Evaluating the Real‐World Safety of Ravulizumab in Generalized Myasthenia Gravis: Insights From a Detailed Analysis of FAERS Data

Background Ravulizumab represents the inaugural long‐acting complement C5 inhibitor that has received approval in various countries around the globe for individuals diagnosed with generalized myasthenia gravis (gMG) who are positive for anti‐acetylcholine receptor antibodies. The objective of this study was to leverage the FDA Adverse Event Reporting System (FAERS) database to detect and analyze signals of adverse events (AEs) associated with ravulizumab in real‐world scenarios, thereby informing the safety management of its clinical use. Methods The FAERS database was retrospectively queried to extract all AEs related to ravulizumab since 2019. Disproportionality analysis was employed to evaluate the safety of ravulizumab in clinical practice, utilizing methods such as the reporting odds ratio (ROR), proportional reporting ratio (PRR), multi‐item gamma Poisson shrinker (MGPS), and Bayesian confidence propagation neural network (BCPNN). AEs that met the positivity threshold for at least one method were classified as potential adverse reactions. Results A total of 6994 reports identified “primary suspected”. Signals were detected for AEs listed on the drug label upper respiratory tract infection (ROR 2.51, 95% CI 1.79–3.52), headache (ROR 2.77, 95% CI 2.53–3.02), diarrhea (ROR 1.09, 95% CI 0.95–1.25), and hypertension (ROR 0.51, 95% CI 0.36–0.72). Additionally, potential new signals were identified for AEs not mentioned on the label, including various muscle diseases (such as muscular weakness [ROR 9.50, 95% C 8.50–10.62] and gait disturbance [ROR 2.54, 95% CI 2.17–2.99]), nervous system reactions (including feeling abnormal [ROR 2.99, 95% CI 2.62–3.42] and dysphagia [ROR 5.27, 95% CI 4.50–6.18]), and eye diseases (such as diplopia [ROR 30.32, 95% CI 26.59–34.57] and eyelid ptosis [ROR 58.10, 95% CI 49.84–67.74]). The significance of monitoring for AEs, particularly during the first month following the initiation of treatment, was underscored. Conclusion This study presents preliminary safety data on the practical application of ravulizumab, confirming some known AEs while also identifying new potential AEs associated with the drug. These findings offer valuable safety information for clinicians who prescribe ravulizumab for the treatment of gMG.