Disproportionality analysis of adverse events associated with ipilimumab and nivolumab combination therapy based on FAERS database.

ingentiumby ingentium

In Melanoma Literature.

Publication date: Jul 01, 2025

The combination of immune checkpoint inhibitors (ICIs), such as ipilimumab and nivolumab, has revolutionized cancer treatment, particularly for advanced melanoma and other solid tumors. However, rare adverse events (AEs) associated with this combination are often underreported in clinical trials. This study aimed to investigate the safety profile of these drugs using the FDA Adverse Event Reporting System (FAERS) database. A retrospective analysis of data from 2015 to the first quarter of 2024 was conducted, focusing on AEs submitted by healthcare professionals. Disproportionality analysis, using algorithms like Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN), identified AE signals. A total of 19,462 reports related to the combination therapy were retrieved, spanning 20 System Organ Classes (SOCs), with endocrine and hepatobiliary disorders being most affected. Additionally, 125 unexpected significant AEs were identified, including thyrotoxic crisis, diabetes insipidus, immune-mediated optic neuritis, cystitis, eyelid ptosis, complete atrioventricular block, etc. The highest frequency of AEs occurred within the first 30 days of treatment (38. 1%), with a decrease in incidence over time, as indicated by the Weibull Shape Parameter (WSP) test. These findings highlight the importance of continuous monitoring of ICIs in clinical practice.

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Concepts Keywords
Diabetes Adverse events
Fda Bayes Theorem
Healthcare Databases, Factual
Tumors FAERS
Female
Humans
Immune Checkpoint Inhibitors
Immune Checkpoint Inhibitors
Ipilimumab
Ipilimumab
Ipilimumab
Male
Melanoma
Nivolumab
Nivolumab
Nivolumab
Pharmacovigilance
Retrospective Studies
United States

Semantics

Type Source Name
drug DRUGBANK Ipilimumab
drug DRUGBANK Nivolumab
disease MESH cancer
disease MESH melanoma
pathway KEGG Melanoma
disease MESH hepatobiliary disorders
disease MESH thyrotoxic crisis
disease MESH diabetes insipidus
disease MESH optic neuritis
disease MESH cystitis
disease MESH eyelid ptosis
disease MESH atrioventricular block
drug DRUGBANK Coenzyme M
disease MESH SIADH
disease MESH Syndrome
pathway REACTOME Immune System
disease MESH liver dysfunction
disease MESH colitis
disease MESH abnormalities
disease MESH hypothyroidism
disease MESH eosinophilic enteritis
disease MESH mononeuritis
disease MESH complications
disease MESH death
disease MESH renal carcinoma
disease MESH malignant mesothelioma
pathway REACTOME Metabolism
disease MESH nutrition disorders
disease MESH Bell’s palsy
disease MESH bilateral deafness
disease MESH endocrine diseases
disease MESH uveitis
disease MESH hypophysitis
disease MESH adrenal insufficiency
disease MESH rhabdomyolysis
disease MESH esophagitis
disease MESH thyroiditis
disease MESH encephalopathy
drug DRUGBANK L-Aspartic Acid
disease MESH Hepatocellular carcinoma
pathway KEGG Hepatocellular carcinoma
disease MESH Gastrointestinal disorders
disease MESH Nervous system disorders
disease MESH Psychiatric disorders
disease MESH Cardiac disorders
disease MESH Infections
disease MESH Immune system disorders
disease MESH Eye disorders
disease MESH salivary gland inflammation
disease MESH nephritis
disease MESH atrial fibrillation
disease MESH ventricular tachycardia
disease MESH lung cancer
disease MESH colorectal cancer
pathway KEGG Colorectal cancer
disease MESH liver cancer
disease MESH carcinoma
disease MESH glioma
pathway KEGG Glioma
disease MESH leukemia
disease MESH cholangiocarcinoma
disease MESH Sinus tachycardia
disease MESH Ileus
disease MESH Cholecystitis
disease MESH thrombosis
disease MESH Bronchopulmonary aspergillosis
disease MESH Facial paralysis
disease MESH Radiculopathy
disease MESH Spinal cord compression
disease MESH Nephrotic syndrome
disease MESH Atelectasis
disease MESH Dermatomyositis
disease MESH Thrombophlebitis
disease MESH arteritis
disease MESH Capillary leak syndrome
disease MESH pneumonitis
disease MESH hepatitis
disease MESH myocarditis
disease MESH hyperthyroidism
disease MESH hyponatremia
drug DRUGBANK Iodide
drug DRUGBANK Water
disease MESH liver failure
disease MESH cholangitis
disease MESH inflammation
disease MESH strictures
disease MESH fibrosis
disease MESH bile
disease MESH jaundice
disease MESH spasms
disease MESH facial neuritis
disease MESH pericarditis
disease MESH vasculitis
disease MESH oxidative stress
pathway REACTOME Apoptosis
disease MESH Adverse Drug Reaction

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