Vedolizumab as Induction and Maintenance for Inflammatory Bowel Disease: 12-month Effectiveness and Safety

Abstract

Background: Vedolizumab is approved for moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). We present prospective, 1-year data of the real-world effectiveness and safety of vedolizumab in inflammatory bowel disease.

Methods: Consecutive patients receiving vedolizumab for treatment of UC or CD with at least 14 weeks of follow-up, regardless of outcome, were included. Patients had clinical activity scores (Harvey-Bradshaw Index [HBI] or Simple Clinical Colitis Activity Index [SCCAI]) and inflammatory markers prospectively measured at baseline and weeks 14, 30, and 52. Clinical response was defined as a reduction ≥3 in HBI or SCCAI, clinical remission as HBI ≤4 or SCCAI ≤2, steroid-free remission as clinical remission without the need for corticosteroids, and mucosal healing (assessed at 6 months) as a Mayo endoscopic subscore of 0 or 1 or CD-SES <3.

Results: A total of 132 patients were included: 61 (45%) male, 94 (71%) with CD, 42 (29%) with UC; 22% and 34% of CD and UC patients, respectively, achieved steroid-free remission by week 14. This increased to 31% in CD patients and plateaued at 35% in UC patients at 12 months. Increasing remission rates to 6 months were seen in patients with CD, but minimal improvements after 3 months of therapy occurred in those with UC. Mucosal healing was achieved in 52% of UC and 30% of CD patients. Most adverse events were minor; 74% remained on vedolizumab at 12 months.

Conclusions: In this real-world study, vedolizumab demonstrated similar efficacy and safety seen in pivotal trials, with sustained clinical response in the majority of patients. Similar rates of response were seen in UC and CD patients. 10.1093/ibd/izx067_video1izx067_Video5754037470001.

FIGURE 1.

Flow chart of patients included in the vedolizumab study.

FIGURE 2.

Change in clinical and biochemical markers of disease activity after vedolizumab treatment. A, Crohn’s disease clinical response and remission rates. *Signifies P < 0.05 when comparing efficacy with week 14, determined using McNemar’s test. B, Mean (SE) Harvey-Bradshaw Index. Clinical disease activity continued to improve to 52 weeks. C, Ulcerative colitis clinical response and remission rates. D, Mean SCCAI (SE). Clinical activity improved up to week 14 but then appeared to stabilize. E, Mean C-reactive protein (SE) at weeks 0, 14, 30, and 52 in CD patients with elevated CRP at baseline. F, Mean C-reactive protein (SE) at weeks 0, 14, 30, and 52 in UC patients with elevated CRP at baseline.

FIGURE 3.

Endoscopic and histological scores before and after vedolizumab. Pre-treatment and post-treatment SES-CD scores and Mayo endoscopic subscores were compared using Wilcoxon signed-rank test and within group differences for histological outcomes were compared using McNemar's test. Significance level P < 0.05. A, SES-CD scores in CD patients before and after vedolizumab. B, Histological scores in CD patients before and after vedolizumab. C, Mayo endoscopic subscores in UC patients before and after vedolizumab. D, Histological scores in UC patients before and after vedolizumab.

FIGURE 4.

Proportion of patients remaining on vedolizumab during follow-up. A, Patients who achieve MH vs those with mucosal inflammation. B, Crohn’s disease vs ulcerative colitis. C, Anti-TNFα-naive vs not anti-TNFα-naive. D, On concurrent treatment with immunomodulator vs not on concurrent immunomodulator.