Endocrine Adverse Reactions of Tyrosine Kinase Inhibitors in Combination With Immune Checkpoint Inhibitors
Authors' conclusion
EARs were more common in TKIs + ICIs therapy. The distribution of EARs in different glands varied among combination therapy and monotherapy. Combination therapy-associated EARs did not increase the risk of mortality.
Study context
- Population
- Cases of endocrine adverse reactions (EARs) in the FDA Adverse Event Reporting System among 938,464 adverse event cases related to tyrosine kinase inhibitors (TKIs), immune checkpoint inhibitors (ICIs) or TKIs + ICIs
- Participants
- 22,275 EAR cases
- Exposure
- TKIs + ICIs vs ICIs vs TKIs
- TKIsn = 9,181
- ICIsn = 11,363
- TKIs + ICIsn = 1,731
- Outcome
- Incidence and risk of EARs
Methodological detailsFDA Adverse Event Reporting System
- FDA Adverse Event Reporting System
Main finding
As reported in the abstract
Odds ratio (95% CI)
TKIs + ICIsvs ICIshypothyroidism
1.47(1.28–1.69)
TKIs + ICIsvs TKIshypothyroidism
0.68(0.58–0.79)
TKIs + ICIsvs TKIsT1D
26.61(18.60–38.07)
TKIs + ICIsvs ICIsT1D
0.63(0.47–0.84)
TKIs + ICIsvs ICIshypoglycemia
2.77(1.95–3.95)
TKIsvs ICIshypoglycemia
3.44(2.93–4.03)
Observational data: associations, not effects.
Further findings
- Mortality risk with TKIs + ICIs comparable to ICIs but significantly lower than TKIs
Original publication
Endocrine Adverse Reactions of Tyrosine Kinase Inhibitors in Combination With Immune Checkpoint Inhibitors. J Clin Endocrinol Metab. Published 23 February 2025. doi:10.
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