P1212 Effectiveness of Vedolizumab to Reduce Bowel Urgency in a Canadian Real-World Ulcerative Colitis Cohort

Abstract Background Vedolizumab is a gut-selective anti-lymphocyte trafficking drug indicated for the treatment of moderately to severely active ulcerative colitis (UC). Bowel urgency, the immediate or sudden need to have a bowel movement, is a common symptom in UC, that reduces quality of life. We are assessing this emerging and important patient-reported outcome among patients treated with vedolizumab in a real-world cohort. Methods This is a retrospective, non-interventional study using data collected as part of the Canadian Takeda Patient Support Program (PSP). Included patients were aged ≥18 years at vedolizumab initiation, consented to secondary use of data and had moderately to severely active UC with an Urgency Numeric Rating Scale (UNRS) score available at baseline. We report the point and percentage reduction from baseline in UNRS 6 weeks following vedolizumab initiation and the association between bowel urgency clinically meaningful improvement (CMI) and clinical remission and response at Week 6, among UC patients with UNRS ≥3 at baseline. Bowel urgency CMI was defined as change from baseline UNRS ≥3 in patients with UNRS ≥3 at treatment baseline. Clinical response was defined as partial Mayo score (pMayo) decrease of ≥2 points and ≥25% from baseline, remission was defined as a score <3. Association between bowel urgency and clinical outcomes was assessed using Fisher’s exact and chi-squared tests with significance specified by a two-sided p-value of <0.05. Results 87 patients with UC (84% bio-naïve) were eligible. Median age was 44 years (Q1, Q3: 32, 60) and 54% of patients were female. Median baseline UNRS was 7 (Q1, Q3: 3, 8), median pMayo was 7 (Q1, Q3: 6, 8). Disease duration prior to vedolizumab was 5 years (Q1, Q3: 1, 14). Overall, patients with baseline UNRS ≥3 (83% of patients) experienced a median reduction of 3 points from baseline to Week 6 (IQR: 2–8), equating to 60% reduction from baseline (IQR: 20, 100) (Table 1). At 2 and 6 weeks, 39% and 61% of patients experienced bowel urgency CMI, respectively. Notably, there was a significant association between bowel urgency CMI at Week 6 and clinical outcomes (Table 2): patients in bowel urgency CMI were more likely to be in remission when compared to those not in bowel urgency CMI (68% vs. 35%, p=0.009), and more likely to be in response (95% vs. 73%, p=0.023). Conclusion Following 6 weeks of vedolizumab induction treatment, bowel urgency decreased from baseline by 60% in patients with moderate to severe UC. Furthermore, bowel urgency CMI was significantly associated with improved clinical outcomes. This study demonstrated the effectiveness of vedolizumab in early reduction of bowel urgency among a real-world cohort of Canadian patients.

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