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Teprotumumab for the Treatment of Active Thyroid Eye Disease (OPTIC)

January 23, 2020

Clinical Trial

Teprotumumab for the Treatment of Active Thyroid Eye Disease.

Douglas RS, Kahaly GJ, Patel A, Sile S, Thompson EHZ, Perdok R, Fleming JC, Fowler BT, Marcocci C, Marinò M, Antonelli A, Dailey R, Harris GJ, Eckstein A, Schiffman J, Tang R, Nelson C, Salvi M, Wester S, Sherman JW, Vescio T, Holt RJ, Smith TJ.

N Engl J Med. 2020 Jan 23;382(4):341-352.
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Main finding: Teprotumumab resulted in better outcomes in proptosis, clinical activity Score, diplopia, and quality of life than placebo

 

  • Purpose: To evaluate the efficacy and safety of teprotumumab, an IGF-IR inhibitor, in patients with clinically active thyroid eye disease
  • Study type: Randomized controlled trial
  • Condition: Thyroid eye disease

Participants: Active thyroid eye disease

 

  • n=83

 

Intervention:

 

Group 1: Insulin-like growth factor I receptor (IGF-IR) inhibitor (Teprotumumab q3weekly for 21 weeks)
Group 2: Placebo

At week 24, Teprotumumab reduced proptosis (2mm or more) in more patients (83% vs 10%).

All secondary outcomes were also significantly better with teprotumumab, including overall response, clinical activity score, mean change in proptosis, diplopia response, and quality of life scores

Most adverse effects were mild-moderate in severity

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Updated on March 7th, 2022

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