Pan-enteric mucosal inflammation in Crohn's disease patients treated with vedolizumab assessed by capsule endoscopy– interim results of a prospective observational study

Aims Mucosal healing (MH) is a paramount treatment goal in Crohn’s disease (CD). The vast majority of data pertains to MH in the colon and terminal ileum. Data regarding pan-enteric MH (P-MH) among patients with active CD who were treated with vedolizumab (VDZ) are lacking. We aimed to evaluate the efficacy of VDZ for achieving P-MH using pan-enteric capsule endoscopy (CE).

Methods This was a prospective open-label observational study. Patients with CD who have started on VDZ, were included. Patients underwent small-bowel (SB) patency-assessment using patency capsule (PC) and were followed by CE (PillCam Crohn’s, Medtronic, USA) before /within 40 days of treatment onset and after 14 and 52 weeks. In patients with exclusive SB involvement, colonic preparation was not performed and colon was not assessed in subsequent CE. Accordingly, Lewis score (LS) and Pan-enteric Pillcam score (PS) were calculated, when available. The primary outcome was P-MH defined as LS<135 and LS<135 & PS<4 for CE confined to the SB/SB &colon, respectively. The main secondary outcomes were SB-MH (LS<135) and colonic-MH (colonic PS<4).

Results 57 patients were recruited, 41 patients were enrolled (median age: 28 [23-45] years, male-44%) and 16 patients were excluded (6- retained PC, 1- technical reason, 2 -did not start VDZ, 7-withdrew consent). Six patients (1- retained PC, 1- multiple strictures, 1- lost to follow-up [F/U], 3- clinical flare) and eight patients (4- discontinued VDZ, 2- capsule adverse events, 1- lost to F/U, 1- clinical flare) were dropped-out before week 14 and week 52, respectively. P-MH was observed in 7/39 (18%) patients at week 14, and in 7/30 (23%) patients at week 52 (two patients and 11 patients have not yet reached 14/52-week, respectively). At week 52, the rates of SB-MH and colonic-MH were 27% and 46%, respectively, and it was consistent with the significant improvement at week 14 in both LS (900 [225-900] vs. 450 [0-900], p<0.001) and PS (12 [2-18] vs. 6 [0-14], p=0.001) compared to baseline, and with the LS (0 [0-300]) and PS (2 [2-6]), at week 52. No cases of retained capsule were observed during F/U.

Conclusions VDZ induces MH in both the SB and the colon among patients with CD, and this effect may persist up to 52 weeks of treatment.

Conflicts of interest

Bella Ungar received consultation fees from Neopharm,Takeda, Janssen, and AbbVie. Rami Eliakim received consultant and speaker fees from Janssen, AbbVie, Takeda, and Medtronic. Uri Kopylov received speaker fees from AbbVie, Janssen, and Takeda; research support from Takeda and Janssen; and consulting fees from Takeda and CTS. Shomron Ben-Horin has received advisory board and/or consulting fees from AbbVie, Takeda, Janssen, Celltrion, Pfizer, GSK, Ferring, Novartis, Roche, Gilead, Neopharm, Predicta Med, Galmed, Medial Earlysign, BMS, and Eli Lilly; holds stocks/options in Predicta Med, Evinature, and Galmed; and received research support from AbbVie, Takeda, Janssen, Celltrion, Pfizer, and Galmed.

Publication History

Article published online:
15 April 2024