The ADAPT trial established the effectiveness of VYVGART for IV infusion in the treatment of gMG in adults who are anti-AChR antibody positive. The ADAPT-SC trial established that VYVGART Hytrulo and VYVGART showed a similar pharmacodynamic (PD) effect in reduction of AChR-Ab levels in adult patients with gMG who are anti-AChR antibody positive, which established the efficacy of VYVGART Hytrulo.1-3
AChR=acetylcholine receptor; gMG=generalized myasthenia gravis.
*The 90% confidence interval for the geometric mean ratios of AChR-Ab reduction at day 29 and AUEC0-4w (area under the effect-time curve from time 0 to 4 weeks post dose) were within the range of 80% to 125%, indicating no clinically significant difference between the two formulations.
†Clinical trial data for anti-AChR antibody positive patients.
‡Seven days after the fourth IV or SC administration.
AChR=acetylcholine receptor; AChR-Ab=acetylcholine receptor antibody; IgG=immunoglobulin G; IV=intravenous; SC=subcutaneous; Tx=treatment.
Study Limitations: ADAPT-SC was a bridging study designed to compare pharmacodynamic effects between VYVGART Hytrulo for subcutaneous injection and VYVGART for intravenous infusion. MSE was observed post hoc; therefore, data should be interpreted with caution and conclusions cannot be drawn.
*Clinical trial data from patients who were anti-AChR antibody positive.
AChR=acetylcholine receptor; MG-ADL=Myasthenia Gravis Activities of Daily Living; Tx=treatment.
Study Limitations: ADAPT-SC was a bridging study designed to compare pharmacodynamic effects between VYVGART Hytrulo for subcutaneous injection and VYVGART for intravenous infusion. MG-ADL response was observed for exploratory purposes; therefore, data should be interpreted with caution and conclusions cannot be drawn.
*Clinical trial data from patients who were anti-AChR antibody positive.
AChR=acetylcholine receptor; MG-ADL=Myasthenia Gravis Activities of Daily Living; Tx=treatment.
Study Limitations: ADAPT-SC was a bridging study designed to compare pharmacodynamic effects between VYVGART Hytrulo for subcutaneous injection and VYVGART for intravenous infusion. QMG response was observed for exploratory purposes; therefore, data should be interpreted with caution and conclusions cannot be drawn.
*Clinical trial data from patients who were anti-AChR antibody positive.
AChR=acetylcholine receptor; QMG=Quantitative Myasthenia Gravis; Tx=treatment.