New Data Suggest Uplinza for the Treatment of NMOSD Did Not Increase the Risk of COVID-19 or Reduce Antibody Levels From Childhood Vaccines
Horizon Therapeutics announced new data suggest Uplinza does not increase susceptibility to COVID infection or deplete childhood vaccine-generated antibodies. Uplinza is the first and only B-cell-depleting monotherapy approved by the FDA and the European Commission for the treatment of NMOSD in adults who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+).
The data from two post-hoc analyses of the N-MOmentum clinical trial of Uplinza for the treatment of NMOSD will be presented at the eighth annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, February 23-25, 2023, in San Diego.
“Uplinza prevents NMOSD attacks by targeting CD19-expressing B cells that are a key driver of NMOSD activity,” Bruce Cree, MD, PhD, MAS, study author and professor of Clinical Neurology at the University of California San Francisco Weill Institute for Neurosciences, said in a company news release. “Through ongoing studies and clinical use, we are learning that Uplinza's impact on NMOSD activity is very focused and may not interfere with certain other immune responses. Patients treated with Uplinza appear to not be more susceptible to COVID-19 infections or to develop waning immunity from prior vaccinations due to treatment.”
This analysis sought to evaluate any correlation between Uplinza treatment and COVID infection risk and outcomes. Reports of COVID infections were analyzed for 182 participants who received Uplinza during the phase 3 pivotal trial (March-November 2020) and in the post-approval U.S. safety database (data cutoff July 31, 2022).
In total, the analysis found a low incidence rate of infections (0.024 events per patient year) among Uplinza-treated patients. A total of 17 confirmed COVID infections were reported (two infections before November 2020, prior to the availability of COVID vaccines, and 15 additional infections as of July 31, 2022). Ten of these events were reported as serious, though vaccine status was not known. Of the 10 patients with known outcomes, six were reported as “recovered/resolved,” two as not recovered/resolved and two patients died. Of the two fatalities, one was unvaccinated; the other had an unknown vaccination status and a history of deep vein thrombosis that was complicated by a pulmonary embolism.
This analysis also aimed to evaluate whether long-term B-cell depletion in patients being treated with Uplinza affects antibody levels from childhood vaccinations against measles, mumps, rubella, varicella-zoster and tetanus. Assay assessments were conducted to measure antibody titers associated with each vaccine at week 156 of the N-MOmentum trial, comparing the change from baseline among Uplinza-treated versus placebo-treated participants. Overall, vaccine titers showed no meaningful reduction after 3.5 years of treatment with Uplinza.