Horizon Therapeutics presents MRI imaging data from Phase 3 trial of UPLIZNA

Horizon Therapeutics announced the presentation of new MRI imaging data from the Phase 3 clinical trial showing UPLIZNA reduced the formation of subclinical optic nerve lesions in people with NMOSD. These findings are being presented during the 49th annual meeting of the North American Neuro-Ophthalmology Society March 11-16, 2023, in Orlando, Florida. UPLIZNA is the first and only B-cell depleting monotherapy 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 only Phase 3 clinical trial in NMOSD that collected MRI data and integrated MRI into its attack adjudication criteria. Results from the study demonstrated the significant effect of UPLIZNA in reducing the risk of NMOSD-associated attacks. This new post-hoc analysis based on MRI imaging provides a deeper understanding of the treatment effect on subclinical lesions. During the trial, MRI imaging was conducted on the spinal cord, optic nerve and brain/brainstem to quantify the frequency, prognosis and treatment response to UPLIZNA of subclinical lesions. This imaging was captured at the time of screening and at the end of the randomized controlled period, at the time of any attack and annually during the open label portion of the trial. The MRI findings showed that a high proportion of participants experienced subclinical optic nerve findings without new symptoms at the end of the RCP. These were shorter than in those with an optic nerve attack and were not found to be associated with future attacks. Importantly, while the total subclinical findings in the optic nerve were not reduced during the RCP, the number of clinical optic neuritis attacks was significantly reduced during this time period. Moreover, the formation of these subclinical findings was reduced with repeated UPLIZNA treatment over the course of the OLP.