NMOSD Therapy Doesn’t Increase COVID-19 Infection or Deplete Antibodies to Childhood Vaccines
New data from 2 post hoc analyses of the N-MOmentum clinical trial (NCT02200770) of inebilizumab (Uplizna; Horizon Therapeutics, Dublin, Ireland) suggest that the therapy approved for treating neuromyelitis optica spectrum disorder (NMOSD) does not increase susceptibility to COVID-19 infection or deplete childhood vaccine-generated antibodies. The trial results were presented at the Americas Committee for Treatment & Research in Multiple Sclerosis (ACTRIMS) Forum 2023.
N-MOmentum was a multicenter, double-blind, randomized placebo-controlled phase 2/3 study designed to determine whether inebilizumab was effective in decreasing the risk of attacks in individuals diagnosed with NMOSD compared with those taking a placebo. One post hoc analysis of data from N-MOmentum sought to evaluate any correlation between those treated with inebilizumab and COVID-19 infection risk and outcomes. Reports of COVID-19 infections were analyzed for 182 participants who received the drug during the phase 3 pivotal trial and in the post-approval US safety database. This analysis found a low incidence rate of infections (0.024 events per patient year) among those treated with inebilizumab. A total of 17 confirmed COVID infections were reported (3 before November 2020—prior to COVID-19 vaccine(s) availability—and 15 additional infections as of July 31, 2022).
The second post hoc analysis evaluated whether long-term B-cell depletion in patients treated with inebilizumab affects antibody levels from childhood vaccinations against measles, mumps, rubella, varicella-zoster, and tetanus. Assays were conducted to measure antibody titers associated with each vaccine at week 156 of the N-MOmentum trial, comparing the change from baseline among inebilizumab-treated versus placebo-treated participants. Overall, vaccine titers showed no meaningful reduction after 3.5 years of treatment with inebilizumab.
“Uplizna prevents NMOSD attacks by targeting CD19-expressing B cells that are a key driver of NMOSD activity,” said Bruce Cree, MD, PhD, MAS, Professor of Clinical Neurology, University of California San Francisco Weill Institute for Neurosciences. “Through ongoing studies and clinical use, we are learning that Uplizna’s impact on NMOSD activity is very focused and may not interfere with certain other immune responses. Patients treated with Uplizna appear to not be more susceptible to COVID-19 infections or to develop waning immunity from prior vaccinations due to treatment.”
Inebilizumab is a CD19-directed cytolytic antibody indicated for the treatment of NMOSD in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. The most common adverse reactions from the therapy were urinary tract infection and arthralgia.