Drug updated on 12/11/2024
Dosage Form | Injection (intravenous; 500 mg/vial) |
Drug Class | Insulin-like growth factor-1 receptor inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of Thyroid Eye Disease.
Latest News
Summary
- 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 intravenous methylprednisolone (IVMP). Teprotumumab was also more effective than intravenous glucocorticoids (IVGCs) in reducing standardized mean difference (SMD) = -1.44, 95% confidence interval (CI) and proptosis.
- Teprotumumab showed superior improvements in proptosis and diplopia, with significant reductions compared to placebo (odds ratio (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 (mean difference (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 Title | Year | Source |
---|---|---|
Tepezza (teprotumumab-trbw) Prescribing Information. | 2023 | Horizon Therapeutics USA Inc., Deerfield, IL |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Expert Consensus on the Use of Teprotumumab for the Management of Thyroid Eye Disease Using a Modified-Delphi Approach | 2022 | Journal of Neuro-Ophthalmology |
The 2021 European Group on Graves' orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves' orbitopathy | 2021 | European Journal of Endocrinology |
Teprotumumab in Clinical Practice: Recommendations and Considerations From the OPTIC Trial Investigators | 2021 | Journal of Neuro-Ophthalmology |