Abstract Details

Title 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

Topic Autoimmune Neurology

Presentation(s) P11 - Poster Session 11 (8:00 AM-9:00 AM)

Poster/Presentation
Number 8-011

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.

Authors/Disclosures
Jeffrey L. Bennett, MD, PhD, FAAN (University of Colorado School of Medicine) PRESENTER	Dr. Bennett has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Bennett has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion. Dr. Bennett has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Bennett has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Bennett has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Mitsubishi Tanabe. Dr. Bennett has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Bennett has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immpact Bio. Dr. Bennett has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Chugai. Dr. Bennett has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Beigene. Dr. Bennett has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Imcyse. Dr. Bennett has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Bennett has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MIAC. Dr. Bennett has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for CorEvitas. Dr. Bennett has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Alexion. Dr. Bennett has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Vindico. Dr. Bennett has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Touch IME. Dr. Bennett has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Efficient LLC. Dr. Bennett has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Pavich. Dr. Bennett has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Marie Bush. Dr. Bennett has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Marks Gray. Dr. Bennett has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Knight, Nicastro, MacKay. The institution of Dr. Bennett has received research support from Alexion. The institution of Dr. Bennett has received research support from Genentech. Dr. Bennett has received intellectual property interests from a discovery or technology relating to health care. Dr. Bennett has received publishing royalties from a publication relating to health care.
Ukwen Akpoji, PharmD (Alexion, AstraZeneca Rare Disease)	Dr. Akpoji has received personal compensation for serving as an employee of Alexion, AstraZeneca Rare Disease. Dr. Akpoji has received personal compensation for serving as an employee of Pfizer, Inc. Dr. Akpoji has stock in Alexion, AstraZeneca Rare Disease.
Shamik Bhattacharyya, MD, FAAN (Brigham and Women's Hospital)	Dr. Bhattacharyya has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NeuroLambda. Dr. Bhattacharyya has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion Pharmaceuticals. Dr. Bhattacharyya has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Bhattacharyya has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Bhattacharyya has received personal compensation in the range of $5,000-$9,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Continuum. Dr. Bhattacharyya has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Wiley. Dr. Bhattacharyya has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Merck. The institution of Dr. Bhattacharyya has received research support from Alexion Pharmaceuticals. The institution of Dr. Bhattacharyya has received research support from National Institute of Health. The institution of Dr. Bhattacharyya has received research support from UCB. The institution of Dr. Bhattacharyya has received research support from Genentech. Dr. Bhattacharyya has received publishing royalties from a publication relating to health care. Dr. Bhattacharyya has received publishing royalties from a publication relating to health care.
Aram Zabeti, MD (University of Cincinnati/Dept of Neurology)	Dr. Zabeti has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Zabeti has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Zabeti has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Octave. Dr. Zabeti has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Dr. Zabeti has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Biogen. Dr. Zabeti has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD-Serono. Dr. Zabeti has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Zabeti has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi-Genzyme. Dr. Zabeti has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Horizon. Dr. Zabeti has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Janssen . Dr. Zabeti has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for BMS. Dr. Zabeti has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for TG.
Michael Levy, MD, PhD, FAAN (Massachusetts General Hospital/Harvard Medical School)	Dr. Levy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mitsubishi Pharma. Dr. Levy has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB Pharma. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. Dr. Levy has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Levy has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Elsevier. Dr. Levy has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Various law firms. The institution of Dr. Levy has received research support from National Institutes Health.
Kerstin Allen	Kerstin Allen has received personal compensation for serving as an employee of Alexion, AstraZeneca Rare Disease. Kerstin Allen has stock in Alexion, AstraZeneca Rare Diseas.
Sean J. Pittock, MD, FAAN (Mayo Clinic Dept of Neurology)	Dr. Pittock has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Arialys. The institution of Dr. Pittock has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. The institution of Dr. Pittock has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. The institution of Dr. Pittock has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. The institution of Dr. Pittock has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion/AstraZeneka. The institution of Dr. Pittock has received research support from NIH. Dr. Pittock has received intellectual property interests from a discovery or technology relating to health care. Dr. Pittock has received intellectual property interests from a discovery or technology relating to health care. Dr. Pittock has received publishing royalties from a publication relating to health care.

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