Disproportionality Analysis on Adverse Reactions Following Immune Checkpoint Inhibitors Using a Nationwide Spontaneous Adverse Event Reporting Database
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Background: The use of immune checkpoint inhibitors (ICIs) for advanced cancer is increasing, particularly in combination with chemotherapy. However, previous studies have focused on immune-related adverse events (irAEs) in specific organs, with limited research on combination therapy. Objective: We aimed to detect signals of adverse drug reaction (ADR) in both ICIs plus chemotherapy and ICIs alone compared to chemotherapy. Methods: We investigated individual case safety reports (ICSRs) between 2014 and 2022 using Korea Institute of Drug Safety and Risk Management Korean Adverse Event Reporting System database (KIDS KAERS DB (2304A0076)). We defined adverse events (AEs) and drugs using MedDRA and the national drug code directory provided by the Ministry of Food and Drug Safety. To detect signals, we performed disproportionality analysis using indices of reporting odds ratio (ROR) and information component (IC). Results: We identified 206,959 ICSRs in the KIDS KAERS DB, of which 5,154 contained ICIs and 201,805 were for chemotherapy. Compared to chemotherapy, radiation pneumonitis (ROR, 2313.6; IC, 5.4), hyperthyroidism (ROR, 53.4; IC, 4.2), and eczema (ROR,18.3; IC, 3.4) were detected as signals for ICIs. For ICIs with chemotherapy, additional signals including heart failure (ROR 9.65; IC 2.45), proteinuria (ROR 28.67; IC 4.16), and urinary tract infections (ROR 3.46; IC 1.03) were detected. Conclusion: The study highlights an essential signal of ADRs associated with ICIs, both alone and in combination therapy, with conditions such as hyperthyroidism, hypothyroidism, and pneumonitis. These AEs should be monitored in clinical settings.
Abstract
Background: The use of immune checkpoint inhibitors (ICIs) for advanced cancer is increasing, particularly in combination with chemotherapy. However, previous studies have focused on immune-related adverse events (irAEs) in specific organs, with limited research on combination therapy. Objective: We aimed to detect signals of adverse drug reaction (ADR) in both ICIs plus chemotherapy and ICIs alone compared to chemotherapy. Methods: We investigated individual case safety reports (ICSRs) between 2014 and 2022 using Korea Institute of Drug Safety and Risk Management Korean Adverse Event Reporting System database (KIDS KAERS DB (2304A0076)). We defined adverse events (AEs) and drugs using MedDRA and the national drug code directory provided by the Ministry of Food and Drug Safety. To detect signals, we performed disproportionality analysis using indices of reporting odds ratio (ROR) and information component (IC). Results: We identified 206,959 ICSRs in the KIDS KAERS DB, of which 5,154 contained ICIs and 201,805 were for chemotherapy. Compared to chemotherapy, radiation pneumonitis (ROR, 2313.6; IC, 5.4), hyperthyroidism (ROR, 53.4; IC, 4.2), and eczema (ROR,18.3; IC, 3.4) were detected as signals for ICIs. For ICIs with chemotherapy, additional signals including heart failure (ROR 9.65; IC 2.45), proteinuria (ROR 28.67; IC 4.16), and urinary tract infections (ROR 3.46; IC 1.03) were detected. Conclusion: The study highlights an essential signal of ADRs associated with ICIs, both alone and in combination therapy, with conditions such as hyperthyroidism, hypothyroidism, and pneumonitis. These AEs should be monitored in clinical settings.