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

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

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 managed with medications for glycemic control, if necessary. Monitor patients for elevated blood glucose and symptoms of hyperglycemia while on treatment with TEPEZZA. Patients with preexisting diabetes should be under appropriate glycemic control before 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, and menstrual disorders.

Please see Full Prescribing Information for more information.

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 managed with medications for glycemic control, if necessary. Monitor patients for elevated blood glucose and symptoms of hyperglycemia while on treatment with TEPEZZA. Patients with preexisting diabetes should be under appropriate glycemic control before 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, 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. 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.