Vedolizumab Achieves Pan-Enteric Mucosal Healing in Crohn's Disease: A Prospective Observational Study
Offir Ukashi1, Adi Lahat1,2, Bella Ungar1
1Sheba Medical Center Tel Hashomer, Faculty of Medical and Health Sciences, Gastroenterology Institute, Tel-Aviv University, Tel Aviv, Israel.
Background:
Mucosal healing (MH) is a key treatment goal in Crohn's disease (CD). However, evidence on pan-enteric MH (PE-MH) in CD patients treated with vedolizumab remains limited. We aimed to assess vedolizumab efficacy in achieving PE-MH using PillCam Crohn's capsule.
Methods:
This prospective, open-label observational study included CD patients with intestinal inflammation (SB-Lewis score [LS] ≥ 220 and/or colonic-Eliakim score [ES] > 0) who initiated vedolizumab and were followed with C-reactive protein (CRP), fecal calprotectin (FCP), and PillCam Crohn's capsule at baseline and after 14 and 52 weeks. In cases of exclusive SB involvement, colonic preparation and assessment were omitted. LS and ES were calculated when applicable. The primary outcome was PE-MH, defined as LS < 135 for SB-VCE assessment, and ES = 0 for PE-VCE assessment. Secondary outcomes included SB-MH (LS < 135), colonic-MH (ES = 0) and biochemical remission (FCP < 150 μg/g). An exploratory outcome for SB-MH was defined as a LS < 350, which has previously been shown to predict future flares in CD.
Results:
Of the 60 screened patients, 44 were enrolled (median age: 29.0 [22.0-45.5] years; 43.2% male; Ileum [L1]-54.5%, Colon [L2]-41.0%, Ileo-colon [L3]-4.5%). At week 52, 7/44 (15.9%) patients reached PE-MH compared to baseline (risk difference [RD] 15.9%, 95% confidence interval [CI] 5.1%-26.7%, p = 0.016). 8/44 (18.2%) and 9/44 (20.5%) patients achieved SB-MH at week 52 and 14, respectively, compared to 2/44 (4.5%) at baseline. Using the less stringent SB-MH criterion (LS < 350), rates improved significantly at week 52 versus baseline (45.5% vs. 25.0%, p = 0.049). All study indices decreased during follow-up (baseline, week 14, week 52): CRP (11.8, 5.8, 5.0: p = 0.152), FCP (758, 418, 158: p = 0.004), LS (900, 225, 225, p < 0.001), and ES (18.0, 4.0, 4.0: p < 0.001). 14/44 (31.8%) patients reached biochemical remission (p = 0.049) at week 52 compared to 5/44 (11.4%) at baseline.
Conclusion:
Vedolizumab treatment led to significant biochemical and endoscopic improvement, including SB-MH and PE-MH, through 52 weeks.
Insights
Vedolizumab treatment significantly improved mucosal healing (MH) in Crohn's disease (CD) patients, achieving pan-enteric MH (PE-MH) and small bowel MH (SB-MH) within 52 weeks. This demonstrates vedolizumab
Area of Science:
- Gastroenterology
- Inflammatory Bowel Disease Research
- Clinical Therapeutics
Background:
- Mucosal healing (MH) is a critical treatment objective in Crohn's disease (CD).
- Limited data exists on pan-enteric MH (PE-MH) with vedolizumab in CD.
- This study evaluates vedolizumab's efficacy for PE-MH using capsule endoscopy.
Purpose of the Study:
- To assess vedolizumab's effectiveness in achieving PE-MH in CD patients.
- To evaluate vedolizumab's impact on small bowel MH (SB-MH) and colonic MH.
- To correlate endoscopic healing with biochemical markers.
Main Methods:
- Prospective, open-label observational study of 44 CD patients initiating vedolizumab.
- Utilized PillCam Crohn's capsule, C-reactive protein (CRP), and fecal calprotectin (FCP) at baseline, 14, and 52 weeks.
- Defined PE-MH as SB-Lewis score (LS) < 135 and colonic-Eliakim score (ES) = 0.
Main Results:
- At 52 weeks, 15.9% of patients achieved PE-MH (p=0.016).
- SB-MH rates increased significantly from baseline to 18.2% at week 52 (p<0.001).
- Significant reductions observed in FCP, LS, and ES, with 31.8% achieving biochemical remission.
Conclusions:
- Vedolizumab treatment promotes significant biochemical and endoscopic improvements in CD patients.
- Achieved notable rates of SB-MH and PE-MH over 52 weeks.
- Supports vedolizumab as an effective therapy for inducing mucosal healing in CD.
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