SAFETY ANALYSIS OF IMMUNOBIOLOGICS IN PATIENTS WITH MYASTHENIA GRAVIS: A SYSTEMATIC REVIEW

Abstract

Introduction: Myasthenia gravis is an autoimmune neuromuscular disease characterized by fluctuating muscle weakness, resulting from impaired neuromuscular transmission mediated by autoantibodies. Although conventional treatments are available, limitations in efficacy and the adverse effects of long-term therapies have driven the development of biologics targeting the complement system and the neonatal Fc receptor (FcRn). Objective: To evaluate the safety and adverse effects associated with the use of biologics in patients with myasthenia gravis, compared to placebo, through a systematic review of randomized clinical trials. Methods: A systematic review of randomized clinical trials published between 2020 and 2025 was conducted using the PubMed and Cochrane databases. The selection focused on studies comparing biologics to placebo with detailed reporting of safety outcomes, using the Cochrane Risk of Bias 2.0 tool for bias assessment. Results: Fifteen studies were included, evaluating drugs such as efgartigimod, ravulizumab, and rozanolixizumab. The therapies demonstrated significant and rapid clinical improvement in functional scores. Treatment-emergent adverse events (TEAEs) were predominantly mild to moderate, with headache and infections being the most frequent, showing incidence comparable to the placebo group. No consistent increase in serious adverse events or mortality attributable to the biological therapies was observed. Conclusion: Biologics represent a safe and effective therapeutic alternative, with an acceptable tolerability profile for the management of myasthenia gravis. Despite their benefits, the short follow-up duration limits the detection of rare events, and the high cost highlights the need for strict clinical criteria for their prescription.