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Burosumab-twza

(Crysvita®)

Crysvita®

Drug updated on 10/29/2024

Dosage FormInjection (subcutaneous; 10 mg/mL, 20 mg/mL, 30 mg/mL)
Drug ClassFibroblast growth factor 23 (FGF23) blocking 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.

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Summary
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  • This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
  • In pediatric patients with X-linked hypophosphatemia (XLH), burosumab significantly improved biochemical markers (1,25-dihydroxyvitamin D, phosphorus, alkaline phosphatase), renal function (TmP/GFR), and skeletal health, as shown by improvements in the rickets severity score (RSS) and the 6-minute walk test (6MWT).
  • Compared to conventional therapy (phosphorus and calcitriol), burosumab was more effective in normalizing phosphate homeostasis and reducing skeletal lesions, including a significant reduction in Thacher's total rickets severity score (SMD: -1.46, 95% CI: -1.76 to -1.17, p < 0.001) and a decline in serum alkaline phosphatase levels (SMD: 130.68, 95% CI: 125.26-136.1, p < 0.001).
  • In adults with XLH, burosumab normalized phosphorus levels (SMD: 1.23, 95% CI: 0.98-1.47, p < 0.001) and led to clinical improvement, while also showing potential as a nonsurgical treatment option for tumor-induced osteomalacia (TIO), particularly in cases of persistent or recurrent disease.
  • Burosumab was well-tolerated in children with X-linked hypophosphatemia (XLH), with only mild treatment-related adverse effects reported, though long-term safety data, particularly regarding height and quality of life, remain to be determined.
  • No specific adverse effects were detailed for tumor-induced osteomalacia (TIO) patients receiving burosumab, and the safety profile in adults with XLH and TIO was generally positive.
  • Burosumab demonstrated significant effectiveness in pediatric patients with X-linked hypophosphatemia (XLH) by improving biochemical markers, renal function, and skeletal health, while in adults with XLH, it normalized phosphorus levels and led to clinical improvement. For tumor-induced osteomalacia (TIO), burosumab showed promise as a nonsurgical treatment, particularly for patients with persistent or recurrent disease.