Phase III pivotal trial of Uplizna shows genetic screening impact in treating neuromyelitis optica spectrum disorder.- Horizon Therapeutics
Horizon Therapeutics announced data from the Phase III pivotal trial of Uplizna (inebilizumab-cdon) in Neuromyelitis Optica Spectrum Disorder Patients with Genetic Variations (NMOSD) illustrating the treatment’s effectiveness among patients with different genetic make-ups, including those with certain variations associated with reduced response to conventional monoclonal antibody (mAb) therapies.
Data from the N-MOmentum pivotal trial (NCT02200770) illustrates the potential advantage of the design of Uplizna. As part of the trial, 142 participants underwent genotyping to identify FCGR3A genotype. The study found no significant differences in disease attacks or disability regardless of FCGR3A genotype, indicating the design of Uplizna was effective even among those whose polymorphism is associated with reduced efficacy of other treatments.
“These data illustrate how mechanistic precision in treatment design can help patients gain benefit from their regimen regardless of the genetic make-up of their immune systems,” said Bruce Cree, M.D., Ph.D., MAS, study author and professor of clinical neurology at the University of California San Francisco Weill Institute for Neurosciences. “These types of genetic analyses may help inform future screening mechanisms to tailor treatment strategies that can optimize the response rate for each patient.” These data are being presented during the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, June 1-4.
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