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Updated: Aug 8, 2025

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Sean J Pittock1, Michael Barnett2,3, Jeffrey L Bennett4

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|March 3, 2023
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Ravulizumab demonstrated high efficacy in preventing relapses for patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder. This terminal complement inhibitor showed a significant reduction in relapse risk with a favorable safety profile.

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Area of Science:

  • Neurology
  • Immunology
  • Clinical Trials

Background:

  • Neuromyelitis optica spectrum disorder (NMOSD) is a severe autoimmune condition targeting the central nervous system.
  • Anti-aquaporin-4 antibodies (AQP4+) are implicated in a significant subset of NMOSD cases, driving inflammatory attacks.
  • Current treatments aim to suppress the complement system, a key mediator of NMOSD pathogenesis.

Purpose of the Study:

  • To evaluate the efficacy and safety of ravulizumab, a long-acting terminal complement inhibitor, in adult patients with AQP4+ NMOSD.
  • To assess the potential of ravulizumab to reduce relapse rates compared to historical placebo data.

Main Methods:

  • CHAMPION-NMOSD (NCT04201262) was a Phase 3, open-label, externally controlled study.
  • Patients received intravenous ravulizumab, with an extended 8-week dosing interval.
  • The placebo group from the eculizumab trial PREVENT served as the external comparator.

Main Results:

  • Ravulizumab achieved the primary endpoint, with no adjudicated relapses in 58 patients over 84.0 patient-years.
  • This represents a 98.6% reduction in relapse risk compared to the external placebo group.
  • The safety profile was consistent with known data for ravulizumab and eculizumab, with mild to moderate adverse events and no reported deaths.

Conclusions:

  • Ravulizumab significantly reduces relapse risk in AQP4+ NMOSD patients.
  • The extended dosing interval offers a potential therapeutic advantage.
  • Ravulizumab presents a safe and effective treatment option for this debilitating neurological disorder.