Hearing Dysfunction After Treatment With Teprotumumab for Thyroid Eye Disease

Sears, Connie Martin; Azad, Amee D.; Amarikwa, Linus; Pham, Brandon; Men, Clara J; Kaplan, Daniel; Liu, Jocelyn; Hoffman, Andrew R.; Swanson, Austin; Alyono, Jennifer C; Lee, Jennifer Y.; Dosiou, Chrysoula; Kossler, Andrea L

doi:10.1016/j.ajo.2022.02.015

Cited by 43 publications

(44 citation statements)

References 66 publications

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“…While patients with pre-existing diabetes were more likely to have hyperglycaemia that was moderate in severity, no AEs of hyperglycaemia were serious or led to discontinuation [ 13 , 15 ]. Most hearing impairment during clinical trials was transient and resolved without treatment [ 14 , 15 ], but there have been case reports of long-term and potentially irreversible hearing loss [ 30 , 32 , 33 ].…”

Section: Tolerability Of Teprotumumabmentioning

confidence: 99%

Teprotumumab: A Review in Thyroid Eye Disease

Nie

Lamb

2022

Drugs

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Teprotumumab (TEPEZZA ® ), a monoclonal antibody that inhibits the insulin-like growth factor 1 receptor (IGF-1R), is the first disease-modifying therapy approved for the treatment of thyroid eye disease (TED) in the USA. In phase II and III clinical trials in adults with active, moderate-to-severe TED, intravenous teprotumumab significantly improved proptosis response rate and a range of other TED outcomes, including overall response rate, Clinical Activity Score, diplopia and disease-specific quality of life. The clinical benefit of teprotumumab was maintained for up to 51 weeks post-treatment in the majority of patients. Teprotumumab was generally well tolerated; adverse events with the greatest risk difference compared with placebo were muscle spasms, hearing loss and hyperglycaemia. Early real-world experience suggests teprotumumab may also be beneficial in a more diverse TED population. Teprotumumab is the first approved treatment for TED and is effective at reducing symptoms which are often unamenable to historical pharmacological interventions. While further data are required, current evidence suggests teprotumumab represents an important advance in the treatment of TED. Supplementary Information The online version contains supplementary material available at 10.1007/s40265-022-01804-1.

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Section: Tolerability Of Teprotumumabmentioning

confidence: 99%

Teprotumumab: A Review in Thyroid Eye Disease

Nie

Lamb

2022

Drugs

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“…In this study, 5 patients, with baseline and posttreatment audiograms, developed teprotumumab-related SNHL and 1 patient developed a patulous eustachian tube. A prior history of hearing loss was identified as a risk factor for teprotumumab-related hearing loss ( 81 ). This led the authors to recommend a baseline audiogram and patulous eustachian testing on all patients with repeat testing should new symptoms develop or persist.…”

Section: Teprotumumabmentioning

confidence: 99%

Teprotumumab and the Evolving Therapeutic Landscape in Thyroid Eye Disease

Kossler

Douglas

Dosiou

2022

The Journal of Clinical Endocrinology &Amp; Metabolism

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Context Thyroid eye disease (TED) is a sight-threatening and debilitating autoimmune condition, with limited therapies available, that often poses diagnostic and therapeutic challenges. In recent years, the treatment landscape has shifted to early intervention with targeted therapy. Methods A PubMed review of the literature was conducted for the period between 1979 and 2021. Search terms included thyroid eye disease, teprotumumab, targeted therapy, Graves disease, Graves ophthalmopathy, dysthyroid optic neuropathy, and related terms in different combinations. Novel biologic therapies for TED have emerged as alternatives to traditional steroid regimens in recent years. New insights into TED pathophysiology have uncovered the role of the insulin-like growth factor 1 receptor (IGF-1R) and led to the development of teprotumumab, an IGF-1R–inhibiting monoclonal antibody. Results Randomized clinical trials demonstrating the efficacy of teprotumumab for TED led to Food and Drug Administration approval. Teprotumumab is gradually replacing immunosuppressive agents as first-line therapy in the United States for active moderate-to-severe TED, while emerging reports also show its use in other stages of the disease. Recent data highlight risk factors for adverse events and screening protocols to maximize patient safety. Personalized therapeutic plans developed through effective partnership between endocrinologists and ophthalmologists aim to enhance the safety and outcomes of TED treatments and improve care for this complex disease. Conclusion TED management is shifting to an era of targeted therapy with multidisciplinary care. Teprotumumab has demonstrated superior efficacy to conventional treatments and has transformed our therapeutic and surgical algorithms. Clinical guidelines and additional studies are needed to further guide and refine therapy.

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“…Recently, there are increasingly case reports on the ototoxicity of teprotumumab (12)(13)(14). Even though current data indicate that most of the otologic symptoms resolved after treatment, hearing loss may be persistent in adults (15). Hearing impairment posed additional risk to the potential pediatric use, especially for school-age children.…”

Section: Concerns About Using Teprotumumab In Childrenmentioning

confidence: 99%

Treating Thyroid Associated Ophthalmopathy in Pediatric Patients

Dong¹,

Fu²,

Wang³

2022

Front. Endocrinol.

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Thyroid associated ophthalmopathy (TAO) is a common extra-thyroid clinical manifestation of Graves’ disease. It is an inflammatory disease of the eye and orbital tissues. Up to one-third of pediatric Graves’ disease patients could be diagnosed with TAO. The symptoms can be variable with remissions and exacerbations of pediatric Graves’ disease, which has negative effects on the quality of life in children. Teprotumumab is a fully human IgG1κ type monoclonal antibody targeting insulin-like growth factor-1 receptor (IGF-1R), and was approved for the treatment of TAO as a “breakthrough therapy” by the FDA in 2020. Nevertheless, the safety and effectiveness have not been established in pediatric patients. IGF-1R plays an important role in human development, which raises concerns of developmental toxicity. As presented in the pharmacology review report, juvenile monkeys were tested in two separate repeated-dose toxicity studies and no NOAEL was identified. Teprotumumab affected the growth, thymus, spleen and decreased the bone growth. Younger animals seemed to be more sensitive to the effects on normal growth and normal thymus. Hearing impairment posed additional risk to the potential pediatric use, especially for school-age children. Considering the nature of the target, Teprotumumab should not be used empirically in children. More efforts would be made for the further development of teprotumumab for pediatric use.

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Hearing Dysfunction After Treatment With Teprotumumab for Thyroid Eye Disease

Cited by 43 publications

References 66 publications

Teprotumumab: A Review in Thyroid Eye Disease

Teprotumumab: A Review in Thyroid Eye Disease

Teprotumumab and the Evolving Therapeutic Landscape in Thyroid Eye Disease

Treating Thyroid Associated Ophthalmopathy in Pediatric Patients

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