ArticlePloS one2025
Eculizumab and ravulizumab clinical trial and real-world pharmacovigilance of meningococcal infections across indications.
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed.
- BCMA-directed mRNA CAR T cell therapy for myasthenia gravis: a randomized, double-blind, placebo-controlled phase 2b trial.Nature medicine · 2026Trial
- Complement Inhibition in the Clinic: Are We Doing Enough to Protect Patients From Infection?European journal of immunology · 2026Review
- Breakthrough serogroup Y meningococcal disease in a vaccinated patient with myasthenia gravis receiving ravulizumab: a case report.BMC infectious diseases · 2026Article
- Complement Dysregulation in Kidney Diseases: Mechanisms, Biomarkers, and Emerging Targeted Therapies.International journal of molecular sciences · 2026Review
- Perspective on the pathogenic Neisseria: milestones, challenges, and future directions.NPJ vaccines · 2026Review
- Complement C5 inhibition in generalized myasthenia gravis is associated with improved survival and increased cardiovascular risk.Frontiers in immunology · 2026Article
- Breaking tolerance in the glomerulus: complement as a driver and therapeutic target in IgA nephropathy.Frontiers in medicine · 2026Review
- Case Report: Fulminant meningococcus-meningitis under treatment with ravulizumab despite complete vaccination-a rare but severe complication.Frontiers in medicine · 2026Article
- Beyond Terminal Blockade: A Mechanism-Based Approach to Complement Inhibitor Selection in Paroxysmal Nocturnal Hemoglobinuria.Drug design, development and therapy · 2026Review
Corrections and comments
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionComplement component 5 inhibitor therapies (C5ITs) for rare hematological, renal, and neurological diseases are associated with increased meningococcal infection risk. Robust risk mitigation measures include vaccination, drug safety programs, patient safety cards, and antibiotic prophylaxis initiation when starting C5ITs. Here we describe the exposure-adjusted meningococcal infection and mortality rates in eculizumab- or ravulizumab-treated patients based on clinical trial and real-world pharmacovigilance data.
methodsGlobal clinical trial and real-world safety data regarding eculizumab and ravulizumab use across indications were recorded in the Alexion pharmacovigilance database. Data for eculizumab (March 2007-October 2024) and ravulizumab (December 2018-December 2024) were searched based on the Medical Dictionary for Regulatory Activities (versions 26.1, 27.0, and 27.1) High-Level Term of Neisseria infection. Only cases associated with Neisseria meningitidis were included. Reporting rates were calculated cumulatively per 100 patient-years (PY).
resultsAt the time of analysis, cumulative exposure across clinical trial and real-world settings were 2457 and 91,052 PY, respectively, for eculizumab and 3287 and 34,582 PY, respectively, for ravulizumab. The cumulative meningococcal infection rate in clinical trials was 0.28 and 0.18 per 100 PY for eculizumab and ravulizumab, respectively. Real-world cumulative meningococcal infection rates in patients treated with eculizumab have decreased since 2007 (0.25 per 100 PY in 2024). In patients treated with ravulizumab, the real-world cumulative rate of meningococcal infection remains low (0.10 per 100 PY in 2024). The rates of meningococcal-associated mortality were ≤0.03 per 100 PY in both eculizumab- and ravulizumab-treated patients in clinical trials and real-world settings.
conclusionsMeningococcal infection and mortality reporting rates have remained stable despite increasing cumulative eculizumab and ravulizumab exposure over time across indications, including rare neurological indications. Infection awareness, existing risk mitigation strategies, and availability of vaccines have effectively reduced the risk of meningococcal infections in C5IT-treated patients, underlining the importance of adhering to those measures.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.