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Burosumab in Chinese adults with X-linked hypophosphatemia: a phase 4 study
Wei Liu1, Zhenlin Zhang2, Yongjian Wang3
1Department of Endocrinology, Key Laboratory of Endocrinology, National Commission of Health, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
JBMR Plus
|January 15, 2026
Summary
Burosumab effectively treats X-linked hypophosphatemia (XLH) in Chinese adults, significantly increasing serum phosphate levels and improving pain and motor function. The treatment demonstrated a favorable safety profile with no new safety signals observed.
Area of Science:
- Endocrinology
- Genetics
- Pharmacology
Background:
- X-linked hypophosphatemia (XLH) is a rare genetic disorder affecting phosphate metabolism.
- Burosumab, an antibody targeting FGF23, is a potential treatment for XLH.
Purpose of the Study:
- To evaluate the efficacy, pharmacokinetics, and safety of burosumab in Chinese adult patients with XLH.
- To assess the impact of burosumab on serum phosphate levels, renal phosphate reabsorption, and patient-reported outcomes.
Main Methods:
- An open-label, multicenter, phase 4 study involving 18 Chinese adult XLH outpatients.
- Patients received conventional phosphate and calcitriol, followed by subcutaneous burosumab (1.0 mg/kg every 4 wk for 48 wk).
- Primary outcomes included changes in serum phosphate levels and TmP/GFR; secondary outcomes included patient-reported pain, quality of life, and motor function.
Main Results:
- Burosumab treatment led to a significant increase in mean serum phosphate levels (50.1% from baseline) and TmP/GFR (from 1.3 to 2.0 mg/dL).
- Improvements were observed in patient-reported outcomes, including reduced pain and stiffness, and increased quality of life scores.
- Motor function, assessed by the 6-min walking test, improved by 72.7% from baseline.
- All treatment-emergent adverse events were mild or moderate, with no serious or treatment-related adverse events reported.
Conclusions:
- Burosumab treatment achieved sustained correction of serum phosphate levels in Chinese adult XLH patients.
- The treatment enhanced renal phosphate reabsorption and improved patient-reported stiffness, pain, and functional exercise capacity.
- Burosumab was well-tolerated, exhibiting no new safety signals in this population.
