New Analysis from N-MOmentum Study Shows UPLIZNA Treatment Reduced Spinal Cord Lesion Formation in Patients with NMOSD
According to analysis of MRI data from the N-MOmentum clinical trial (NCT02200770), treatment with Uplizna (inebilizumab-cdon, Horizon Therapeutics PLC, Dublin, Ireland) reduced subclinical transverse myelitis lesion formation in people with neuromyelitis optica spectrum disorder (NMOSD) compared with a placebo. Researchers also found an association between subclinical lesion formation and future NMOSD attacks. The results were presented at the 9th Congress of the European Academy of Neurology (EAN).
N-MOmentum was a multicenter, double-blind, randomized placebo-controlled phase 2/3 clinical trial evaluating the safety and efficacy of Uplizna for treatment of patients with NMOSD. MRI scans of the optic nerve, brain/brainstem, and spinal cord were obtained in participants at baseline, at the time of any NMOSD attack, after a 28-week randomized controlled period (RCP), and annually during the open-label portion of the trial.
At the end of the RCP, there were 134 trial participants with full neuroaxis MRI scans and no new reported NMOSD symptoms. Of this pool, 20 participants (15%) showed subclinical lesions on their spinal cords detected in MRI. The lesions occurred less frequently in Uplizna-treated participants compared with those given a placebo and were smaller than NMOSD attack-associated lesions. Additionally, lesion formation decreased with continued treatment using Uplizna. Analysis of study results also indicate that subclinical lesion formation on the spinal cord is associated with NMOSD attack in the following year.
“This analysis offers new insights into the significance of subclinical MRI findings on the spinal cord as a potential signal of future attacks, adding to the growing list of tools available for physicians to better monitor their patients,” said study author Friedemann Paul, MD.
Uplizna is a CD19-directed cytolytic antibody indicated for the treatment of NMOSD in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. The most common adverse reactions from the therapy were urinary tract infections and arthralgia.