Two main serum biomarkers are associated with acute attacks and disability worsening in patients with neuromyelitis optica spectrum disorder (NMOSD), according to new data from a phase 3 clinical trial, which is testing the efficacy of inebilizumab in reducing the risk of NMOSD attacks.
This finding was announced by Horizon Therapeutics, the developers of inebilizumab, in a press release. It also appeared as a publication in the Journal of Neurology, Neurosurgery, and Psychiatry.
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“This analysis provides valuable insights into how we can improve care for people with NMOSD by integrating easily accessible serum biomarker assessments into treatment decision-making,” said Orhan Aktas, MD, of the Heinrich-Heine University, in Düsseldorf, Germany, and the first author of the publication.
“The availability of these data in a rare and challenging disease like NMOSD can inform disease management strategies and contribute to improved outcomes for this population over time,” added Kristina Patterson, MD, PhD, senior medical director of neuroimmunology medical affairs at Horizon.
During the trial, investigators assessed 4 biomarkers associated with NMOSD disease activity and neuronal injury. These were serum neurofilament light chain (sNfL), ubiquitin C-terminal hydrolase L1 (sUCHL1), tau (sTau), and serum glial fibrillary acidic protein (sGFAP).
They found that the levels of all 4 biomarkers increased during and in the days leading up to an NMOSD attack. They also reported that sNfL was the strongest predictor of worsening disability during and after an attack and sGFAP was predictive of future attacks.
In patients treated with inebilizumab, the increase in biomarker levels during an NMOSD attack was hindered and the overall biomarker levels were reduced over time in the absence of attacks suggesting that the treatment could potentially reduce the frequency and severity of these attacks.
NMOSD is a rare chronic inflammatory disease of the central nervous system. NMOSD attacks can cause irreversible optic nerve, spinal cord, and brain damage.
Inebilizumab is a monoclonal antibody against CD19 indicated for the treatment of adults with anti-aquaporin-4 antibody-positive NMOSD.
Reference
Biomarker analysis publication highlights key signals of disability worsening associated with neuromyelitis optica spectrum disorder (NMOSD) attacks, illustrates efficacy of UPLIZNA® (inebilizumab-cdon). News release. Horizon Therapeutics. June 1. 2023.
Aktas O, Hartung HP, Smith MA, et al. Serum neurofilament light chain levels at attack predict post-attack disability worsening and are mitigated by inebilizumab: analysis of four potential biomarkers in neuromyelitis optica spectrum disorder. J Neurol Neurosurg Psychiatry. Published online May 23, 2023. doi:10.1136/jnnp-2022-330412
N-MOmentum: A clinical research study of inebilizumab in neuromyelitis optica spectrum disorders. US National Library of Medicine. Updated December 3, 2021. Accessed June 15, 2023.
