Drug updated on 9/4/2024
Dosage Form | Injectable (subcutaneous; 10 mg/mL, 20 mg/mL, 30 mg/mL) |
Drug Class | Monoclonal antibodies |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.
- Indicated for the treatment of FGF23-related hypophosphatemia in tumor induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older.
Latest News
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Summary
- Crysvita (burosumab-twza) is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older, and for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older.
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Burosumab significantly increased serum phosphorus levels in patients with X-linked hypophosphatemia (XLH), with an increase of 0.52 mg/dL (95% CI 0.24-0.80 mg/dL) in randomized controlled trials and 0.78 mg/dL (95% CI 0.61-0.96 mg/dL) in the overall meta-analysis.
- In XLH patients, Burosumab significantly increased TmP/GFR by 0.86 mg/dL (95% CI 0.60-1.12 mg/dL) and 1,25-dihydroxyvitamin D levels by 13.23 pg/mL (95% CI 4.82-21.64 pg/mL), demonstrating effectiveness in improving phosphate metabolism.
- Burosumab is highlighted as a promising nonsurgical therapy for patients with tumor-induced osteomalacia (TIO), especially in cases of persistent, recurrent, or inoperable TIO, with evidence of potential effectiveness in a small cohort of patients.
- In RCTs, the safety profile of burosumab in patients with X-linked hypophosphatemia (XLH) was not significantly different from the control group.
- In single-arm trials for XLH, there was a high incidence of treatment-emergent adverse events (TEAEs), with most being mild to moderate in severity and a low rate of serious TEAEs.
- No specific safety concerns or adverse effects were detailed for tumor-induced osteomalacia (TIO) patients treated with burosumab in the provided studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Crysvita (burosumab) Prescribing Information. | 2020 | Ultragenyx Pharmaceutical Inc., Novato, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy and safety of burosumab in X-linked hypophosphataemia: Systematic review and meta-analysis. | 2023 | The Journal of Endocrinology and Metabolism |
Tumor-induced osteomalacia: a systematic review and individual patient's data analysis. | 2022 | The Journal of Endocrinology and Metabolism |
Persistence and recurrence in tumor-induced osteomalacia: a systematic review of the literature and results from a national survey/case series. | 2022 | Endocrine |