Teprotumumab-trbw

(Tepezza®)

Teprotumumab-trbw

Drug updated on 9/4/2024

Dosage FormInjection (intravenous; 500 mg/vial)
Drug ClassInsulin-like growth factor-1 receptor inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of Thyroid Eye Disease.

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Summary
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  • Tepezza (teprotumumab-trbw) is indicated for the treatment of Thyroid Eye Disease.
  • This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
  • Proptosis Response: Teprotumumab significantly improved proptosis response compared to placebo, with odds ratios (OR) of 17.81 (95% CI = [10.32, 30.76], I² = 50%) in the intention-to-treat (ITT) population and 24.53 (95% CI = [12.96, 46.45], I² = 14%) in the per-protocol population. Clinical trials indicated an 83% proptosis response with teprotumumab.
  • Overall and Diplopia Response: Teprotumumab showed significant overall response improvement (OR = 8.35, 95% CI = [4.74, 14.71], I² = 79%) and improved diplopia response (OR = 5.53, 95% CI = [3.24, 9.44], I² = 0%), with better outcomes than intravenous methylprednisolone (IVMP) for diplopia (OR = 2.32, 95% CI = [1.07-5.03]).
  • Clinical Activity Score and Quality of Life: Patients receiving teprotumumab were more likely to achieve a clinical activity score (CAS) of 0 or 1 (OR = 6.26, 95% CI = [3.87, 10.12], I² = 0%) and experienced significant improvements in Graves' ophthalmopathy-specific quality of life (MD = 11.48, 95% CI = [11.03, 11.93], I² = 95%).
  • Adverse Events: Teprotumumab is associated with a higher risk of adverse events, including serious adverse events, gastrointestinal adverse reactions, and muscle spasms. Common adverse reactions noted include muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache, and dry skin.
  • Significant Safety Concerns: Gastrointestinal adverse reactions and muscle spasms are significant concerns for patients receiving teprotumumab.
  • There is no population types or subgroups information available in the reviewed studies.