Pharmacodynamic Properties of Subcutaneous Immunoglobulin in Myasthenia Gravis: Sub-analyses From an Open-Label Trial

Background: We previously reported an open-label prospective trial of subcutaneous immunoglobulin (SCIg) in mild to moderate exacerbations of myasthenia gravis (MG). The effective dose of SCIg in MG and whether measured immunoglobulin G (IgG) levels correlated with measures of disease burden were not reported. Objectives: To understand the relationship between SCIg dosing and serum IgG levels on measures of disease burden: quantitative MG (QMG), MG activities of daily living (MG-ADL), MG composite (MGC), and manual muscle testing (MMT) scores. Methods: We performed post-hoc analyses of variance to assess change in oculobulbar and generalized sub-scores. We assessed the improvement in QMG, MG-ADL, MGC, or MMT over intervals from baseline to week 2, weeks 2-4, and week 4 to end of study. Improvement was either greater than (coded 1) or was equal to or less than (coded 0) the previous 2 weeks. Binaries were assessed in binary logistic regression as a function of SCIg dose over the two-week interval as the independent variable. We also performed linear regression analyses with change in the clinical scores as the dependent variable and change in IgG level over the entire study period and over the interval from weeks 2 to 4, during which change in IgG level was maximal, as the independent variables. Results: Subanalysis of QMG and MG-ADL scores demonstrated significant reductions in the oculobulbar and the generalized portions of both measures. Binary logistic regression analyses did not find any statistically significant correlations between the odds of improvement and weight-adjusted dose of SCIg over 2-week intervals. There were no significant relationships between changes in scores and IgG level over the entire study period or over the interval from weeks 2 to 4. Conclusions: Although SCIg dose varied over the study period, the odds of improvement were not significantly correlated with this, which suggests that the current dose of 2 g/kg for SCIg should be compared to different, possibly lower, dosing regimens head-to-head. The change in clinical scores was not significantly associated with IgG levels suggesting a complex relationship. SCIg may be effective for both ocular and generalized presentations of MG.