Early Versus Late Use of Vedolizumab in Ulcerative Colitis: Clinical, Endoscopic, and Histological Outcomes

Background and Aims: We explored the potential for differential efficacy of vedolizumab between early and late ulcerative colitis [UC] with evaluation of clinical, endoscopic, and histological endpoints. Methods: This was a multicentre, multinational, open-label study in patients with moderately-to-severely active UC, defining early UC by a disease duration <4 years and bio-naive and late UC by a disease duration > 4 years and additional exposure to tumour necrosis factor antagonists. Patients received standard treatment with intravenous vedolizumab for 52 weeks [300 mg Weeks 0, 2, 6, every 8 weeks thereafter without escalation]. The primary endpoint was corticosteroid-free clinical remission with endoscopic improvement [total Mayo score <= 2 with no subscore >1] at both Weeks 26 and 52. Results: A total of 121 patients were included: in the early group, 25/59 [42.4%] achieved the primary endpoint versus 19/62 [30.6%] in the late group [p = 0.18]. There were no significant differences between the two groups in endoscopic improvement [Week 26: early 32/59 [54.2%] versus late 29/62 [46.8%]; p = 0.412; Week 52: 27/59 [45.8%] versus 25/62 [40.3%]; p = 0.546] or in histological remission [Robarts Histopathology Index <3 without neutrophils in the epithelium and lamina propria] [Week 26: 24/59 [40.7%] versus 21/62 [33.9%]; p = 0.439; Week 52: 22/59 [37.3%] versus 22/62 [35.5%]; p = 0.837]. Conclusions: No significant differences in clinical, endoscopic, and histological outcomes were observed between early and late disease.

Automated summary

This study explored the differential efficacy of vedolizumab in early and late ulcerative colitis and evaluated clinical, endoscopic, and histological outcomes. The results showed no significant differences between early and late UC in terms of clinical, endoscopic, and histological improvement.