Vedolizumab Achieves Pan-Enteric Mucosal Healing in Crohn's Disease: A Prospective Observational Study.

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.