PP102 - PHARMACOVIGILANCE OF METABOLIC AND NUTRITIONAL ADVERSE EVENTS ASSOCIATED WITH IMMUNE CHECKPOINT INHIBITORS: A CONTEMPORARY FAERS ANALYSIS (2020-2025)

PP102

PHARMACOVIGILANCE OF METABOLIC AND NUTRITIONAL ADVERSE EVENTS ASSOCIATED WITH IMMUNE CHECKPOINT INHIBITORS: A CONTEMPORARY FAERS ANALYSIS (2020-2025)

I. Bayraktar^1,*, N. Yalcin¹, B. Kelleci Cakir¹, O. Dizdar², A. Bayraktar-Ekincioglu¹

¹Clinical Pharmacy, Hacettepe University, ²Medical Oncology, Hacettepe University, Cancer Institute, Ankara, Türkiye

Rationale: Immune checkpoint inhibitors (ICIs) have metabolic and nutritional adverse events (MNAEs), including glucose dysregulation,electrolyte imbalances,endocrinopathies,nutritional impairment.This study provides a comprehensive adverse events profile of ICIs as monotherapy and in combination regimens through Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods: FAERS datasets were analyzed,including eight ICIs.Disproportionality analysis used Reporting Odds Ratio-ROR and Information Component-IC with dual-criterion signal detection (ROR₀₂₅>1;IC₀₂₅>0). Time-to-onset analyses were conducted for significant signals.

Results: In total, 11,583 ICI-treated cases with MNAEs and 586,983 non-ICI reference cases were identified. 67 significant MedDRA terms were detected.The overall ICI signal was robust (ROR:2.73,95% CI:2.68–2.79), with combination regimens showing higher disproportionality than monotherapy (ROR:3.32 vs.2.63).Nutritional disorders including cachexia, decreased appetite, malnutrition and failure to thrive showed consistent signals across PD-1/PD-L1 inhibitors, with cachexia strongest signal under nivolumab (ROR:39.32). Endocrine disorders included adrenal insufficiency (combination regimen ROR:37.07) and type 1 diabetes (ROR-56.12, ipilimumab+nivolumab regimen). Electrolyte disturbances, including hyponatraemia and hypokalaemia, were also detected (ROR 4.89 and 3.87). Time-to-onset ranged from acute electrolyte disturbances (hypomagnesaemia:3 days) to delayed endocrine events (adrenal insufficiency:70 days).

Conclusion: ICI-associated MNAEs constitute a wide-ranging and clinically important alerts. Monitoring strategies should be tailored to both regimen type and treatment initiation time.These findings support the integration of early nutritional assessment and sustained metabolic surveillance into routine ICI care.

Disclosure of Interest: None declared