Abstract Details

Title Incidence of Relapses After Meningococcal Vaccination in Clinical Trials of Eculizumab and Ravulizumab in Anti-Aquaporin-4 Antibody-Positive (AQP4-Ab+) Neuromyelitis Optica Spectrum Disorder (NMOSD)

Topic Autoimmune Neurology

Presentation(s) P2 - Poster Session 2 (2:45 PM-3:45 PM)

Poster/Presentation
Number 006

Objective To report on relapses of NMOSD symptoms occurring within 4 weeks of meningococcal vaccination administered before initiating complement C5 inhibitors (C5ITs) in patients screened in CHAMPION-NMOSD (NCT04201262) and enrolled in PREVENT (NCT01892345).

Background Ravulizumab and eculizumab are C5ITs approved for AQP4-Ab+ NMOSD. Because C5ITs are associated with increased Neisseria meningitidis infection risk, patients are generally advised to be vaccinated ≥2 weeks before receiving C5ITs; however, vaccination may further activate the complement pathway. Patients with complement-mediated diseases, including NMOSD, may experience increased signs and symptoms of their underlying disease when vaccinated before C5IT initiation.

Design/Methods Patients analyzed included those with vaccination data who were screened in CHAMPION-NMOSD, irrespective of screening outcome, and those randomized to placebo or eculizumab in PREVENT (vaccination data unavailable for screen failures). Outcomes were relapses occurring within 4 weeks of last meningococcal vaccination and before study drug initiation.

Results In CHAMPION-NMOSD (N=71), 1 enrolled patient was excluded from this analysis because of vaccination before AQP4-Ab+ confirmation. Among the remaining patients (57 enrolled; 13 screen failures), 2/70 (2.9%) patients experienced a relapse; both were screen failures. In PREVENT, 3.1% (3/96) of eculizumab and 10.6% (5/47) of placebo patients had a relapse.

Conclusions This retrospective analysis indicates a low relapse incidence (2.9%–3.1%) within 4 weeks of meningococcal vaccinations before C5IT initiation and up to 10.6% for those randomized to placebo. Available information precludes determination as to whether relapses observed are attributable to meningococcal vaccination or inherent relapse risk among patients with AQP4-Ab+ NMOSD.

Authors/Disclosures
Josin James, PharmD, RPh (Alexion RDU, AstraZeneca) PRESENTER	Dr. James has received personal compensation for serving as an employee of Alexion, AstraZeneca Rare Disease . Dr. James has stock in Alexion, AstraZeneca Rare Disease .
Sami Fam	Sami Fam has received personal compensation for serving as an employee of Alexion Pharmaceuticals. Sami Fam has or had stock in Astra Zeneca.
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.
Becky J. Parks, MD (Blueprint Medicines)	Dr. Parks has received personal compensation for serving as an employee of Alexion Pharmaceuticals. An immediate family member of Dr. Parks has received personal compensation for serving as an employee of Edward P. Evans Foundation. Dr. Parks has stock in Biogen. An immediate family member of Dr. Parks has stock in Regeneron. Dr. Parks has stock in Blueprint Medicines. Dr. Parks has stock in Sanofi. An immediate family member of Dr. Parks has stock in Vertex. Dr. Parks has stock in AstraZeneca. The institution of an immediate family member of Dr. Parks has received research support from NIH/NCI. The institution of an immediate family member of Dr. Parks has received research support from Leukemia & Lymphoma Society. The institution of an immediate family member of Dr. Parks has received research support from AstraZeneca Scholar Award.

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