作者
Suzanne Jan De Beur, Thomas Carpenter, MD Karine Briot, Erik Imel, MD Peter Kamenický, Mary Ruppe, Anthony Portale, Thomas Weber, Pisit Pitukcheewanont, Hae Il Cheong, MD Yasuo Imanishi, MD Nobuaki Ito, MD Robin Lachmann, Hiroyuki Tanaka, Matt Mealiffe, MD Javier San Martin, Karl Insogna
发表日期
2018/4/1
期刊
Endocrine Practice
卷号
24
页码范围
112-112
出版商
Elsevier Limited
简介
Objective: In adults with XLH, inappropriately elevated circulating fibroblast growth factor 23 (FGF23) causes hypophosphatemia with consequent osteomalacia, musculoskeletal pain, stiffness, pseudofractures, osteoarthritis, enthesopathy, muscle dysfunction, and impaired physical function. Burosumab, an investigational fully human monoclonal antibody, binds FGF23 and inhibits its activity. UX023-CL303 is an ongoing, Phase 3, double-blind, multicenter study examining the efficacy and safety of burosumab in adults with XLH.
Methods: Eligible participants (pts) had fasting serum phosphorus (Pi) levels< 2.5 mg/dL and skeletal pain (Brief Pain Inventory [BPI]-Question 3, Worst Pain Score> 4 on an 11-point scale). Pts (N= 134) were randomized 1: 1 to receive burosumab 1 mg/kg or placebo subcutaneously every 4 weeks for 24 weeks. Changes in pharmacodynamic measures, stiffness, physical functioning, and …
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SJ De Beur, T Carpenter, MD Karine Briot, E Imel… - Endocrine Practice, 2018