Vedolizumab for chronic antibiotic-refractory pouchitis

Abstract

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.

Inflammatory bowel disease position statement of the Italian Society of Colorectal Surgery (SICCR): ulcerative colitis

“…As regards anti-TNF agents, there is clearly more benefit in CD-like complications of the pouch than in refractory pouchitis, highlighting the need to differentiate these two entities both in daily practice and clinical trials [181]. Recent studies suggest that vedolizumab is effective and can be safely used for chronic antibiotic refractory pouchitis patients [182][183][184]. Lastly, ustekinumab appears to be a safe and effective treatment for chronic pouchitis and CD of the pouch in biologic-naïve patients and those who failed anti-TNF or vedolizumab therapy [185].…”

Clinical guidelines for the management of inflammatory bowel disease: Update of a French national consensus

“…Opinions were, however, split when it came to treatment strategies for patients who did not respond to optimized anti-TNFα. The continued inclusion of vedolizumab as a treatment option is supported by a number of recent studies [35][36][37][38]. Ustekinumab, which was voted for by 11% of experts, has been investigated in at least one study and was shown to lead to improvement of clinical and endoscopic endpoints [38].…”

Medical treatment of pouchitis: a guide for the clinician

“…Multiple studies have evaluated the role of vedolizumab (VDZ) in the treatment of chronic pouchitis. 64 – 71 In a retrospective study of 20 patients with CADP or CARP, 55% of whom were anti-TNF experienced, the mean PDAI decreased from 10 to 3 ( p < 0.01) at week 14. Clinical response to VDZ was defined as a decrease in PDAI by 3 points, which was achieved in 64% of patients.…”