Efficacy of Vedolizumab in Patients with Antibiotic and Anti-tumor Necrosis Alpha Refractory Pouchitis

Refractory pouchitis is a risk factor for pouch failure and surgical excision. While TNFa inhibitors have been reported to be effective as treatment for pouchitis there is no data regarding the use of vedolizumab in refractory pouchitis. In this study we evaluated the clinical and endoscopic response to vedolizumab in refractory pouchitis. This is an open label case series. Three patients were identified as having refractory pouchitis with loss or lack of response to antibiotics, corticosteroids, and at least one TNFa inhibitor along with a variety of other modalities of therapy. Each patient underwent pouch endoscopy before initiation of vedolizumab and repeat endoscopy within 4 months of initiation of treatment. Vedolizumab was administered as per standard dosing regimen. The Pouch Disease Activity Index (PDAI) endoscopic subscore was evaluated by the 2 investigators independently and reported as an average. The clinical record was reviewed to determine patient reported response to therapy. Patient 1, a 54 year old male, had undergone colectomy and IPAA in 2000 for medically refractory ulcerative colitis (UC). He suffered from ankylosing spondylitis and chronic pouchitis. He had been treated serially with antibiotics, budesonide, infliximab, methotrexate, adalimumab, in combination with hyperbaric oxygen therapy with severe diarrhea. His pouchoscopy prior to initiation revealed confluent ulceration with PDAI endoscopic subscore of 4. Endoscopy 4 months after the initiation of vedolizumab therapy revealed visual improvement, with few small ulcers noted, with PDAI endoscopic subscore of 3. He experienced improvement in clinical symptoms and has avoided surgical resection of his pouch but did require maintenance therapy with budesonide. Patient 2, a 54 year old female underwent colectomy and IPAA in 1991 for medically refractory UC. She developed recurrent stricturing at the pouch inlet and afferent limb and pouchitis, treated with surgical stricturoplasty, antibiotics, thiopurines, mesalamine, intravenous immunoglobulin therapy, fecal microbiota transplant, and adalimumab. She continued to have symptoms of diarrhea and pain. Pouch endoscopy revealed chronic pouchitis with edema and loss of vascular pattern consistent with a PDAI score of 5, along with cuffitis, and ulcerated strictures in the neo-terminal ileum. She underwent pouchoscopy 4 months after the therapy with vedolizumab which revealed improvement in pouchitis, normal appearing mucosa and PDAI endoscopic subscore 1, but ongoing ulceration at cuff and inlet. Patient 3, a 54 year old female post restorative proctocolectomy for refractory UC in 2012 had required pouch redo surgery in 2014 for severe pouch dysfunction. She suffered from diarrhea requiring intravenous hydration despite use of antibiotics, infliximab with azathioprine, and mesalamine. Her pouchoscopy revealed pouchitis and ileitis with a PDAI score of 3. Pouch endoscopy 4 months after initiation of vedolizumab which revealed improved mucosa of the pouch with PDAI score of 1. She noted improvement in symptoms of diarrhea. All 3 patients had improved endoscopic scores and reported clinical improvement in terms of diarrhea and pain. Vedolizumab in open label use for chronic antibiotic- and anti- TNFα-refractory, chronic pouchitis demonstrated improvement in both symptoms and endoscopy scores.