Background: Chronic antibiotic-refractory pouchitis (CARP) is a complication of ileal pouch-anal anastomosis (IPAA), which poses a therapeutic challenge. Vedolizumab, a gut-selective monoclonal antibody to the α4β7 of integrin, has been used in such patients, but data on its efficacy are limited. Our aim was to assess the efficacy and safety of vedolizumab as induction therapy in CARP patients.
Methods: In this single-center, historic cohort, patients with CARP who received vedolizumab between January 2015 to June 2017 were identified and analysed. Patients were included if they had active pouchitis with a total of modified pouch disease activity index (mPDAI) score ≥5 or if unavailable clinician diagnosis of active pouchitis. Pre-treatment and at 3-month post-therapy pouchoscopy and clinical visits were used to calculate mPDAI.
Results: A total of 19 patients were included in the study. The mean age was 26.7 ± 12.8 years, with 10 (53%) males. Nine (47%) patients had been treated with anti-tumor necrosis factor (TNF) agents before colectomy and 10 (53%) had anti-TNFs after colectomy and IPAA. Six (32%) patients had improvement in the mPDAI symptom subscores (P = 0.031) and 14 (74%) had improvement in both endoscopic and total mPDAI scores with a median change of -2 units (both P = 0.031). Adverse events were noted only in two (11%) patients and four (21%) required surgery for CARP.
Conclusions: Our study suggests that vedolizumab has efficacy and can be safely used for CARP patients. Larger studies with a higher number of patients are required to confirm these findings.
Keywords: Vedolizumab; chronic antibiotic-refractory puchitits; modified pouch disease activity index.