Drug updated on 10/28/2024
Dosage Form | Injection (subcutaneous; 120 mg/mL) |
Drug Class | Interleukin-6 (IL-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
Latest News
Summary
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Satralizumab (Enspryng) demonstrated a significant reduction in annualized relapse rate (mean difference: -2.6, 95% CI: - 2.71 to - 1.68; p < 0.001 (ARR)) and risk of relapse in patients with neuromyelitis optica spectrum disorder (NMOSD). In the SAkura studies, the proportion of relapse-free patients ranged from 70% to 80%.
- FDA-approved monoclonal antibodies (mAbs), including satralizumab, showed a lower risk of relapse compared to standard treatments (95% CI (HR): 0.13, 95% CI: 0.07-0.24) and a reduction in ARR of -0.27 (95% CI: -0.37 to -0.16). Comparatively, off-label mAbs demonstrated a similar reduction in relapse risk (HR: 0.16, 95% CI: 0.07-0.37).
- Satralizumab demonstrated a safety profile comparable to placebo, with relatively mild adverse events such as injection site reactions. It did not significantly impact pain or fatigue scores, suggesting it may be well-tolerated but with no additional benefit for symptom relief.
- Tocilizumab showed an acceptable safety profile, with 56% of patients reporting adverse events and 11% experiencing serious adverse events (SAEs), but no treatment-related deaths were reported. Satralizumab had a similar safety profile to tocilizumab and azathioprine.
- Satralizumab and tocilizumab were both studied in patients with active neuromyelitis optica spectrum disorder (NMOSD), showing promising efficacy and safety in this population. Eculizumab was particularly effective in reducing relapse risk among aquaporin-4 (AQP4) seropositive patients, with a relative risk (RR) of 0.07 (95% CI 0.02–0.23), indicating its strong relevance for this specific subgroup. There were no significant findings related to age or gender differences.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Enspryng (satralizumab-mwge) Prescribing Information. | 2022 | Genentech Inc., South San Francisco, CA |