Safety Profile of Ipilimumab in Elderly Patients: A Disproportionate Analysis Based on the FDA Adverse Event Reporting System Database

This study analyzed 18,698 adverse event reports from the FAERS database to assess the safety of ipilimumab in elderly patients (≥65 years). It identified 245 positive signals of adverse events, including common ones like malignant neoplasm progression, diarrhea, and colitis, as well as less common ones not listed on the drug label, such as orchitis and alopecia areata. Approximately 40% of adverse events occurred within one month of starting treatment, with a median onset time of 42 days. Skin-related adverse events had the shortest onset time, while endocrine-related events had the longest. The study highlights the importance of monitoring gastrointestinal and endocrine toxicities in elderly patients using ipilimumab.