Uplizna Treatment for NMOSD Shows Sustained Clinical Benefit Over 4 Years According to Full N-MOmentum Data

New end-of-study results from the N-MOmentum clinical trial (NCT02200770) which included data from the randomized controlled period and the open-label extension periods were published in The Lancet Neurology. According to the findings, long-term treatment with Uplizna (inebilizumab-cdon; Amgen, Dublin, Ireland) for adults diagnosed with neuromyelitis optica spectrum disorder (NMOSD) was associated with continued and sustained clinical benefit, including decreased incidence of adjudicated attacks and decreased annualized attack rates,

N-MOmentum was a multicenter, double-blind, randomized placebo-controlled phase 2/3 clinical trial evaluating the safety and efficacy of Uplizna for the treatment of people with NMOSD. Of the 230 participants from the randomized controlled period, 165 (95%) in the Uplizna group and 51 (91%) in the placebo group were assessed in the open label period from 2015 to 2018. The end-of-study endpoints were time to adjudicated attack and annualized attack rate and safety outcomes. The end-of-study analysis included 225 participants who received Uplizna at any point during either study period (referred to as “any Uplizna”), while 208 (92%) were included in the AQP4+ subgroup.

New findings include the following:

• A total of 63 adjudicated attacks occurred in 47 (21%) participants in the “any Uplizna” group (N=225).
• 60 attacks occurred in 44 (21%) participants in the AQP4+ subgroup (n=208).
• 40 (63%) of the adjudicated attacks occurred in 34 (15%) of the participants in the “any Uplizna” group during the first year of treatment.
• 36 (77%) of the 47 participants who experienced an adjudicated attack were attackfree at the end of the 4-year study period.
• Annualized attack rates decreased yearon-year.
• End-of-study adjusted annualized attack rates were similar across the AQP4+ subgroup and the “any Uplizna” population (.097 [95% CI, .070 to .14] vs .092 [95% CI, .067 to .13]).

At least one treatment-emergent adverse event was present in 208 (92%) participants in the “any Uplizna” population, most commonly including urinary tract infection, nasopharyngitis, and arthralgia.