New data suggest Uplizna for neuromyelitis optica spectrum disorder did not increase the risk of COVID-19 infection or reduce antibody levels from childhood vaccines

These data suggest Uplizna does not increase susceptibility to COVID infection or deplete childhood vaccine-generated antibodies. Uplizna 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+).

Low Rate of COVID Infections Reported in Uplizna-Treated Patients: This analysis sought to evaluate any correlation between Uplizna treatment and COVID infection risk and outcomes. Reports of COVID infections were analyzed for 182 participants who received Uplizna during the Phase III 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 Uplizna-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.

Long-term UPLIZNA Treatment Did Not Affect Vaccine-Generated Antibodies in NMOSD Patients: This analysis aimed to evaluate whether long-term B-cell depletion in patients being treated with Uplizna 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 Uplizna-treated versus placebo-treated participants. Overall, vaccine titers showed no meaningful reduction after 3.5 years of treatment with Uplizna.

“The N-MOmentum trial has provided a rich body of data that we are mining to better understand the mechanisms of Uplizna and its impact among people with NMOSD beyond protection against attacks,” said Kristina Patterson, M.D., PhD, medical director, neuroimmunology, Horizon. “The results of these analyses provide further support that Uplizna is an effective long-term treatment for NMOSD with a favorable safety profile.”