Add on batoclimab tied to sustained improvement in activities of Daily Living score in Myasthenia Gravis : JAMA
MG is caused by autoantibodies disrupting the neuromuscular junction. The neonatal fragment crystallizable receptor (FcRn) antagonists, efgartigimod and rozanolixizumab, reduce circulating immunoglobulin G (IgG) levels and alleviate symptoms in generalized MG cases.
A recent study found that batoclimab led to a sustained improvement in the Myasthenia Gravis Activities of Daily Living score compared to the placebo group. No severe side effects were reported. This suggests that batoclimab, an FcRn inhibitor, could be an important addition to the limited treatments available for Myasthenia gravis (MG).
This original investigation was published in JAMA Neurology.
The clinical trial was conducted at 27 centres in China from September 15, 2021, to June 29, 2022. It enrolled adult patients who tested positive for antibodies. These patients received either batoclimab or a placebo in addition to standard treatment. Each cycle consisted of six weekly subcutaneous injections of batoclimab or placebo, followed by four weeks of observation. A second cycle was given to those who required ongoing treatment. The primary outcome was a 3-point or greater improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score for at least four consecutive weeks in individuals with antibodies to acetylcholine receptors or muscle-specific kinase.
Key findings from the study are:
• The study population included 43 men and 88 women, the mean age being 43, with a history of generalized myasthenia gravis.
• The study was carried out in 27 hospitals in China.
• The rate of sustained MG-ADL improvement in the first cycle in antibody-positive patients in the placebo and batoclimab groups was 31.3% (20/ 64) and 58.2% (39/ 67), respectively, with an odds ratio of 3.45.
• The MG-ADL score diverged between the two groups as early as week 2.
• The rates of treatment-related and severe treatment-emergent adverse events in patients were 36.9% and 7.7% in the placebo group vs 70.1% and 3.0% in the batoclimab group, respectively.
Study strengths include a more significant number of participating centres and a broad representation of the overall generalized MG patient population.
Study limitations include limited treatment cycles, lack of data on long-term safety, and enrolment of only one patient with negative AChR/MuSK antibodies.
Concluding further, batoclimab resulted in a higher rate of sustained MG-ADL improvement in adult patients with generalized MG than placebo.
Reference:
Yan C, Yue Y, Guan Y, et al. Batoclimab vs Placebo for Generalized Myasthenia Gravis: A Randomized Clinical Trial. JAMA Neurol. Published online March 04, 2024. doi:10.1001/jamaneurol.2024.0044
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