Uplizna reduces severity of neuromyelitis optica spectrum disorder attacks
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In a company release, Horizon Therapeutics announced results from a phase 2/3 trial demonstrating that its B-cell-depleting agent Uplizna reduced the severity of attacks in people with neuromyelitis optica spectrum disorder.
According to the release, data from the 28-week, randomized-controlled N-MOmentum trial showed that 89% of 161 patients in the Uplizna (inebilizumab-cdon, Horizon Therapeutics) treatment group remained attack-free compared with 58% of 52 patients in the placebo group.
“NMOSD attacks can be incredibly detrimental to the well-being of patients,” Jeffrey Bennett, MD, PhD, professor of neurology and ophthalmology at the University of Colorado School of Medicine, told Healio. “While a primary goal of treatment is to prevent attacks, it is also important to understand whether they reduce the severity of attacks and whether the effects are limited to certain attack subtypes, such as optic neuritis. This analysis specifically assessed the impact of Uplizna on the severity of optic neuritis and transverse myelitis NMOSD attacks and the levels of disease-related biomarkers of astrocyte and neuronal injury, serum glial fibrillary acidic protein (sGFAP) and serum neurofilament light (sNfL).”
Additional analysis was conducted to understand the effect of inebilizumab-cdon on the severity of attacks in 11% of trial participants who were not attack-free following treatment. A key finding was that of 18 total attacks in the inebilizumab-cdon group, 12 (67%) were minor and six (33%) were major, compared with 12 (55%) and 10 (45%), respectively, in the placebo group.
Data also showed levels of the sGFAP biomarker were significantly higher during major vs. minor attacks overall and trended higher for optic neuritis-specific attacks. Concentration levels of the biomarker increased significantly from baseline at the time of attacks in those receiving placebo but not in those treated with inebilizumab-cdon.
In addition, sNfL levels were higher for major vs. minor attacks overall, although the levels did not correlate with severity of optic neuritis attacks. Among participants that suffered attacks during the trial, rates of this marker were higher in the placebo group than in treated participants at week 26, according to the release.
“There was a lower frequency of severe optic neuritis and transverse myelitis attacks in Uplizna-treated participants,” Bennett added. “Assessments of sGFAP at the time of relapse showed no significant elevation in Uplizna-treated patients, and among patients with attacks, Uplizna-treated patients showed lower sNfL levels than placebo-treated patients at the end of the randomized control period. The current analysis shows that treatment with Uplizna may reduce NMOSD attack severity and injury-related biomarkers.”