Teprotumumab-Related Adverse Events in Thyroid Eye Disease: A Multicenter Study

Area of Science:

• Ophthalmology
• Endocrinology
• Rheumatology

Background:

• Thyroid eye disease (TED) is a debilitating autoimmune condition affecting the orbit.
• Teprotumumab is an insulin-like growth factor 1 receptor (IGF-1R) inhibitor used to treat TED.
• Understanding the safety profile of teprotumumab is crucial for clinical decision-making.

Purpose of the Study:

• To evaluate the incidence, duration, reversibility, and severity of adverse events (AEs) associated with teprotumumab therapy in patients with TED.
• To assess the impact of AEs on treatment continuation and patient outcomes.

Main Methods:

• A multicenter, retrospective, observational cohort study was conducted.
• 131 patients with TED treated with at least 4 infusions of teprotumumab were included.
• Adverse event data, including onset, severity, duration, and reversibility, were collected and analyzed.

Main Results:

• Adverse events occurred in 81.7% of patients, with a median of 4 AEs per patient. Most AEs were mild (74.0%) and reversible (mean duration 17.6 weeks).
• Musculoskeletal (58.0%), gastrointestinal (38.2%), and skin (38.2%) AEs were most common. Serious AEs occurred in 8.4% of patients.
• Significant improvements in proptosis (77%), clinical activity score (CAS), and diplopia were observed. 12.2% discontinued therapy due to AEs.

Conclusions:

• Teprotumumab is associated with a high incidence of AEs, predominantly mild and reversible.
• Physicians must counsel patients on AE risks, screen appropriately, and monitor closely for AE management.
• While generally safe, serious AEs can occur, potentially leading to treatment discontinuation.