Risk of Pituitary Immune-Related Adverse Events Caused by Immune Checkpoint Inhibitors: A Systematic Review and Meta-Analysis
Authors' conclusion
The results showed that ICIs are associated with a significantly higher risk of pituitary irAEs, and ICI combination may further increase the risk. In monotherapy, CTLA-4 inhibitors caused the highest incidence and severity of pituitary irAEs, while PD-L1 inhibitors caused the lowest. In combination therapy, PD-1 inhibitors combined with CTLA-4 inhibitors resulted in a higher incidence of hypophysitis.
Study context
- Population
- Trials of immune checkpoint inhibitor (ICIs) reporting pituitary immune-related adverse events (irAEs); PubMed, Embase and Cochrane Library from inception to October 31, 202421 single-arm trials · 17 randomized controlled trials (RCTs)
- Comparison
- ICIs vs control; ICI combination therapy vs monotherapy
- Outcome
- Risk of pituitary irAEs
Pooled result
As reported in the abstract
Pituitary irAEs (RCTs)
Relative risk (95% CI)
ICIsvs Control
10.09(6.90–14.75)
ICI combination therapyvs Monotherapy
5.42(3.36–8.73)
Further pooled results
Incidence in single-arm trials
- Hypophysitis with CTLA-4 inhibitor monotherapy (highest in monotherapy)
- 4.00%
- Hypopituitarism with CTLA-4 inhibitor monotherapy (highest in monotherapy)
- 3.84%
- Hypophysitis with PD-1 plus CTLA-4 inhibitors (highest in ICI combination therapy)
- 9.36%
Incidence in monotherapy (RCTs)
- Hypophysitis with CTLA-4 inhibitors (highest)
- 16.17%
- Hypopituitarism with CTLA-4 inhibitors (highest)
- 1.75%
Severe pituitary irAEs with CTLA-4 inhibitors (highest severity)
- Single-arm trials
- 5.12%
- RCTs
- 16.35%
Original publication
Risk of Pituitary Immune-Related Adverse Events Caused by Immune Checkpoint Inhibitors: A Systematic Review and Meta-Analysis. Endocr Pract. Published 16 June 2025. doi:10.
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