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

C. Verdon*1, U. Kopylov1,2, C. Y. Chao1,3, S. Restellini-Kherad1, M. Girardin1, W. Afif1, P. Lakatos1, T. Bessissow1, A. Bitton1, E. Seidman1

1Research Insitute of the McGill University Health Centre, Gastroenterology, Montreal, Canada, 2Sheba Medical Center, Gastroenterology, Ramat Gan, Israel, 3Princess Alexandra Hospital, Gastroenterology and Hepatology, Brisbane, Australia

Background

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.

Methods

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.

Results

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).

Conclusion

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.