Abstract Details

Title Incidence and Outcome of Meningococcal Infection With Eculizumab or Ravulizumab in Patients With gMG or NMOSD: An Analysis of US Clinical Practice

Topic Autoimmune Neurology

Presentation(s) C19 - Monitoring Necessities for Immunotherapy Prescribers (4:38 PM-4:45 PM)
P3 - Poster Session 3 (12:00 PM-1:00 PM)

Poster/Presentation
Number 076

Background Eculizumab and ravulizumab are effective treatments for gMG and NMOSD. Safety mitigations, including vaccinations, are used to reduce the risk of Nm infection associated with these treatments.

Objective

To evaluate US exposure-adjusted Neisseria meningitidis (Nm) infection and mortality in eculizumab- or ravulizumab-treated patients with generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD) using postmarketing pharmacovigilance data (Nm case counts) and commercial data (exposure).

Design/Methods The US Alexion safety database was searched for eculizumab and ravulizumab (data cutoff: December 2022) across approved indications (gMG, NMOSD, paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome) using the MedDRA High Level Term “Neisseria infection.” Only Nm-associated cases were included. Reporting rates were calculated cumulatively per 100 patient-years (PY).

Results

US Nm infection and mortality annual reporting rates in eculizumab-treated patients remained stable over 15 years across approved indications (2022: 0.13 and 0.01, respectively; exposure: 29,758.4 PY). In 2022, US postmarketing Nm infection reporting rates in eculizumab-treated patients with gMG and NMOSD were 0.02 (exposure: 8,042.0 PY) and 0.07 (exposure: 1,470.1 PY), respectively. At data cutoff, there were no Nm infections among ravulizumab-treated patients with gMG. No Nm fatalities were noted for eculizumab- or ravulizumab-treated patients with gMG and NMOSD.

Conclusions Nm infection and mortality reporting rates for patients with gMG and NMOSD remained stable despite increasing eculizumab and ravulizumab exposure over time. These results suggest US Nm-related risk mitigation strategies are effective in patients receiving eculizumab or ravulizumab.

Authors/Disclosures
Shirali Pandya, PhD (Alexion Pharmaceuticals) PRESENTER	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 stock in Alexion Pharmaceuticals.
Imad Al-Dakkak	Imad Al-Dakkak has received personal compensation for serving as an employee of AstraZeneca. Imad Al-Dakkak has stock in AstraZeneca.
Feifei Yang	Feifei Yang has received personal compensation for serving as an employee of Alexion Pharmaceuticals. Feifei Yang has stock in Alexion Pharmaceuticals.
Vidya Chitikireddi	Vidya Chitikireddi has nothing to disclose.
Hua Zhang	No disclosure on file
Arshad Mujeebuddin, MBBS	Dr. Mujeebuddin has received personal compensation for serving as an employee of Alexion AstraZeneca Rare Disease. Dr. Mujeebuddin has stock in AstraZeneca.