Abstract Background Liver diseases and chronic inflammatory bowel diseases (IBD) are closely associated, particularly primary sclerosing cholangitis (PSC) and ulcerative colitis (UC). In severe cases of PSC, liver transplantation may become necessary; likewise, severe IBD may require treatment with biologics. However, combining standard immunosuppression after liver transplantation with biologics for IBD constitutes an off-label use. Consequently, there is little data on efficacy and safety in this setting, especially regarding hepatotoxicity, infection susceptibility, and drug interactions in these patients. The aim of this study was to evaluate the efficacy and safety of biologics used for the treatment of inflammatory bowel disease in liver-transplanted patients. Particular focus was placed on effects on liver function, interactions between biologics and post-transplant immunosuppressive agents, and the incidence of infections. Methods In this retrospective, single-center case series, all patients from our university outpatient clinics for inflammatory bowel disease and post-liver transplantation at the University Hospital Regensburg were screened. Those with both a history of liver transplantation and a diagnosis of IBD were included. Medical records, laboratory results, and imaging data were reviewed. Results A total of 17 liver-transplanted patients with IBD were identified. Eleven patients had PSC as their underlying liver disease; the others had autoimmune hepatitis (AIH), PSC–AIH overlap, or cryptogenic liver cirrhosis. Three patients had Crohn’s disease and 14 had ulcerative colitis. In five patients, biologic therapy was required due to disease severity. Two patients had been treated with two different biologics, and one patient had received three different biologics. To date, no serious safety signals have been observed concerning hepatotoxicity, infection susceptibility, or interactions with concomitant immunosuppressive therapies such as tacrolimus, mycophenolate mofetil, ciclosporin, or prednisolone. Conclusion Based on the available data, no evidence of harmful effects associated with biologic therapy in liver-transplanted patients with IBD was found. Therefore, their use in combination with other immunosuppressive agents in cases of active IBD after liver transplantation appears reasonable despite the off-label status. However, further studies with larger cohorts are needed to confirm these findings. Conflict of interest: Mrs. Elger, Tanja: No conflict of interest Lecruit, Chiara: No conflict of interest Loibl, Johanna: No conflict of interest Baier-Kleinhenz, Lucia: No conflict of interest Kandulski, Arne: No conflict of interest Müller-Schilling, Martina: No conflict of interest Tews, Hauke: No conflict of interest
Elger et al. (Thu,) studied this question.
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