A 104 week mucosal healing and intention to treat analysis of symptomatic small bowel Crohn’s disease
B Hall1, G Holleran1, L Chapman1, B Ryan1, N Mahmud2, D McNamara1
1Department of Gastroenterology, AMNCH, Tallaght, Dublin 24 2Department of Gastroenterology, St James's Hospital, James's Street, Dublin 8
Mucosal healing in colonic Crohn’s disease (CD) is recognised as an important treatment goal. Limited data from small bowel studies suggest mucosal healing is achievable in ileal CD. However, there is no follow-up data available to show improved long-term outcomes in patients achieving complete mucosal healing of the small bowel.
This study provides the first two-year prospective data on mucosal healing outcomes in a cohort of symptomatic small bowel CD patients.
Patients commencing thiopurine or adalimumab therapy were recruited and initially followed over a one year period. Capsule endoscopy (SBCE) was utilised to diagnose and monitor small bowel CD activity. As part of this study extension, a further two year assessment was performed. An intention to treat analysis was also performed assessing long-term outcomes between patients with or without mucosal healing; including need for steroids and/or hospitalisation over the two year period.
In total, 71 patients were screened with 51 included in the final analysis. Overall, 125 SBCE were performed on 43 patients over the 2 years. One year data demonstrated a 42% mucosal healing rate (p<0.0001 95% CI -0.62 to -0.22). In all, 17 patients underwent 2 year SBCE assessment. There was only a 5% drop-off in mucosal healing rates compared to one year assessment. In ITT analysis, mucosal healing was associated with decreased steroid usage (p<0.006 95% CI -0.90 to -0.27), decreased need for step-up in therapy (p<0.001 95% CI -0.88 to -0.24) and decreased hospitalisation rates (p<0.0059 95% CI -0.79 to -0.14). Although not quite statistically significant, there was also a decreased need for surgical intervention (p<0.06)
Mucosal healing of small bowel CD can be safely and effectively monitored using SBCE. Importantly, mucosal healing is achievable (42%) and sustainable (95%) over a long time period. Mucosal healing also correlates with improved long-term patient outcomes including decreased need for steroids, hospitalisation and surgery.