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Updated: May 1, 2026
Multiplexed Immunofluorescence Analysis and Quantification of Intratumoral PD-1+ Tim-3+ CD8+ T Cells
Published on: February 8, 2018
Association between immune-mediated cystitis and PD-1, PD-L1, CTLA-4, and LAG-3 immune checkpoint inhibitors: A
1Department of Medicine, University of British Columbia, Vancouver, BC, Canada.
Background:
Immune checkpoint inhibitors (ICIs) have transformed oncology but predispose patients to immune-related adverse events. Immune-mediated cystitis represents a rare yet clinically significant urological complication requiring enhanced surveillance. This studies characterizes the pharmacovigilance profile of immune-mediated cystitis across ICI classes using real-world post-market surveillance data.
Patients And Methods:
This disproportionality analysis utilized the FDA Adverse Event Reporting System (FAERS) database, encompassing reports from Q4 2003 through Q3 2025. Fourteen ICIs were evaluated across four mechanistic classes: PD-1 (n = 7), PD-L1 (n = 4), CTLA-4 (n = 2), and LAG-3 (n = 1) inhibitors.
Results:
Among 14,104,743 adverse event reports, 69 cases of immune-mediated cystitis were identified. PD-1 inhibitors demonstrated the strongest signals: pembrolizumab (ROR 241.59; 95% CI 149.40-390.68; n = 28), nivolumab (ROR 118.56; 95% CI 68.56-205.02; n = 17), toripalimab (ROR 454.65; n = 2), and tislelizumab (ROR 266.31; n = 3). Ipilimumab exhibited robust disproportionality (ROR 297.28; 95% CI 167.73-526.89; n = 15). PD-L1 inhibitors showed minimal signals with isolated cases.
Conclusion:
Immune-mediated cystitis demonstrates strongest association with PD-1 and CTLA-4 inhibitors, warranting enhanced clinical surveillance, prompt recognition, and evidence-based management protocols.
Insights
Immune-mediated cystitis is most strongly linked to PD-1 and CTLA-4 inhibitors. Enhanced surveillance and prompt management are crucial for patients receiving these immune checkpoint inhibitors.
Area of Science:
- Oncology
- Immunology
- Pharmacovigilance
Background:
- Immune checkpoint inhibitors (ICIs) have revolutionized cancer treatment.
- However, ICIs can cause immune-related adverse events, including rare but significant immune-mediated cystitis.
- This study investigates the real-world safety profile of immune-mediated cystitis associated with various ICI classes.
Purpose of the Study:
- To characterize the pharmacovigilance of immune-mediated cystitis across different classes of immune checkpoint inhibitors.
- To identify which ICI classes are most associated with this specific adverse event.
Main Methods:
- A disproportionality analysis was conducted using the FDA Adverse Event Reporting System (FAERS) database.
- Data spanned from Q4 2003 to Q3 2025, evaluating 14 ICIs across PD-1, PD-L1, CTLA-4, and LAG-3 inhibitor classes.
Main Results:
- Out of 14,104,743 adverse event reports, 69 cases of immune-mediated cystitis were identified.
- PD-1 inhibitors (pembrolizumab, nivolumab, toripalimab, tislelizumab) and CTLA-4 inhibitor (ipilimumab) showed the strongest association.
- PD-L1 inhibitors exhibited minimal signals for this adverse event.
Conclusions:
- Immune-mediated cystitis is most strongly associated with PD-1 and CTLA-4 inhibitors.
- Enhanced clinical surveillance, early recognition, and evidence-based management are recommended for patients on these therapies.
