Real-world experience shows Tepezza was effective in treating people with dysthyroid optic neuropathy (DON).- Horizon Therapeutics plc

DON is a complication of TED characterized by thyroid-related impairment of visual function and can lead to permanent sight loss related to optic nerve compression. Tepezza is the first and only medicine approved by the FDA for the treatment of TED – a serious, progressive and potentially vision-threatening rare autoimmune disease.

This analysis summarizes real-world experience of people living with TED and DON who were treated with Tepezza between January 2020 and September 2022. During this period, 24 patients were identified from literature and the author’s clinical experience with most (22 out of 24) receiving treatment with oral or intravenous steroids, surgery and/or radiation prior to Tepezza. After Tepezza treatment, meaningful improvement was observed in visual acuity in eyes with DON (mean lines of improvement of 3.7 – 23 patients, range 1-15, mean improvement in the mean deviation on visual field testing of -5.87 – 7 patients); proptosis (mean reduction of 4.4 mm – 19 patients); diplopia (mean improvement of 0.75 grade – 8 patients); and Clinical Activity Score (CAS) (mean reduction of 5.1 – 17 patients). Reported adverse events were consistent with Tepezza clinical trials and included fatigue, dysgeusia, hearing issues, nausea, hyperglycemia and muscle spasms.

“We know how devastating Thyroid Eye Disease can be for patients, and the risk of blindness in those with dysthyroid optic neuropathy is one of the most worrisome complications, especially when traditional therapies fail,” said Madhura A. Tamhankar, M.D., study author and associate professor of ophthalmology and neurology at the Hospital of the University of Pennsylvania. “These data are encouraging for physicians looking for an option to treat patients at the highest risk of losing their sight and provide evidence that Tepezza can help improve symptoms and preserve visual acuity.”

A recent health state analysis in JAMA Ophthalmology assessed the burden of TED, revealing people with moderate-to-severe disease experience substantial disutility in their day-to-day lives. In the study of over 100 general population participants, the worst impact on quality of life was associated with the most severe disease state (constant diplopia and large proptosis).

S ee _ Horizon Therapeutics plc announced results of an analysis of real-world treatment with Tepezza in Thyroid Eye Disease (TED) patients with DON (Dysthyroid Optic Neuropathy), the majority of whom had not previously responded to other treatments. DON is a complication of TED characterized by thyroid-related impairment of visual function and can lead to permanent sight loss related to optic nerve compression. Tepezza is the first and only medicine approved by the FDA for the treatment of TED – a serious, progressive and potentially vision-threatening rare autoimmune disease.

This analysis summarizes real-world experience of people living with TED and DON who were treated with Tepezza between January 2020 and September 2022. During this period, 24 patients were identified from literature and the author’s clinical experience with most (22 out of 24) receiving treatment with oral or intravenous steroids, surgery and/or radiation prior to Tepezza. After Tepezza treatment, meaningful improvement was observed in visual acuity in eyes with DON (mean lines of improvement of 3.7 – 23 patients, range 1-15, mean improvement in the mean deviation on visual field testing of -5.87 – 7 patients); proptosis (mean reduction of 4.4 mm – 19 patients); diplopia (mean improvement of 0.75 grade – 8 patients); and Clinical Activity Score (CAS) (mean reduction of 5.1 – 17 patients). Reported adverse events were consistent with Tepezza clinical trials and included fatigue, dysgeusia, hearing issues, nausea, hyperglycemia and muscle spasms.

“We know how devastating Thyroid Eye Disease can be for patients, and the risk of blindness in those with dysthyroid optic neuropathy is one of the most worrisome complications, especially when traditional therapies fail,” said Madhura A. Tamhankar, M.D., study author and associate professor of ophthalmology and neurology at the Hospital of the University of Pennsylvania. “These data are encouraging for physicians looking for an option to treat patients at the highest risk of losing their sight and provide evidence that Tepezza can help improve symptoms and preserve visual acuity.”

A recent health state analysis in JAMA Ophthalmology assessed the burden of TED, revealing people with moderate-to-severe disease experience substantial disutility in their day-to-day lives. In the study of over 100 general population participants, the worst impact on quality of life was associated with the most severe disease state (constant diplopia and large proptosis).

See- Horizon Therapeutics plc announced results of an analysis of real-world treatment with Tepezza in Thyroid Eye Disease (TED) patients with DON (Dysthyroid Optic Neuropathy), the majority of whom had not previously responded to other treatments. DON is a complication of TED characterized by thyroid-related impairment of visual function and can lead to permanent sight loss related to optic nerve compression. Tepezza is the first and only medicine approved by the FDA for the treatment of TED – a serious, progressive and potentially vision-threatening rare autoimmune disease.

This analysis summarizes real-world experience of people living with TED and DON who were treated with Tepezza between January 2020 and September 2022. During this period, 24 patients were identified from literature and the author’s clinical experience with most (22 out of 24) receiving treatment with oral or intravenous steroids, surgery and/or radiation prior to Tepezza. After Tepezza treatment, meaningful improvement was observed in visual acuity in eyes with DON (mean lines of improvement of 3.7 – 23 patients, range 1-15, mean improvement in the mean deviation on visual field testing of -5.87 – 7 patients); proptosis (mean reduction of 4.4 mm – 19 patients); diplopia (mean improvement of 0.75 grade – 8 patients); and Clinical Activity Score (CAS) (mean reduction of 5.1 – 17 patients). Reported adverse events were consistent with Tepezza clinical trials and included fatigue, dysgeusia, hearing issues, nausea, hyperglycemia and muscle spasms.

“We know how devastating Thyroid Eye Disease can be for patients, and the risk of blindness in those with dysthyroid optic neuropathy is one of the most worrisome complications, especially when traditional therapies fail,” said Madhura A. Tamhankar, M.D., study author and associate professor of ophthalmology and neurology at the Hospital of the University of Pennsylvania. “These data are encouraging for physicians looking for an option to treat patients at the highest risk of losing their sight and provide evidence that Tepezza can help improve symptoms and preserve visual acuity.”

A recent health state analysis in JAMA Ophthalmology assessed the burden of TED, revealing people with moderate-to-severe disease experience substantial disutility in their day-to-day lives. In the study of over 100 general population participants, the worst impact on quality of life was associated with the most severe disease state (constant diplopia and large proptosis).

See-Smith TJ, Cockerham K, Lelli G, et al." Utility Assessment of Moderate to Severe Thyroid Eye Disease Health States". JAMA Ophthalmol. Published online December 29, 2022. doi:10.1001/jamaophthalmol.2022.3225.