Drug updated on 3/28/2024
| Dosage Form | Injection (subcutaneous: 120 mg/mL) |
| Drug Class | Interleukin-6 receptor antagonists |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- For the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Summary
- Satralizumab (Enspryng) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
- Three systematic reviews/meta-analyses were reviewed, providing insights into the efficacy and safety of satralizumab compared to other treatments for NMOSD.
- The first review found that both FDA-approved monoclonal antibodies like satralizumab and off-label drugs significantly lower risk of relapse than standard treatments, with hazard ratios indicating a 20% lower risk associated with FDA-approved options; however, this did not reach statistical significance.
- In another study comparing various therapies including rituximab, azathioprine and new molecules such as eculizumab and tocilizumab against satralizumab, it was observed that all these agents showed high effectiveness in managing NMOSD but rituximab demonstrated superior performance on multiple outcomes including disability degree improvement, annual relapse rate reduction and longer time to first relapse.
- A third analysis focused on interleukin-6-receptor inhibitors like tocilizumab alongside satralziumb revealed promising results in terms of reducing mean Annualized Relapse Ratio (ARR), proportion of relapse-free patients at follow up while maintaining an acceptable toxicity profile; although no significant difference was noted in change in Extended Disability Status Scale score after treatment initiation.
- Despite limited data available for comparison between different monoclonal antibodies used as therapeutic agents for NMOSD management due to recent introduction into clinical practice or ongoing trials status - preliminary findings suggest comparable efficacy among them with subtle differences potentially attributable to individual patient characteristics or disease severity level rather than drug-specific effects alone based on current evidence from systematic reviews/meta-analyses conducted so far involving satralizumab.
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 |
| Australian public assessment report for satralizumab. | 2021 | Australian Government: Department of Health |
| Assessment report: Enspryng. | 2021 | EMA |
| Clinical review report: satralizumab (Enspryng). | 2021 | CADTH |
| 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 |