A recent study published in Clinical Epidemiology found that while efgartigimod alfa is generally safe for individuals with myasthenia gravis (MG), some patients may experience adverse events not currently listed in the drug’s instructions.
Among these side effects are falls, sepsis, kidney stones, atrial fibrillation and inflammation of the colon.
Efgartigimod alfa, sold as Vyvgart Hytrulo, was approved by the U.S. Food and Drug Administration (FDA) for patients with generalized MG in December 2021. Although several clinical trials have demonstrated the safety and efficacy of the drug, few studies have analyzed its safety profile in a real-world, noncontrolled setting.
Using the FDA’s Adverse Event Reporting System, the authors identified 3,182 reports of adverse events attributed to efgartigimod alfa. Hospitalization was the most common serious outcome, occurring in 40% of these cases.
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Other common side effects included fatigue, urinary tract infections and difficulty breathing. The authors note that some adverse events, particularly those pertaining to weakness, are also symptoms of MG. This underscores the need to carefully monitor patients to determine whether the drug may be causing or exacerbating their symptoms.
Sex-based analysis revealed that women were more likely than men to experience weakness or exhaustion, symptom reoccurrence and urinary tract infections after taking efgartigimod alfa. Men, on the other hand, were more likely to experience atrial fibrillation and difficulty speaking after taking the drug.
Most of the adverse events reported in this study occurred within six months of beginning efgartigimod alfa, meaning the likelihood of experiencing side effects decreases with prolonged use.
The authors also assessed 152 reports of patients receiving a combination of efgartigimod alfa, prednisolone and mestinon. They found that these individuals were more likely to experience urinary tract infections and seasonal allergies than those receiving efgartigimod alfa alone.
“Our study provides significant evidence regarding the clinical safety of efgartigimod alfa, and we hope that it will contribute to enhancing the safety of patients during their course of treatment,” the authors concluded.
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