Barnes, Edward L.

Abstract Background and Aims Inflammation of the pouch after ileal pouch-anal anastomosis (IPAA) can significantly impact quality of life and be difficult to treat. We assessed the effectiveness and safety of vedolizumab in Crohn’s disease (CD) of the pouch and chronic antibiotic-dependent or antibiotic-refractory pouchitis. Methods This was a retrospective, multicenter cohort study at 5 academic referral centers in the United States. Adult patients with endoscopic inflammation of the pouch who received vedolizumab were included. The primary outcome was clinical response at any time point. Secondary outcomes included clinical remission, endoscopic response, and remission. Univariate analysis and multivariate analysis were performed for the effect of the following variables on clinical response: fistula, onset of pouchitis less than 1 year after IPAA, younger than 35 years old, gender, previous tumor necrosis factor inhibitor-alpha use, and BMI >30. Results Eighty-three patients were treated with vedolizumab for inflammation of the pouch between January 2014 and October 2017. Median follow-up was 1.3 years (interquartile range 0.7–2.1). The proportion of patients that achieved at least a clinical response was 71.1%, with 19.3% achieving clinical remission. Of the 74 patients with a follow-up pouchoscopy, the proportion of patients with endoscopic response and mucosal healing was 54.1% and 17.6%, respectively. Patients who developed pouchitis symptoms less than 1 year after undergoing IPAA were less likely to respond to vedolizumab, even after controlling for other risk factors. Conclusions Vedolizumab is safe and effective in the management of CD of the pouch and chronic pouchitis. Further studies are needed to compare vedolizumab with other biologic therapies for pouchitis and CD of the pouch.

SummaryBackgroundThe impact of combination therapy on disease‐related morbidity in patients with established Crohn's disease (CD) or ulcerative colitis (UC) remains to be well‐defined.AimTo examine the effect of combination therapy on disease outcomes in CD and UC.MethodsUsing a multicenter prospective cohort, we classified CD and UC patients as being on monotherapy with anti‐TNF or on combination with an immunomodulator. The primary outcome was a composite of new IBD‐related surgery, hospitalisations, penetrating complications, need for corticosteroids or new biological at 1 year. Multivariable regression models adjusted for potential confounders.ResultsWe included 707 patients with CD (45% combination therapy) and 164 with UC (38% combination therapy). Combination therapy was not associated with reduction in the composite outcome in either CD (OR: 0.87, 95% CI: 0.63‐1.22) or UC (OR: 1.45, 95% CI: 0.63‐3.38). However, while no difference was noted in those with nonstricturing, nonpenetrating CD, a significant reduction in the likelihood of the outcome was seen in those with stricturing or penetrating CD (30% vs 39%, OR: 0.58, 95% CI: 0.37‐0.90). A stronger effect was also observed in those with disease duration <5 years (OR: 0.35, 95% CI: 0.14‐0.87) compared to those with a longer duration (OR: 0.75, 95% CI: 0.45‐1.27). A similar reduction in occurrence of composite outcome was noted with infliximab and with other anti‐TNF biologics.ConclusionThe benefit of combination immunomodulator‐biological therapy is stronger in those with complicated Crohn's disease, particularly early on in their disease course.