Inebilizumab in AQP4-Ab-positive neuromyelitis optica spectrum disorder

Until recently, the use of preventative immunotherapy in neuromyelitis optica spectrum disorders (NMOSD) was based on observational studies and clinical experiences. Meanwhile, the first drugs, among others the monoclonal antibody inebilizumab, were approved for the treatment of aquaporin-4 (AQP4) antibody-positive NMOSD. Inebilizumab binds to the CD19 antigen on B cells and leads to B-cell depletion. The first two dosages of 300 mg inebilizumab are administered intravenously at an interval of 2 weeks followed by further infusions every 6 months. In the placebo-controlled pivotal phase II/III study N-MOmentum, inebilizumab significantly prolonged the time to a first adjudicated relapse in AQP4 antibody-positive patients compared with placebo. The most frequent side effects were infusion reactions, urinary and respiratory tract infections, and arthralgia. This review presents data on clinical and preclinical pharmacology, administration, safety aspects and clinical trials of inebilizumab.