Drug updated on 9/4/2024
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.
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Summary
- 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.
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 |