Teprotumumab 500mg powder for solution for infusion vials

ObjectiveTo ascertain trends in ototoxicity observed with monoclonal antibodies (mABs) and understand the impact they may have on hearing function.Data sourcesPubMed, Embase, Scopus.Review methodsA systematic review was performed following PRISMA guidelines. Data were reviewed for demographics, utilized mABs with respective indication and dosing, audiometric outcomes, and treatment for otologic effects.ResultsOf 757 studies reviewed, a total of 44 were included, encompassing 18,046 patients treated with mABs. Mean age of the sample was 57.8 years old. The search yielded 18 agents of ototoxicity, with reported symptoms of ototoxicity such as hearing loss, tinnitus, and/or aural fullness occurring in 1079 of total patients. Main agents causing ototoxicity were teprotumumab (n = 17/44 studies), nivolumab (n = 10/44), ipilimumab (n = 9/44), pembrolizumab (n = 5/44), and rituximab (n = 4/44). Thirty-one of 44 studies encompassing eight agents reported audiometric data for ototoxic agents, showing sensorineural hearing loss primarily in the high-frequency range. Only two articles performed ultrahigh-frequency audiograms.ConclusionMonoclonal antibody usage is expanding, but the vast majority of studies lack substantial audiometric data. Where reported, study design and inclusion criteria vary greatly. Future studies would benefit from rigid inclusion of audiometric data, prospective study design, and consideration of formal ototoxicity screening. Otolaryngologists should be aware of the cochlear immune response and potential impact of this expanding medication class on hearing function. Laryngoscope, 135:491-506, 2025.

Abstract licence: CC BY-NC-ND

Background: Thyroid eye disease (TED) is a disabling, organ-specific autoimmune disease that is a global health concern. Recently, certain biological agents have demonstrated unique advantages for the treatment of TED. Teprotumumab is an emerging biological agent used for TED treatment. This study assessed whether teprotumumab can serve as an effective and safe treatment for active TED through a meta-analysis of the literature. Methods: We searched 4 databases (PubMed, The Cochrane Library, Web of Science, and Embase) for randomized controlled trials regarding the treatment of Graves’ ophthalmopathy by teprotumumab by March 31, 2024. We screened the literature library and extracted the data according to the inclusion and exclusion criteria. Results: Our study included 5 articles that involved 411 cases. Significant differences were reported in the change from baseline in proptosis (proptosis vs baseline), diplopia response at week 24, and clinical activity score of 0 or 1 at week 24 in the teprotumumab versus placebo group. The teprotumumab group reported no significant risk of adverse events or serious adverse events during the intervention. Conclusion: Teprotumumab significantly decreased proptosis and clinical activity score and improved diplopia response in patients with TED, with fewer adverse effects. Therefore, it is a promising biological agent. However, this conclusion should be further validated by high-quality, long-term randomized controlled trials with large sample sizes.

Abstract licence: CC BY 4.0

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.

Abstract licence: CC BY