Abstract
Teprotumumab is a medication for thyroid eye disease. We conducted a review of studies assessing teprotumumab for thyroid eye disease treatment from MEDLINE (Medical Literature Analysis and Retrieval System Online) and CINHAL (Cumulative Index to Nursing and Allied Health Literature) from inception to September 20, 2025. The outcome of interest was hearing impairment. We included nine studies (four randomized controlled trials and five observational studies). The randomized controlled trials included 153 teprotumumab-treated patients. Using both broad and strict definitions of hearing loss, teprotumumab continued to demonstrate a statistically significant increased risk of hearing impairment (Broad: risk ratio (RR) 3.57, 95% CI 1.27-9.97; Strict: RR 5.23, 95% CI 1.40-19.57). Observational studies included over 2,000 patients treated with teprotumumab. Using the broad definition, the RR amongst observational studies was 2.78 (95% CI, 2.38-3.24); using the strict definition, the RR amongst observational studies was 2.76 (95% CI, 2.30-3.31). Sensitivity analyses were performed, with results remaining statistically significant, without heterogeneity or publication bias. Teprotumumab is associated with hearing impairment using broad and strict definitions, consistent amongst both RCTs and observational studies. Further research is required to address potential treatment options, the likelihood of recurrence with retreatment, and the chance of recovery.