Amgen has shared new findings from the phase 3 N-MOmentum clinical trial that offer insights on the peripheral presence of inflammatory biomarkers associated with neuromyelitis optica spectrum disorder (NMOSD) and reinforce the ‘durable impact’ of Uplizna (inebilizumab) in reducing disease-related attacks.
Approximately one to ten per 100,000 people are affected by NMOSD, a rare and debilitating autoimmune disease that attacks the optic nerve, spinal cord, brain and brain stem.
Most patients experience unpredictable relapses that reoccur after days, months or even years and may lead to further disability.
Uplizna is the first and only CD19+ B-cell-depleting therapy approved in the US, Europe and other markets to treat NMOSD in adults who are AQP4-IgG positive.
A new analysis from N-MOmentum, presented at this year’s European Committee for Treatment and Research in Multiple Sclerosis, focuses on the relationship between levels of small signalling proteins called cytokines, which are associated with inflammation throughout the body, and disease activity in NMOSD.
According to Amgen, the analysis found significantly elevated levels in 18 of the 92 proteins in both treated and placebo group patients at baseline, most notably IL-17a, which was elevated in approximately 60% of patients.
Regardless of baseline cytokine levels, attack rates decreased among those who received Uplizna throughout the open-label period, Amgen said.
“Tracking changes in cytokine levels for people with NMOSD shows potential clinical utility to understand the patho-immunology of disease,” explained Bruce Cree, study author and professor of clinical neurology at the University of California San Francisco Weill Institute for Neurosciences.
He continued: “This data shows that Uplizna is effective in reducing disabling NMOSD attacks regardless of how inflammatory an individual’s baseline cytokine profile may be and underscores Uplizna’s effectiveness.”
Additionally, using data from the trial’s open-label extension period, it was found that Uplizna significantly extended the time to onset of an NMOSD attack compared to reported data on immunosuppressive therapies, such as azathioprine, or placebo.
The presentation comes just a few days after Amgen completed its previously-announced $27.8bn acquisition of Horizon Therapeutics after reaching a proposed consent order with the US Federal Trade Commission to address the “potential competitive harm” that could result from the deal.
In addition to Uplizna, the merger has also added Tepezza (teprotumumab-trbw) and Krystexxa (pegloticase) to Amgen’s inflammation portfolio.