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.