From the FDA Drug Label
Inebilizumab-cdon is a CD19-directed humanized afucosylated IgG1 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The molecular weight is approximately 149 kDa. Inebilizumab is a humanized IgG1 monoclonal antibody that targets CD19, a cell surface antigen present on pre-B and mature B lymphocytes. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture, with a molecular weight of approximately 149 kDa 1.
From the Research
Definition and Mechanism of Action
- Inebilizumab is a humanized, affinity-optimized, afucosylated IgG1 κ monoclonal antibody that binds to the B-cell specific surface antigen CD19, resulting in rapid, profound and sustained depletion of circulating peripheral B cells 2, 3, 4.
- It targets and depletes CD19-expressing B cells through antibody-dependent cell-mediated cytotoxicity 3.
Therapeutic Use
- Inebilizumab is approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are seropositive for immunoglobulin G autoantibodies against aquaporin-4 (AQP4-IgG) 3, 5, 6.
- It is also being developed for the treatment of other autoimmune diseases, including kidney transplant desensitization, myasthenia gravis, and IgG4-related disease 3.
- Inebilizumab has been shown to reduce the risk of NMOSD attacks, disability score worsening, and NMOSD-related hospitalizations in AQP4-antibody seropositive patients 5, 6.
Administration and Pharmacokinetics
- Inebilizumab is administered intravenously, with the first two dosages of 300 mg given at an interval of 2 weeks, followed by further infusions every 6 months 5.
- The pharmacokinetics of inebilizumab are characterized by a two-compartment model with parallel first-order and time-dependent nonlinear elimination pathways 4.
- The elimination half-life of inebilizumab is approximately 18 days, and the maximum velocity of the nonlinear elimination pathway decreases with time due to the depletion of B cells upon inebilizumab administration 4.