Abstract Details

Title 2025 U.S. Update of Meningococcal Infection Incidence & Outcomes in Eculizumab or Ravulizumab Patients with Generalized Myasthenia Gravis or Neuromyelitis Optica Spectrum Disorder in Clinical Practice

Topic Autoimmune Neurology

Presentation(s) P1 - Poster Session 1 (12:00 PM-1:00 PM)
C9 - Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disease (NMOSD) (9:01 AM-9:11 AM)

Poster/Presentation
Number 1-083

Objective

To update U.S. exposure-adjusted Nm infection and mortality rates in eculizumab- or ravulizumab-treated patients with gMG and NMOSD using post-marketing pharmacovigilance (Nm case counts) and commercial data (exposure).

Background Eculizumab and ravulizumab are approved therapies for generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Vaccinations and antibiotic prophylaxis are used to reduce the risk of Neisseria meningitidis (Nm) infection associated with these treatments.

Design/Methods

The Alexion safety database was searched for eculizumab (data cutoff: October 2025) and ravulizumab (December 2025) across approved indications (i.e., gMG, NMOSD, paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome) using the MedDRA high-level term “Neisseria infection”. Only U.S., Nm-associated cases were included. Cumulative reporting rates were calculated per 100 patient-years (PY) of exposure.

Results By 2025, cumulative U.S. exposures reached 34,713 PY for eculizumab and 21,348 PY for ravulizumab. Cumulative U.S. Nm infection and mortality rates remained stable across indications (eculizumab: 0.14 and 0.01; ravulizumab: 0.07 and 0.01, respectively). In eculizumab-treated patients, Nm infection rates were 0.05 in gMG (9,545 PY) and 0.12 in NMOSD (2,464 PY). In ravulizumab-treated patients, corresponding rates were 0.03 (gMG; 6,522 PY) and 0.13 (NMOSD; 792 PY). No Nm-associated fatalities occurred among U.S. neurology patients despite nearly 20,000 PY of combined exposure.

Conclusions Nm infection rates remained low and stable despite 2–3-fold increases in U.S. complement inhibitor exposure from initial gMG approvals through 2025, without Nm-related fatalities in neurology indications. These results support the effectiveness of U.S. risk mitigation strategies for the safe use of eculizumab and ravulizumab.

Authors/Disclosures
Ukwen Akpoji, PharmD (Alexion, AstraZeneca Rare Disease) PRESENTER	Dr. Akpoji has received personal compensation for serving as an employee of Alexion, AstraZeneca Rare Disease. Dr. Akpoji has or had stock in Alexion, AstraZeneca Rare Disease.
Shirali Pandya, PhD (Alexion Pharmaceuticals)	Dr. Pandya has received personal compensation for serving as an employee of Alexion, Astra Zeneca Rare Disease. Dr. Pandya has received personal compensation for serving as an employee of Rhythm Pharmaceuticals. Dr. Pandya has stock in Sanofi. Dr. Pandya has stock in Alexion, Astra Zeneca Rare Disease.
Lokesh Jha, MD	Dr. Jha has received personal compensation for serving as an employee of Alexion Pharmaceuticals. Dr. Jha has or had stock in Alexion Pharmaceuticals.
Feifei Yang	Feifei Yang has received personal compensation for serving as an employee of Alexion Pharmaceuticals. Feifei Yang has stock in Alexion Pharmaceuticals.
Katie Gonsalves, RN	Ms. Gonsalves has received personal compensation for serving as an employee of Alexion, AstraZeneca Rare Disease. Ms. Gonsalves has or had stock in AstraZeneca .
Meghana Koneru, PhD	Dr. Koneru has nothing to disclose.
Samirah Qureshi, MD	Dr. Qureshi has nothing to disclose.
Cynthia Carrillo-Infante, MD, PhD	Dr. carrillo-infante has received personal compensation for serving as an employee of Alexion Pharmaceuticals.

��ɫ��

��ɫ��