By treating TED at the source, TEPEZZA can

After my 8th infusion, my eye bulging had gone down and I had no double vision. I couldn’t have been happier.

Karen W., real

TEPEZZA patient4

Proptosis Data

TEPEZZA significantly decreased proptosis, one of
the most disfiguring symptoms of TED1,2,5,6

Similar results were seen in Study 1: TEPEZZA achieved a significantly greater proptosis response rate* vs placebo at Week 24 (71% [N=42] vs 20% [N=45]; P<0.001).1,5

*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


TEPEZZA started working early and continued to
decrease proptosis through Week 241,7

Similar results were seen in Study 1: TEPEZZA significantly decreased proptosis vs placebo at Week 24
(-3.0 mm vs -0.3 mm; P<0.001)7


Maintenance of proptosis response 51 weeks
after the last infusion of TEPEZZA in Study 11

53% of patients (16/30) who were proptosis responders at Week 24 maintained a
≥2-mm reduction in proptosis from baseline at Week 72 (~1 year off treatment)

Diplopia Data

TEPEZZA resolved diplopia, a debilitating symptom
of TED, for more than twice as many patients vs
placebo in Studies 1 and 2 (53% [N=66] vs 25%
[N=59]; P<0.01)1,2

Diplopia was evaluated on a 4-point scale where scores ranged from 0 for no diplopia to 3 for constant diplopia. A diplopia responder was defined as a patient with baseline diplopia >0 and a score of 0 at Week 24.1


Maintenance of diplopia response was
demonstrated 51 weeks after the last infusion of
TEPEZZA in Study 11†

67% of patients (12 of 18) who were diplopia responders (Grade 0) at Week 24 maintained a response at Week 721

Diplopia score is a 4-point scale where scores range from 0 for no diplopia to 3 for constant diplopia. A diplopia responder was defined as a patient with baseline diplopia >0 and a score of 0 at Week 24.1

Inflammatory Signs and Symptoms Data

The majority of patients taking TEPEZZA had little or no signs or symptoms of inflammation (pain, redness, and swelling) at Week 24 in Study 22,3

Similar results were seen in Study 1: TEPEZZA achieved a CAS responder rate of 0 or 1 in 59% [N=41] of patients vs 21% [N=42] of patients with placebo at Week 242,3

Clinical Activity Score (CAS) is a 7-point composite score measuring spontaneous orbital pain, gaze-evoked orbital pain, eyelid swelling, eyelid erythema, conjunctival redness, chemosis, and inflammation of caruncle or plica. A lower score indicates fewer symptoms.8

§The CAS is a composite score with equal weighting of a number of factors. However, the factors may not be of equal clinical weight to patients or to physicians treating these patients.

Functional Vision and Appearance Data

TEPEZZA improved functional vision and patient appearance at Week 24 vs placebo in Studies 1 and 22,3

Functional Vision

TEPEZZA improves functional vision, as defined by a patient’s ability to perform daily activities
(eg, read, watch TV)1-3,12

Patient Appearance

TEPEZZA improves patient appearance, so patients no longer need to hide behind sunglasses or have
the perception of being watched1-3,12

Hear how TEPEZZA has changed the treatment landscape in TED

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Dr Raymond Douglas discusses the efficacy of TEPEZZA in reducing the signs and symptoms of TED.1,2

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 vision.

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 both 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.

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 for more information.

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 for more information.

  1. TEPEZZA (teprotumumab-trbw) [prescribing information] Horizon.
  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. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18):1748-1761.
  4. Data on File. Horizon, May 2022.
  5. Data on File. Horizon, December 2019.
  6. Bruscolini A, Sacchetti M, La Cava M, et al. Quality of life and neuropsychiatric disorders in patients with Graves’ orbitopathy: current concepts. Autoimmun Rev. 2018;17(7):639-643.
  7. Data on File. Horizon, October 2016.
  8. European Group on Graves’ Orbitopathy (EUGOGO); 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.
  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)(suppl):341-352.
  10. 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
  11. Rollet J. Symptoms, quality of life improve with teprotumumab for adults with thyroid eye disease. Endocrine today. October 31, 2019. Accessed on November 11, 2021. https://www.healio.com/news/endocrinology/20191031/symptoms-quality-of-life-improve-with-teprotumumab-for-adults-with-thyroid-eye-disease
  12. 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