ADAPT
The ADAPT phase 3 clinical trial established the efficacy and safety of VYVGART for the treatment of gMG in adults who are anti-AChR antibody positive.
AChR=acetylcholine receptor; gMG=generalized myasthenia gravis.
IMPROVEMENT IN DAILY FUNCTION
VYVGART demonstrated greater improvement in daily function vs placebo at week 41*†
*Clinical trial data from patients who were anti-AChR antibody positive.
†Four weeks after the initial infusion of the first treatment cycle.
AChR=acetylcholine receptor; MG-ADL=Myasthenia Gravis Activities of Daily Living; Tx=treatment.
REDUCTION IN MUSCLE WEAKNESS
VYVGART demonstrated greater reduction in muscle weakness vs placebo at week 41*†
*Clinical trial data from patients who were anti-AChR antibody positive.
†Four weeks after the initial infusion of the first treatment cycle.
AChR=acetylcholine receptor; QMG=Quantitative Myasthenia Gravis; Tx=treatment.
EXPLORATORY ENDPOINT
Exploratory endpoint: early response data for patients on VYVGART2,3*
84%
(n=37/44)
of patients treated with VYVGART who were MG-ADL responders showed a response by week 2 in the first treatment cycle. These patients were considered early responders.†
Of the 19 placebo-treated patients who met the primary endpoint, 16 (84%) showed a response by week 2.
Study Limitations: Percentage of early responders (response by week 2) in anti-AChR antibody positive patients treated with VYVGART was a prespecified descriptive exploratory analysis not controlled for multiplicity and not powered; therefore, data should be interpreted with caution and conclusions cannot be drawn.
*Clinical trial data for anti-AChR antibody positive patients. Patients were treated with VYVGART + current treatment or placebo + current treatment.
†MG-ADL early response was defined as a ≥2-point reduction in the total MG-ADL score compared to the treatment cycle baseline for at least 4 consecutive weeks during the first treatment cycle (by week 8), with the first reduction occurring no later than one week after the scheduled second infusion (week 2).
AChR=acetylcholine receptor; MG-ADL=Myasthenia Gravis Activities of Daily Living.
Study Limitations: The MG-ADL responder data across first or second treatment cycles was a post-hoc analysis based on a prespecified exploratory endpoint not controlled for multiplicity and not powered; therefore, data should be interpreted with caution and conclusions cannot be drawn.
*Clinical trial data from patients who were anti-AChR antibody positive. Patients were treated with VYVGART + current treatment or placebo + current treatment.
†MG-ADL response was defined as a ≥2-point reduction in the total MG-ADL score compared to the treatment cycle baseline for at least 4 consecutive weeks during the first treatment cycle (by week 8), with the first reduction occurring no later than 1 week after the last infusion of the cycle.
‡The same measure for response was applied to the analysis during the second treatment cycle.
AChR=acetylcholine receptor; MG-ADL=Myasthenia Gravis Activities of Daily Living; Tx=treatment.