P500 Capsule endoscopy reveals small intestinal mucosal Crohn’s disease healing after treatment with adalimumab: preliminary results of the SIMCHA study
E. Seidman*1, U. Kopylov2, C.-Y. Chao1, M. Girardin3, M. Starr4
1Research Institute of the McGill University Hospital, Gastroenterology, Montreal, Canada, 2Sheba Medical Centre, Gastroenterology, Tel Hashomer, Tel Aviv, Israel, 3University Hospital of Geneva, Department of Gastroenterology and Hepatology, Geneva, Switzerland, 4Research Institute of the McGill University Health Centre, Rheumatology, Montreal, Canada
Mucosal healing is increasingly recognised as an important treatment goal in Crohn’s disease (CD). Most studies have relied on the results of ileocolonoscopy, without assessing the vast majority of the small bowel (SB). Video capsule endoscopy (VCE) is a well-established non-invasive and accurate diagnostic modality for the evaluation of the extent and severity of SB CD. The aim of this study was to investigate SB mucosal healing of CD after 6 months of adalimumab therapy.
Prospective single-centre study in consecutive adult patients (> 18 y) with moderate-to-severe CD involving the SB, defined by a baseline VCE exam at diagnosis with a Lewis score > 790 (normal <135, mild disease 135–790) in at least 1 tertile. Exclusion criteria included use of drugs known to induce SB lesions such as NSAIDs for the previous month. Patients were also excluded for a history suggestive of obstructive symptoms, known strictures or a failed patency capsule exam. Patients were all treated with adalimumab monotherapy for 24 weeks. 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 10 consenting patients (5 M and 5 F) recruited (2012–2015). Mean baseline Lewis score was 2 305 (range 790–6 340; 95% CI 952–3 108). Mean repeat Lewis score was 673 (range 112–2 734; 95% CI 178–1 096; p = 0.0047). Complete mucosal healing was observed in 4/10 cases, and partial response in 5 others. A persistent stricture resulted in a limited (38.3%) improvement in 1 other case. The mean decrease in Lewis score was 1632 (95% CI 643–2 622), representing a mean decrease of 74.4%. Baseline VCE demonstrated one or more ulcerated SB strictures in 3 cases; 2 had non-ulcerated strictures at week 24 that were traversed. No capsule retention or other adverse events were observed. The HBI was elevated (> 5) in 6 cases before therapy. Repeat HBI was consistent with clinical remission in all 6 at week 24. Mean faecal calprotectin decreased (300.3 to 169.7), but the difference did not achieve significance.
This is the first study using VCE demonstrating highly significant improvement of small intestinal mucosal Crohn’s disease after treatment with adalimumab for 6 months. Our preliminary data suggest that VCE is a safe and effective method to re-assess small bowel mucosal healing in CD.