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

Abstract

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-naïve 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.

Keywords: LOVE-UC Trial; anti-integrin; biologic; inflammatory bowel disease.