Horizon Therapeutics has shared positive new MRI data from a late-stage study of Uplizna (inebilizumab-cdon) in patients with neuromyelitis optica spectrum disorder (NMOSD).

Approximately one to ten per 100,000 people are affected by NMOSD, a rare and debilitating autoimmune disease characterised by inflammatory lesions that primarily damage the optic nerve and spinal cord.

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 by the US Food and Drug Administration and European Commission to treat NMOSD in adults who are AQP4-IgG positive. Around 80% of all patients with NMOSD test positive for anti-AQP4 antibodies.

A new analysis of MRI data from the phase 3 N-MOmentum trial, presented by Horizon at this year’s Congress of the European Academy of Neurology in Budapest, shows that Uplizna effectively reduced the formation of subclinical (asymptomatic) lesions in NMOSD patients.

The new post-hoc analysis also demonstrated that subclinical spinal cord lesions were associated with future NMOSD attacks.

During the trial, MRI imaging was conducted on the spinal cord, optic nerve and brain/brain stem to quantify the frequency, prognosis and response to treatment with Uplizna.

Of the 134 patients enrolled in the study with full neuroaxis MRI and no new NMOSD symptoms at the end of the 28-week randomised control period, 15% were found to have subclinical MRI lesions on the spinal cord. These were shorter than attack-associated lesions and less frequent among those receiving Uplizna, the company said.

Subsequent MRI findings showed that the formation of these lesions decreased as treatment with Uplizna continued.

Kristina Patterson, senior medical director, neuroimmunology medical affairs at Horizon, said: “Attack prevention is a priority in managing NMOSD, as just one attack can lead to life-altering vision loss and mobility challenges.

“We are pleased to see that the long-term phase 3 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.”

Reference：
https://www.pmlive.com/pharma_news/horizon_shares_positive_results_for_uplizna_in_neuromyelitis_optica_spectrum_disorder_1494262