Safety profile of ipilimumab in elderly patients: a disproportionate analysis based on the FDA Adverse Event Reporting System database

Front Oncol. 2026 Jun 3;16:1689130. doi: 10.3389/fonc.2026.1689130. eCollection 2026.

ABSTRACT

BACKGROUND: Ipilimumab is the first cytotoxic T lymphocyte protein-4 (CTLA-4) inhibitor approved in the United States. However, there is insufficient data on the safety of this drug in elderly patients. This study aimed to identify adverse events (AEs) associated with ipilimumab in elderly patients through the Adverse Event Reporting System (FAERS) database.

METHOD: This study retrieved adverse event reports related to ipilimumab in elderly patients (≥65 years) from the first quarter of 2011 to the first quarter of 2025 in the FAERS database. Multiple disproportionality analysis methods were used to detect adverse event signals associated with ipilimumab.

RESULTS: A total of 18,698 adverse event reports were included. We identified 245 positive signals using four disproportionality methods. Common AEs included malignant neoplasm progression, diarrhea, colitis, pyrexia, rash, adrenal insufficiency, hypophysitis, and immune-mediated enterocolitis. In addition, we also identified some signals not listed on the drug label, such as orchitis, dropped head syndrome, and alopecia areata. Approximately 40% of AEs related to ipilimumab in elderly patients occurred within one month of medication use, with a median onset time of 42 days (interquartile range[IQR] 18-80days). Among these, AEs related to skin and subcutaneous tissue disorders had the shortest median time to onset, while those related to endocrine disorders had the longest median time to onset and continued to occur over time. The weight subgroup analysis indicated a statistically significant difference in the median time to AEs between the <70 kg and ≥70 kg populations (P<0.001).

CONCLUSION: This study provides safety data on the use of ipilimumab in elderly patients and suggests prioritizing monitoring for gastrointestinal events and endocrine toxicities in elderly patients during treatment.

PMID:42318455 | PMC:PMC13272015 | DOI:10.3389/fonc.2026.1689130