17 January 2024 | James F. Howard Jr., Vera Bril, Tuan Vu, Chafic Karam, Stojan Peric, Jan L. De Bleecker, Hiroyuki Murai, Andreas Meisel, Said R. Beydoun, Mamatha Pasnoor, Antonio Guglietta, Benjamin Van Hoorick, Sophie Steeland, Caroline Tjoen, Kimiaki Utsugisawa, Jan Verschuuren, Renato Mantegazza on behalf of the ADAPT+ Study Group
The ADAPT+ study evaluated the long-term safety, tolerability, and efficacy of efgartigimod in patients with generalized myasthenia gravis (gMG). The study was an open-label extension of the phase 3 ADAPT study, involving 151 participants who had rolled over from ADAPT and 145 who had received at least one dose of efgartigimod. The mean study duration was 548 days, with participants receiving up to 17 treatment cycles.
Results showed that efgartigimod was well tolerated, with most adverse events being mild or moderate. Clinically meaningful improvements in MG-ADL and QMG scores were observed as early as one week after the first infusion. The maximal improvements in these scores aligned with the reduction in total IgG and AChR-Ab levels. Over 90% of AChR-Ab+ participants achieved clinically meaningful improvement in MG-ADL scores across the first 10 treatment cycles, while 69.4% to 91.3% achieved similar improvements in QMG scores.
Efgartigimod demonstrated consistent and repeatable clinical improvements across multiple treatment cycles. The mean number of annualized cycles was 4.7 per year for AChR-Ab+ participants with at least one year of combined follow-up. The study also showed that efgartigimod did not reduce serum albumin levels or increase total cholesterol or LDL cholesterol levels.
The study supports the long-term safety, tolerability, and efficacy of efgartigimod in the treatment of gMG. The individualized dosing regimen was effective in achieving sustained clinical improvements. The results of ADAPT+ corroborate the substantial clinical improvements seen with efgartigimod in ADAPT and support its long-term use in the treatment of gMG.The ADAPT+ study evaluated the long-term safety, tolerability, and efficacy of efgartigimod in patients with generalized myasthenia gravis (gMG). The study was an open-label extension of the phase 3 ADAPT study, involving 151 participants who had rolled over from ADAPT and 145 who had received at least one dose of efgartigimod. The mean study duration was 548 days, with participants receiving up to 17 treatment cycles.
Results showed that efgartigimod was well tolerated, with most adverse events being mild or moderate. Clinically meaningful improvements in MG-ADL and QMG scores were observed as early as one week after the first infusion. The maximal improvements in these scores aligned with the reduction in total IgG and AChR-Ab levels. Over 90% of AChR-Ab+ participants achieved clinically meaningful improvement in MG-ADL scores across the first 10 treatment cycles, while 69.4% to 91.3% achieved similar improvements in QMG scores.
Efgartigimod demonstrated consistent and repeatable clinical improvements across multiple treatment cycles. The mean number of annualized cycles was 4.7 per year for AChR-Ab+ participants with at least one year of combined follow-up. The study also showed that efgartigimod did not reduce serum albumin levels or increase total cholesterol or LDL cholesterol levels.
The study supports the long-term safety, tolerability, and efficacy of efgartigimod in the treatment of gMG. The individualized dosing regimen was effective in achieving sustained clinical improvements. The results of ADAPT+ corroborate the substantial clinical improvements seen with efgartigimod in ADAPT and support its long-term use in the treatment of gMG.
Understanding Long-term safety%2C tolerability%2C and efficacy of efgartigimod (ADAPT%2B)%3A interim results from a phase 3 open-label extension study in participants with generalized myasthenia gravis