Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders

Feng Jinzhou80 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Neuromyelitis Optica Spectrum Disorders

Interventions

InebilizumabDRUG

Inebilizumab: 300mg IV on Day1 and Day 15. The first dose of inebilizumab was given after IVMP.

Rituximab(RTX)DRUG

RTX: 500mg IV on Day 1 and Day15. The first dose of RTX was given after IVMP.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Expanded Disability Status Scale Score (EDSS) from baseline.

Change in Expanded Disability Status Scale (EDSS) score from baseline to 12 months after treatment (EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).

Time frame: 12 months

Time to first relapse

Relapse: A monophasic clinical episode with patient-reported symptoms and objective findings reflecting a focal or multifocal inflammatory demyelinating event in the central nervous system (CNS), developing acutely or subacutely, with a duration of at least 24h, without fever or infection.

Time frame: 12 months

Number of new, and/or enlarging T2- hyperintense lesions detected by Magnetic Resonance Imaging (MRI)

Number of new, and/or enlarging T2-hyperintense lesions detected by Magnetic Resonance Imaging (MRI) at the last visit.

Time frame: 12 months

Secondary Outcomes

Change in Expanded Disability Status Scale (EDSS) score from baseline

Change in Expanded Disability Status Scale (EDSS) score from baseline at month 6 (EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).

Time frame: 6 months

Percentage of Participants with Disability Improvement

Disability improvement is defined as a reduction in EDSS score of: A) \>=1.0 from the baseline EDSS score when the baseline score was \<=5.5 B) \>= 0.5 when the baseline EDSS score \> 5.5(EDSS: Minimum Score 1, Maximum score 10, higher scores mean a worse outcome).

Time frame: 12 months

Percentage of Participants with Disability Worsening

A participant was considered to have a worsening in overall EDSS score of at least 2 if baseline EDSS score was 0, or at least 1 point if baseline EDSS score is 1 to 5, or at least 0.5 point if baseline EDSS score is 5.5 or more.

Central Contacts

Jinzhou Feng, Ph.D

CONTACT

023-89012487 203756@cqmu.edu.cn

Data from ClinicalTrials.gov

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