Inhibition of FcRn with rozanolixizumab in adults with immune thrombocytopenia: Two randomised, double-blind, placebo-controlled phase 3 studies and their open-label extension.

• Tác giả: James B Bussel, Sarah Cluck, Nichola Cooper, Birgit Haier, Maciej Kaźmierczak, David J Kuter, Andreea Lavrov, Rocío Lledó García, Yoshitaka Miyakawa, Puneet Singh, Rose Snipes
• Ngôn ngữ: eng
• Ký hiệu phân loại: 953.801 Ancient history to 622
• Thông tin xuất bản: England : British journal of haematology , 2025
• Bộ sưu tập: NCBI
• ID: 59633

Tóm tắt

 Primary immune thrombocytopenia (ITP) is an antiplatelet-antibody-mediated disorder with accelerated platelet clearance and decreased platelet production. Rozanolixizumab, a monoclonal IgG4 anti-FcRn antibody, blocks IgG recycling and decreases IgG levels. We report efficacy and safety of rozanolixizumab in adults with persistent/chronic ITP in 24-week phase 3 studies (TP0003
  TP0006), and their 52-week open-label extension (OLE). Primary end-point was durable clinically meaningful platelet response (DCMPR) of ≥50 × 10