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Safety Profile of TEPEZZA

Proven efficacy with a demonstrated safety and tolerability profile, regardless of disease activity or duration
  • PHASE 2/3
  • PHASE 4

9

out of

10

completed full course of treatment with TEPEZZA 1

Most adverse events were:1

  • Mild or moderate
  • Manageable
  • Resolved during or after treatment
Adverse reactions occurring in ≥5% of patients treated with TEPEZZA with greater incidence than placebo2
Adverse reactions TEPEZZA n=84, n (%) Placebo n=86, n (%)
Muscle spasms 21 (25%) 6 (7%)
Nausea 14 (17%) 8 (9%)
Alopecia 11 (13%) 7 (8%)
Diarrhea 10 (12%) 7 (8%)
Fatiguea 10 (12%) 6 (7%)
Hyperglycemiab 8 (10%) 1 (1%)
Hearing impairmentc 8 (10%) 0
Dysgeusia (taste disturbance) 7 (8%) 0
Headache 7 (8%) 6 (7%)
Dry skin 7 (8%) 0
Weight decreased 5 (6%) 0
Nail disorderd 4 (5%) 0
Menstrual disorderse 5 (23%) 1 (4%)

aFatigue includes asthenia.

bHyperglycemia includes blood glucose increase.

cHearing impairment including hearing loss (deafness, including sensorineural deafness, eustachian tube dysfunction, hyperacusis, hypoacusis, autophony and tinnitus).

dNail disorder includes nail discoloration and onychoclasis.

eMenstrual disorders include amenorrhea, metrorrhagia, and dysmenorrhea. (TEPEZZA=22, Placebo=25).

Hyperglycemia: previous glycemic abnormalities in patients receiving TEPEZZA1

In the Phase 2 and 3 studies (N=84)1

10%

(n=8/84)

of patients experienced a hyperglycemic event1

63%

(n=5/8)

of patients who experienced a hyperglycemic event had preexisting diabetes1

The majority of hyperglycemia events resolved during or shortly after treatment1

  • Of 8 total events, 6 resolved during treatment, 2 resolved after the last dose

Most hearing impairment events were transient, mild or moderate, and resolved during or after treatment1

In the Phase 2 and 3 studies (N=84)1

10%

(n=8/84)

of patients experienced a hearing impairment event1

75%

(n=6/8)

of the cases of hearing impairment resolved, and 1 case improved, during the 24-week double-masked period1

In an observational study, patients at greatest risk of hearing impairment events caused by TEPEZZA:3,*

  • Are older age (>65) with a higher CAS
  • Have preexisting hearing issues

*Results from a prospective observational study of 52 TED patients who completed a full course of TEPEZZA treatment. Data is not derived from a controlled clinical study and no conclusions of statistical or clinical significance can be drawn.3

CAS, Clinical Activity Score.

>9

out of

10

completed treatment with TEPEZZA 4

Adverse events of special interest and other AEs of importance4
Adverse reactions TEPEZZA n=41, n (%) Placebo n=20,* n (%)
Muscle spasms 17 (42%) 2 (10%)
Fatigue 9 (22%) 2 (10%)
Hearing impairment 9 (22%) 2 (10%)
Diarrhea 8 (20%) 4 (20%)
Headache 7 (17%) 2 (10%)
Hyperglycemia 6 (15%) 2 (10%)
Dry skin 5 (12%) 0
Dysgeusia 4 (10%) 1 (5%)
Infusion reaction 2 (5%) 3 (15%)
Nausea 2 (5%) 1 (5%)
Alopecia 2 (5%) 0 (0%)
Nail bed disorder 2 (5%) 0 (0%)
*Includes patient who received 1 dose of TEPEZZA in error.

Most adverse events were:4

  • Mild or moderate
  • Manageable
  • Resolved during or after treatment (as assessed in 30-day follow-up period)

*Includes patient who received 1 dose of TEPEZZA in error.

Hyperglycemia: previous glycemic abnormalities in patients receiving TEPEZZA4

In the Phase 4 study (N=41):4

15%

(n=6/41)

of patients experienced a hyperglycemic event4

83%

(n=5/6)

of patients who experienced a hyperglycemic event had preexisting diabetes or possibility of preexisting diabetes/impaired glucose tolerance4,*

The majority of hyperglycemic events were managed with adjustment of medication with none leading to discontinuation of treatment4

  • *One patient had a history of diabetes mellitus, and for 4 other patients, Day 1 of HbA1c values (range, 5.7%-6.0%) suggest the possibility of preexisting prediabetes/impaired glucose tolerance (prediabetes: HbA1c 5.7%-6.4%), as defined by the American Diabetes Association, 2019.

Hearing impairments were mostly mild or moderate4

In the Phase 4 study (N=41):4

22%

(n=9/41)

of patients who received TEPEZZA experienced a hearing impairment event4

33%

(n=3/9)

of cases of hearing impairment resolved/resolving at 30-day follow-up4

Patients at greatest risk of hearing impairment events caused by TEPEZZA:3,*

  • Are older age (>65) with a higher CAS
  • Have preexisting hearing issues

*Results from a prospective observational study of 52 TED patients who completed a full course of TEPEZZA treatment. Data is not derived from a controlled clinical study and no conclusions of statistical or clinical significance can be drawn.3

CAS, Clinical Activity Score.

TEP Icon Set

Understand the facts
about TEPEZZA and
hearing impairment

  • Read transcript

    If you see patients with Thyroid Eye Disease, or T-E-D, you may be considering treating them with TEPEZZA, the first and only FDA-approved treatment option for T-E-D regardless of disease duration or activity.

    One of the adverse events that occurred in TEPEZZA clinical trials was hearing impairment.

    Please stay tuned for Important Safety Information about TEPEZZA at the end of this video.

    First, let us look more closely at the data on hearing from the clinical trials.

    TEPEZZA has a proven efficacy with a demonstrated safety and tolerability profile.

    TEPEZZA has been studied in three placebo-controlled clinical trials in active and chronic T-E-D.

    Before we get started, please note that baseline hearing tests were not conducted for these trials.

    Some patients taking TEPEZZA in clinical trials reported a range of hearing-related side effects, including hearing loss, deafness, including sensorineural deafness, eustachian tube dysfunction, hyperacusis, hypoacusis, autophony, and tinnitus.

    In the Phase 2 and 3 trials, approximately 10% (8 of 84) patients treated with TEPEZZA reported experiencing hearing impairment versus none of the 86 patients treated with placebo.

    In the 8 TEPEZZA-treated patients, hearing events resolved in 6 and improved in 1 patient, during the 24-week double-masked period.

    In the Phase 4 trial, approximately 22% (or 9 of 41) patients treated with TEPEZZA reported experiencing hearing impairment versus 10% (2 of 20) patients treated with placebo.

    In the TEPEZZA-treated patients, 3 out of 9 cases of hearing impairment resolved or were resolving during the follow-up period. Note that this follow-up period was only 30 days.

    One patient discontinued TEPEZZA in the open-label treatment period due to left ear conductive hearing loss, later found to be linked to a congenital anomaly, discovered prior to the completion of the double-masked period.

    Most hearing events were mild or moderate, and a majority of the patients completed treatment.

    A separate prospective observational study identified potential risk factors related to hearing impairment in 52 patients who completed a full course of TEPEZZA.

    Audiometry showed that approximately 38% (20 of 52) of these patients had hearing dysfunction at baseline. They found that patients reporting hearing impairment with TEPEZZA tended to be older and had higher baseline Clinical Activity Score (or C-A-S), along with preexisting hearing issues as assessed at baseline.

    Please note that, since this data was not derived from a controlled clinical study, no conclusions of statistical or clinical significance can be drawn.

    To better understand how TEPEZZA may impact the auditory system, let us look at the role of IGF-1R in T-E-D and how it is targeted by TEPEZZA.

    IGF-1R is involved in the pathogenesis of Thyroid Eye Disease because it is overexpressed in T-E-D orbital fibroblasts.

    TEPEZZA is designed to bind to IGF-1R and block its activation and signaling.

    By targeting IGF-1R in orbital fibroblasts, TEPEZZA reduces inflammation and prevents muscle and fat tissue remodeling and expansion behind the eye.

    Though the exact mechanism of hearing impairment with TEPEZZA is unknown, IGF-1 signaling provides a plausible link.

    Among other signaling pathways in various extraorbital tissues, IGF-1R and IGF-1 are also linked to the maintenance of hearing function.

    IGF-1 is involved in the maintenance of the number of inner and outer hair cells, it potentially has a protective and proliferative effect on the cochlea, and regulates the timing of sensory cell differentiation.

    Sensorineural hearing loss can occur in patients with IGF-1 deficiency.

    Although there is more to learn about the role of IGF-1 signaling in hearing, it may provide a link between hearing impairment and TEPEZZA.

    Studies have suggested that patients with Graves’ disease can experience a decrease in hearing ability, especially at higher frequencies.

    The FDA-approved label for TEPEZZA states to evaluate patients’ hearing before, during, and after treatment with TEPEZZA.

    It is important to have a conversation with your patients prior to treatment with TEPEZZA to set expectations and ensure you have a monitoring plan in place.

    There is a risk of hearing impairment with TEPEZZA. I think it's important to note that it doesn't always mean hearing loss or sensorineural hearing loss or deafness, other side effects such as tinnitus or ringing in the ears or muffling in the ears, which can sound like somebody's underwater.

    If you were thinking about starting your patient on TEPEZZA, I would recommend establishing a protocol for monitoring for hearing impairment. I would first counsel the patient about potential risks, benefits associated with TEPEZZA, and hearing-related side effects. I would then also ensure that patients have a protocol for baseline audiology testing, audiology testing after the fourth infusion, and again, repeat audiology testing at the end of treatment and I gather all the data and review it together with the patient.

    One thing that I've done in my practice is that I have established good rapport with a few local audiologists. In my experience, patients that have hearing-related side effects do tend to have improvement or resolution of those symptoms after treatment is completed.

    One of the things I’m doing is, I’m getting a baseline audiogram and through the course of the TEPEZZA infusions, I’d meet with the patient in subsequent visits, and I do always ask about hearing changes and if they have noticed any change in their hearing. If they do, we do get a confirmatory audiogram.

    I’m at an academic hospital, so I’m lucky in that I have all specialties under one roof. So, I commonly will do audiology consults now for thyroid eye disease patients. I have ear, nose, and throat colleagues around the corner that I can send patients to, to get formal evaluations of their hearing should we notice that there is a deficit, and to make sure there’s no other problems which could be contributing to their hearing changes.

    I think it's really important to counsel patients on hearing.

    As my practice has evolved over the five years, I really find that it's best for patients that they get into the formal audiology center. And the reason for that is if a patient has noticed any changes in their hearing, now we have some sort of quantitative factor where I can compare what their hearing was.

    In addition, I find that it's really helpful for patients because when they've gone in and had a formal hearing study, now they're already established at a location. So, if there's issues now, they are not panicked about where to go, but they know to go back to the same facility again.

    INDICATION

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

    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.

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

For any additional questions regarding the safety profile or adverse events, please speak with your Amgen Representative. 


If you do not have an Amgen Representative, complete this form.

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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. 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.
    2. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen. 3. Douglas RS, Parunakian E, Tolentino J, et al. A prospective study examining audiometry outcomes following teprotumumab treatment for thyroid eye disease. Thyroid. 2024;34(1):134-137. 4. 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.

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