Safety of Biologic Therapy for Inflammatory Bowel Disease in Liver Transplant Recipients.

Background/Objectives: 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 (LT) may be required, just as severe IBD may necessitate biologic therapy. Evidence on combining biologics with post-transplant immunosuppression is limited, particularly regarding hepatotoxicity, infections, and drug-drug interactions. We therefore assessed the safety of biologic therapy for IBD in LT recipients. Methods: In this retrospective, single-center analysis, all patients treated at the inflammatory bowel disease and post-liver transplantation outpatient clinics of the University Hospital Regensburg were screened. Patients with both LT and IBD were included in the analysis. Medical records, laboratory parameters, and imaging studies were reviewed. Conclusions: A total of 17 liver transplant recipients with IBD were identified. Eleven patients had PSC as the underlying liver disease, while the remaining patients had autoimmune hepatitis (AIH), PSC-AIH overlap syndrome, or cryptogenic liver cirrhosis. Three patients had Crohn's disease, and 14 had ulcerative colitis. Five patients required biologic therapy because of active IBD. Two patients received two sequential biologic agents, whereas one patient received four different biologics during follow-up. No significant safety signals were observed regarding hepatotoxicity, susceptibility to infections, or interactions with concomitant immunosuppressive therapy, including tacrolimus, mycophenolate mofetil, ciclosporin, and prednisolone. No evidence of clinically relevant safety concerns associated with biologic therapy was identified in liver transplant recipients with IBD. Therefore, biologic therapy combined with conventional post-transplant immunosuppression appears feasible and well tolerated in LT recipients with active IBD; larger prospective studies are needed. However, larger prospective studies are needed to confirm these findings.