Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders

A Multicentric, Retrospective, Real-Word Study to Evaluate the Efficacy and Safety of Inebilizumab Compare With Rituximab in Neuromyelitis Optica Spectrum Disorders

To compare the safety and efficacy of Inebilizumab and Rituximab in neuromyelitis optica spectrum disorders (NMOSD) patients.

Inebilizumab is a humanized anti-CD19 monoclonal antibody. CD19 is broadly expressed on B-lineage cells, particularly late-stage memory B-lymphocytes and plasma blasts. Inebilizumab depletes antibody-secreting plasmablasts and some plasma cells.

Rituximab (RTX) is a chimeric anti-CD20 monoclonal antibody that promotes B-lymphocyte depletion through antibody-dependent cellular cytotoxicity (ADCC)/complement-dependent cytotoxicity (CDC), promotes an immunoregulatory T-lymphocyte phenotype, and activates neutrophil/macrophage phagocytosis.

This is a retrospective, multicentre, real-world study which aims to compare Inebilizumab with RTX in neuromyelitis optica spectrum disorders patients. Eighty patients from 8 centres in China will be enrolled.

Inclusion Criteria:

• 1. Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis).
• 2. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the acute phase.
• 3. Patients have given their written informed consent.

Exclusion Criteria:

• 1. Lactating and pregnant females.
• 2. Participate in other interventional studies within 30 days or within 5 half-lives of the investigational agent before received inebilizumab and rituximab (RTX).
• 3. Receipt of any experimental B-cell depleting agent within 6 months prior inebilizumab and RTX, and B-cells below the lower limit of normal
• 4. Known history of a severe allergy or reaction to any component of the investigational product formulation.
• 5. Known active severe bacterial, viral, or other infection or any major episode of infection requiring hospitalization (including viral hepatitis, active tuberculosis or positive tuberculosis screening).
• 6. History of alcohol, drug, or chemical abuse, or a recent history of such abuse < 1 year prior to treatment.
• 7. History of malignancies.
• 8. Combined with severe mental disorders and other conditions and unable to cooperate with follow-up.