Immune checkpoint inhibitor-related thyroid dysfunction during treatment of lung cancer: a disproportionality analysis based on the FDA adverse event reporting system

This is the authors' abstract. We don't add key points for this paper.

Background Immune checkpoint inhibitors (ICIs) have exhibited remarkable clinical benefits in the treatment of lung cancer, yet a large-scale pharmacovigilance investigation on ICI-related thyroid dysfunction (ICI-TD) remained limited. This study aimed to comprehensively analyze the demographic characteristics of ICI-TD in lung cancer patients and the pharmacovigilance signal patterns of the adverse events (AEs) using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Methods All existing data ranging from January 1 st 2014 to March 31 st 2026 were retrieved from the FAERS database. In descriptive analysis, the demographic characteristics of ICI-TD in lung cancer patients were collected and categorized. Disproportionality analysis was conducted to evaluate the signal characteristics of ICI-TD by employing three disproportional algorithms, namely reporting odds ratio (ROR), proportional reporting ratio (PRR), and information component (IC). Results A total of 2,001 reports of ICI-TD during treatment of lung cancer were identified after data processing, involving 1,758 patients and 10 ICIs. In general, ICI-TD were mainly reported in male patients (n = 959, 54.55%) and patients aged ≥ 65 years (n = 856, 48.69%; median [lower quartile (Q1), upper quartile (Q3)] = 67 [60, 73]). After data cleaning, we found that reports from 752 patients had valid time-to-onset (TTO) values. The median TTO of ICI-TD was 42 days [Q1, Q3] = [14, 98], and ICI-TD was predominantly reported within 30 days after ICI administration (n = 323, 42.95% of all 752 patients). The vast majority of patients were reported as having serious reaction outcome (n = 1,690, 96.13%). Among all ICIs, nivolumab had the greatest number of ICI-TD reports (a = 655, 32.73% of all 2,001 reports, ROR 025 = 2.97, IC 025 = 1.32, PRR = 3.21, χ 2 = 782.34). The most frequently reported ICI-TD was “hypothyroidism” (a = 901, 45.03% of all 2,001 reports, ROR 025 = 4.83, IC 025 = 1.22, PRR = 5.36, χ 2 = 1,138.77). Conclusions The present study provided a comprehensive overview of the demographic features of patients and pharmacovigilance signal patterns of ICI-TD during the treatment of lung cancer. Our findings would offer a referential perspective for the clinical understanding of the pharmacovigilance signals of ICI-TD.