P177 Small intestinal mucosal healing assessed by video capsule endoscopy in Crohn’s disease patient treated with adalimumab: The SIMCHA study—interim results

Video capsule endoscopy (VCE) has been established as the most sensitive modality in evaluating small bowel (SB) Crohn’s disease (CD). Endoscopic mucosal healing is recognised as a key treatment target in IBD. However, studies have generally employed ileocolonoscopy. The aim of this study was to investigate SB mucosal healing of CD after 6 months of adalimumab therapy using VCE. Prospective single-centre study in consecutive adult CD patients (>17 years) with moderate-to-severe SB involvement, defined by a baseline VCE examination at diagnosis with a Lewis score > 790 (normal <135, mild disease 135–790) in at least one tertile. Exclusion criteria included the use of drugs known to induce SB lesions such as NSAIDs for a minimum of 1 month. Patients were also excluded if there was a history suggestive of obstructive symptoms, known strictures or a failed patency capsule examination. Patients were all treated with adalimumab monotherapy for 24 weeks prior to undertaking a second VCE. Primary endpoint was the Lewis score on repeat VCE at 24 weeks. Mucosal healing was defined as a repeat Lewis score <350, whereas partial response was defined as a >50% decrease in repeat Lewis score. Secondary outcomes included clinical index of remission (Harvey–Bradshaw Index <5) and faecal calprotectin. Interim results are available for the first 14 consenting patients (8 males, 6 females) recruited (2012–2018). Mean baseline Lewis score was 1940 (range 475–6340). Mean Lewis score on second VCE was 331 (range 112–2734; p = 0.0005 vs. baseline). Complete mucosal healing was observed in 7 (50%) cases, and partial response in 5 others. The mean decrease in Lewis score was 1632 (range 363–5189), representing a mean reduction of 80.2%. Baseline VCE demonstrated one or more ulcerated SB strictures in three cases; two had non-ulcerated strictures at Week 24 that were traversed. No capsule retention or other adverse events were observed. The HBI was elevated (>4) in 10 cases prior to starting therapy. Repeat HBI was consistent with clinical remission (HBI < 4) in all cases at Week 24. Mean faecal calprotectin decreased from 409 (range 62–1676) to 135 (range 30–329), but the difference did not achieve significance (p = 0.1). Adalimumab led to significant improvement of small intestinal mucosal Crohn’s disease, with 50% achieving mucosal healing. Our preliminary data suggest that VCE is a safe and effective method to diagnose and monitor SB mucosal healing in CD.