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

Topic:

Other

Poster Number: P365

Author(s):

Shirali Pandya, MPH, PhD, Alexion, AstraZeneca Rare Disease, Lokesh Jha, MD, Alexion, AstraZeneca Rare Disease, Boston, MA, USA, Imad Al-Dakkak, DMD, MPA, MPH, FACE, Alexion, AstraZeneca Rare Disease, Boston, MA, USA, Feifei Yang, MS, MD, Alexion, AstraZeneca Rare Disease, Boston, MA, USA, Hua Zhang, MD, PhD, Alexion, AstraZeneca Rare Disease, Boston, MA, USA, Arshad Mujeebuddin, MBBS, Alexion, AstraZeneca Rare Disease, Boston, MA, USA

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.

Conclusion: 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.