TEPEZZA® (teprotumumab-trbw) Efficacy | TEPEZZA® for HCPs

Efficacy

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Improve Proptosis Beyond Proptosis Durability
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TEPEZZA: a nonsurgical treatment proven to significantly reduce proptosis, regardless of disease activity or duration1-3

Phase 3

Phase 3 Study Design
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*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.

TEPEZZA Placebo

Phase 4

Phase 4 Study Design
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*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.

TEPEZZA Placebo

The benefits of TEPEZZA go beyond proptosis reduction1-3,5-7

Phase 2/3 Study Design
Phase 4 Study Design
Pooled analysis of Phase 2/3 studies (N=171)5
dplopia-eye
DIPLOPIA

2X more patients had complete diplopia resolution vs placebo3,5

Secondary endpoint

Diplopia resolution rate (grade 0) at Week 24 within the subset of patients in the studies with diplopia at baseline

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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 24.2,3

In the Phase 4 trial in patients with chronic TED, no differences between the teprotumumab and placebo groups were observed for diplopia endpoints. The trial was not powered to detect a treatment difference in diplopia due to the low incidence of diplopia at baseline among the study subjects.1

TEPEZZA Placebo

inflammation-eye
INFLAMMATION

Almost 3X more patients experienced reduction in inflammation5,7

Secondary endpoint

In patients with CAS ≥4 at baseline inflammatory response (CAS 0 or 1, inactive disease state) at Week 24

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The Clinical Activity Score (CAS) is a composite score with equal weighting of each of these seven factors: spontaneous orbital pain, gaze-evoked orbital pain, eyelid swelling that isconsidered to be due to active TED, eyelid erythema (redness), conjunctival redness considered to be due to active TED, chemosis (swelling of the conjunctive), and inflammation of the caruncle or plica. However, the factors may not be of equal clinical weight to patients or to physicians treating these patients and as such the clinical meaningfulness is unknown.8

TEPEZZA Placebo

Phase 2 and 3: Patients with active TED were studied in 24-week, randomized, double-masked, placebo-controlled trials.2,6

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Phase 4 study (N=62)1
Decrease
MRI

In 6 patients who were assessed, decrease in orbital fat/muscle volume was observed1

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In observation of 6 TEPEZZA patients who had an orbital MRI (12 eyes total), a decrease in orbital fat and muscle volume was shown. Analysis is exploratory and has not been adjusted for multiple comparisons. No conclusions of statistical or clinical significance can be drawn.

Phase 4: Patients with chronic TED studied in a 24-week, randomized, double-masked, placebo-controlled trial.1

TEPEZZA Placebo

Increase
GO-QOL

Changes in GO-QOL vs placebo6,†

GO-QOL (Graves’ ophthalmopathy quality of life patient-reported questionnaire) is a 16-item self-administered questionnaire divided into 2 subscales that is used to measure changes over time in visual functioning and appearance. Equal weight is assigned to 8 measures of visual functioning and appearance, respectively, however their relative importance is unknown. The GO-QOL is not validated in patients with TED. As such, results should be interpreted with caution.2

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TEPEZZA Placebo

Bonnie
“Without TEPEZZA, I don’t think that I would have been able to go back to work. When working on a computer all day, the double vision would have made it impossible.”
—Bonnie S., real TEPEZZA patient

Results sustained nearly 2 years after treatment11

Follow-up analyses of outcomes in Phase 2, Phase 3 (OPTIC study), and OPTIC Extension (OPTIC-X) (N=112)11

~2 years after treatment
82-percent-desktop 82-percent-desktop

of TEPEZZA patients did not report additional treatment for TED, including surgery11

Proptosis responders who flared and received an additional course were excluded from the additional treatment count if they were still ≥2 mm proptosis improvement from baseline (n=6).11

~1 year after treatment‡
Responses sustained across key endpoints
68-percent 68-percent

(n=38/56)

Proptosis
response

CI [0.54, 0.80]11

73-percent 73-percent

(n=35/48)

Diplopia
response

CI [0.58, 0.85]11

91-percent 91-percent

(n=52/57)

Improvement of ≥2
points in CAS score CI

CI [0.81, 0.97]11

Kahaly 2024: 112 patients who received 7 or 8 infusions of TEPEZZA in the Phase 2, Phase 3 (OPTIC study), and OPTIC Extension (OPTIC-X) studies were analyzed for long-term maintenance of responses. Responses were assessed and pooled from study baseline to Week 24 (formal study) and up to Week 72 (formal follow-up).§ Outcomes included the percentages of observed patient responses from the study baseline. Studies differed in the timing of follow-up visits, and data from some visits were unavailable.11

‡Consider open-label treatment phase study limitations when interpreting results. The OPTIC-X study was not blinded, not controlled, and included inherent self-selection bias for remaining in the trial.11

§Responses assessed included clinical activity score (CAS ≥2-point improvement), the European Group of Graves’ Orbitopathy ophthalmic composite outcome, diplopia (≥1 Gorman grade improvement), proptosis (≥2-mm improvement), Overall (improvement in proptosis and CAS), and disease inactivation (CAS ≤1).11

CAS, Clinical Activity Score; TED, Thyroid Eye Disease.

Paris
“My symptoms haven’t returned since I finished treatment. I feel in control again.”
—Paris M., real TEPEZZA patient

Hear how TEPEZZA has changed the way Dr Kimberly Cockerham treats TED

My name is Amina Malik and I'm an oculoplastic surgeon at Houston Methodist Hospital in Houston, Texas.

So I have a busy oculoplastics practice there with a big proportion of patients with thyroid eye disease.

Thyroid eye disease is a very heterogeneous disease. So I think it's important for general practitioners, general ophthalmologists, endocrinologists, just to be aware that it can present in a variety of ways.

So I think it's important general practitioners consider referring to a TED specialist so that they can catch the disease early in the process and uh hopefully optimally treat them.

Thyroid eye disease can be a very debilitating process. I've had more than one patient in my office in tears because of how this disease has affected them.

I've been treating patients with TEPEZZA from the onset since 2020

TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.
TEPEZZA may cause infusion reactions. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion.
Please listen to additional Important Safety Information later in this video.

I have had excellent experience in seeing huge impacts on my patients' proptosis, their double vision. Whereas in other patients, they might have

milder disease and yet I've still treated them and have seen really significant improvements there as well. And there is definitely a subset of patients who are very bothered by pressure behind their eyes um and other symptoms that would prompt them to want to pursue treatment with TEPEZZA.

So the spectrum for which I have had experience is quite broad

and the results have been really dramatic. When I speak to my patients who have thyroid eye disease who are symptomatic enough to want to consider therapy,

We, I go over the options of TEPEZZA as the first FDA-approved treatment

for Thyroid Eye Disease and I'll go over the side effects and potential risks involved. Prior to the development of TEPEZZA, surgery was really the mainstay

And it's been really remarkable to have something to offer my patients that is a medical option and it's

just really exciting to see the gratitude that patients have for the transformations that they’re seeing after treatment with this drug.

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.

Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of inflammatory bowel disease (IBD). IBD has been reported in some patients without a prior diagnosis of IBD. Monitor patients for signs and symptoms of IBD. If IBD exacerbation is suspected, discontinue use 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, ear discomfort, weight decreased, nail disorders, and menstrual disorders.

Please see Full Prescribing Information or visit TEPEZZAhcp.com for more information.

Talk to your Amgen representative today to learn more about TEPEZZA.

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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.

 

Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of inflammatory bowel disease (IBD). IBD has been reported in some patients without a prior diagnosis of IBD. Monitor patients for signs and symptoms of IBD. If IBD exacerbation is suspected, discontinue use 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, ear discomfort, weight decreased, nail disorders, and menstrual disorders.

 

INDICATION

 

TEPEZZA is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration.

 

Please see Full Prescribing Information for more information.
References:

1. Douglas RS, Couch S, Wester ST, et al. Efficacy and safety of teprotumumab in patients with thyroid eye disease of long duration and low disease activity. J Clin Endocrinol Metab. 2024;109(1):25-35. 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. TEPEZZA (teprotumumab-trbw) [prescribing information] Amgen. 4. Supplement to: 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. 5. Kahaly GJ, Douglas RS, Holt RJ, et al. 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 Diabetes Endocrinol. 2021;9(6):360-372. 6. Smith TJ, Kahaly GJ, Ezra DG, et al. Teprotumumab for thyroid-associated ophthalmopathy. N Engl J Med. 2017;376(18):1748-1761. 7. Supplement to: Kahaly GJ, Douglas RS, Holt RJ, et al. 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 Diabetes Endocrinol. 2021;9(6):360-372. 8. Barrio-Barrio J, Sabater AL, Bonet-Farriol E, et al. Graves’ ophthalmopathy: VISA versus EUGOGO classification, assessment, and management. J Ophthalmol. 2015;2015:249125. 9. Data on File. Amgen. May 2019. 10. Data on File. Amgen. June 2023. 11. Kahaly GJ, Subramanian PS, Conrad E, et al. Long-term efficacy of teprotumumab in thyroid eye disease: follow-up outcomes in three clinical trials. Thyroid. 2024;34(7):880-889.
TEPEZZA® (teprotumumab-trbw) Efficacy | TEPEZZA® for HCPs
TEPEZZA® (teprotumumab-trbw) Efficacy | TEPEZZA® for HCPs