Real-World Study Shows High Rates of Endocrinopathies Are Linked to Immune Checkpoint Inhibitors

Rachel Narozniak, MA
Published: Wednesday, Jan 29, 2020
Use of immune checkpoint inhibitors (ICIs) correlates with high incidence of endocrinopathies, especially anti–CTLA-4 therapy, according to a retrospective study based on real-world data. Investigators evaluated >29 million patient records from the FDA Adverse Events Reporting System (FAERS), a database of adverse events (AEs) reported by patients, healthcare providers, and others. Records were sourced from 2014 to early 2019 and investigators identified 6260 reports of endocrine-related AEs after ICI treatment.


Table. Associations of Endocrine AEs With Single-Agent ICIs (Click to Enlarge)

Investigators used RORs and information components (ICs) to evaluate disproportionality. The IC measures a higher- or lower-than-expected result. In the study, an ROR was defined as a signal for association if the lower limit of the 95% CI (ROR025) was >1, with ≥3 cases. The lower end of the 95% CI of IC (IC025) >0 was considered statistically significant.

Overall, patients treated with ICIs were much more likely to have reported endocrinopathies (IC025 = 2.49; ROR025 = 5.99). In addition to being the most common type of immune-related AE seen with ICIs, endocrinopathies are potentially life-threatening and irreversible.

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