Related Experiment Video
Updated: Nov 4, 2025
Identifying PD-1/PD-L1 Inhibitors with Surface Plasmon Resonance Technology
Published on: May 2, 2025
Rare Adverse Events with Programmed Death-1 and Programmed Death-1 Ligand Inhibitors: Justification and Rationale for
Caleb J Smith1, Yahya Almodallal2, Aminah Jatoi3
1Department of Medicine, Mayo Clinic, Rochester, MN, USA.
Purpose:
Immune checkpoint inhibitors are a new class of cancer drug that spawn unusual adverse events that generate unusual and sometimes unexpected adverse events. Despite databases that track such adverse events, there remains a need to also generate systematic reviews to capture side effects from such agents.
Findings:
We generated a systematic compendium of adverse event reports. Extensively reviewing the published literature of case reports and case series, we relied on the peer process to compile a resource for clinicians of rare adverse events associated with checkpoint inhibitors. We used this compendium as a platform to provide broad-based comments on the role of systematic reviews in gathering such adverse event data. This approach generated 265 types of rare adverse events that had been reported, the most frequent of which were autoimmune type I diabetes (n = 62), pneumonitis (n = 40), myocarditis (n = 39), and colitis (n = 36). More unusual adverse events were also catalogued. Some adverse events that initially seemed unusual turned out to be more frequently reported over time and thus lost their novelty-an important point which provides context for how adverse events should be viewed when new drugs become available. Additionally, in contrast to such resources as the FDA Adverse Event Reporting System (FAERS), this systematic review relied on peer-reviewed data-another important point which adds strength to such systematic reviews. This report provides a compendium of rare and usual adverse events, serves as a resource to cancer clinicians, and appears to be justified based on the reported findings.
Insights
Immune checkpoint inhibitors can cause rare side effects. A systematic review identified 265 adverse events, including type I diabetes and pneumonitis, offering a valuable resource for clinicians managing these cancer drugs.
Area of Science:
- Oncology
- Immunology
- Pharmacovigilance
Background:
- Immune checkpoint inhibitors (ICIs) are novel cancer therapeutics.
- ICIs can cause unique and unexpected adverse events.
- Existing adverse event databases may not fully capture these side effects.
Purpose of the Study:
- To systematically review and compile rare adverse events associated with immune checkpoint inhibitors.
- To create a resource for clinicians regarding ICI-induced side effects.
- To comment on the utility of systematic reviews for capturing adverse event data.
Main Methods:
- Conducted an extensive review of published literature, focusing on case reports and case series.
- Compiled a compendium of adverse event reports from peer-reviewed sources.
- Analyzed and categorized reported adverse events.
Main Results:
- Identified 265 distinct types of rare adverse events linked to immune checkpoint inhibitors.
- Most frequent events included autoimmune type I diabetes (n=62), pneumonitis (n=40), myocarditis (n=39), and colitis (n=36).
- Observed that some initially rare events became more frequently reported over time.
Conclusions:
- Systematic reviews of peer-reviewed literature provide a robust method for cataloging ICI adverse events.
- The generated compendium serves as a valuable resource for cancer clinicians.
- This approach strengthens pharmacovigilance by utilizing peer-reviewed data, complementing existing databases.
