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Drug-Drug Interactions Between Immune Checkpoint Inhibitors and Glucocorticoids: A Real-World Pharmacovigilance
Zhen Zhang1, Tao Gao2, Linpei Li1
1Hunan Academy of Chinese Medicine, Changsha, PR China.
Introduction:
Immune checkpoint inhibitors (ICIs) are frequently co-administered with glucocorticoids (GCs) in cancer treatment, yet the potential drug-drug interactions (DDIs) between these drug classes remains incompletely characterized. This study aimed to identify adverse event reporting patterns suggestive of potential interactions between ICIs and GCs.
Methods:
We performed a retrospective pharmacovigilance analysis of Food and Drug Administration Adverse Event Reporting System (FAERS) from January 1, 2014, to December 31, 2024. After deduplication, 14,357,295 unique reports were included. Reports were classified into 4 groups: ICIs alone, GCs alone, concomitant ICIs and GCs, and neither exposure. Potential interaction signals were evaluated at the Medical Dictionary for Regulatory Activities System Organ Class (SOC) level using descriptive statistics, disproportionality analysis, additive risk difference model, multiplicative risk ratio model, Ω shrinkage measure and chi-square signal.
Results:
Three SOC met the prespecified composite signal criterion: metabolism and nutrition disorders (glucose abnormalities, appetite or nutritional abnormalities, and related metabolic complications), gastrointestinal disorders (for example nausea, vomiting, diarrhea, colitis, abdominal pain, and other gastrointestinal toxicities), and investigations (for example, elevated liver enzymes or electrolyte abnormalities). In stratified analyses, co-administered programmed death-ligand 1 (PD-L1) inhibitors and GCs reports met the criterion for metabolism and nutrition disorders and gastrointestinal disorders, whereas co-administered programmed cell death protein 1 (PD-1) inhibitors and GCs reports met the criterion for gastrointestinal disorders and investigations. Co-administered Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors and GCs reports did not show consistent algorithmic support across these SOC.
Conclusion:
These findings indicate that co-administered ICIs and GCs were associated with reporting of specific adverse outcomes, particularly metabolic/nutritional and gastrointestinal events. These findings do not suggest that clinically indicated GCs use should be avoided in patients receiving ICIs. Rather, they support closer monitoring of metabolism and nutrition disorders, gastrointestinal disorders, and investigations when these agents are co-administered.
Insights
Immune checkpoint inhibitors (ICIs) combined with glucocorticoids (GCs) may increase risks for metabolic and gastrointestinal adverse events. Closer monitoring for these side effects is recommended when co-administering these cancer therapies.
Area of Science:
- Oncology
- Pharmacovigilance
- Drug Interactions
Background:
- Immune checkpoint inhibitors (ICIs) and glucocorticoids (GCs) are common cancer treatments.
- Potential drug-drug interactions (DDIs) between ICIs and GCs are not fully understood.
Purpose of the Study:
- To identify adverse event reporting patterns suggesting potential DDIs between ICIs and GCs.
- To analyze safety signals associated with concomitant ICI and GC use.
Main Methods:
- Retrospective pharmacovigilance analysis of FDA Adverse Event Reporting System (FAERS) data (2014-2024).
- Included 14,357,295 unique reports, categorized by drug exposure.
- Evaluated potential interaction signals using statistical methods at the System Organ Class (SOC) level.
Main Results:
- Metabolism and nutrition disorders (e.g., glucose abnormalities) and gastrointestinal disorders (e.g., nausea, diarrhea, colitis) met composite signal criteria.
- Specific ICI subclasses (PD-L1, PD-1) showed distinct patterns of associated adverse events when combined with GCs.
- CTLA-4 inhibitors with GCs did not consistently meet signal criteria across analyzed SOCs.
Conclusions:
- Co-administration of ICIs and GCs is associated with specific adverse outcomes, notably metabolic/nutritional and gastrointestinal events.
- Clinically indicated GC use should not be avoided but warrants closer patient monitoring.
- Enhanced surveillance for metabolic, nutritional, and gastrointestinal adverse events is crucial during combined ICI and GC therapy.
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