Adverse Event Reporting with Immune Checkpoint Inhibitors in Older Patients: Age Subgroup Disproportionality Analysis in VigiBase

SIMPLE SUMMARY: Due to the changes that occur with aging in the immune system, older patients represent a subpopulation of concern for immune checkpoint inhibitor toxicity. This pharmacovigilance study aimed to assess whether older patient age (65 years and older) was a risk factor for increased reporting of adverse drug reactions with immune checkpoint inhibitors as compared to other antineoplastic drugs in VigiBase, the World Health Organization global database of spontaneous reporting. Disproportionality analysis by age subgroups (<18 years, 18–64 years, 65–74 years, 75–84 years and ≥85 years) did not highlight older patient age as risk factor for increased reporting of any specific toxicity with immune checkpoint inhibitors as compared to other antineoplastic drugs. A signal of disproportionate reporting emerged for eye disorders with immune checkpoint inhibitors in patients aged 18–64 years, which deserves further investigation aimed at elucidating risk factors and defining management strategies. ABSTRACT: Older patients represent a subpopulation of concern for immune checkpoint inhibitor (ICI) toxicity because of changes in the aging immune system and the potentially relevant clinical implications for their quality of life. Current evidence on ICI safety in older patients is conflicting. This study aimed to assess whether older patient age was a risk factor for increased reporting with ICIs as compared to other antineoplastic drugs in VigiBase, the World Health Organization database of suspected adverse drug reactions. Disproportionality analyses computing the reporting odds ratios (RORs) were performed by age subgroups (<18 years, 18–64 years, 65–74 years, 75–84 years and ≥85 years). There were not signals of disproportionate reporting with ICIs specifically detected in older patient age subgroups (≥65 years), which were not present in the disproportionality analysis over the entire dataset. A signal of disproportionate reporting with ICIs emerged for eye disorders only in the age subgroup 18–64 years (ROR 1.13, 95% confidence interval 1.05–1.23). These findings showed that adverse event reporting with ICIs in older patients was comparable to that in the overall patient cohort and prompt for the further investigation of eye disorders with ICIs to elucidating risk factors and defining management strategies.