DOP007 Change in Histological inflammation in patients with ulcerative colitis treated with vedolizumab: Results from the continuing VERDICT trial
Authors: Jairath V , Peyrin-Biroulet L , Magro F , Zou G , Adsul S , Colombel J F , D’Haens G R , Freire M , Moran G W , Sebastian S , Travis S , Vermeire S , Hanžel J , Ma C , Sedano R , Sheridan P , Arya N , Beaton M , Bossuyt P , Danese S , Green D , Horynski M , Kierkus J , Kopoń A , Klopocka M , Petroniene R , Wolanski L , Silverberg M S , Feagan B G 
Published: January 2025

Background

Ulcerative colitis (UC) treatment targets include symptomatic, endoscopic, or histologic remission. The aim of the continuing VERDICT trial (NCT04259138) is to determine the optimal treatment target in patients with moderately-to-severely active UC.1,2 Patients follow treatment algorithms involving early introduction of vedolizumab (VDZ). In this analysis, we report changes in histology indices: Nancy index (NI), Robarts Histopathological index (RHI) and Geboes score from baseline to weeks 16, 32 and 48 in patients for whom histologic remission was included as a treatment target.

Methods

Patients received VDZ 300 mg IV, as per a treatment algorithm related to baseline UC treatment, until assigned treatment target was reached, with escalation steps between week 16,32 and 48, as indicated. Treatment target groups 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 ≤1, and CSF histologic remission was defined as Geboes score&lt;2B.0. For this analysis, we report the findings for Group 3, the only group with histologic remission included as a treatment target.

Results

At the interim data cutoff point for this analysis 672 patients were enrolled, with 265 patients in Group 3. Histologic scores improved by Week 16, with mean changes from baseline in NI of -1.4, and changes in RHI of -9.0. Histologic improvements continued to increase incrementally at Weeks 32 and 48 (Table). By Week 48, mean change from baseline in NI was -1.9 (Table). For RHI, mean change from baseline to Week 48 was -12.2. For both NI and RHI, mean change from baseline to Week 48 was greater in bionaïve than bio-exposed patients (Table). Histologic remission assessments were similar for NI, RHI, and Geboes score, with 50% of patients achieving corticosteroid-free histologic remission at Week 16, and 66.7% at Week 48 (Figure).

Conclusion

Vedolizumab treatment was associated with rates of corticosteroid-free histologic remission that were evident as early as Week 16 and increased incrementally through to Week 48, when it reached two thirds. The magnitude of histologic improvement was similar for all three scoring methods.

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.