DOP11 Disease clearance after 16 weeks of treatment with vedolizumab in patients with moderate to severe Ulcerative Colitis: An interim analysis from the VERDICT trial

Abstract

Abstract Background Disease clearance in ulcerative colitis (UC) is defined as concurrent achievement of clinical, endoscopic, and histologic remission.1 Regardless of the drug used in clinical trials, no more than 20% of patients reach disease clearance after 1 year; thus, it is a high bar to achieve with a potential for disease modification.2 VERDICT is a continuing, randomised, controlled trial (NCT04259138) with a primary objective of determining the optimal treatment target in moderately-to-severely active UC, by comparing target Group 1 (corticosteroid-free [CSF] symptomatic remission), target Group 2 (CSF symptomatic remission + endoscopic improvement), and target Group 3 (CSF symptomatic remission + endoscopic improvement + histologic remission). Patients follow treatment algorithms that feature early introduction of vedolizumab (VDZ) with no dose escalation before week 16 and no week 10 dosing. Here we report the achievement of CSF disease clearance at week 16 in Group 3. Methods CSF disease clearance was defined as achievement of a CSF Mayo rectal bleeding subscore=0 + endoscopic improvement (Mayo Endoscopic Score [MES] ≤1) + histologic remission (Geboes score <2B.0). VDZ 300 mg was administered intravenously following a treatment algorithm based upon baseline UC treatment until assigned treatment target was reached at week 16. Results are summarized overall and by bio-exposure status. Results As of 18 Aug 2023, 553 patients were enrolled in VERDICT with 253 assigned to target Group 3. The group had a mean age of 41.2 years (standard deviation [SD] 14.3), mean disease duration of 7.3 years (SD 7.8), and 42% were female (Table). In total, 216 (85%) were bionaïve, 159 (63%) had a baseline MES of 3, and 129 (51%) were receiving concomitant corticosteroids. Figure 1 shows the breakdown of the 253 patients. At time of analysis, remission target status was unavailable for 30 bionaïve and 11 bio-exposed patients. Among the 212 patients with observed data, 86 (41%) achieved CSF remission, including 77 (41%) of the 186 bionaïve patients with data and 9 (35%) of the 26 bio-exposed patients with data. Corresponding values of achieving CSF disease clearance in the intention-to-treat population were 34% (86/253), 36% (77/216), and 24% (9/37), respectively. All patients with disease clearance were receiving VDZ treatment from baseline. Conclusion At week 16, 41% of patients enrolled in the target group of CSF symptomatic remission + endoscopic improvement + histologic remission had achieved CSF disease clearance, with a numerically higher percentage in bionaïve compared to bio-exposed. References 1 D’Amico et al. Inflamm Bowel Dis. 2023 doi:10.1093/ibd/izad1592. 2 Colombel et al. Gastroenterol Hepatol. 2021;17:233