New analysis of MRI findings shows Uplizna reduced the formation of subclinical spinal cord lesions in people With neuromyelitis optica spectrum disorder . - Horizon Therapeutics

This analysis is being presented at the 9th Congress of the European Academy of Neurology (EAN), July 1-4 in Budapest.

Uplizna is the first and only targeted CD19+ B-cell-depleting therapy approved by the FDA, the European Commission and the Brazilian Health Regulatory Agency (ANVISA) for the treatment of NMOSD in adults who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+). The N-MOmentum pivotal trial (NCT02200770) is also the largest Phase III clinical trial in NMOSD and the only Phase III trial that collected MRI data, which were also incorporated into its attack adjudication criteria. Results from this post-hoc analysis demonstrate that Uplizna effectively reduced the formation of subclinical MRI lesions, while also showing an association between subclinical spinal cord lesions and future attacks.

“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 Friedemann Paul, study author and Group Leader of the Clinical Neuroimmunology Department of NeuroCure Clinical Research Centre at the Charité, Berlin. “It is encouraging to see that Uplizna reduced the formation of these lesions. Future studies evaluating subclinical findings will help offer additional clarity on their relationship with disease activity.”

During the trial, MRI imaging was conducted on the spinal cord, optic nerve and brain/brainstem to quantify the frequency, prognosis and response to treatment with Uplizna of subclinical lesions. This was taken at the time of screening, at the end of the 28-week randomized controlled period (RCP), at the time of any attack and annually during the open-label portion (OLP) of the trial. Of the 134 pivotal trial participants with full neuroaxis MRI and no new NMOSD symptoms at the end of the 28-week RCP, 20 (15%) were found to have asymptomatic MRI lesions on the spinal cord. These lesions were shorter than attack-associated lesions, and importantly were less frequent among those receiving Uplizna.

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Subsequent MRI findings showed that the formation of these lesions decreased as treatment with Uplizna continued. Interestingly, these findings showed that subclinical lesions were associated with domain-specific attacks in the following year.

“Attack prevention is a priority in managing NMOSD, as just one attack can lead to life-altering vision loss and mobility challenges,” said Kristina Patterson, M.D., Ph.D., senior medical director, neuroimmunology medical affairs, Horizon. “We are pleased to see that the long-term Phase III pivotal trial data show that Uplizna effectively reduced subclinical MRI findings and NMOSD attacks while continuing to offer new learnings that help advance our understanding of the disease and improve patient care.”