Please ensure JavaScript is enabled for purposes of website accessibility Diagnosing Thyroid Eye Disease | TEPEZZA® (teprotumumab-trbw) for HCPs

About Thyroid Eye Disease (TED)

TED is a progressive autoimmune disease1-4

Thyroid

TED has a distinct pathophysiology from autoimmune thyroid conditions like Graves’ disease2-5

  • Treating only the thyroid won’t treat TED2-5
  • Even TED patients who have had their thyroid gland completely removed can continue to suffer6-8
  • IGF-1R activation on orbital fibroblasts leads to inflammation and expansion of muscle and fat tissue behind the eye2-4,9
Visible-Symptoms

Damage can start before visible symptoms appear5,10-12

  • In a study of patients with untreated Graves’ disease and no diagnosed clinical ophthalmopathy, 71% (n=17) showed extraocular muscle swelling in orbital MRI11
Pressure-and-pain

Symptoms can worsen and flare over time1,13,14

  • Like other autoimmune diseases, patients with TED experience disease flares13,14
  • In a retrospective chart review of 415 patients, 16% (65) were identified as having disease flares/recurrent TED, regardless of initial treatment1,*

*Recurrent TED was evidenced by prior medical or surgical intervention for TED, prior orbital imaging with diagnostic evidence for TED, or patient report of painless orbital inflammatory disease or photographs demonstrating a change in appearance consistent with TED.1

IGF-1R, insulin-like growth factor-1 receptor; MRI, magnetic resonance imaging; TED, Thyroid Eye Disease.

Orbital MRI imaging in patients with TED

Healthy Eye and Orbital Tissue

Healthy-Eye-Orbital -issue

Images provided with permission from Jody Abrams, MD.

Increased Tissue Volume in TED

Increased-Tissue-Volume-in-TED

Images provided with permission from Mark Lupo, MD.

IR, inferior rectus; LR, lateral rectus; MR, medial rectus; SO, superior oblique; SR, superior rectus.

  • Green arrows point to a coronal view of the extraocular muscles (white areas)
  • Extraocular muscle volume increase in patients with TED

TED can cause a wide range of visible and nonvisible signs and symptoms3,9

TED is more than proptosis. If your patients with thyroid conditions present with any of the following signs or symptoms, it could be TED9

Visible Signs15,16

Proptosis
Proptosis
Retraction
Eyelid retraction
Redness
Redness, swelling, and excessive tearing
Soft issue
Soft tissue changes around eyes

Nonvisible Symptoms15,16

Diplopia-1
Diplopia
Blurry
Blurry vision
Itchy-eyes
Itchy eyes
Dryness
Dryness and grittiness
Presure
Pressure/Pain behind the eye
Photophobia
Photophobia
Color-vision-loss
Color vision loss

Screen all patients with thyroid conditions for all visible signs and nonvisible symptoms of TED9,17

TED is commonly misdiagnosed due to shared symptoms
with other diseases18

thyroid-stimulating-hormone-desktop thyroid-stimulating-hormone-desktop

TSH, thyroid-stimulating hormone.

Signs-and-SYMPTOMS

Patients with TED often show symptoms of dry eye disease19

DRY EYE DISEASE (DED): Affects lacrimal glands and ocular surface causing insufficient lubrication to aqueous tear-film layer20

The real impact of TED goes beyond the eyes

The visible and nonvisible symptoms of TED can have a debilitating impact on your patients’ daily activities and self-confidence21-23

Car

61% had trouble performing 1 or more daily activities23 

(n=242/394)

Trouble-reading

45% Had trouble reading23

(n=177/394)

Based on an online 62-question survey of 443 TED patients with a diagnosis that ranged from <1 to >10 years23

Self-Confidence_Icon

71% felt their self-confidence had been negatively affected24

(n=50/70)

71%

(n=50/70)

felt their self-confidence had been negatively affected24

Based on responses from 70 patients with TED with a duration of disease ranging from 12 to 18 months who answered 16 questions from the GO-QOL questionnaire24

GO-QOL, Graves’ Ophthalmopathy Quality of Life.

Kim

Thyroid Eye Disease kind of put me into a shell. I didn’t want to do things with people and I didn’t want my picture taken.

— Kim E, Patient with TED

ATA & ETA 2022 Consensus Statement Recommendation:
Assess the physical and psychosocial impact of TED for all patients17

Assess the full impact of TED using the Burden-Impact Model

Consider the signs and symptoms of TED, as well as patients’ ability to manage daily activities, for a deeper
understanding of disease burden

Patient-Reported Impact
Degree to which symptoms impact patients’ daily
activities and emotional well-being

Not an official medical tool.

SEE HOW THE BURDEN-IMPACT MODEL IS USED

The Patient Intake Form includes the Burden-Impact Model—ask your AMGEN representative for a copy.

Signs-and-SYMPTOMS

Signs and SYMPTOMS15,16

Some examples: eye pain, redness, swelling, eye bulging, and double vision. These are not all the signs and symptoms of TED

sign-popup
Daily-Activities

Daily Activities9,25

Some examples: walking outdoors, driving, reading

daily-popup
Emotional-well-being

Emotional well-being21,22

Some examples: negative impact to self-esteem, hiding their appearance in public

emotional-popup
TEP Icon Set

Hear how the signs
and symptoms of
TED interfered with
Kim’s everyday life

  • Read transcript

    Kim: I'm Kim. And this is my journey with Thyroid Eye Disease.

    When I was 17, I started to get really tired, and my mom was worried about me, so she took me to the doctor to have me checked for Mono. And the doctor did the blood work and said, you do not have Mono. I think it's just growing pains and kind of just sent me on my way.

    And then I went to college where I was recruited to play volleyball and run track. When I went to the volleyball camp before the season, the coach called me into the office and she looked at me and she said, “You play like you're sick, I'm cutting you.” And I was devastated.

    So, I went to a doctor on campus and he basically told me I was a hypochondriac.

    My uncle is an ophthalmologist and he looked at me and said, ”Oh my gosh, you are so sick.” My uncle got me into an endocrinologist, and he said, “You have Graves’ disease and you need treatments immediately.”

    So, I started radiation treatments. Once that was stabilized, my eye symptoms started to get worse. And my uncle at that time said, “You have Thyroid Eye Disease and it is independent from your Grave's disease.”

    I had the tightness in my eyes. The bulging. And they kept getting worse and worse as time was going on. My eyelids wouldn't close. So, I was putting night eye ointment in all the time. I was using drops constantly, so I always knew my eyes were there. So, they got me into a ocular plastic surgeon and I had my first Levator surgery.

    That took care of the major symptoms. But I was still using the eye ointment at night. I was still using drops.

    I could drive during the day, but nighttime no, everything, all the lights were double.

    You just kind of learn to live with those symptoms and move on because you think there's nothing you can do anymore. So, I thought this is just how it was going to be.

    You just aren't comfortable anymore with yourself in your own skin and everything bothers you. I didn't want to really be around people. I didn't want to go to events. It got to a point where I didn't want to be out in public because people would look at me and I knew they were looking at my eyes.

    Discovering TEPEZZA

    After 25 years and four surgeries I said to my optometrist, I need some help. So that’s when she recommended that I see an oculoplastic surgeon and the new oculoplastic surgeon said, “Hey, there's this new medicine out called TEPEZZA. I think before we do any more surgeries on you, you should try it.

    I had told her I saw the commercials and I said I didn't think it was an option for me because I thought I had to be in that bad phase with all those bad symptoms I had before.

    And she said, “No, I’m pretty sure this is going to be it.”

    Kim’s Treatment Experience & Results

    When I went for my first infusion, I was very anxious.

    Then after the second treatment, I got used to everything. And by the third treatment is when I really noticed that the pink in my eyes was gone. And then after the fourth treatment, I noticed the bulging had decreased.

    It was exciting to, to see that.

    The most significant difference was infusions five through eight. The tightness was gone. I was blinking normally again, and I could sleep without using eye ointment.

    When I was done, my eye bulging, decreased three millimeters in each eye, which is a significant difference.

    Post Treatment

    To see myself now, after this treatment, it's been inspiring and uplifting and healing because I don't think about my eyes every day anymore. I can go about my day being confident and people aren't asking me about my eyes.

    When my son got married, I actually couldn't wait to see the pictures. And you see a picture. You don't see eyes.

    It's been an amazing experience. If I can help somebody who was in the same stage as I was and thinks they can't do this, they should make sure they ask their doctor, “is this an option for me?” Because I didn't think it was and it's been incredible.

    I wish 25 years ago TEPEZZA would have been around because I would have gotten back 25 years of my life of not having to think or feel something constantly every day.

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 controlled with medications for glycemic control, if necessary. Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with TEPEZZA. Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving TEPEZZA.

Hearing Impairment Including Hearing Loss: TEPEZZA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients’ hearing before, during, and after treatment with TEPEZZA and consider the benefit-risk of treatment with patients.

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, weight decreased, nail disorders, and menstrual disorders.

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.

Please see Full Prescribing Information for more information.

REFERENCES:
  1. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.
  2. Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for the treatment of active Thyroid Eye Disease.N Engl J Med. 2020;382(4):341-352.
  3. Douglas RS, Couch S, Wester ST, et al. A randomized, quadruple-masked, placebo-controlled, multicenter trial to evaluate the efficacy and safety of teprotumumab in patients with chronic (inactive/low CAS) Thyroid Eye Disease. Presented at: ENDO 2023; June 15-18, 2023; Chicago, IL. Poster SAT-459.
  4. Douglas RS. Teprotumumab, an insulin-like growth factor-1 receptor antagonist antibody, in the treatment of active Thyroid Eye Disease: a focus on proptosis. Eye (Lond). 2019;33(2):183-190.
  5. Data on File. Amgen, July 2023.
REFERENCES:
  1. Bahn RS. Graves' ophthalmopathy. N Engl J Med. 2010;362(8):726-738.
  2. Wang Y, Patel A, Douglas RS. Thyroid Eye Disease: how a novel therapy may change the treatment paradigm. Ther Clin Risk Manag. 2019;15:1305-1318.
  3. Patel A, Yang H, Douglas RS. A new era in the treatment of Thyroid Eye Disease. Am J Ophthalmol. 2019;208:281-288.
  4. Wang Y, Sharma A, Padnick-Silver L, et al. Physician-perceived impact of Thyroid Eye Disease on patient quality of life in the United States. Ophthalmol Ther. 2021;10(1):75-87.
  5. Dik WA, Virakul S, van Steensel L. Current perspectives on the role of orbital fibroblasts in the pathogenesis of Graves' ophthalmopathy. Exp Eye Res. 2016;142:83-91.
  6. Patel P, Khandji J, Kazim M. Recurrent Thyroid Eye Disease. Ophthal Plast Reconstr Surg. 2015;31(6):445-448.
  7. Douglas RS, Kahaly GJ, Ugradar S, et al. Teprotumumab efficacy, safety and durability in longer-duration Thyroid Eye Disease and re-treatment: OPTIC-X study. Ophthalmology. 2022;129(4):438-449.
  8. Bothun ED, Scheurer RA, Harrison AR, Lee MS. Update on Thyroid Eye Disease and management. Clin Ophthalmol.2009;3:543-551.
  9. Barrio-Barrio J, Sabater AL, Bonet-Farriol E, Velázquez-Villoria Á, Galofré JC. Graves' ophthalmopathy: VISA versus EUGOGO classification, assessment, and management. J Ophthalmol.2015;2015:249125.
  10. Thyroid Eye Disease. National Organization for Rare Disorders. 2020. Accessed December 8, 2022. https://rarediseases.org/rare-diseases/thyroid-eye-disease
  11. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.
  12. Risk factors for the development of Thyroid Eye Disease in patients with Graves' disease. Clin Thyroidology for the Public. 2021;14(8):5-6.
  13. Verjee MA, Brissette AR, Starr CE. Dry eye disease: early recognition with guidance on management and treatment for primary care family physicians.Ophthalmol Ther. 2020;9:877-888.
  14. Burch HB, Perros P, Bednarczuk T, et al. Management of Thyroid Eye Disease: a consensus statement by the American Thyroid Association and the European Thyroid Association. Thyroid. 2022;32(12):1439-1470.
  15. Dolman PJ. Grading severity and activity in Thyroid Eye Disease. Ophthalmic Plast Reconstr Surg. 2018;34(4S supp 1):S34-S40.
  16. Ozzello DJ, Dallalzadeh LO, Liu CY. Teprotumumab for chronic Thyroid Eye Disease. Orbit. 2022;41(5):539-546.
  17. Ponto KA, Merkesdal S, Hommel G, Pitz S, Pfeiffer N, Kahaly GJ. Public health relevance of Graves' orbitopathy.J Clin Endocrinol Metab. 2013;98(1):145-152.
  18. McAlinden C. An overview of Thyroid Eye Disease. Eye Vis (Lond). 2014;1:9.
  19. Bartley GB, Fatourechi V, Kadrmas EF, et al. Clinical features of Graves' ophthalmopathy in an incidence cohort. Am J Ophthalmol. 1996;121(3):284-290.
  20. Terwee C, Wakelkamp I, Tan S, Dekker F, Prummel MF, Wiersinga W. Long-term effects of Graves' ophthalmopathy on health-related quality of life. Eur J Endocrinol. 2002;146(6):751-757.
  21. Bartley GB. The epidemiologic characteristics and clinical course of ophthalmopathy associated with autoimmune thyroid disease in Olmsted County, Minnesota. Trans Am Ophthalmol Soc. 1994;92(1):477-588.
  22. Neigel JM, Rootman J, Belkin RI, et al. Dysthyroid optic neuropathy. The crowded orbital apex syndrome.phthalmology. O1988;95(11):1515-1521.
  23. Cockerham KP, Padnick-Silver L, Stuertz N, Francis-Sedlak M, Holt RJ. Quality of life in patients with chronic Thyroid Eye Disease in the United States. Ophthalmol Ther. O 2021;10(4):975-987.
  24. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18)(suppl):1748-1761.
  25. Wiersinga WM, Perros P, Kahaly GJ, et al. Clinical assessment of patients with Graves' orbitopathy: the European Group on Graves' Orbitopathy recommendations to generalists, specialists and clinical researchers. Eur J Endocrinol. 2006;155(3):387-389.
  26. Stan MN, Garrity JA, Bahn RS. The evaluation and treatment of Graves ophthalmopathy. Med Clin North Am. 2012;96(2):311-328.
  27. Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for the treatment of active Thyroid Eye Disease. N Engl J Med. 2020;382(4):341-352.
  28. Ross DS, Burch HB, Cooper DS, et al. 2016 American Thyroid Association guidelines for diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis. Thyroid. 2016;26(10):1343-1421.
REFERENCES:
  1.  TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen. 
  2. Patel A, Yang H, Douglas RS. A new era in the treatment of Thyroid Eye Disease. Am J Ophthalmol. 2019;208:281-288. 
  3. Bahn RS. Graves' ophthalmopathy. N Engl J Med. 2010;362(8):726-738. 
  4. Douglas RS. Teprotumumab, an insulin-like growth factor-1 receptor antagonist antibody, in the treatment of active Thyroid Eye Disease: a focus on proptosis. Eye (Lond). 2019;33(2):183-190. 
  5. Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for the treatment of active Thyroid Eye Disease. N Engl J Med. 2020;382(4):341-352.
  6. Dik WA, Virakul S, van Steensel L. Current perspectives on the role of orbital fibroblasts in the pathogenesis of Graves' ophthalmopathy. Exp Eye Res. 2016;142:83-91.
  7. Ugradar S, Kang J, Kossler AL, et al. Teprotumumab for the treatment of chronic Thyroid Eye Disease. Eye (Lond). 2022;36(8):1553-1559.
  8. Data on File. Amgen, November 2020.
REFERENCES:
  1.  TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.  
  2. Patel A, Yang H, Douglas RS. A new era in the treatment of Thyroid Eye Disease. Am J Ophthalmol. 2019;208:281-288. 
  3. Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for the treatment of active Thyroid Eye Disease. N Engl J Med. 2020;382(4):341-352.
  4. Douglas RS. Teprotumumab, an insulin-like growth factor-1 receptor antagonist antibody, in the treatment of active Thyroid Eye Disease: a focus on proptosis. Eye (Lond). 2019;33(2):183-190.
  5. Kahaly GJ, Douglas RS, Holt RJ, Sile S, Smith TJ. Teprotumumab for patients with active Thyroid Eye Disease: a pooled data analysis, subgroup analyses, and off-treatment follow-up results from two randomised, double-masked, placebo-controlled multicentre trials. Lancet. 2021;9(6):360-372.
  6. Data on File. Amgen, April 2023.
  7. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy.N Engl J Med. 2017;376(18):1748-1761.
  8. Data on File. Amgen, May 2022.
  9. Wiersinga WM, Perros P, Kahaly GJ, et al. Clinical assessment of patients with Graves' orbitopathy: the European Group on Graves' Orbitopathy recommendations to generalists, specialists and clinical researchers. Eur J Endocrinol. 2006;155(3):387-389.
  10. Bothun ED, Scheurer RA, Harrison AR, Lee MS. Update on Thyroid Eye Disease and management. Clin Ophthalmol.2009;3:543-551.
  11. Rollet J. Symptoms, quality of life improve with teprotumumab for adults with Thyroid Eye Disease.Endocrine Today. October 31, 2019. Accessed September 11, 2021.
    https://www.healio.com/news/endocrinology/20191031/symptoms-quality-of-life-improve-with-teprotumumab-for-adults-with-thyroid-eye-disease
REFERENCES:
  1. Douglas RS, Couch S, Wester ST, et al. A randomized, quadruple-masked, placebo-controlled, multicenter trial to evaluate the efficacy and safety of teprotumumab in patients with chronic (inactive/low CAS) Thyroid Eye Disease. Presented at: ENDO 2023; June 15-18, 2023; Chicago, IL. Poster SAT-459.
  2. Data on File. Amgen, April 2023.
  3. TEPEZZA (teprotumumab-trbw) prescribing information Amgen.
REFERENCES:
  1. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.
  2. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18):1748-1761.
  3. Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for the treatment of active Thyroid Eye Disease. N Engl J Med. 2020;382(4):341-352.
REFERENCES:
  1. Diniz SB, Cohen LM, Roelofs KA, Rootman DB. Early experience with the clinical use of teprotumumab in a heterogenous Thyroid Eye Disease population. Ophthalmic Plast Reconstr Surg. 2021;37(6):583-591
  2. Ugradar S, Kang J, Kossler AL, et al. Teprotumumab for the treatment of chronic Thyroid Eye Disease.Eye (Lond) . 2022;36(8):1553-1559.
  3. Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for the treatment of active Thyroid Eye Disease. N Engl J Med. 2020;382(4):341-352. 
  4. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.
  5. Data on File. Amgen, January 2020.
  6. Ozzello DJ, Dallalzadeh LO, Liu CY. Teprotumumab for chronic Thyroid Eye disease. Orbit. 2022;41(5):539-546.
  7. Douglas RS, Kahaly GJ, Ugradar S, et al. Teprotumumab efficacy, safety and durability in longer duration Thyroid Eye Disease and retreatment: OPTIC-X study.Ophthalmol. 2022:129(4):438-449.
REFERENCES:
  1. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.
  2. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18)(suppl):1748-1761.
    https://www.nejm.org/doi/suppl/10.1056/NEJMoa1614949/suppl_file/nejmoa1614949_appendix.pdf
    .
  3. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18)(protocol):1748-1761.
    https://www.nejm.org/doi/suppl/10.1056/NEJMoa1614949/suppl_file/nejmoa1614949_protocol.pdf
  4. Wiersinga WM, Perros P, Kahaly GJ, et al. Clinical assessment of patients with Graves’ orbitopathy: the European Group on Graves’ Orbitopathy recommendations to generalists, specialists and clinical researchers. Eur J Endocrinol. 2006;155(3):387-389.
  5. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18):1748-1761.
  6. Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for the treatment of active thyroid eye disease. N Engl J Med. 2020;382(4):341-352.
  7. Smith TJ, Hoa N. Immunoglobulins from patients with Graves’ disease induce hyaluronan synthesis in their orbital fibroblasts through the self-antigen, insulin-like growth factor-1 receptor.J Clin Endocrinol Metab. 2004;89:5076-5080.
  8. Kahaly GJ, Douglas RS, Holt RJ, Sile S, Smith TJ. Teprotumumab for patients with active thyroid eye disease: a pooled data analysis, subgroup analyses, and off-treatment follow-up results from two randomised, double-masked, placebo-controlled, multicentre trials. Lancet. 2021;9(6):360-372.
  9. Data on File. Amgen, May 2022.
REFERENCES:
  1. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.
  2. Data on File. Amgen, April 2022.
REFERENCES:
  1. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.
REFERENCES:
  1. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen.
  2. Data on File. Amgen, May 2022.
REFERENCES:
  1. Ross DS, Burch HB, Cooper DS, et al. 2016 American Thyroid Association guidelines for diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis. Thyroid. 2016;26(10):1343-1421.
  2. Barrio-Barrio J, Sabater AL, Bonet-Farriol E, Velázquez-Villoria Á, Galofré JC. Graves’ ophthalmopathy: VISA versus EUGOGO classification, assessment, and management. J Ophthalmol. 2015;2015:249125.
REFERENCES:
  1. TEPEZZA (teprotumumab-trbw) [prescribing information] Horizon.
  2. Patel A, Yang H, Douglas RS. A new era in the treatment of thyroid eye disease. Am J Ophthalmol. 2019;208:281-288.
  3. Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for the treatment of active thyroid eye disease. N Engl J Med. 2020;382(4):341-352.
  4. Douglas RS. Teprotumumab, an insulin-like growth factor-1 receptor antagonist antibody, in the treatment of active thyroid eye disease: a focus on proptosis. Eye (Lond). 2019;33(2):183-190.
  5. Douglas RS, Couch S, Wester ST, et al. A randomized, quadruple-masked, placebo-controlled, multicenter trial to evaluate the efficacy and safety of teprotumumab in patients with chronic (inactive/low CAS) thyroid eye disease. Presented at: ENDO 2023; June 15-18, 2023; Chicago, IL. Poster SAT-459.
  6. Diniz SB, Cohen LM, Roelofs KA, Rootman DB. Early experience with the clinical use of teprotumumab in a heterogenous thyroid eye disease population. Ophthalmic Plast Reconstr Surg. 2021;37(6):583-591.
  7. Ugradar S, Kang J, Kossler AL, et al. Teprotumumab for the treatment of chronic thyroid eye disease. Eye (Lond). 2022;36(8):1553-1559.
  8. Wang Y, Patel A, Douglas RS. Thyroid eye disease: how a novel therapy may change the treatment paradigm. Ther Clin Risk Manag. 2019;15:1305-1318.
  9. Estcourt S, Hickey J, Perros P, Dayan C, Vaidya B. The patient experience of services for thyroid eye disease in the United Kingdom: results of a nationwide survey. Eur J Endocrinol. 2009;161(3):483-487.
  10. Konuk O, Anagnostis P. Diagnosis and differential diagnosis of Graves’ orbitopathy. In: Wiersinga WM, Kahaly GJ, eds. Graves’ Orbitopathy: A Multidisciplinary Approach - Questions and Answers. 3rd ed. S Karger AG; 2017:74-92.
  11. Ross DS, Burch HB, Cooper DS, et al. 2016 American Thyroid Association guidelines for diagnosis and management of hyperthyroidism and other causes of thyrotoxicosis. Thyroid. 2016;26(10):1343-1421.
  12. Barrio-Barrio J, Sabater AL, Bonet-Farriol E, Velázquez-Villoria Á, Galofré JC. Graves’ ophthalmopathy: VISA versus EUGOGO classification, assessment, and management. J Ophthalmol. 2015;2015:249125.
  • REFERENCES:
    1. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen. 2. Douglas RS, Couch S, Wester ST, et al. Efficacy and safety of teprotumumab in patients with thyroid eye disease of long duration and low disease activity. J Clin Endocrinol Metab. 2024;109(1):25-35. 3. Kahaly GJ, Petrak F, Hardt J, et al. Psychosocial morbidity of Graves’ orbitopathy. Clin Endocrinol (Oxf). 2005;63(4):395-402. 4. Estcourt S, Vaidya B, Quinn A, et al. The impact of thyroid eye disease upon patients’ wellbeing: a qualitative analysis. Clin Endocrinol (Oxf). 2008;68(4):635-639. 5. Smith TJ, Hegedüs L, Lesser I, et al. How patients experience thyroid eye disease. Front Endocrinol (Lausanne). 2023;14:1283374. 6. Kahaly GJ, Douglas RS, Holt RJ, et al. Teprotumumab for patients with active thyroid eye disease: a pooled data analysis, subgroup analyses, and off-treatment follow-up results from two randomized double-masked placebo-controlled multicenter trials. Lancet Diabetes Endocrinol. 2021;9(6):360-372. 7. Supplement to: Kahaly GJ, Douglas RS, Holt RJ, Sile S, Smith TJ. Teprotumumab for patients with active thyroid eye disease: a pooled data analysis, subgroup analyses, and off-treatment follow-up results from two randomized double-masked placebo-controlled multicenter trials. Lancet Diabetes Endocrinol. 2021;9(6):360-372. 8. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18):1748-1761. 9. Douglas RS, Kahaly GJ, Patel A, et al. Teprotumumab for the treatment of active thyroid eye disease. N Engl J Med. 2020;382(4):341-352. 10. Data on File. Amgen, October 2024. 11. Douglas RS, Kahaly GJ, Ugradar S, et al. Teprotumumab efficacy, safety and durability in longer-duration thyroid eye disease and re-treatment: OPTIC-X study. Ophthalmology. 2022;129(4):438-449. 12. US Food and Drug Administration. FDA approves first treatment for thyroid eye disease. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-thyroid-eyedisease

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