Proptosis Data

TEPEZZA significantly decreased proptosis1-3

Similar results were seen in the Phase 2 study: TEPEZZA achieved a significantly greater proptosis response rate* vs placebo at Week 24 (71% [N=42] vs 20% [N=45]; P<0.001)1,3,5

*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

Each patient responds differently–it is important that patients complete the full treatment course of 8 IV infusions, as studied in clinical trials1


TEPEZZA started working early and continued to
decrease proptosis through Week 241,4

Similar results were seen in the Phase 2 study: TEPEZZA significantly decreased proptosis vs placebo at Week 24 (-3.0 mm vs -0.3 mm; P<0.001)4,5


Sustained proptosis response maintained 51 weeks
after the last infusion of TEPEZZA in the Phase 2 study1

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 fully resolved diplopia, a debilitating symptom of
TED, for more than twice as many patients vs placebo in
Phase 2 and 3 studies (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


Sustained diplopia response nearly 1 year after last
infusion of TEPEZZA in the Phase 2 study1†

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
the Phase 3 study2,5

Similar results were seen in the Phase 2 study: 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 242,5

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.6

§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.

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."7

Functional Vision and Appearance Data

TEPEZZA improved functional vision and patient appearance at
Week 24 vs placebo in Phase 2 and 3 studies2,5

Functional Vision

TEPEZZA improved functional vision, as defined by a patient’s ability to perform daily activities
(eg, read, watch TV)1,2,5

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 watched1,2,5

patient-quote

patient-quote

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.

P-TEP-US-01064-2 07/23

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.

P-TEP-US-01064-2 07/23

  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. Data on File. Horizon, December 2019. 
  4. Data on File. Horizon, October 2016.
  5. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18):1748-1761.
  6. 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.
  7. Data on File. Horizon, January 2023.
  8. Rollet J. Symptoms, quality of life improve with teprotumumab for adults with thyroid eye disease. Endocrine Today. October 31, 2019. Accessed November 11, 2021. https://www.healio.com/news/endocrinology/20191031/symptoms-quality-of-life-improve-with-teprotumumab-for-adults-with-thyroid-eye-disease
  9.  Data on File. Horizon, May 2022.