Evanthia Bernitsas, MD

"They are underrepresented in clinical trials. The reason for that could be cultural, could be bias. Either way, they don’t have the opportunity to try a new medication before approval."

Previous studies have shown that African Americans diagnosed with neuromyelitis optica spectrum disorder (NMOSD) may have a distinct experience managing their disease, including an earlier age of onset and more severe relapses compared with Caucasians, as well as different responses to targeted therapies. Subanalysis data from N-MOmentum, a pivotal phase 3 trial evaluating inebilizumab (Uplizna; Horizon Therapeutics), an FDA-approved therapy for patients with aquaporin-4 antibody NMOSD, highlighted the therapies success in treating this racial population.

The data, presented at the 15th World Congress on Controversies in Neurology, September 23-26, showed that African Americans treated with inebilizumab over a 28-week period had an annualized attack rate of 0.06 compared to 0.09 in the overall group. Furthermore, African Americans in the inebilizumab group developed fewer infections than those in the placebo group, although 1 participant in the treatment group developed cytopenia that resolved in 4 weeks.

, neurologist, Wayne State University, felt as though the data was compelling enough for clinicians to feel confident when prescribing this treatment. She sat down with 

to discuss why it’s important to conduct NMOSD trials that feature underserved populations.

Videos

The neurologist at Wayne State University provided background on why there needs to be a continued focus on including and studying African American patients with NMOSD in trials. [WATCH TIME 3 minutes]

Understanding Disadvantages to African Americans in NMOSD Trials: Evanthia Bernitsas, MD

"No African Americans experienced disability worsening on inebilizumab compared to 1 patient in the placebo group. We also saw rapid and sustained B-cell depletion, with IgM below their normal limit in 60% of African Americans.”

At the 15th World Congress on Controversies in Neurology, September 23-26, data from a retrospective analysis of the pivotal phase 2/3 N-MOmentum clinical trial (NCT02200770) was presented. The analysis evaluated 

 (Uplizna; Viela Bio), an FDA-approved anti-CD19 B-cell depleting humanized monoclonal antibody, in a subpopulation of 20 African Americans with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD).

Previous research has suggested that African Americans with NMOSD have a different experience managing this disease, including an earlier age of onset and more severe relapses compared with Caucasians, as well as different responses to targeted therapeutics. At the end of the study, treatment with inebilizumab resulted in an annualized attack rate (AAR) of 0.06 for African Americans compared with 0.09 in the overall group. For reference, median AAR in the African American group in the 2 years before enrollment was 1.38.

Evanthia Bernitsas, MD, neurologist, Wayne State University School of Medicine, and lead author of the study, sat down with 

to discuss the importance of the results, including the most top-level findings. She also provided background on the history of the drug and its role within the treatment landscape.

Horizon Therapeutics plc announces data showing Uplizna also produces rapid and sustained B-cell depletion in African Americans with neuromyelitis optica spectrum disorder. News release. Horizon Therapeutics. September 23, 2021. Accessed October 5, 2021. https://ir.horizontherapeutics.com/news-releases/news-release-details/horizon-therapeutics-plc-announces-data-showing-upliznar

The neurologist at Wayne State University School of Medicine discussed recently published data describing inebilizumab’s role in producing rapid and sustained B-cell depletion in African Americans with NMOSD [WATCH TIME: 4 minutes]

Evanthia Bernitsas, MD

Articles

Understanding Disadvantages to African Americans in NMOSD Trials: Evanthia Bernitsas, MD

Inebilizumab’s Efficacy in African Americans With NMOSD: Evanthia Bernitsas, MD