-- Real-world analysis of TEPEZZA use since U.S. Food and Drug Administration (FDA) approval evaluates percentage of people who received a second course of treatment --

-- Poster presentation on inflammatory TED to discuss impact on patients throughout the course of disease --

Horizon Therapeutics plc (Nasdaq: HZNP) today announced new data will be presented at the 91^st Annual Meeting of the American Thyroid Association (ATA 2022) in Montreal, October 19-23. TEPEZZA is the first and only medicine approved by the FDA for the treatment of TED. It is only approved in the U.S.

“Our understanding of Thyroid Eye Disease is ever-evolving, and we are committed to ongoing research that reflects the experiences of those living with this debilitating disease,” said Jeffrey W. Sherman, M.D., FACP, executive vice president, chief medical officer, Horizon. “We look forward to bringing these important data to the forefront to help physicians better understand the condition for their patients.”

Horizon presentations include:

• Title: Steroid Treatment Patterns For Thyroid Eye Disease in the United States Before and After Teprotumumab Approval
  • Session: Parallel Sessions, Oral 11, Abstract 127, C Choudhary
  • Date: Friday, Oct. 21, 9:45-11 a.m. ET
    
    

• Title: Sequelae of Shorter versus Longer Duration Inflammatory Thyroid Eye Disease
  • Session: Exhibit Hall, Poster 308, Abstract 357, TJ Smith
  • Date: Friday, Oct. 21, 10:30-4:30 p.m. ET
    
    

• Title: Comparison of Steroid and Ophthalmic Surgery Use in Thyroid Eye Disease (TED) Patients with Longer Versus Shorter Disease Duration in United States Clinical Practices
  • Session: Exhibit Hall, Poster 307, Abstract 384, TJ Smith
  • Date: Friday, Oct. 21, 10:30-4:30 p.m. ET
    
    

• Title: Evaluation of United States Thyroid Eye Disease Patients Receiving an Additional Course of Teprotumumab Treatment Over 2 Years
  • Session: Exhibit Hall, Late-Breaking Poster 572, Abstract 653, RJ Holt
  • Date: Saturday, Oct. 22, 10:30-2:30 p.m. ET
    
    

About Thyroid Eye Disease (TED)

TED is a serious, progressive and potentially vision-threatening rare autoimmune disease.¹ TED often occurs in people living with Graves’ disease, but is a distinct disease that is caused by autoantibodies activating an IGF-1R-mediated signaling complex on cells within the retro-orbital space.^2,3 This leads to a cascade of negative effects, which may cause long-term, irreversible damage, including blindness. Early signs and symptoms of TED may include dry eyes and grittiness; redness, swelling and excessive tearing; eyelid retraction; proptosis; pressure and/or pain behind the eyes; and diplopia.^4,5

About TEPEZZA

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Infusion Reactions: TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity. Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic, or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.

Preexisting Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of preexisting inflammatory bowel disease (IBD). Monitor patients with IBD for flare of disease. If IBD exacerbation is suspected, consider discontinuation of TEPEZZA.

Hyperglycemia: Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA. In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia. Hyperglycemic events should be managed with medications for glycemic control, if necessary. Monitor patients for elevated blood glucose and symptoms of hyperglycemia while on treatment with TEPEZZA. Patients with preexisting diabetes should be under appropriate glycemic control before receiving TEPEZZA.

Adverse Reactions

The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache, dry skin, and menstrual disorders.

Please see Full Prescribing Information or visit TEPEZZAhcp.com for more information.

About Horizon

Horizon is focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: We apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

References

1. Barrio-Barrio J, et al. Graves' Ophthalmopathy: VISA versus EUGOGO Classification, Assessment, and Management. Journal of Ophthalmopathy. 2015;2015:249125.
2. Weightman DR, et al. Autoantibodies to IGF-1 Binding Sites in Thyroid Associated Ophthalmopathy. Autoimmunity. 1993;16(4):251–257.
3. Pritchard J, et al. Immunoglobulin Activation of T Cell Chemoattractant Expression in Fibroblasts from Patients with Graves’ Disease Is Mediated Through the Insulin-Like Growth Factor 1 Receptor Pathway. J Immunol. 2003;170:6348-6354.
4. Bartalena L, et al. The 2021 European Group on Graves’ Orbitopathy (EUGOGO) Clinical Practice Guidelines for the Medical Management of Graves’ Orbitopathy. Eur J Endocrinol. 2021;185:G43–G67.
5. McKeag D, et al. Clinical features of dysthyroid optic neuropathy: a European Group on Graves' Orbitopathy (EUGOGO) survey. Br J Ophthalmol. 2007;91:455-458.

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