*All patients received stable doses of their current gMG treatment.
†All patients received an initial cycle, with subsequent cycles administered based on individual clinical evaluation when their MG-ADL score was at least 5 (with >50% MG-ADL nonocular) and if the patient was an MG-ADL responder, when they no longer had a clinically meaningful decrease (defined as having ≥2-point improvement in total MG-ADL score) compared to baseline. The minimum time between treatment cycles, specified by study protocol, was 50 days. A maximum of 3 cycles were possible in the 26-week study.
‡The percentage of anti-AChR antibody positive patients who were MG-ADL responders, 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.
AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; MG-ADL=Myasthenia Gravis Activities of Daily Living; Tx=treatment.
The pivotal trial population represented a range of adult patients with gMG1-3
(QMG score; both arms)*
Range: 4-28 (overall)
(0=normal; 39=most severe)
*MG-ADL total score of ≥5 required at screening.
†Sum of the percentages is over 100% due to rounding.
‡Conditions shown represent the 5 most prevalent comorbidities reported by investigator at baseline in the ADAPT clinical trial (N=167).
AChR=acetylcholine antibody receptor; MG-ADL=Myasthenia Gravis Activities of Daily Living; MGFA=Myasthenia Gravis Foundation of America; NSIST=nonsteroidal immunosuppressive therapy; QMG=Quantitative Myasthenia Gravis.