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)
Year: 2024
Type: article
Abstract: 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.
Source: Neurology
Authors: Sami Fam, Kerstin Allen, Becky Parks
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4403206626