Immune Checkpoint Inhibitor-related New-onset Thyroid Dysfunction: A Retrospective Analysis Using the US FDA Adverse...

Area of Science:

• Endocrinology
• Oncology
• Pharmacovigilance

Background:

• Immune checkpoint inhibitors (ICIs) are revolutionary cancer therapies.
• Thyroid dysfunction is a known side effect of ICIs.
• Understanding ICI-related thyroid dysfunction (ICI-TD) prevalence and risk factors is crucial for patient management.

Purpose of the Study:

• To determine the prevalence and demographic characteristics of ICI-TD.
• To identify risk factors for poor clinical outcomes in patients with ICI-TD.
• To analyze ICI-TD patterns based on different ICI therapies.

Main Methods:

• Retrospective study using the US FDA Adverse Event Reporting System (FAERS) database.
• Identified new-onset or new-diagnosed thyroid dysfunction related to FDA-approved ICIs (2011-2020).
• Analyzed data on age, gender, co-occurring endocrinopathies, and prognosis.

Main Results:

• ICI-TD identified in 2.60% of patients; hypothyroidism was most frequent (62.0%).
• Anti-programmed cell death protein-1 (PD-1) therapy increased hypothyroidism risk.
• Combination anti-cytotoxic T-cell-associated protein-4 (CTLA-4) and anti-PD-1 therapy elevated risk of other endocrinopathies and severe cases.

Conclusions:

• Regular thyroid function monitoring is essential for patients on ICIs, particularly combination therapies.
• Hypothyroidism in ICI-treated patients may signal poor clinical outcomes.
• Healthcare professionals should maintain high awareness of ICI-TD for timely intervention.