Breakthrough Efficacy of TEPEZZA for Thyroid Eye Disease

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

TEPEZZA significantly decreased proptosis, one of the most disfiguring symptoms of TED1,2,6,7

Graph showing the TEPEZZA response rate to proptosis Graph showing the TEPEZZA response rate to proptosis Graph showing the TEPEZZA response rate to proptosis
  • Similar results were seen in Study 1: TEPEZZA achieved a significantly greater proptosis response rate* vs placebo at Week 24 (71% vs 20%; P<0.001) 1,6

*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 241,9

Graph showing the average change from baseline in proptosis with TEPEZZA Graph showing the average change from baseline in proptosis with TEPEZZA Graph showing the average change from baseline in proptosis with TEPEZZA
  • 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) 9
  • Mean change in proptosis across visits from baseline through Week 24 was -2.8 mm vs -0.5 mm with placebo in Study 2 (P<0.001) 1,2

Durable proptosis response was demonstrated 51 weeks after the last infusion of TEPEZZA in Study 11

53% of proptosis responder patients maintained reduction in proptosis at Week 72 53% of proptosis responder patients maintained reduction in proptosis at Week 72 53% of proptosis responder patients maintained reduction in proptosis at Week 72

TEPEZZA resolved diplopia, a debilitating symptom of TED, in significantly more patients based on the Bahn-Gorman scale1,10

Graph showing diplopia responder rate with TEPEZZA Graph showing diplopia responder rate with TEPEZZA Graph showing diplopia responder rate with TEPEZZA

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

Durable 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 12 of 18 patients who were diplopia responders at week 24 maintained response at week 72 12 of 18 patients who were diplopia responders at week 24 maintained response at week 72

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 241.

TEPEZZA showed significantly higher response rate for proptosis reduction and improved inflammatory signs and symptoms of TED (pain, redness, and swelling) per CAS2,3‡§

>2/3 of patients taking TEPEZZA were overall responders|| at Week 24 (Studies 1 and 2)

Graph showing significantly higher response rate for proptosis reduction and improved inflammation Graph showing significantly higher response rate for proptosis reduction and improved inflammation Graph showing significantly higher response rate for proptosis reduction and improved inflammation
  • More patients were overall responders with TEPEZZA vs placebo as early as Week 6 in Study 2 (44% vs 5%) 2
  • Similar results were seen in Study 1: TEPEZZA significantly decreased proptosis and improved the inflammatory signs of TED vs placebo at Week 24 (69% vs 20%) 3

||An overall responder was defined as having a ≥2-mm reduction in proptosis in the study eye from baseline and a ≥2-point reduction in CAS (a 7-point scale where a lower score indicates fewer symptoms) without deterioration (≥2-mm increase in proptosis or a ≥2-point increase in CAS) in the non-study eye.3

||

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

  • Similar results were seen in Study 1: TEPEZZA achieved a CAS responder rate of 0 or 1 in 69% of patients vs 21% of patients with placebo at Week 24 3
  • In Study 2, more patients had little or no signs or symptoms of inflammation with TEPEZZA vs placebo as early as Week 6 (22% vs 0%) 2

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 (e.g. read, watch TV)1-4

Patient appearance icon

Patient Appearance

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


Safety and efficacy demonstrated across 2 pivotal trials1

TEPEZZA was studied in the largest clinical trial program for TED consisting of two replicate 24-week, randomized, double-masked, placebo-controlled trials1

INDICATION AND IMPORTANT SAFETY INFORMATION

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, and dry skin.

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

Please see Full Prescribing Information for more information.

INDICATION AND IMPORTANT SAFETY INFORMATION

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, and dry skin.

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

Please see Full Prescribing Information for more information.

REFERENCES:

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, January 2020. 6. Data on File. Horizon, December 2019. 7. 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. 8. Data on File. Horizon, April 2019. 9. Data on File. Horizon, October 2016. 10. 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. 11. Rollet J. Symptoms, quality of life improve with teprotumumab for adults with thyroid eye disease. Healio.com. https://www.healio.com/endocrinology/thyroid/news/ online/%7Bf309783c-b540-4acb-bf65-1f2a004b7e7d%7D/symptoms-quality-of-life-improve-with-teprotumumab-for- adults-with-thyroid-eye-disease. October 31, 2019. Accessed December 21, 2019. 12. 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. 13. 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. 14. 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.