% vs 0.0%; White: 27.8% vs 14.3%; Fig. A). The proportions of prucalopride-treated patients with treatment-related treatment-emergent adverse events (TEAEs) were similar across all racial and ethnic groups (Asian: 36.1%; Black or African American: 37.0%; Hispanic: 37.5%; White: 36.3%) and were higher than for placebo (Fig. B). However, most TEAEs were unrelated to the study drug and were mild or moderate in severity across each racial and ethnic group analyzed (Fig. B).

Discussion: Efficacy and safety outcomes for prucalopride in patients with CIC were similar across the racial and ethnic groups analyzed; however, this analysis was limited by the small numbers of Black or African American and Hispanic patients recruited into the original studies. This may affect the generalizability of the results and highlights the need to recruit more diverse and representative patient populations in future clinical studies.



Disclosures:


Anthony Lembo, MD¹, Kyle Staller, MD, MPH², Brian Terreri, PharmD, MBA³, Brooks D Cash, MD, FACG⁴, Paul Feuerstadt, MD, FACG⁵, André Gabriel, MS, MD⁶, William Spalding, MS⁷, Yaping Wan, MS⁶, Yunlong Xie, PhD⁶, Ashraf Youssef, MD, PhD, MBA⁸, Mena Boules, MD³. P1959 - Efficacy and Safety of Prucalopride in Patients With Chronic Idiopathic Constipation From Different Racial and Ethnic Groups: A Post Hoc Analysis of Phase 3 and 4 Clinical Study Data, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.