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Drug updated on 5/17/2024
Dosage Form | Injection (subcutaneous; 120 mg/mL) |
Drug Class | Interleukin-6 receptor antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment ofneuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Summary
- Satralizumab-mwge (Enspryng) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. It has been found to be highly effective and safe, with promising results in NMOSD treatment.
- Three systematic reviews/meta-analyses provided detailed insights into the safety and effectiveness of satralizumab compared to other drugs used for treating NMOSD.
- These studies highlighted that both FDA-approved monoclonal antibodies like Enspryng and off-label ones significantly reduced the risk of relapse compared to standard treatments. However, due to lower costs, off-label monoclonal antibodies might serve as the first option in resource-limited settings despite a slight trend towards higher efficacy in FDA-approved options.
- Comparative analysis showed new molecules like satralizumab have superior performance across multiple outcomes, including reducing relapses during treatment time. However, rituximab had more extensive evidence supporting its use than newer alternatives such as satralizumab.
- In terms of population types and subgroup considerations, studies varied on their inclusion criteria but suggested that due to its specific targeting mechanism, the use of Enspryng might be particularly advantageous among populations intolerant or resistant to other treatments.
- Overall, the safety profile for interleukin 6 receptor inhibitors, including Enspryng, was favorable, with no reported deaths related specifically to these medications according to one study reviewed.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Enspryng (satralizumab-mwge) Prescribing Information. | 2022 | Genentech Inc., South San Francisco, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy and safety of monoclonal antibody therapy in patients with neuromyelitis optica spectrum disorder: a systematic review and network meta-analysis. | 2023 | Frontiers in Neurology |
Effectiveness of treatments in neuromyelitis optica to modify the course of disease in adult patients. Systematic review of literature. | 2021 | Multiple Sclerosis and Related Disorders |
Safety and efficacy of interleukin-6-receptor inhibitors in the treatment of neuromyelitis optica spectrum disorders: a meta-analysis. | 2021 | BMC Neurology |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Tocilizumab for neuromyelitis optica spectrum disorder: CADTH health technology review. | 2023 | Canadian Agency for Drugs and Technologies in Health |