Breakthrough Efficacy of TEPEZZA for Thyroid Eye Disease

With TEPEZZA, You Can Help Your Patients:

…in patients with Thyroid Eye Disease (TED), without concomitant steroids (vs placebo at Week 24) in 2 clinical studies.2-4


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

Graph showing the TEPEZZA response rate to proptosis in clinical trials Graph showing the TEPEZZA response rate to proptosis in clinical trials Graph showing the TEPEZZA response rate to proptosis in clinical trials
  • 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 non-study eye.1

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

Graph showing the average change from baseline in proptosis with TEPEZZA in clinical trials over 24 weeks Graph showing the average change from baseline in proptosis with TEPEZZA in clinical trials over 24 weeks Graph showing the average change from baseline in proptosis with TEPEZZA in clinical trials over 24 weeks
  • 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 proptosis responder patients maintained durable proptosis response after 51 weeks in clinical trials 53% of proptosis responder patients maintained durable proptosis response after 51 weeks in clinical trials 53% of proptosis responder patients maintained durable proptosis response after 51 weeks in clinical trials

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 responder rate with TEPEZZA in clinical trials Diplopia responder rate with TEPEZZA in clinical trials Diplopia responder rate with TEPEZZA in clinical trials

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†

12 of 18 patients who were diplopia responders at week 24 maintained response at week 72 in clinical trials 12 of 18 patients who were diplopia responders at week 24 maintained response at week 72 in clinical trials 12 of 18 patients who were diplopia responders at week 24 maintained response at week 72 in clinical trials

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

The majority of patients taking TEPEZZA had little or no signs or symptoms of inflammation (pain, redness, and swelling) at Week 242,3

59% of patients taking TEPEZZA had little or no signs or symptoms of inflammation, per Thyroid Eye Disease CAS (Clinical Activity Score) in clinical trials 59% of patients taking TEPEZZA had little or no signs or symptoms of inflammation, per Thyroid Eye Disease CAS (Clinical Activity Score) in clinical trials59% of patients taking TEPEZZA had little or no signs or symptoms of inflammation, per Thyroid Eye Disease CAS (Clinical Activity Score) in clinical trials

  • Similar results were seen in Study 1: TEPEZZA achieved a CAS responder rate of 0 or 1 in 69% [N=42] of patients vs 21% [N=45] of patients with placebo at Week 243

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.

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

Functional vision icon

Functional Vision

TEPEZZA improves functional vision, as defined by a patient’s ability to perform daily activities (eg, read, watch TV)1-4

Patient appearance icon

Patient Appearance

TEPEZZA improves patient appearance, so patients no longer feel the need to hide behind sunglasses or have the perception of being watched1-4


In the OPTIC-X study, TEPEZZA decreased proptosis in patients who had a disease flare and were retreated13

Graph showing the trial design and follow-up for TEPEZZA OPTIC-X trial Graph showing the trial design and follow-up for TEPEZZA OPTIC-X trial Graph showing the trial design and follow-up for TEPEZZA OPTIC-X trial

OPTIC-X retreatment efficacy with TEPEZZA13

Proptosis responders (patients achieving a ≥2-mm reduction in proptosis) after retreatment (OPTIC-X)13

Graph showing proptosis responders after OPTIC-X retreatment Graph showing proptosis responders after OPTIC-X retreatment Graph showing proptosis responders after OPTIC-X retreatment

||Defined by general presence of symptoms indicating flare, in addition to at least 1 of the following: increase in proptosis of ≥2 mm in the study eye since Week 24, or an absolute CAS of at least 4 in the study eye with a ≥2-point increase.13

**Only 8 patients contributed to data at Week 24, as 1 patient had a significantly delayed visit due to COVID-19 and was excluded from Week 24 analysis per the statistical analysis plan.13

Hear how TEPEZZA has changed the treatment landscape in TED

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

Dr raymond douglas thumbnail
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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. 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. 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. 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. 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. doi:10.1155/2015/249125. 10. 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. 11. 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. 12. 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. 13. Douglas RS, Kahaly GJ, Ugradar S, et al. Teprotumumab efficacy, safety and durability in longer duration thyroid eye disease and retreatment: OPTIC-X study. Ophthalmology. Published online October 21, 2021. doi:10.1016/j.ophtha.2021.10.017. 14. 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.