Comparison of Adverse Events Following Immunosuppressant Administration for Pediatric Patients With Renal Transplants Categorized by Two-Year Age Increments Using the U.S. Food and Drug Administration Adverse Event Reporting System.

Abstract

Background Immunosuppressants are frequently administered to prevent transplant rejection in patients with renal transplants but cause various adverse events. The incidence of each adverse event may differ between pediatric and adult patients with renal transplants. Because the development of organs and bodies in pediatric patients varies greatly annually, the incidence of each adverse event following immunosuppressant administration may vary by age. Consequently, the age-specific incidence of each adverse event in pediatric patients represents invaluable information for clinical settings. To clarify trends in the occurrence of adverse events by age, a large sample size for each age is required. However, it is difficult to conduct clinical trials in pediatric patients with renal transplants with a large sample size for each age. One method to address this difficulty is to use a database. Objectives This study aimed to investigate the trends in the occurrence of each adverse event following immunosuppressant administration in pediatric patients with renal transplants, categorized by two-year age increments. Methods We extracted data on pediatric patients aged 0-17 years who received immunosuppressants after renal transplant between January 2004 and March 2024 from the U.S. Food and Drug Administration Adverse Event Reporting System. Because adverse events were greatly affected by age, the patients were divided into groups by two-year age increments. We analyzed the relationship between the groups and the reporting proportion of each adverse event by using the reporting regression coefficient (RRC) from univariate regression analysis and the adjusted RRC (aRRC), which controlled for differences in patient background. Results Renal tubular necrosis, renal impairment, chronic allograft nephropathy, and headache were the adverse events that required more attention with increasing age because RRC and aRRC were significantly > 0. By contrast, Epstein-Barr virus infection was the adverse event that required attention, especially in younger pediatric patients, because RRC and aRRC were significantly < 0. Additionally, there were various trends among other adverse events, including those that required careful monitoring across all ages 0-17 years. Conclusions This study demonstrated that the types of adverse events requiring attention in pediatric patients with renal transplants differ by age. These findings can help enhance treatment and care in pediatric clinical settings.