Time to Vaccination After Rituximab (RTX) Discontinuation in Patients with anti–Aquaporin–4 Antibody–Positive (AQP4-Ab+) Neuromyelitis Optica Spectrum Disorder (NMOSD): A Post-Hoc Analysis of the CHAMPION-NMOSD Trial
Jeffrey Bennett1, Ukwen Apoji2, Shamik Bhattacharyya3, Aram Zabeti4, Michael Levy5, Kerstin Allen2, Sean Pittock6
1Departments of Neurology and Ophthalmology, Programs in Neuroscience and Immunology, University of Colorado, Aurora CO, USA, 2Alexion, AstraZeneca Rare Disease, Boston, MA, USA, 3Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA, 4University of Cincinnati Gardner Neuroscience Institute, Cincinnati, OH, USA, 5Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA, 6Department of Neurology, Center for Multiple Sclerosis and Autoimmune Neurology, Mayo Clinic, Rochester, MN, USA
Objective:
To characterize the time from last RTX dose to the first administered meningococcal vaccine in patients from the CHAMPION-NMOSD trial previously on RTX.
Background:
RTX is often prescribed off-label for patients with AQP4-Ab+ NMOSD, and patients may transition to ravulizumab, an approved therapy. Vaccination against Neisseria meningitidis (Nm) is the primary risk-mitigating strategy for complement inhibitors. Although meningococcal vaccines trigger a T-cell response, prior anti-B-cell therapy may attenuate responses to clinically relevant vaccines. CHAMPION-NMOSD (NCT04201262) is a global, open-label, phase 3 study evaluating ravulizumab in patients with AQP4-Ab+ NMOSD, approximately one-third of whom had RTX exposure.
Design/Methods:
Descriptive post-hoc analyses were performed in a subgroup of patients on ravulizumab who received meningococcal vaccinations (MenACWY or MenB) after their last RTX dose (N=19). Clinical laboratory parameters, vaccine administration, and time to first meningococcal vaccination and ravulizumab dose post-RTX are summarized.
Results:
Patients were primarily White (63.2%), North American (68.4%), and female (94.7%). Lymphocytes were within normal limits in most patients (13/14, 92.3%); lymphocyte subsets were not collected in this study. All patients received ≥1 meningococcal vaccine ≥2 weeks prior to ravulizumab initiation. Most patients (68.4%) received their first meningococcal vaccinations either 0–3 months (15.8%) or 3–6 months (52.6%) after the last dose of RTX prior to ravulizumab. Most patients (84.2%) received both MenACWY and MenB vaccinations at the same visit; 4 patients (21.0%) received multiple doses of either vaccine. There were no reports of meningococcal infection in patients whose initial Nm vaccination occurred after their last dose of RTX.
Conclusions:
Most patients received a meningococcal vaccination ≤6 months after their last dose of RTX, with MenACWY and MenB vaccines at the same visit. Total lymphocyte counts were normal in most patients with no reports of meningococcal infection or NMOSD attacks in patients who received their initial Nm vaccination after their last RTX dose.
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