Post-hoc analysis from N-MOmentum phase III trial of Uplizna shows effectiveness in neuromyelitis optica spectrum disorder.- Horizon Therapeutics

Uplizna is the first and only FDA-approved CD19+ B-cell-depleting monotherapy proven to reduce the risk of attacks in adults with NMOSD who are anti-aquaporin-4 (AQP4) antibody positive. This analysis aimed to clarify how prior history of attacks might affect the response to Uplizna by evaluating the medicine’s effect among individuals with newly-presenting NMOSD who were enrolled in the 28-week randomized, placebo-controlled period of the trial after their first attack compared to individuals with a history of two or more attacks.

The analysis finds that of the 37 study participants who had experienced only one attack before joining the study, 4.2% (1/24) of those who were treated with Uplizna experienced an attack compared to 23.1% (3/13) of those who were treated with placebo. in addition, of the 176 study participants who had experienced more than one attack before joining the study, 12.4% (17/137) of those who were treated with Uplizna experienced an attack compared to 48.7% (19/39) of those who were treated with placebo. No significant differences in attacks or Expanded Disability Status Scale (EDSS) worsening were found between participants with one pre-study attack and those with two or more pre-study attacks. Treatment-emergent adverse events among those enrolled after their first attack were consistent with pivotal trial outcomes. These data are being presented during a poster session at the American Academy of Neurology (AAN) 2022 Annual Meeting in Seattle April 2-7 and virtually April 24-26, 2022.