The Use of Vedolizumab in Patients With Concomitant Cirrhosis and Crohnʼs Disease

Nikhil Kapila,Jamak M Esfeh,Bo Shen,Gianina Flocco

doi:10.14309/00000434-201810001-02051

Nikhil Kapila, Jamak M Esfeh + Show 2 more

Open Access

https://doi.org/10.14309/00000434-201810001-02051

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Abstract

The use of vedolizumab in patients with concomitant inflammatory bowel disease (IBD) and cirrhosis has not been reported. We wish to report our center's experience with vedolizumab in 3 patients with cirrhosis and concomitant Crohn's disease (CD). From 1/2014 to present, 1542 patients with IBD were treated with vedolizumab. Three patients had cirrhosis based on liver biopsy, biochemical data, and/or imaging. The 1st patient is a 64 y/o female with a history of CD of the colon and small bowel (SB) and cirrhosis secondary to autoimmune hepatitis. She was diagnosed with CD 13 years prior and failed treatment with certolizumab and infliximab, requiring a colectomy with end ileostomy. Vedolizumab and azathioprine were started and 36 months after treatment, she is in deep remission. Prior to treatment, she had a modified model for end stage liver disease (MELD-Na) score of 8 and Child Turcott Pugh (CTP) score A5. Post-treatment, she has not required hospitalization for serious infection, and her MELD-Na and CTP are unchanged. Our 2nd case is a 57 y/o male with history of SB CD and cirrhosis due to HCV. He had a prior resection of the distal ileum and previous treatment with budesonide and 6-mercatopurine (6-MP) with persistent disease. Five years later, vedolizumab and 6-MP were started. Prior to therapy, his MELD-Na was 6 and CTP A5. Thirty-two months later, he continues on vedolizumab and is doing well with no significant infections or decompensation of his liver disease. The 3rd case is a 65 y/o male with an 11 year history of SB CD and cryptogenic cirrhosis. He was treated with steroids, infliximab, and azathioprine, however due to non-response, vedolizumab was started. Prior to treatment, his MELD-Na was 9 and CTP A6. After 5 months, the MELD-Na was 11 and CTP was A6 with no decompensation of his liver disease or significant infection. There is a paucity of data with regards to use of vedolizumab in patients with cirrhosis. The landmark studies supporting the use of vedolizumab in patients with IBD do not identify patients with cirrhosis. Recent reports suggest a favorable safety profile of vedolizumab, however patients with cirrhosis are unique as they have a predilection for opportunistic infection and hepatocellular carcinoma. Our limited study demonstrates that in patients with compensated liver disease, vedolizumab appears to be well tolerated and efficacious, however further research in patients with decompensated cirrhosis is required.

Highlights

We report our experience in three patients with concomitant Crohn’s disease (CD) and cirrhosis, who were treated with vedolizumab
Vedolizumab is a humanized monoclonal α4β7 integrin antibody that is approved for use in the management of patients with moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC)
Neither the landmark studies that described the efficacy of vedolizumab nor the recent studies that describe their long-term safety have reviewed the use of vedolizumab in patients with concomitant inflammatory bowel disease (IBD) and cirrhosis [2,3]

Summary

Introduction

Vedolizumab is a humanized monoclonal α4β7 integrin antibody that is approved for use in the management of patients with moderate to severe Crohn’s disease (CD) and ulcerative colitis (UC). Cirrhosis was confirmed by liver biopsy and the patient achieved a sustained virologic response after completing therapy with interferon and ribavirin He has a five-year history of CD involving the small bowel, had undergone a prior resection of the distal ileum, and has previously been treated with budesonide and 6-mercaptopurine (6-MP). Thirty-two months post treatment, the patient continues on vedolizumab 300 mg every eight weeks and his CD is in clinical remission He has not had any episodes of hepatic decompensation and his posttreatment MELD-Na score is seven and CTP A6. The last case is of a 65-year-old male with an 11-year history of small bowel CD and cryptogenic cirrhosis He was initially treated with steroids, infliximab, and azathioprine; due to non-response, vedolizumab therapy was considered. After initiation of vedolizumab 300 mg every eight weeks for five months, the patient’s MELD-Na was 11 and CTP A6 with no decompensated cirrhosis or significant infection

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Disclosures