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     133  0 Kommentare New Data Suggest UPLIZNA (inebilizumab-cdon) for the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) Did Not Increase the Risk of COVID-19 Infection or Reduce Antibody Levels From Childhood Vaccines

    Horizon Therapeutics plc (Nasdaq: HZNP) today announced new data from two post-hoc analyses of the N-MOmentum clinical trial of UPLIZNA for the treatment of neuromyelitis optica spectrum disorder (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. 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 U.S. Food and Drug Administration and the European Commission for the treatment of NMOSD in adults who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+).

    “UPLIZNA prevents NMOSD attacks by targeting CD19-expressing B cells that are a key driver of NMOSD activity,” said Bruce Cree, M.D., Ph.D., MAS, study author and professor of Clinical Neurology at the 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 susceptibile to COVID-19 infections or to develop waning immunity from prior vaccinations due to treatment.”

    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 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 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.

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    New Data Suggest UPLIZNA (inebilizumab-cdon) for the Treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD) Did Not Increase the Risk of COVID-19 Infection or Reduce Antibody Levels From Childhood Vaccines Horizon Therapeutics plc (Nasdaq: HZNP) today announced new data from two post-hoc analyses of the N-MOmentum clinical trial of UPLIZNA for the treatment of neuromyelitis optica spectrum disorder (NMOSD) will be presented at the eighth annual …