Uplizna reduced formation, frequency of subclinical spinal cord lesions in NMOSD

Key takeaways:

• Phase 3 clinical trial included 134 adults with full neuroaxis MRI and no new NMOSD symptoms.
• At 28 weeks, 15% of patients on Uplizna had asymptomatic spinal cord lesions, which were shorter and less frequent.

Horizon Therapeutics announced positive results of MRI data from the phase 3 clinical trial of Uplizna, which showed reduction in formation of subclinical transverse myelitis lesions in patients with neuromyelitis optica spectrum disorder.

According to a Horizon release, post-hoc analysis of the N-Momentum clinical trial demonstrated that Uplizna (inebilizumab-cdon, Horizon), a CD19+ B-cell depleting therapy, effectively decreased formation of subclinical MRI lesions, while establishing a link between subclinical spinal cord lesions and future attacks.

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

During the trial, researchers performed MRI imaging of the spinal cord, optic nerve and brain/brainstem at screening, at completion of the 28-week randomized controlled interval, during any attack and annually during the open-label phase to assess frequency, prognosis and treatment response of subclinical lesions to Uplizna, per the release.

According to the release, among 134 participants with full neuroaxis MRI and no new NMOSD symptoms at the end of the 28-week randomized controlled period, 15% had asymptomatic MRI lesions on the spinal cord, which were shorter and less frequent than attack-associated lesions. Subsequent MRI results revealed lesion formations decreased as Uplizna treatment continued.

“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,” Friedemann Paul, MD, study author and group leader of the clinical neuroimmunology department of NeuroCure Clinical Research Center in Berlin, said in the release.