Horizon presents new analysis of MRI data from Uplinza Phase 3 trial

Horizon Therapeutics announced the presentation of a new analysis of MRI data from the Phase 3 clinical trial of Uplinza showing a reduction in the formation of subclinical transverse myelitis lesions in people with NMOSD. This analysis is being presented at the 9th Congress of the European Academy of Neurology, or EAN), July 1-4, the company noted. “Uplinza is the first and only targeted CD19+ B-cell-depleting therapy approved by the U.S. Food and Drug Administration, the European Commission and the Brazilian Health Regulatory Agency for the treatment of NMOSD in adults who are anti-aquaporin-4 immunoglobulin G seropositive. The N-MOmentum pivotal trial is also the largest Phase 3 clinical trial in NMOSD and the only Phase 3 trial that collected MRI data, which were also incorporated into its attack adjudication criteria. Results from this post-hoc analysis demonstrate that Uplinza effectively reduced the formation of subclinical MRI lesions, while also showing an association between subclinical spinal cord lesions and future attacks,” the company said. 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 Uplinza of subclinical lesions. This was taken at the time of screening, at the end of the 28-week randomized controlled period, at the time of any attack and annually during the open-label portion 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, or 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 Uplinza.