DOP050 Target achievement after 48 weeks of vedolizumab treatment in patients with moderate to severe Ulcerative Colitis: An interim analysis from the VERDICT trial
Authors: Jairath V , 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 , Magro F , Petroniene R , Wolanski L , Silverberg M S , Peyrin-Biroulet L , Feagan B G 
Published: January 2025

Background

The VERDICT study is a continuing, randomised controlled trial (NCT04259138)1-3 with a goal of determining the optimal treatment target for patients with moderate to severe ulcerative colitis (UC) by comparing 3 groups: Group 1 (corticosteroid-free [CSF] symptomatic remission); Group 2 (CSF symptomatic remission + CSF endoscopic remission); Group 3 (CSF symptomatic remission + CSF endoscopic remission + CSF histologic remission, also termed as disease clearance). This interim analysis reports target achievement up to week 48.

Methods

Following a treatment algorithm related to baseline UC treatment, vedolizumab (VDZ) 300 mg was administered intravenously until assigned treatment target was reached at week 48. 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&lt;2B.0. Patients reaching CSF remission are considered to maintain remission at future visits.

Results

As of 05SEP2024, 672 patients were enrolled with 185, 222, and 265 patients assigned to Groups 1, 2, and 3, respectively. Baseline age, disease duration, and proportion of patients with MES=3 were similar amongst groups. Concomitant corticosteroids were received by 43.2%, 40.1%, 50.6% of patients, respectively (median dose 25.5, 25.3, 23.8 mg) and baseline MES=3 was similar across all 3 groups (60.0%, 61.7%, 65.3%). Bionaïve patients comprised 71.9%, 77.5%, 83.4% of patients in Groups 1, 2, and 3, respectively.

In patients with observed data and a week 32 visit, 80.7% (92/114), 63.0% (97/154), and 53.3% (113/212) achieved CSF remission at week 32. In patients with observed data and a week 48 visit, 90.3% (84/93), 77.3% (102/132), 67.2% (123/183) achieved CSF remission by week 48, with higher proportions in bionaïve (70.1%) compared to bio-exposed (50.0%) for Group 3 (Figure 1).

In the intention-to-treat population, 49.7%, 43.7%, and 42.6% of patients, respectively, achieved CSF remission at week 32, with higher proportions in patients who were bionaïve (45.7%) compared to bio-exposed (27.3%) in Group 3. By week 48, 45.4% (84/185), 45.9% (102/222), and 46.4% (123/265) of patients achieved CSF remission, with higher proportions with bionaïve (49.8% [110/221]) versus bio-exposed (29.5% [13/44]) in Group 3. At time of analysis, 50.3%, 59.5%, 69.1% of randomised patients had completed the week 48 visit.

Conclusion

These interim week 48 results provide evidence of improvement from week 32 to 48 across all endpoints and continue to support the efficacy of VDZ in achieving the stringent endpoint of CSF disease clearance. 96-week follow-up for all patients in the trial will be complete March 2026.

References

1Jairath V, Zou G, Wang Z, et al. Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial. BMJ Open Gastroenterol. 2024;11:e001218. Doi:10.1136/bmjgast-2023-001218

2Jairath V, Zou G, Adsul S, et al. 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. J Crohns Colitis. 2024;18 (Suppl 1):i92-i93. Doi: 10.1093/ecco-jcc/jjad212.0051

3Jairath V, Zou G, Adsul S, et al. PP0556 Target achievement after 32 weeks of vedolizumab treatment in patients with moderate to severe ulcerative colitis: An interim analysis from the VERDICT trial. UEG Week 2024 Poster Presentations. United European Gastroenterol J. 2024;12:665-1360. Doi: 10.1002/ueg2.12615