Abstract Background Crohn’s disease (CD) complications affect 25% of patients at diagnosis and may progress to over 70% within ten years, often evolving into more complex forms. Controlling inflammation is essential to prevent disease progression, with biologics playing a central role. Video capsule endoscopy (VCE) and intestinal ultrasound (IUS) have proven effective in monitoring CD and predicting future complications. However, prospective data on pan-enteric mucosal inflammation and transmural healing in CD remain limited. Methods This prospective observational study included patients with CD who started on first-line biologics. Patients were followed at baseline, 14 weeks, and 52 weeks with assessments including CD Activity Index (CDAI), C-reactive protein (CRP), fecal calprotectin (FCP), pan-enteric VCE after confirming small-bowel patency via patency capsule (PC) ingestion, and IUS. The primary outcome was the continuation of biologic therapy after one year. Biochemical, endoscopic, and ultrasonographic remission were defined as follows: FCP<150 µg/g, Lewis score (LS)<135 or Eliakim score (ES)<4, and terminal ileum-bowel wall thickness (TI-BWT)<3 mm. Results Seventy-eight patients were screened, with 59 enrolled (median age: 30 [23-43] years; male: 31/59 [52%]; B2/3 disease phenotype: 12/59 [20.3%]), and 19 excluded (Figure, A). The patients started vedolizumab (21/59, 35%), infliximab (11/59, 19%), adalimumab (24/59, 41%) and ustekinumab (3/59, 5%). Eight patients were dropped out before the 14-week time point (Figure, A). At 52 weeks, 34/59 (58%) patients continued their biologics. Among patients with abnormal baseline biochemical, endoscopic, and ultrasonographic measures, 11/42 (26.2%) achieved biochemical normalization, 7/52 (13.5%) achieved small-bowel mucosal healing (MH), 6/38 (15.8%) achieved pan-enteric MH, and 8/28 (28.6%) achieved transmural healing at 14 weeks (Figure, B). Seventeen patients discontinued the study between the 14-week and 52-week time points (Figure, A). At 52 weeks, 17/42 (40.5%) of patients achieved biochemical normalization, 9/52 (17.3%) achieved small-bowel MH, 12/38 (31.6%) achieved pan-enteric MH, and 10/28 (35.7%) achieved transmural healing (Figure, B).All median study indices significantly improved during follow-up: CDAI: 103→64→63 (p=0.08); CRP (mg/dL): 6.6→5.0→4.1 (p=0.016); FCP (μg/g): 678→190→101 (p=0.009); LS: 750→225→225 (p<0.001); ES: 11→4→2 (p<0.001); TI-BWT (mm): 3.8→ 3.3→2.3 (p<0.001) (Figure, C). Conclusion First-line biologics significantly improve pan-enteric MH rates, along with clinical, biochemical, and ultrasonographic indices, in patients with CD over one year, with more than half of patients remaining on therapy during this period.
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