Real-world safety of satralizumab in neuromyelitis optica spectrum disorder: a FAERS-based risk stratification study - PubMed
7 hours ago
- #Pharmacovigilance
- #NMOSD
- #Satralizumab
- Satralizumab is an established therapy for neuromyelitis optica spectrum disorder (NMOSD).
- Real-world safety data from the FDA Adverse Event Reporting System (FAERS) was analyzed.
- Infections were the most prominent adverse events, including atypical mycobacterial infection, pneumonia pneumococcal, and pyelonephritis.
- 40 unlabeled adverse events were identified, such as lymphocyte count decrease.
- Concomitant corticosteroid use increased reporting of infectious and hepatic adverse events.
- Factors associated with severe outcomes included age ≥ 65 years, male sex, and septic shock.
- Median time to onset of adverse events was 97 days, with early and late peaks.
- The study supports risk-adapted monitoring strategies for satralizumab in NMOSD.