Teprotumumab-associated adverse events in thyroid eye disease: four-year review of the Federal Drug Administration Adverse Events Reporting System database
Author: Merve Kulbay
Base Hospital / Institution: Department of Ophthalmology & Visual Sciences, McGill University, Montreal, QC, Canada
ePoster presentation
Abstract ID: 25-373
Purpose
Teprotumumab, an insulin-like growth factor-1 receptor inhibitor, has emerged as a prominent therapeutic option for thyroid eye disease since its approval by the United States Food and Drug Administration (FDA) in January 2020. Post-marketing surveillance is crucial for assessing long-term safety and adverse event (AE) profiles not fully elucidated in clinical trials. Understanding these AEs can enhance patient management and inform clinical decision-making, thus optimizing therapeutic outcomes.
Methods
A cross-sectional retrospective analysis was conducted using the FDA Adverse Event Reporting System database, extracting data for teprotumumab-associated AEs reported from January 2020 to December 2024. Healthcare-professional reports containing complete demographic and outcome data were retained and stratified by, sex, age, country of origin, seriousness, and event category. One-sided independent-sample t-tests compared event frequencies; effect size was expressed as Cohen’s d, with significance at p<0.05.
Results
The analysis included 785 reported cases: 745 (94.9%) from the United States, 4 (0.5%) from France, 3 (0.4%) from Israel, 1 (0.1%) from Brazil, and 32 (4.1%) from unspecified. Serious AEs higher in males (46.9%, SD 0.5) than females (35.1%, SD 0.5; p=0.03, d=0.48). Weight loss trended higher in males (11.1% vs 4.9%; p=0.05, d=0.26). Older age linked to hearing loss (61.2 vs 55.6 years; p<0.001, d=0.42), nail changes (69.0 vs 57.5 years; p<0.001, d=0.85), musculoskeletal pain (62.3 vs 57.1 years; p=0.01, d=0.38), and psychiatric symptoms (62.6 vs 57.2 years; p=0.01, d=0.40). Menstrual changes (32.7 vs 58.5 years; p<0.001, d=-2.02) and abdominal pain (61.7 vs 57.1 years; p=0.02, d=0.34) were more common in younger patients.
Conclusion
Male sex and older age predict higher rates of serious or specific AEs, whereas younger patients disproportionately experience menstrual and abdominal symptoms. These patterns underscore the need for internationally integrated, age- and sex-stratified pharmacovigilance to optimize teprotumumab safety in thyroid eye disease.
Additional Authors
| First name | Last name | Base Hospital / Institution |
|---|---|---|
| Raheem | Remtulla | Department of Ophthalmology & Visual Sciences, McGill University, Montreal, QC, Canada |
| Reese | Kapusta | Faculty of Medicine & Health Sciences, McGill University, Montreal, QC, Canada |
| Stuti Misty | Tanya | Department of Ophthalmology & Visual Sciences, McGill University, Montreal, QC, Canada |
| Sara | Tullis Wester | Oculofacial Plastic and Reconstructive Surgery, Orbital Surgery and Oncology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine |
| Femida | Kherani | Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, BC, Canada |
