Infection rates of Neisseria meningitidis (Nm) have steadily decreased over time in patients treated with eculizumab (Soliris®) for neurological conditions, including neuromyelitis optica spectrum disorder (NMOSD) and generalized myasthenia gravis (gMG), and hematological conditions, including paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), according to pharmacovigilance data presented at the 9th Congress of the European Academy of Neurology (EAN 2023).
Both eculizumab and ravulizumab (Ultomiris®), a therapy approved for the treatment of patients with PNH and aHUS, are terminal complement-inhibiting therapies (C5ITs) that are associated with an increased risk of Nm infections. Improvements in global risk-mitigation measures, including patient safety cards, the distribution of educational materials, and increased vaccinations, have reduced this risk over time despite increased patient exposure.
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Data from March 2007 until October 2022 shows a steady decline in Nm infection rates among patients despite increased cumulative exposure to eculizumab in a real-world setting. During clinical trials, across all 4 indications, the cumulative Nm infection rate for eculizumab was approximately .30 cases per 100 patient-years (PY), while cumulative postmarketing rates were reported at .24 cases per 100 PY.
Similar results were observed for ravulizumab from December 2018 to June 2022. During clinical trials, the Nm infection rate was .21 cases per 100 PY which was reduced to .08 cases per 100 PY in postmarket reporting.
Nm mortality rates have remained steady over time as well for both drugs. During clinical trials, only 1 Nm-related death occurred with ravulizumab per 2870 PY (.03 per 100 PY), and 0 deaths occurred with eculizumab over 2331 PY. In real-world usage, a total of 1 patient death occurred in 7533 PY (.02 per 100 PY) for ravulizumab while 20 deaths occurred per 78,416 PY (.03 per 100 PY) for eculizumab.
“Raised infection awareness, risk mitigation strategies, and availability of additional vaccines effectively reduced the risk of Nm infections in C5IT-treated patients, underlining the importance of adhering to those measures,” the authors wrote.
Fam S, Werneburg B, Pandya S, et al. EPO-260. Clinical and real-world pharmacovigilance data of meningococcal infections in eculizumab or ravulizumab-treated patients. ePoster presented at: 9th Congress of the European Academy of Neurology (EAN 2023); July 1-4, 2023.