Safety and efficacy of batoclimab for generalized myasthenia gravis: a systematic review and meta-analysis

Background: Several neonatal Fc receptor (FcRn) inhibitors represent a possibility in the treatment of generalized Myasthenia Gravis (gMG). However, the precise therapeutic profile and efficacy of batoclimab in this context are not yet fully understood. Objective: To evaluate the efficacy and safety of batoclimab for the treatment of generalized Myasthenia Gravis. Methods: MEDLINE, Scopus, and Web of Science databases were systematically searched. Data were examined using the DerSimonian Laird method and 95% confidence intervals. Heterogeneity was assessed using I² statistics. R, version 4.3.2, was used for statistical analysis. Results: A total of 3 randomized control trials and 179 patients were included. Compared with placebo, treatment with batoclimab achieved better reduction of MG-ADL score (MD -2.07; 95% CI -2.06 - -1.49; P ≤0.000001; I²= 0%); treatment with batoclimab had a better improvement of QMG score (MD -5.47; 95% CI -7.70 - -3.25; P=0.000001; I²=79%). The rate of treatment-emergent adverse effects and other specific adverse effects such as diarrhea, headache, and upper respiratory tract infection did not reach a statistically significant difference between groups. Conclusion: Consistent results suggest that the use of batoclimab is associated with efficacy in the treatment of gMG, reducing MG-ADL and QMG scores. The drug had no significantly relevant adverse events in comparison to placebo. In conclusion, our results support the use of batoclimab for the treatment of gMG.