According to Horizon Therapeutics, the analysis shows subclinical spinal cord lesions were associated with future NMOSD attacks. The analysis was being presented at the 9th Congress of the European Academy of Neurology in Budapest.
Horizon Therapeutics plc today announced the presentation of a new
analysis of MRI data from the Phase 3 clinical trial of inebilizumab-cdon (UPLIZNA), showing a reduction in the formation of subclinical (asymptomatic) transverse myelitis lesions in people with neuromyelitis optica spectrum disorder (NMOSD).
According to the company’s news release, the analysis is being presented at the 9th Congress of the European Academy of Neurology (EAN), July 1-4 in Budapest.
The company noted that inebilizumab-cdon “isthe 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+).
Moreover, in its news release the company noted the N-MOmentum pivotal trial (NCT02200770) 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 inebilizumab-cdoneffectively 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,” Friedemann Paul, study author and Group Leader of the Clinical Neuroimmunology Department of NeuroCure Clinical Research Centre at the Charité, Berlin, Germany, said in the news release.
“It is encouraging to see that UPLIZNA reduced the formation of these lesions,” Paul added in the news release. “Future studies evaluating subclinical findings will help offer additional clarity on their relationship with disease activity.”
According to the news release, researchers noted that 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 inebilizumab-cdon of subclinical lesions.
The company noted this was done at the time of screening, at the end of the 28-week randomly assigned 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.
The company noted that additional MRI findings showed that the formation of these lesions decreased as treatment with inebilizumab-cdon 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,” Kristina Patterson, MD, PhD, senior medical director, neuroimmunology medical affairs, Horizon, said in the news 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.”
NMOSD is a unifying term for neuromyelitis optica (NMO) and related syndromes. It is a rare, severe, relapsing, neuroinflammatory autoimmune disease that attacks the optic nerve, spinal cord, brain and brain stem.1,2
Approximately 80% of all patients with NMOSD test positive for anti-AQP4 antibodies.3 AQP4-IgG binds primarily to astrocytes in the central nervous system and triggers an escalating immune response that results in lesion formation and astrocyte death.4
The company noted that inebilizumab-cdon is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.