Immune-Related Adverse Events in Bladder Cancer Patients Treated With Immune Checkpoint Inhibitors: Insights From a
Pooja Gokhale1, Lorenzo Villa Zapata1
1Department of Clinical and Administrative Pharmacy, University of Georgia College of Pharmacy, Athens, Georgia, USA.
Cancer Medicine
|April 2, 2026
Summary
Immune checkpoint inhibitors (ICIs) for bladder cancer show varied immune-related adverse events (irAEs). Real-world data analysis identified specific safety signals for hyperthyroidism, rash, and myositis, highlighting the need for ongoing surveillance.
Area of Science:
- Oncology
- Pharmacovigilance
- Immunology
Background:
- Immune checkpoint inhibitors (ICIs) are crucial for bladder cancer treatment.
- Clinical trials indicate ICIs are associated with immune-related adverse events (irAEs).
- Real-world data is needed to understand irAEs in bladder cancer patients.
Purpose of the Study:
- To evaluate real-world evidence of irAEs associated with specific ICIs in bladder cancer.
- To identify safety signals for irAEs using the FDA Adverse Event Reporting System (FAERS).
Main Methods:
- Analysis of FAERS data up to December 2024.
- Inclusion of atezolizumab, pembrolizumab, avelumab, and nivolumab.
- Case/non-case pharmacovigilance analysis for specific irAEs.
Main Results:
- Significant safety signals identified for hyperthyroidism with atezolizumab, rash with pembrolizumab, and myositis with avelumab.
- Hypothesis-generating signal for nephritis with atezolizumab.
- Borderline signal observed for hypothyroidism with avelumab.
Conclusions:
- The incidence of irAEs differs among ICI agents in bladder cancer.
- Post-marketing surveillance is vital for detecting real-world safety signals.
- Proactive management and patient education are key to mitigating irAEs and improving quality of life.
