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Drug updated on 5/17/2024
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.
Summary
- Teprotumumab-trbw (Tepezza) is indicated for the treatment of Thyroid Eye Disease (TED), showing efficacy in improving proptosis, diplopia, overall response rate, clinical activity score, and quality of life in patients with TED.
- Four studies were reviewed to gather information about the drug's safety and effectiveness compared to other treatments for TED.
- Compared to a placebo, Tepezza demonstrated superior efficacy across multiple measures including integrated proptosis response, overall response, diplopia response, and improvements in both proptosis and quality of life. It was, however, associated with a higher risk of adverse events such as serious adverse events, gastrointestinal reactions, and muscle spasms.
- When indirectly compared with Intravenous Methylprednisolone (IVMP), teprotumumab proved more effective, especially regarding reduction in proptosis (-2.31 mm favoring teprotumumab over IVMP) and achieving a one-grade or higher reduction in diplopia; IVMP showed only small changes from baseline versus placebo that were not clinically relevant.
- The results suggest that Tepezza could be effective during both acute and chronic phases of TED; it has shown promise particularly within chronic-inactive TED where traditional glucocorticoids often have limited effectiveness. This suggests potential for its adoption as a preferred option due to its beneficial impact on disease symptoms like protrusion or double vision along with improved patient quality-of-life outcomes.
- While specific subgroup analyses based on age, gender, or race are not detailed within these studies, broad evidence points towards general efficacy across populations affected by TED alongside manageable safety profiles, suggesting future research may provide insights into subgroup-specific responses or considerations.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Tepezza (teprotumumab-trbw) Prescribing Information. | 2023 | Horizon Therapeutics USA Inc., Lake Forest, IL |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
The efficacy and safety of teprotumumab in Thyroid Eye Disease: evidence from randomized controlled trials. | 2023 | International Journal of Clinical Practice |
Proptosis and diplopia response with teprotumumab and placebo vs the recommended treatment regimen with intravenous methylprednisolone in moderate to severe Thyroid Eye Disease: a meta-analysis and matching-adjusted indirect comparison. | 2022 | JAMA Ophthalmology |
Teprotumumab for the treatment of thyroid eye disease. | 2020 | Expert Review of Clinical Immunology |
Current understanding of the progression and management of thyroid associated orbitopathy: a systematic review. | 2020 | Ophthalmology and Therapy |
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 |