DOP094 Improvement in biomarkers in patients with ulcerative colitis treated with vedolizumab: Results from the continuing VERDICT trial

Abstract Background Treatment targets in ulcerative colitis (UC) include symptomatic remission, endoscopic remission, and histologic remission. The ongoing VERDICT trial (NCT04259138) aims to determine the optimal treatment target in patients with moderately-to-severely active UC.1,2 Patients follow treatment algorithms involving early use of vedolizumab (VDZ). Here we report biomarker changes (fecal calprotectin [FCP] and C-reactive protein [CRP]) from baseline to weeks 8, 16, 32 and 48. Methods VDZ 300 mg was administered intravenously following a treatment algorithm related to baseline UC treatment until assigned treatment target was reached, with an escalation step between week 16, 32 and 48 as indicated. Treatment targets were as follows: Group 1 (corticosteroid-free [CSF] symptomatic remission), Group 2 (CSF symptomatic remission + CSF endoscopic remission), and Group 3 (CSF symptomatic remission + CSF endoscopic remission + CSF histologic remission, also termed disease clearance). CSF symptomatic remission was defined as Mayo rectal bleeding subscore=0, CSF endoscopic remission was defined as Mayo Endoscopic Score [MES]≤1, and CSF histologic remission was defined as Geboes score<2B.0. Biomarker assessments included FCP and CRP at weeks 8, 16, 32, and 48. Biomarker remission was defined as FCP ≤250 mg/kg and CRP ≤5 mg/l. Results As of 1st October 2024, 672 patients were enrolled, with 185, 222, and 265 patients in Groups 1, 2, and 3, respectively. Biomarkers improved from baseline to Week 16 and incrementally through to Week 48 (Table). Mean changes from baseline to Week 48 in FCP in groups 1, 2, and 3 were: -1268.8 mg/kg, -1515.9 mg/kg, and -1230.1 mg/kg (Table). For CRP, mean changes from baseline to Week 48 were -1.5 mg/l (Group 1), -3.4 mg/l (Group 2), and -1.8 mg/l (Group 3). For FCP, mean changes to Week 48 in all 3 groups were greater in bio-exposed than bionaïve patients, whereas mean change in CRP was greater in bio-exposed patients in Group 1 only (Table). In patients who achieved biomarker remission (FCP≤ 250 mg/kg + CRP ≤5 mg/l) at Week 48, the proportions who had met their treatment target were 51.6% (Group 1), 57.1% (Group 2), and 48.6% (Group 3) [Figure]. Higher baseline FCP was associated with lower odds of histologic remission at Week 16, 32, and 48, with corresponding odds ratios (95% CI) for histologic remission per 100 µg/g increase of baseline FCP of 0.89 (0.86, 0.93), 0.89 (0.86, 0.93), and 0.82 (0.76, 0.87). Conclusion Biomarker data from VERDICT shows improvements in FCP and CRP concentrations from baseline to Week 16, with incremental improvements through to Week 48. Almost half or more of all patients who achieved biomarker remission achieved their assigned treatment target. References 1.Jairath et al., 2024. Doi:10.1136/bmjgast-2023-001218 2.Jairath et al., 2024. Doi: 10.1093/ecco-jcc/jjad212.0051 Funding The VERDICT trial is a collaborative study between Alimentiv and Takeda. Acknowledgements We thank the patients who participated in the trial, their caregivers, and the study investigators and members of the VERDICT study team. Medical writing support was provided by Paul Hassan, PhD, of Envision Pharma Group, and was funded by Takeda.

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