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

See results for patients treated with TEPEZZA in 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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Baseline4

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)4

Proptosis: 21 mm

Diplopia: 0

CAS: 0

Inflammatory signs and symptoms:

  • No inflammatory signs or symptoms
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Baseline4

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)4

Proptosis: 21 mm

Diplopia: 0

CAS: 0

Inflammatory signs and symptoms:

  • No inflammatory signs or symptoms

Patient treated with TEPEZZA in a clinical trial. Patient completed a full course (8 infusions) of treatment with TEPEZZA. Results shown are with no surgical intervention. Individual results may vary.3,6

Patient treated with TEPEZZA in a clinical trial. Patient completed a full course (8 infusions) of treatment with TEPEZZA. Results shown are with no surgical intervention. Individual results may vary.4,6

See results for patients with chronic 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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Baseline2

Proptosis: 32 mm OD, 32.5 mm OS

Diplopia: 2

CAS: 3 OU

Post-treatment2

Proptosis: 26 mm OD, 28 mm OS

Diplopia: 0

CAS: 0 OU

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Baseline5

Proptosis: 25 mm

Diplopia: Not measured

CAS: 1

Post-treatment (Week 34 [13 weeks after last infusion])5

Proptosis: 19 mm

Diplopia: Not measured

CAS: 0

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Baseline5

Proptosis: 28 mm

Diplopia: Not measured

CAS: 0

Post-treatment (8 infusions)5

Proptosis: 21 mm

Diplopia: Not measured

CAS: 0

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Baseline7

Proptosis: 28 mm OD, 29 mm OS

Diplopia: 3

CAS: 4

Post-treatment (Week 104 [83 weeks after last infusion])7

Proptosis: 22 mm OD, 22 mm OS

Diplopia: 0

CAS: 0

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Diniz patient #6 after 6th infusion of TEPEZZA1

In this study, TEPEZZA reduced proptosis, inflammation, diplopia,
and orbital soft tissue volume in patients with chronic TED2

UGRADAR SUMMARY

In this retrospective review, patients with chronic, stable TED (≥2 years) who had received ≥3 infusions of TEPEZZA and a CAS ≤3 were included.2

All 31 patients had measurements of proptosis and calculation of the CAS and diplopia scores before and after therapy.2

RESULTS2
62 percent patients62 percent patients

Mean (SD) reduction in proptosis was

  • 3.5 mm (0.4) for each study orbit and
  • 3.0 mm for the fellow orbit
62 percent patients62 percent patients

Of the 15 patients who had diplopia at baseline, 67% had a clinically significant response and 47% had complete resolution following treatment.

62 percent patients62 percent patients

Following TEPEZZA, mean (SD) reduction of muscle tissue was 2011 mm3 (1847) in the study orbit and 1620 mm3 (1759) in the fellow orbit.

Patient treated with TEPEZZA in a retrospective case series (N=31) with chronic TED. At time of analysis, 17 patients completed a full course (8 infusions) of treatment with TEPEZZA.2,6

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 infusions) of treatment with TEPEZZA.5,6

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 infusions) of treatment with TEPEZZA.5,6

Patient treated with TEPEZZA in OPTIC-X (N=51; TEPEZZA n=14, placebo n=37), an open-label (previous treatment-masked) TEPEZZA treatment and re-treatment trial with patients from the randomized double-masked, multicenter, placebo-controlled phase 3 OPTIC study. Patient received placebo in OPTIC and TEPEZZA in OPTIC-X and completed a full course of treatment with TEPEZZA (8 infusions).7

DINIZ SUMMARY
  • Cross-sectional cohort study including 21 patients with clinical diagnosis of TED who were treated with teprotumumab. The entire cohort was analyzed together and subsequently in clinical subgroups based on stage and grade of disease1
  • Primary outcome was change in proptosis ≥2 mm1
  • Secondary outcome measures included change in Clinical Activity Score (CAS), ductions, strabismic deviation, MRD1, and MRD2. Bivariate and multivariate statistics were performed1
RESULTS
62 percent patients62 percent patients

Reduction in proptosis ≥2 mm was achieved in 71.4% of the sample.1 

62 percent patients62 percent patients
  • 2.5 (±1.8 mm) reduction of proptosis (P<0.0001)1
  • 2.2 (±1.4 mm) reduction in CAS (P<0.0001)1
  • 16.9 (±19.3) degree improvement in extraocular motility (P<0.0001)1
62 percent patients62 percent patients

There were no significant differences for change in CAS, proptosis, ductions, or MRD2 between different grades and stages of disease. Total strabismus and MRD1 improvement were greater in the active stage of disease (P<0.05).1

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

*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.

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.

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-00828 12/22

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 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.

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-00828 12/22

  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. Data on File. Horizon, January 2020.
  5. Ozzello DJ, Dallalzadeh LO, Liu CY. Teprotumumab for chronic thyroid eye disease. Orbit. 2021:1-8. 1933081 Published online June 1, 2021.
  6. TEPEZZA (teprotumumab-trbw) [prescribing information] Horizon.
  7. Douglas RS, Kahaly GJ, Ugradar S, et al. Teprotumumab efficacy, safety, and durability in longer-duration thyroid eye disease and re-treatment: OPTIC-X study. Ophthalmol. 2022;129(4):438-449.