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Thyroid eye disease (TED) treatment has been recently revolutionized with the approval of teprotumumab, a targeted insulin growth factor 1 receptor (IGF1R) inhibitor. To date, teprotumumab is the only FDA-approved drug for treating TED. In this article, we would like to temper the current enthusiasm around IGF1R inhibitors.

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Background: Teprotumumab, an IGF-1R monoclonal antibody, has shown significant efficacy in treating thyroid eye disease (TED). However, since teprotumumab was launched in 2020 and first approved in the United States, there were limited reports of post-marketing adverse events (AEs). In this study, we aimed to mine and analyze the AEs signals with teprotumumab on the basis of the United States Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) to provide instructions in clinical practice concerning adverse reactions and assistance in drug development and import/export into other countries.

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Objectives: To evaluate otologic adverse reactions (OARs), including hearing loss (OARs-HL) among patients taking teprotumumab, a new biologic approved for the treatment of active thyroid eye disease, using publicly available pharmacovigilance reporting data.

Study Design: Retrospective database review.

Methods: The Food and Drug Administration Adverse Events Reporting System (FAERS) was queried for cases involving teprotumumab from 2020Q1 to 2023Q1.

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Article Synopsis
  • Thyroid Eye Disease (TED) is a serious autoimmune condition linked with thyroid issues, leading to significant eye problems and discomfort.
  • Recent breakthroughs in TED treatment include Teprotumumab, the first FDA-approved medication specifically for the disease, which effectively reduces inflammation and improves patient quality of life.
  • Management of TED requires a team of specialists and includes advancements in both medical treatments and surgical techniques, ensuring comprehensive care for affected patients.
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Background: Thyroid eye disease (TED) can result in proptosis and ocular misalignment, leading to eye pain, diplopia, and vision loss. Teprotumumab, a humanized antibody against insulin-like growth factor 1 receptor, was approved in 2020 for the treatment of TED. The purpose of this study was to describe the effect of a full course of teprotumumab on ocular misalignment.

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