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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed group 1 | Intravenous methylprednisolone (IVMP) plus Inebilizumab |
| |
| Exposed group 2 | IVMP plus Rituximab (RTX) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inebilizumab | Drug | Inebilizumab: 300mg IV on Day1 and Day 15. The first dose of inebilizumab was given after IVMP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 months |
| Percentage of Participants with Disability Improvement |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Neuromyelitis Optica Spectrum Disorders
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinzhou Feng, Ph.D | Contact | 023-89012487 | 203756@cqmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jinzhou Feng, Ph.D | First Affiliated Hospital of Chongqing Medical University | Principal Investigator |
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| ID | Term |
|---|---|
| D009471 | Neuromyelitis Optica |
| ID | Term |
|---|---|
| D009188 | Myelitis, Transverse |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000609745 | inebilizumab |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Blood samples are collected before the treatment and at the last follow-up.
| Rituximab(RTX) | Drug | RTX: 500mg IV on Day 1 and Day15. The first dose of RTX was given after IVMP. |
|
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). |
| 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. | 12 months |
| Change in modified Rankin score (mRS) from baseline | Change in modified Rankin score (mRS) from baseline at month 12(mRS: Minimum Score 0, Maximum score 6, higher scores mean a worse outcome). | 12 months |
| Change in Timed 25 Foot Walk Test from baseline | Change in time taken to complete the timed 25foot walk test from baseline | 12 months |
| Number of NMOSD attacked related rescue treatment. | 12 months |
| Annual relapse rate (ARR) before and after Inebilizumab/Rituximab | ARR will be measured in the baseline (according to patients' history before inebilizumab/rituximab) and after 12 months of intervention. | 12 months |
| Change in serum glial fibrillary acidic protein antibody (GFAP-Ab) levels from baseline. | Change in serum GFAP-Ab levels from baseline at the last visit | 12 months |
| Change in aquaporin 4 antibody (AQP4-Ab) titers from baseline. | Change in AQP4-ab titers from baseline at the last visit. | 12 months |
| Change in serum Neurofilament light chain protein (NfL) levels from baseline. | Change in serum NfL levels from baseline at the last visit. | 12 months |
| Change in Visual Acuity (VA) from baseline | Change in Visual Acuity (VA) at month 12. | 12 months |
| Changes in The Five Level of EuroQol Five Dimensions Questionnaire (EQ-5D-5L) scores from baseline | Changes in EQ-5D scores from baseline at month 12(EQ-5D-5L: Minimum Score 5, Maximum score 25, lower scores mean a better quality of life). | 12 months |
| Change in retinal nerve fiber layer (RNFL) loss from baseline | Change in retinal nerve fiber layer (RNFL) loss measured by optical coherence tomography (OCT) from baseline at month 12. | 12 months |
| Adverse reactions during treatment and follow-up | 12 months |
| D009902 | Optic Neuritis |
| D009901 | Optic Nerve Diseases |
| D003389 | Cranial Nerve Diseases |
| D003711 | Demyelinating Diseases |
| D005128 | Eye Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |