The mechanism of action of teprotumumab in patients with TED has not been fully characterized. Teprotumumab-trbw binds to IGF-1R and blocks its activation and signaling.

IGF-1R, insulin-like growth factor-1 receptor.

Physician Tools

TEPEZZA has been shown to be effective in
patients with TED with a wide range of clinical manifestations1-3

Because each patient responds differently to treatment, it is important that patients complete the full TEPEZZA treatment course of 8 IV infusions as studied in clinical trials4

See results for patients treated with TEPEZZA in Phase 2/3 clinical trials

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Baseline3

Proptosis: 24 mm

Diplopia: 0

Clinical Activity Score (CAS): 5

Inflammatory signs and symptoms:  

  • Eyelid swelling
  • Eyelid erythema
  • Conjunctival redness
  • Chemosis
  • Inflammation of caruncle/plica

Post-treatment (Week 24)3

Proptosis: 19 mm

Diplopia: 0 

CAS: 1

Inflammatory signs and symptoms:

  • Eyelid swelling 
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Baseline5

Proptosis: 25 mm

Diplopia: 3

CAS: 5

Inflammatory signs and symptoms:  

  • Spontaneous orbital pain
  • Gaze-evoked orbital pain
  • Eyelid swelling
  • Eyelid erythema
  • Conjunctival redness

Post-treatment (Week 24)5

Proptosis: 21 mm

Diplopia: 0

CAS: 0

Inflammatory signs and symptoms:

  • No inflammatory signs or symptoms
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Baseline5

Proptosis: 25 mm

Diplopia: 3

CAS: 5

Inflammatory signs and symptoms:  

  • Spontaneous orbital pain
  • Gaze-evoked orbital pain
  • Eyelid swelling
  • Eyelid erythema
  • Conjunctival redness

Post-treatment (Week 24)5

Proptosis: 21 mm

Diplopia: 0

CAS: 0

Inflammatory signs and symptoms:

  • No inflammatory signs or symptoms
Thyroid Eye Disease MRI showing baseline and post-treatment results of TEPEZZA at Week 24

Baseline5

Proptosis: 23 mm

Diplopia: 3

Inflammatory signs and symptoms:  

  • Gaze-evoked orbital pain
  • Eyelid swelling
  • Eyelid erythema
  • Conjunctival redness
  • Chemosis
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Post-treatment (Week 24)5

Proptosis: 18 mm

Diplopia: 0

Inflammatory signs and symptoms:

  • No inflammatory signs or symptoms
Patient treated with TEPEZZA in a clinical trial.5 At baseline, inferior rectus muscle (white arrowhead) and orbital fat (white arrow) are enhanced. Muscle and fat reduction at Week 24 includes: reduction of orbital fat (yellow arrow), reduction of the size of the inferior rectus muscle by 49% according to volumetric analysis (yellow arrowhead), and reduction in volume of the medial rectus muscle by 41%.2

Shown above are coronal, contrast-enhanced, fat-saturated, T1-weighted MRI scans from a patient in the teprotumumab group.2 Adapted from 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. Copyright Massachusetts Medical Society.

Patient treated with TEPEZZA in a clinical trial. Patient completed a full course (8 IV infusions) of treatment with TEPEZZA. Results shown are with no surgical intervention. Individual results may vary.3,4

Patient treated with TEPEZZA in a clinical trial. Patient completed a full course (8 IV infusions) of treatment with TEPEZZA. Results shown are with no surgical intervention. Individual results may vary.4,5

IV, intravenous.

IV, intravenous.

See results for patients with low disease activity TED treated with TEPEZZA

Treatment of TED with teprotumumab in a heterogeneous patient population demonstrated improvement in proptosis and CAS*† across all patient subgroups1

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Baseline

Proptosis: 25 mm OD, 23.5 mm OS

CAS: 1/7 OU

Post-treatment (Week 24)

Proptosis: 23 mm OD, 22 mm OS

Proptosis Improvement: -2 mm OD, -1.5 mm OS

CAS: 0/7 OU

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Baseline6

Proptosis: 28 mm

Diplopia: Not measured

CAS: 0

Post-treatment (8 infusions)6

Proptosis: 21 mm

Diplopia: Not measured

CAS: 0

Patient treated with TEPEZZA in a retrospective case series (N=9) of patients with chronic TED and low CAS. Patient completed a full course (8 IV infusions) of treatment with TEPEZZA.4,6

See more results for additional patients treated with
TEPEZZA throughout the full course of 8 IV infusions

Case of patient with TED and their individual experience with TEPEZZA. Individual results may vary. Clinical presentations represent a range of patients with TED. Patients with prior surgery or orbital radiation treatment for TED, history of compressive optic neuropathy, and concomitant steroid use were excluded from clinical trials for TEPEZZA.

OD, oculus dexter (right eye); OS, oculus sinister (left eye); OU, oculus uterque (both eyes).

Additional Study Data

In the OPTIC-X study, TEPEZZA decreased proptosis in
patients who had a disease flare and were re-treated7
Graph showing the trial design and follow-up for the TEPEZZA OPTIC-X retreatment for patients who have had a disease flare Graph showing the trial design and follow-up for the TEPEZZA OPTIC-X retreatment for patients who have had a disease flare Graph showing the trial design and follow-up for the TEPEZZA OPTIC-X retreatment for patients who have had a disease flare

*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.7

For patients who had a proptosis response at Week 24 and then experienced a flare,* the majority (63%; 5 of 8) achieved improvements in proptosis (≥2-mm reduction from OPTIC-X baseline) with a second course of TEPEZZA at Week 24 in OPTIC-X7†

The OPTIC-X patients who did not experience a ≥2-mm improvement in proptosis (n=3) had reductions relative to their OPTIC baseline (3 mm, 3 mm, and 4 mm, respectively)7

For patients who had a proptosis response at Week 24 and then experienced a flare,* the majority (63%; 5 of 8) achieved improvements in proptosis (≥2-mm reduction from OPTIC-X baseline) with a second course of TEPEZZA at Week 24 in OPTIC-X7†

The OPTIC-X patients who did not experience a ≥2-mm improvement in proptosis (n=3) had reductions relative to their OPTIC baseline (3 mm, 3 mm, and 4 mm, respectively)7

*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.7

OPTIC-X re-treatment efficacy with TEPEZZA7

†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.7

Preparation and administration of TEPEZZAPreparation and administration of TEPEZZA

Learn more about prescribing TEPEZZA

Preparation and administration of TEPEZZAPreparation and administration of TEPEZZA

Watch TEPEZZA block IGF-1R

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 for more information.

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 for more information.

  1. Diniz SB, Cohen LM, Roelofs KA, Rootman DB. Early experience with the clinical use of teprotumumab in a heterogenous Thyroid Eye Disease population. Ophthalmic Plast Reconstr Surg. 2021;37(6):583-591.
  2. Ugradar S, Kang J, Kossler AL, et al. Teprotumumab for the treatment of chronic Thyroid Eye Disease. Eye (Lond). 2022;36(8):1553-1559.
  3. 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.
  4. TEPEZZA (teprotumumab-trbw) [prescribing information] Horizon.
  5. Data on File. Horizon, January 2020.
  6. Ozzello DJ, Dallalzadeh LO, Liu CY. Teprotumumab for chronic Thyroid Eye Disease. Orbit. 2022;41(5):539-546.
  7. Douglas RS, Kahaly GJ, Ugradar S, et al. Teprotumumab efficacy, safety and durability in longer duration Thyroid Eye Disease and retreatment: OPTIC-X
    study. Ophthalmol. 2022:129(4):438-449.