Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial

  title={Inebilizumab for the treatment of neuromyelitis optica spectrum disorder (N-MOmentum): a double-blind, randomised placebo-controlled phase 2/3 trial},
  author={Bruce A. C. Cree and Jeffrey L. Bennett and Ho Jin Kim and Brian G. Weinshenker and Sean J. Pittock and Dean M. Wingerchuk and Kazuo Fujihara and Friedemann Paul and Gary R. Cutter and Romain Marignier and Ari J. Green and Orhan Aktas and H. P. Hartung and Fred D Lublin and Jorn Drappa and Gerard Barron and Soraya Madani and John N. Ratchford and Dewei She and Daniel M. Cimbora and Eliezer Katz},
  journal={The Lancet},

Progress in treatment of neuromyelitis optica spectrum disorders (NMOSD): Novel insights into therapeutic possibilities in NMOSD

It is of strong demand to further conduct large sample, double‐blind, randomized, clinical trials, and novel therapeutic possibilities in NMOSD to confirm their efficacy, safety, and tolerability.

Inebilizumab: A Review in Neuromyelitis Optica Spectrum Disorder

In the pivotal phase 2/3 N-MOmentum trial, inebilizumab reduced the risk of NMOSD attacks compared with placebo, including in AQP4-antibody seropositive patients, and was effective at preventingNMOSD relapseCompared with placebo in a pivotal phase2/3 trial.

Hope for patients with neuromyelitis optica spectrum disorders — from mechanisms to trials

Improved understanding of the pathophysiological mechanisms of neuromyelitis optica spectrum disorder enabled the development and testing of targeted treatments that have now received regulatory approval, and clinical trials have led to the approval of new targeted therapies for NMOSD.

Monoclonal Antibody Therapy in Neuromyelitis Optica Spectrum Disorders: a Meta-analysis of Randomized Control Trials

Compared to the control arm, monoclonal antibody therapy showed a significantly better outcome in restraining the HR for relapse among patients withNMOSD but insignificant effects in NMOSD patients with seronegative APQ4-IgG.

Satralizumab in the treatment of neuromyelitis optica spectrum disorder.

Two randomized, double-blind, Phase III trials that investigated the subcutaneous administration of satralizumab as add-on treatment and monotherapy revealed positive effects concerning the reduction of relapse risk for AQP4 seropositive NMOSD patients and generally good tolerability.

Disability Outcomes in the N-MOmentum Trial of Inebilizumab in Neuromyelitis Optica Spectrum Disorder

This study provides Class II evidence that for patients with NMOSD, inebilizumab reduces the risk of worsening disability and means EDSS scores improved with longer-term treatment.

Long-term efficacy and safety of inebilizumab in neuromyelitis optica spectrum disorder: Analysis of aquaporin-4–immunoglobulin G–seropositive participants taking inebilizumab for ⩾4 years in the N-MOmentum trial

Background: Efficacy and safety of inebilizumab for treatment of neuromyelitis optica spectrum disorder in adults seropositive for aquaporin-4 (AQP4)–immunoglobulin (Ig) G were demonstrated in the



Eculizumab in Aquaporin-4-Positive Neuromyelitis Optica Spectrum Disorder.

Patients with AQP4-IgG-positive NMOSD who received eculizumab had a significantly lower risk of relapse than those who received placebo, and there was no significant between-group difference in measures of disability progression.

Investigational drugs in development to prevent neuromyelitis optica relapses

Eculizumab, a C5 complement inhibitor, may prove useful in the treatment of intractable cases of NMOSD, but physicians must be aware of the known risk of meningococcal infection.

Efficacy and Safety of Rituximab Therapy in Neuromyelitis Optica Spectrum Disorders: A Systematic Review and Meta-analysis.

Evidence is provided that rituximab therapy reduces the frequency of NMOSD relapses and neurological disability in patients with NMOSDs, however, the safety profile suggests caution in prescribing ritUXimab as a first-line therapy.

Statistical Considerations for an Adaptive Design for a Serious Rare Disease

The application of several statistical methods in the N-MOmentum trial is novel in NMOSD and aims to achieve a balance between minimizing risk and maintaining scientific integrity.

Update on the diagnosis and treatment of neuromyelitis optica: Recommendations of the Neuromyelitis Optica Study Group (NEMOS)

The Neuromyelitis Optica Study Group (NEMOS) summarizes recently obtained knowledge on NMO and highlights new developments in its diagnosis and treatment, based on current guidelines, the published literature and expert discussion at regular NEMOS meetings.

Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis

Among patients with primary progressive multiple sclerosis, ocrelizumab was associated with lower rates of clinical and MRI progression than placebo; there was no clinically significant difference between groups in the rates of serious adverse events and serious infections.

An open label study of the effects of rituximab in neuromyelitis optica

Eight patients with worsening neuromyelitis optica were treated with rituximab to achieve B cell depletion and seven of eight patients experienced substantial recovery of neurologic function over 1 year of average follow-up.

Safety and tolerability of inebilizumab (MEDI-551), an anti-CD19 monoclonal antibody, in patients with relapsing forms of multiple sclerosis: Results from a phase 1 randomised, placebo-controlled, escalating intravenous and subcutaneous dose study

Inebilizumab had an acceptable safety profile in relapsing MS patients and showed a trend in reductions in new/newly enlarging and gadolinium-enhancing lesions.

Disease exacerbation after rituximab induction in neuromyelitis optica

Clinical histories of 6 patients with NMO treated at the New York University Multiple Sclerosis Center who experienced a relapse within 1 week of RTX induction are reviewed and potential biological mechanisms that may account for apparent disease rebound are discussed.