Adverse events associated with the use of nivolumab in the middle-aged and older population (>45 years): A pharmacovigilance analysis based on the FAERS database.

Clinical Snapshot

Key Findings

• P Value: Not applicable for pharmacovigilance analysis

• Effect Size: Top 3 signals: malignant neoplasm progression, death, and pyrexia

• Primary Outcome: Adverse event signals in middle-aged and older nivolumab users

• Nnt Or Sensitivity: 65.7% male predominance; highest reports in 65-85 year age group; majority of AEs within first month

• Confidence Interval: Not reported for signal detection methods

Clinical Application

Findings support enhanced monitoring protocols for older patients initiating nivolumab Relevant to PBS-subsidised nivolumab use; supports TGA post-market surveillance and RACGP guidance on immunotherapy monitoring Australian patients >45 years receiving nivolumab, particularly for NSCLC

Abstract

The clinical use of nivolumab has significantly improved the prognosis for survival in patients with a wide range of advanced malignancies. Given the increased incidence of tumors, there is a need to gain insight into the true extent of adverse events (AEs) associated with the nivolumab drug in the middle-aged and elderly population. This pharmacovigilance study was based on an analysis of reports from the US Food and Drug Administration's adverse event reporting system for the period January 1, 2014 to December 31, 2024, and compared AEs of the drug nivolumab in the middle-aged and elderly populations using proportional reporting ratio, reporting odds ratio, BCPN, and multi-item gamma Poisson shrinker methods. The analyses showed the presence of AEs in a variety of systems, mainly involving several systems such as endocrine disorders, nervous system disorders, skin and subcutaneous tissue disorders. The immune-related AEs listed in the package insert were validated by us and their clinical significance warrants careful consideration to further guide clinical dosing, adjust therapeutic decision-making, and develop age-adapted dosing algorithms for population pharmacokinetic development in order to minimize potential risks to patients. With the exception of reports of an unspecified nature, a greater proportion of the sample was male (65.7%) than female (32.5%), indicating significant variations. The highest percentage of reports was observed in patients aged between 65 and 85 years and in patients with a body mass index ranging from 50 to 100 kg/m2. The primary indication was non-small cell lung cancer. The top 3 AE signals reported with nivolumab were malignant neoplasm progression, death, and pyrexia, with the majority of AE cases occurring within the first month following nivolumab initiation.