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Safety and efficacy of inebilizumab for the treatment of neuromyelitis optica spectrum disorder: end-of-study results from the open-label period of the N-MOmentum trial

Safety and Efficacy of Inebilizumab for Neuromyelitis Optica Spectrum Disorder

End-of-Study Results from N-MOmentum Trial

In a recent study published in Lancet Neurology, the safety and efficacy of inebilizumab for treating neuromyelitis optica spectrum disorder were investigated. The study included both the randomised controlled period and the open-label extension period.

Key Findings

  • 225 participants received inebilizumab, with 208 being AQP4-IgG seropositive.
  • Over a 4-year period, 63 adjudicated neuromyelitis optica spectrum disorder attacks occurred in 47 participants, with 40 attacks occurring in the first year.
  • Annualised attack rates decreased year-on-year, and most participants who had an attack while receiving inebilizumab were subsequently attack-free at the end of 4 years.
  • Overall, 92% of participants who received inebilizumab experienced at least one treatment-emergent adverse event, with urinary tract infection, nasopharyngitis, and arthralgia being the most frequent.

Implications

The end-of-study analysis showed sustained clinical benefits of long-term inebilizumab treatment for individuals with neuromyelitis optica spectrum disorder. This supports the role of inebilizumab as a CD19+ B-cell-depleting therapy in this disorder.

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