Uplizna Treatment for Neuromyelitis Optica Spectrum Disorders Rapid B-Cell Depletion Correlates With Improved Outcomes

Analysis of data from the phase 2/3 N-MOmentum trial (NCT02200770) of inebilizumab (Uplizna; Horizon Therapeutics, Deerfield, IL) showed B-cell depletion occurred within the first week of treatment. There was also a correlation between the extent of B-cell depletion and improved outcomes for individuals with neuromyelitis optica spectrum disorder (NMOSD). Inebilizumab resulted in a 97% reduction in annualized attack rate (AAR) and a 73% reduction in new or enlarging lesions compared with placebo. 

After 4 weeks of treatment, median B-cell counts were 2.5 (1.0–7.6) cells/mcL in people treated with inebilizumab and 112.3 (96.3–176.9) cells/mcL in those who received placebo. After 3 years of inebilizumab treatment, the median B-cell count was 0.33 cells/mcL. Although all individuals treated with inebilizumab had decreased annualized attack rate (AAR), those who had B-cell depletion to less than 4 cells/mcL after approximately 4 months of treatement had more AAR reduction (rate ratio 0.4) and fewer new/enlarging lesions (0.36). Participants experienced sustained B-cell depletion 2.5 years after treatment and decreased NMOSD activity.

“This analysis provides additional evidence that B-cells play a central role in NMOSD, and that there is a link between the depth of B-cell depletion in the blood and long-term clinical outcomes,” said Jeffrey Bennett, MD, PhD, University of Colorado. “We found that B-cell levels at the end of the 28-week randomized, placebo-controlled period of the N-MOmentum trial were predictive of stable and deep B-cell depletion continuing through long-term exposure.”