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Background: Management of solid-organ transplant (SOT) recipients with systemic inflammatory diseases represents a clinical challenge, as only limited data are available concerning the safety of post-transplantation biologic therapy. As infections represent a major concern in SOT recipients, the concomitant use of biologics with immunosuppression may increase this risk. Objectives: To investigate the rate of serious infections and other safety outcomes in SOT recipients with inflammatory diseases treated with biologics in a tertiary medical center in Israel. Methods: A retrospective study collected clinical data (2000-2023) on adult SOT recipients with inflammatory diseases treated with biologic therapy, including serious infections (primary outcome) defined as those requiring hospitalization or led to death, graft rejection, cancer, and death. Flares of the inflammatory disease and the reasons for discontinuation of biologic treatment were recorded. Results: A total of 14 solid organ transplant (SOT) recipients were included in the study, composed of kidney (n=10, 71.43%) and liver (n=4, 28.57%) recipients, with a median follow-up of 59.6 (SD 39.8) months since the initiation of post-transplant biologic therapy (Table 1). The most prevalent underlying inflammatory diseases were inflammatory bowel disease (n=6, 42.86%) and Familial Mediterranean Fever (FMF) (n=4, 28.57%). The primary cause for the kidney transplant was amyloidosis (n=5). TNF and IL-1 inhibitors were the most prescribed biologics, with a median treatment duration of 59.58 months. Ten (57.14%) patients received the same biologic therapy prior to and post-transplantation. Post-transplantation serious infections occurred in six (42.86%) patients, with three (21.43%) patients experiencing multiple serious infections. The most prevalent infection was urinary tract infection (UTI) (n=7, 58.34%), followed by COVID-19 (n=2, 14.29%), and bacterial pneumonia (n=1, 7.14%). There was no evidence of opportunistic infections in the study cohort. Only one patient with IBD and liver transplant had an acute graft rejection, and chronic graft rejection one year later, with both events unrelated to biologic treatment (adalimumab) that was continued through both events. Two patients developed skin cancers: basal cell carcinoma and squamous cell carcinoma. Seven patients were hospitalized due to exacerbations of the underlying inflammatory disease (IBD and FMF) that occurred on biologic treatment, with a median time to onset after biologic introduction of 64.4 (SD 45.12) months. During the follow-up period, there were nine cases of biologic treatment discontinuation. The two primary reasons were either exacerbations of inflammatory diseases (n=2, 22.22%) or serious infections (n=3, 33.37%). One patient reinstituted the biologic treatment after the resolution of infection. There were two deaths attributed to COVID-19 infection and a car accident. Conclusion: Our real-world cohort supports the feasibility of the use of biologic treatment in SOT recipients with systemic inflammatory diseases. Most patients continued the biologic therapy over 5 years, without evidence of opportunistic infections. Increased risk of infections should be weighted with administration of biologics in this highly immunosuppressed group of patients. Acknowledgements: NIL. Disclosure of Interests: None declared.
Furer et al. (Sat,) studied this question.