Retrospective Analysis of Inebilizumab for Neuromyelitis Optica Spectrum Disorder Among Black Participants in Clinical Trial
A retrospective analysis of data from a clinical trial (NCT02200770) of inebilizumab (Uplizna; Horizon Therapeutics, Deerfield, IL) for neuromyelitis optica spectrum disorder (NMOSD) has been completed. Analysis of the 8.6% of participants who self-identified as Black or African-American suggests inebilizimab provided durable efficacy for this subgroup. The prevalence of NMOSD in Black people is thought to be 10 times higher than in whites.
The median annualized attack rate (AAR) in this subgroup 2 years before enrollment was 1.38, which dropped to 0.06 after inebilizumab treatment. The full study population treated with inebilizumab has achieved an AAR of 0.09 after inebilizumab exposure during the study. Inebilizumab produced rapid and sustained B-cell depletion in this subgroup, consistent with what was seen across the full study population.
“Studies have shown that (Black people) diagnosed with NMOSD often have a distinct experience managing this disease, including an earlier age of onset and more severe relapses compared with (white people), as well as different responses to targeted therapeutics,” said Evanthia Bernitsas, MD, Department of Neurology at Wayne State University School of Medicine and lead study author. “This analysis provides useful information about how (Black people) may benefit from UPLIZNA’s CD19 B-cell depleting mechanism to help reduce the incidence of acute attacks.”
This clinical trial consisted of a 28-week randomized controlled period (RCP). Among participants who self-identified as Black or African-American, 15 study participants received inebilizumab, 5 received placebo. The 28-week period was followed by an optional open-label period (OLP) during which all 20 participants in this group received inebilizumab for at least 2 years.
The data were presented during the 15th World Congress on Controversies in Neurology (CONy Virtual), Sept. 23-26, 2021. Inebilizumab is an antiCD19 B-cell depleting humanized monoclonal antibody for the treatment of adults with antiaquaporin-4 (AQP4) antibody positive NMOSD.