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.

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LOW DISEASE
ACTIVITY PATIENT

See results for a patient with low disease activity and long duration TED treated with TEPEZZA

Results
Results

Patient completed a full course (8 IV infusions) of treatment with TEPEZZA. Results shown are with no surgical intervention.
Individual results may vary.

IV, intravenous.

STUDY DESIGN

Study Design

Patients with low disease activity and long duration TED studied in
a 24-week, randomized, double-masked, placebo-controlled trial1

Graphic showing study design inclusion and exclusion criteria (select inclusion criteria including an age greater than or equal to 18 , a TED duration greater than or equal to 2 years but less than 10 years, a Clinical Activity Score less than or equal to 1 for greater than or equal to 1 year OR no progress in proptosis or diplopia or new inflammatory symptoms in greater than or equal to a year, and euthyroid or mildly hypo/hyperthyroid; select exclusion criteria including previous surgery in study eye and optic neuropathy), 1:1 randomization (with Phase 4 patients receiving TEPEZZA (n=42) once every 3 weeks for 8 IV infusions and patients receiving placebo (n=20) once every 3 weeks for 8 IV infusions, and Week 24 evaluation (with primary endpoint being change in proptosis (mm) in study eye from baseline and secondary endpoint being proptosis responder rate (% of patients with ≥ 2-mm proptosis reduction)) Graphic showing study design inclusion and exclusion criteria (select inclusion criteria including an age greater than or equal to 18 , a TED duration greater than or equal to 2 years but less than 10 years, a Clinical Activity Score less than or equal to 1 for greater than or equal to 1 year OR no progress in proptosis or diplopia or new inflammatory symptoms in greater than or equal to a year, and euthyroid or mildly hypo/hyperthyroid; select exclusion criteria including previous surgery in study eye and optic neuropathy), 1:1 randomization (with Phase 4 patients receiving TEPEZZA (n=42) once every 3 weeks for 8 IV infusions and patients receiving placebo (n=20) once every 3 weeks for 8 IV infusions, and Week 24 evaluation (with primary endpoint being change in proptosis (mm) in study eye from baseline and secondary endpoint being proptosis responder rate (% of patients with ≥ 2-mm proptosis reduction))

*Euthyroid or with mild hypo- or hyperthyroidism defined as free thyroxine (FT4) and free triiodothyronine (FT3) levels <50% above or below the normal limits (every effort should be made to correct the mild hypo- or hyperthyroidism promptly).1

CAS, Clinical Activity Score.

REDUCE
PROPTOSIS

Proptosis Data

Significant and continuous reductions in proptosis1

Mean change from baseline in proptosis (mm) over 24 weeks (primary endpoint, Phase 4 study)

Chart comparing mean change from baseline in proptosis (in mm) between TEPEZZA and placebo patients, with the TEPEZZA (n=41) group experiencing a change of -2.41 at Week 24 and the placebo (n=20) group experiencing a change of -.92 at Week 24Chart comparing mean change from baseline in proptosis (in mm) between TEPEZZA and placebo patients, with the TEPEZZA (n=41) group experiencing a change of -2.41 at Week 24 and the placebo (n=20) group experiencing a change of -.92 at Week 24

Majority of TEPEZZA patients had clinically meaningful
proptosis reduction1,2

Patients achieving ≥2-mm reduction in proptosis§ at Week 24 (secondary endpoint, Phase 4 study)

Charts comparing change from baseline in patients achieving a ≥2-mm reduction in proptosis (in %) between TEPEZZA and placebo patients, with the TEPEZZA (n=42) group experiencing a change of 62% at Week 24 and the placebo (n=20) group experiencing a change of 25% at Week 24Charts comparing change from baseline in patients achieving a ≥2-mm reduction in proptosis (in %) between TEPEZZA and placebo patients, with the TEPEZZA (n=42) group experiencing a change of 62% at Week 24 and the placebo (n=20) group experiencing a change of 25% at Week 24

Per-protocol analysis∥: 63% of TEPEZZA patients (n=30) vs 7% of placebo patients (n=14) (P<0.001)1

‡Intent-to-treat (ITT) analysis included all patients as originally allocated after randomization, even those who discontinued treatment early, were lost to follow-up, received the wrong study treatment, or received no treatment at all.

§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.

∥Per-protocol analysis only included patients who received the treatment they were originally allocated to, did not discontinue the study early, and did not have any other significant deviations from the protocol.

SAFETY DATA

Phase 4 study supports safety and tolerability profile in Phase 2/3 studies1

Low discontinuation rate due to adverse events1

98percent

98percent

  • Only 1 patient in each arm discontinued treatment (2% with TEPEZZA, 5% with placebo) due to adverse events
  • No new safety signals were identified

Overall summary of treatment-emergent adverse events2
Adverse events TEPEZZA
n=41, n (%)		 PLACEBO
n=20, n (%)
Treatment-emergent adverse events 33 (81%) 16 (80%)
Treatment-related adverse events 31 (76%) 12 (60%)
Grade 3 or higher adverse events 1 (2%) 1 (5%)
Treatment-related serious adverse events 1 (2%) 1 (5%)
Adverse events leading to discontinuation 1 (2%) 1 (5%)
Adverse events of special interest
Infusion reactions 2 (5%) 3 (15%)
Hyperglycemia 6 (15%) 2 (10%)
Hearing impairmenta 9 (22%) 2 (10%)
New-onset IBD and exacerbation of IBD 0 0

aHearing impairment includes autophony, conductive deafness, deafness unilateral, eustachian tube dysfunction, hypoacusis, tinnitus, and tympanic membrane disorder.

IBD, inflammatory bowel disease.

TEPEZZA: conductive hearing loss occurred in the double-masked period; patient completed the masked period and discontinued in the open-label period; Placebo: infusion reaction.

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Learn about the safety profile of TEPEZZA

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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. Douglas RS, Couch S, Wester ST, et al. A randomized, quadruple-masked, placebo-controlled, multicenter trial to evaluate the efficacy and safety of teprotumumab in patients with chronic (inactive/low CAS) Thyroid Eye Disease. Presented at: ENDO 2023; June 15-18, 2023; Chicago, IL. Poster SAT-459.
  2. Data on File. Horizon, April 2023.
  3. TEPEZZA (teprotumumab-trbw) [prescribing information] Horizon.