Opening book details…
Can I read Safety and Efficacy of Nipocalimab in Patients With Generalized Myasthenia Gravis on EtoBox?
Safety and Efficacy of Nipocalimab in Patients With Generalized Myasthenia Gravis by Carlo Antozzi; Jeffrey Guptill; Vera Bril; Josep Gamez; Sven G. Meuth; Richard J. Nowak; Dianna Quan; Teresa Sevilla; Marie-Helene Jouvin; Jim Jin; Keith Karcher; Sindhu Ramchandren; Hong Sun; Leona Ling; Yaowei Zhu; Santiago Arroyo; for the Vivacity-MG Phase 2 Study Group is a Medicine article available to read on EtoBox.
What is Safety and Efficacy of Nipocalimab in Patients With Generalized Myasthenia Gravis about?
## Background and Objectives To evaluate in a phase 2 study the safety and efficacy of IV nipocalimab, a fully human, antineonatal Fc receptor monoclonal antibody, in patients with generalized myasthenia gravis (gMG). ## Methods Patients with gMG with inadequate response to stable standard-of-care (SOC) therapy were randomized 1:1:1:1:1 to receive either IV placebo every 2 weeks (Q2W) or one of 4 IV nipocalimab treatments: 5 mg/kg once every 4 weeks (Q4W), 30 mg/kg Q4W, 60 mg/kg Q2W each for 8 weeks, or a 60 mg/kg single dose, in addition to their background SOC therapy. Infusions (placebo or nipocalimab) were Q2W in all groups to maintain blinding. The primary safety endpoint was incidence of treatment-emergent adverse events (TEAEs), including serious adverse events and adverse events of special interest. The primary efficacy endpoint was change from baseline to day 57 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total scores. Dose response of change at day 57 was analyzed with a linear trend test over the placebo, nipocalimab 5 mg/kg Q4W, nipocalimab 30 mg/kg Q4W, and nipocalimab 60 mg/kg Q2W groups. ## Results Sixty-eight patients (nipocalimab: n = 54; placebo, n =
Who reads Safety and Efficacy of Nipocalimab in Patients With Generalized Myasthenia Gravis?
It is typically read by researchers, students, and practitioners in Medicine.
- Author
- Carlo Antozzi; Jeffrey Guptill; Vera Bril; Josep Gamez; Sven G. Meuth; Richard J. Nowak; Dianna Quan; Teresa Sevilla; Marie-Helene Jouvin; Jim Jin; Keith Karcher; Sindhu Ramchandren; Hong Sun; Leona Ling; Yaowei Zhu; Santiago Arroyo; for the Vivacity-MG Phase 2 Study Group
- Publisher
- Lippincott Williams & Wilkins
- Published
- 2023
- Language
- EN
- Field
- Medicine (Health Sciences)