Uplizna effective, safe for African Americans with neuromyelitis optica spectrum disorder

Horizon Therapeutics plc announced results of a retrospective analysis that showed Uplizna appeared to offer durable efficacy and a favorable safety profile for African American patients with neuromyelitis optica spectrum disorder.

Researchers presented these data at the World Congress on Controversies in Neurology.

“Neuromyelitis optica spectrum disorder (NMOSD) is a challenging B-cell mediated disease that disproportionately affects non-white populations, including Black or African American individuals, making it valuable to have clinical trial data and subsequent analyses that are inclusive of this population,” lead study author Evanthia Bernitsas, MD, of the department of neurology at Wayne State University School of Medicine, told Healio Neurology. “Given that African Americans are underrepresented in clinical trials, this analysis offers clinicians a glimpse at how African American participants responded to Uplizna (inebilizumab-cdon, Horizon Therapeutics), which was consistent among all other participants in reducing annualized attack rate, B-cell depletion and overall safety profile.”

Bernitsas and colleagues conducted the retrospective analysis of the pivotal phase 2/3 N-MOmentum clinical trial, which consisted of a 28-week randomized controlled period during which African American participants received either inebilizumab-cdon (n = 15) or placebo (n = five). It was followed by an optional open-label period during which all participants received the treatment for 2 years or longer.

Three of 19 participants who received the treatment during the randomized controlled period and/or the open-label period had attacks 18, 29 and 104 days after their first dose. African American participants had an annualized attack rate (AAR) of 0.06 compared with 0.09 in the overall group with any inebilizumab-cdon exposure, with a median AAR of 1.38 among the African American group in the 2 years prior to enrollment. The treatment produced rapid and sustained B-cell depletion among African American participants, consistent with other participants of the N-MOmentum trial. African American participants who received the treatment developed fewer infections (26.7%) compared with those in the placebo group (60%) during the randomized controlled period. One participant in the treatment arm developed cytopenia that resolved in 4 weeks.

“We are encouraged to see that in this analysis, African American Uplizna recipients experienced rapid and sustained B-cell depletion, as well as significantly reduced attack rates over the course of the study period,” Bernitsas said. “This is important as we work to understand how different sub-populations respond differently to treatment, particularly in African Americans, who often have an earlier age of onset, more severe relapses and, at times, a different response to disease-modifying agents compared with Caucasians.”