Evanthia Bernitsas, MD, of the Department of Neurology at Wayne State University School of Medicine, discusses the results of a retrospective analysis of the pivotal Phase 2/3 N-MOmentum clinical trial, which indicate inebilizumab may provide durable efficacy and a favorable safety profile for African Americans with neuromyelitis optica spectrum disorder (NMOSD).
NMOSD is a rare central nervous disorder that primarily affects the spinal cord and optic nerves. Symptoms of NMOSD may include blindness in one or both eyes, weakness or paralysis of arms or legs, spasming, loss of sensation, uncontrollable vomiting and hiccups, and bladder/bowel problems due to spinal cord damage.
African American NMOSD patients often have an earlier age of onset and more severe relapses compared to Caucasian patients.
Recently, results of a retrospective analysis of the pivotal Phase 2/3 N-MOmentum clinical trial were announced during the 15th World Congress on Controversies in Neurology (CONy 2021). Inebilizumab was approved by the FDA to treat NMOSD in 2020. However, due to the fact that African American NMOSD patients may respond differently to targeted therapies than Caucasian patients, it was crucial to determine the drug’s safety and efficacy in this patient population.
The N-MOmentum study consisted of a 28-week randomized controlled period (RCP), in which study participants received inebilizumab or placebo, followed by an optional open-label period (OLP) during which all participants received inebilizumab for at least two years. The analysis presented at CONy 2021 represents the experience of 20 African Americans who participated in the RCP (15 received inebilizumab, five received placebo) and the OLP (20 received inebilizumab).
Among African American participants who received inebilizumab during the RCP and/or OLP, 3 of 19 had attacks after their first inebilizumab dose. Annualized attack rate (AAR) for African Americans was 0.06 compared with 0.09 in the overall group with any inebilizumab exposure; median AAR in the African American group in the two years before enrollment was 1.38. Finally, during the RCP, African American participants in the inebilizumab group developed fewer infections (26.7%) than those in the placebo group (60%), although one participant in the treatment arm developed cytopenia that resolved in four weeks.
To learn more about NMOSD and other neurological disorders, visit checkrare.com/diseases/neurology
