The mechanism of action of teprotumumab in patients with TED has not been fully characterized. Teprotumumab-trbw binds to IGF-1R and blocks its activation and signaling.

IGF-1R, insulin-like growth factor-1 receptor.

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REDUCE
PROPTOSIS

Proptosis Data

Rapid and clinically meaningful reductions in proptosis1,2

Phase 3 study: Patients achieving ≥2-mm reduction in proptosis* at Week 24 (primary endpoint)1,2
Pie charts showing that 83% of TEPEZZA patients (n=41) achieved a ≥2-mm reduction in proptosis from Thyroid Eye Disease, vs 10% of placebo patients (n=42) Pie charts showing that 83% of TEPEZZA patients (n=41) achieved a ≥2-mm reduction in proptosis from Thyroid Eye Disease, vs 10% of placebo patients (n=42) Pie charts showing that 83% of TEPEZZA patients (n=41) achieved a ≥2-mm reduction in proptosis from Thyroid Eye Disease, vs 10% of placebo patients (n=42)

*A proptosis responder was defined as having a ≥2-mm reduction in proptosis from baseline in the study eye without deterioration (≥2-mm increase in proptosis) in the nonstudy eye.1

Rapid and continuous reductions in proptosis were significant1,2

Phase 3 study: Mean change from baseline in proptosis (mm) over 24 weeks (secondary endpoint)1,2

All TEPEZZA patients completing treatment had proptosis reduction–it is important that patients complete the full treatment course of 8 IV infusions, as studied in clinical trials1,2

  • Durable proptosis improvement maintained nearly 1 year after eighth infusion—53% of patients (16 of 30) with proptosis reduced by ≥2 mm at Week 24 maintained proptosis reduction through Week 72 (Phase 2 study)1

IV, intravenous.

IMPROVE
DIPLOPIA

Diplopia Data

TEPEZZA completely resolved diplopia in twice as many patients
vs placebo in Phase 2 and 3 studies

Phase 2 and 3 studies: Diplopia resolution† rate (grade 0) at Week 241

Graphic showing diplopia responder rate of TEPEZZA in clinical trials, with 53% of patients having no diplopia at Week 24 vs 25% of the placebo groupGraphic showing diplopia responder rate of TEPEZZA in clinical trials, with 53% of patients having no diplopia at Week 24 vs 25% of the placebo group

†Diplopia was evaluated on a 4-point scale ranging from 0 for no diplopia to 3 for constant diplopia. Diplopia resolution was defined as a patient with baseline diplopia >0 and a score of 0 at Week 24.1

  • Durable diplopia improvement‡ maintained nearly 1 year after eighth infusion—67% of patients (12 of 18) with diplopia improved by ≥1 grade at Week 24 maintained diplopia improvement through Week 72 (Phase 2 study)1

‡A diplopia responder was defined as a patient with baseline diplopia >0 and a score improved by ≥1 Bahn-Gorman grade.1

REDUCE ORBITAL PAIN,
REDNESS, AND SWELLING

Inflammatory Signs and Symptoms Data

Pain, redness, and swelling improved during treatment5

Phase 2 and 3 studies: Mean change from baseline in CAS over 24 weeks

Graphic showing TEPEZZA patients (n=84) had a -3.99 mean change from baseline in Thyroid Eye Disease Clinical Activity Score (CAS) in clinical trials, whereas the placebo group (n=87) had a -2.31 mean change from baseline, at Week 24Graphic showing TEPEZZA patients (n=84) had a -3.99 mean change from baseline in Thyroid Eye Disease Clinical Activity Score (CAS) in clinical trials, whereas the placebo group (n=87) had a -2.31 mean change from baseline, at Week 24

TEPEZZA is proven to treat more than just proptosis—more patients (TEPEZZA vs placebo) had complete resolution across ALL CAS symptoms5

CAS, Clinical Activity Score.

Inflammatory symptoms assessed with 7-point CAS included5

  • Spontaneous orbital pain
  • Gaze-evoked orbital pain
  • Conjunctival redness
  • Chemosis
  • Eyelid swelling
  • Eyelid erythema
  • Inflammation of caruncle or plica

TEPEZZA is proven to treat more than just proptosis—more patients (TEPEZZA vs placebo) had complete resolution across ALL CAS symptoms5

CAS, Clinical Activity Score.

TED signs icon

TEPEZZA inclusion/exclusion criteria and study design

Graphic of Thyroid Eye Disease surgery statistics showing that 8 out of 10 TED patients would prefer IV medicine before trying eye surgery

§From a patient survey of 102 TED patients. Results based on a 5-point agreement scale; 79.4% completely/somewhat agreed with the statement “I would prefer prescription intravenous (IV) medicine before trying eye surgery.”6

IMPROVE FUNCTIONAL VISION
AND PATIENT APPEARANCE

Functional Vision and Appearance Data

TEPEZZA improved functional vision and patient appearance at
Week 24 vs placebo in Phase 2 and 3 studies3,7||

Functional Vision

TEPEZZA improved functional vision, as defined by a patient’s ability to perform daily activities
(eg, read, watch TV)1,3,7

||Patient-reported based on GO-QOL scale.

GO-QOL, Graves' ophthalmopathy quality of life.

Patient Appearance

TEPEZZA improved patient appearance, so patients no longer need to hide behind sunglasses or have
the perception of being watched1,3,7

patient-quote

patient-quote

Hear how TEPEZZA has changed
the treatment landscape in TED
Preview image of Dr. Raymond Douglas, MD, PhD video

Dr Raymond Douglas discusses the efficacy of TEPEZZA in reducing the signs and symptoms of TED.1,3

Read transcript

I’m Raymond Douglas and I’m an oculoplastic and orbital surgeon here in Los Angeles. Since the approval of TEPEZZA, it has really become first line in my treatment algorithm for patients.

Patients present with Thyroid Eye Disease with a very heterogenous group of symptoms and signs as we call them. And so they may present with just proptosis or double vision or eye swelling, et cetera. Patients with double vision have a significantly harder time just dealing with going to a grocery store or being able to drive. It affects their daily life. A particular patient comes to mind: she had swelling around the eyes that was red, often painful. Deep pain around the eyes, which can be very common, and an inability to look up. So any time she tried to read, any time she tried to look at the computer, one time it’s in focus, and the next time she’s seeing double. After receiving the full course of TEPEZZA treatment, the eye that was normal stayed pretty much normal and the same. But the eye that was affected by Thyroid Eye Disease that was bulging and couldn’t look up had now come back about three millimeters in proptosis. And now she had nearly full range of movement. So that now she could look down and look up without seeing double.

So when patients start to see the results of TEPEZZA, usually it’s relatively early in their treatment. And usually it’s accompanied by a “hug” moment. And they’re not fully there yet. And we still have to finish the course of therapy, but for the first time now they’re seeing an improvement that they haven’t seen.

TEPEZZA in patients with Thyroid Eye Disease has been shown to improve the proptosis, double vision, the pain and redness associated with Thyroid Eye Disease, their functional vision, and their appearance.

For me, it’s an honor to participate in their care and to be able to offer a treatment that hopefully will help them throughout this process.

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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 for more information.

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 for more information.

  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. 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. Horizon, 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. Horizon, 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