Satralizumab-mwge

(Enspryng®)

Satralizumab-mwge

Drug updated on 9/4/2024

Dosage FormInjection (subcutaneous; 120 mg/mL)
Drug ClassInterleukin-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.

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Summary
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  • Enspryng (satralizumab-mwge) is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
  • This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
  • Satralizumab demonstrated a significantly lower risk of relapse compared to standard treatments, with a hazard ratio (HR) of 0.13 (95% CI: 0.07, 0.24), and it reduced the annualized relapse rate (ARR) by a mean difference of -0.27 (-0.37, -0.16).
  • In terms of the Expanded Disability Status Score (EDSS), satralizumab showed subtle improvements, and in two trials, a reduction in EDSS from baseline was observed, although it was not significantly superior to other treatments.
  • In the SAkura studies, 70% to 80% of patients treated with satralizumab remained relapse-free, highlighting its effectiveness in maintaining relapse-free status among patients with NMOSD.
  • New molecules, including satralizumab, demonstrated a favorable safety profile with fewer adverse events compared to older treatments like azathioprine, although specific adverse event rates for satralizumab were not detailed.
  • Satralizumab's safety findings were noted to be similar to tocilizumab, with an acceptable toxicity profile; however, specific rates for adverse and serious adverse events were not isolated for satralizumab.
  • There is no population type or subgroup information available in the reviewed studies.