Teprotumumab-trbw

(Tepezza®)

Tepezza®

Drug updated on 10/28/2024

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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  • This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
  • Teprotumumab demonstrated significant improvements in Clinical Activity Score (CAS), with a matching-adjusted indirect comparison showing better outcomes compared to IVMP (intravenous methylprednisolone). Teprotumumab was also more effective than intravenous glucocorticoids (IVGCs) in reducing SMD = -1.44, 95% confidence interval (CI (CAS) and proptosis.
  • Teprotumumab showed superior improvements in proptosis and diplopia, with significant reductions compared to placebo (OR = 6.26, 95% CI = [3.87, 10.12]) and better outcomes than odds ratio, 2.69; 95% CI, 0.94-7.70 (IVMP) in these measures.
  • Quality of life (QoL) also improved significantly with teprotumumab, as evidenced by marked improvements in both components of the Graves' Ophthalmopathy QoL questionnaire (MD = 11.48, 95% CI = [11.03, 11.93]).
  • Teprotumumab was associated with a higher risk of adverse events, including serious adverse events, gastrointestinal reactions, and muscle spasms, compared to glucocorticoids or placebo (OR = 2.91, 95% CI: 1.12-7.56). Common side effects included muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, and hearing impairment.
  • While monoclonal antibodies, including teprotumumab, showed an elevated rate of adverse events, most of these were mild to moderate in severity, with few serious adverse events reported across studies.
  • The population types primarily included patients with moderate to severe, active Graves' ophthalmopathy, with studies focusing on comparing the effectiveness of monoclonal antibodies like teprotumumab against glucocorticoids and other treatments. No specific subgroups were identified outside of the general population with thyroid eye disease, and all interventions were generally applied across this patient group.

Product Monograph / Prescribing Information

Document TitleYearSource
Tepezza (teprotumumab-trbw) Prescribing Information.2023Horizon Therapeutics USA Inc., Deerfield, IL

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines