Efficacy and safety of anti-TNF and vedolizumab in liver transplant recipients with inflammatory bowel disease (IBD)

The aim of this study was to evaluate the efficacy and safety of anti-TNFs and Vedolizumab in liver transplant recipients with IBD. We reviewed the medical records of consecutive liver transplant recipients with IBD, who had been treated with anti-TNFs and/or Vedolizumab at four academic French centres. Response and remission at Weeks 4–8 and 48–52 were assessed by Mayo, Harvey-Bradshaw, and Pouch Disease Activity Index scores. Mucosal healing was defined as disappearance of endoscopic signs of activity. Infectious risk was estimated by incidence and time to first infection, both before and after biologics. We studied 20 consecutive patients (14 men, median age 35 (20–61) years at biotherapy introduction: 7 CD, 11 UC, 2 chronic pouchitis). Main liver transplantation indications were primary sclerosing cholangitis (13/20) and overlap syndrome (2/20). The majority of patients had a combination of Tacrolimus (100%), an anti-metabolite and low dose of corticosteroids. They received 20 lines of anti-TNF (16 in first line) and 8 lines of Vedolizumab (4 in first line). Median time between liver transplantation and introduction of biologics was 73.5 months (12–287). The average duration of each line of biologics was 12 months (0–48). The table summarises efficacy of biologics. Forty-nine infections were identified. All infections required hospitalisation, including three in intensive care, all treated with anti-TNF. No patient had died. Twenty-eight infections were observed in 11 patients (55%) before biologics and 21 infections in 7 patients (35%) during biologics. Before exposure to biologics, yearly incidence of infection was 0.36 ± 0.60; it was 46.38 ± 166 under anti-TNF and 0.09 ± 0.24 under Vedolizumab. Differences were not significant (p = 0.35). Median time to first infection was 53.5 months before biologics and 13 months under biologics (HR = 1.692, 95% CI 0.572–5.002). Anti-TNFs and Vedolizumab induce and maintain clinical remission in approximately half of liver recipients with IBD. Severe infections are possible, particularly in patients treated with anti TNFs.