Offir Ukashi, Adi Lahat, Bella Ungar, Hadar Levy, Adi Talan Asher, Pinhas Eidler, Shomron Ben-Horin, Rami Eliakim, Uri Kopylov
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引用次数: 0
Abstract
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.
期刊介绍：
United European Gastroenterology Journal (UEG Journal) is the official Journal of the United European Gastroenterology (UEG), a professional non-profit organisation combining all the leading European societies concerned with digestive disease. UEG’s member societies represent over 22,000 specialists working across medicine, surgery, paediatrics, GI oncology and endoscopy, which makes UEG a unique platform for collaboration and the exchange of knowledge.
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