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Findings were presented in an abstract at ACG 2023, highlighting the importance of addressing bowel urgency in patients with ulcerative colitis.
Results from a posthoc analysis of the phase 2 ARTEMIS-UC trial are calling attention to the impact of PRA023 on health-related symptoms associated with ulcerative colitis (UC).
Presented by Marla Dubinsky, MD, chief of the division of pediatric gastroenterology at Mount Sinai Kravis Children’s Hospital, in an abstract at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting in Vancouver, findings revealed significantly decreased bowel urgency, nocturnal bowel movement, nocturnal waking, and abdominal pain among patients treated with PRA023.
For inclusion, patients were required to have a modified Mayo score of 4-9, centrally read endoscopy subscore ≥2, rectal bleeding subscore ≥1, and history of corticosteroid dependence or insufficient response, loss of response, and/or intolerance to conventional and/or advanced therapies. In total, 135 patients were stratified by prior biologic exposure status and companion diagnostic status and randomized in a 1:1 ratio to receive placebo (n = 67) or intravenous PRA023 (n = 68).
During the trial, participants recorded nocturnal bowel movement and bowel urgency daily with an electronic diary. Bowel urgency during the prior 24 hours was measured using the Urgency Numeric Rating Scale (UNRS). Nocturnal waking and abdominal pain were reported using the Inflammatory Bowel Disease Questionnaire at baseline and week 12. For patients with baseline UNRS ≥3, clinically meaningful improvement was defined as a ≥3-point decrease and bowel urgency remission was defined as a score of ≤1.
Of 127 patients with baseline UNRS ≥3, a significantly greater proportion of patients receiving PRA023 achieved clinically meaningful improvement in bowel urgency (52.4% PRA023 vs 20.3% placebo; ∆32.1%; P = .0002) and bowel urgency remission (22.2% PRA023 vs 3.1% placebo; ∆19.1%; P = .0013) at week 12. Investigators pointed out a significant decrease in bowel urgency and nocturnal bowel movement was observed as early as week 2 and continued to improve throughout the 12-week induction period. Patients treated with PRA023 also experienced greater improvements in nocturnal waking and abdominal pain compared to those treated with placebo (1.74 vs 0.87 and 1.62 vs 0.93, respectively).
In an interview with HCPLive, Dubinsky described the importance of adequately addressing the burdens faced by patients with UC and how clinicians can take this into consideration in practice.
Dubinsky MC, Rubin DT, Rubin DT, Peyrin-Biroulet L, et al. PRA023 Improved Bowel Urgency, Nocturnal Bowel Movement, Nocturnal Waking, and Abdominal Pain in a Phase 2 Trial of Patients with Moderately to Severely Active Ulcerative Colitis. Paper presented at: ACG 2023 Annual Scientific Meeting. Vancouver, Canada. October 20 – 25, 2023.