Safety of biologic therapy in kidney and liver transplant recipients with systemic inflammatory diseases: a real-world study from Israel

Abstract Objectives Safety is a concern for solid-organ transplant (SOT) recipients with systemic inflammatory diseases (SIDs) treated with biologic therapy. This study evaluated the safety of biologic therapy in SOT recipients with SIDs. Methods This retrospective study between 2000 and 2024 included 20 biologic-treated SOT recipients with SIDs matched to 56 SOT control recipients without SIDs, not treated with biologic therapy. The study compared post-transplant safety outcomes, with serious infections defined as the primary outcome. Kaplan–Meier survival analysis evaluated time-to-safety event outcomes. Results The biologic-treated group included patients with SIDs, mainly with IBD and FMF treated with TNF and IL-1 inhibitors, respectively, 60% (n = 12) of whom were treated with biologics over 5 years post-SOT. There was a non-significant trend for serious infections in the biologic-treated group vs controls, 40% (n = 8) vs 23.21% (n = 13), P = 0.15, with urinary tract infections being the most prevalent in both groups. Recurrent serious infections were more prevalent in the biologic-treated group vs controls, 20% (n = 4) vs 12.5% (n = 2), P = 0.029. No opportunistic infections were observed. No graft rejection occurred in the biologic-treated group, compared with 5.37% in the control group. Cancer rates in the biologic-treated group were comparable with those in the control group, 15% vs 7.14%, P = 0.3. There were two deaths in the biologic-treated group (one attributed to COVID-19 infection and one from a car accident), compared with none in the control group, P = 0.003. There were six cases of biologic treatment discontinuation, mainly due to loss of efficacy. Conclusion This real-world cohort with 5-year follow-up since the post-SOT biologic initiation supported the feasibility of biologic therapy in SOT recipients with SIDs.