Fact checked byHeather Biele

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May 08, 2023
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Vyvgart well-tolerated, improved clinical outcomes in generalized myasthenia gravis

Fact checked byHeather Biele
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Key takeaways:

  • Long-term treatment with efgartigimod resulted in consistent and repeatable reductions in IgG antibody levels in patients with generalized myasthenia gravis.
  • Improvements in quality of life were also reported.

BOSTON — Long-term treatment with Vyvgart was safe, well-tolerated and effective in reducing immunoglobulin G antibody levels and improving clinical outcomes in patients with generalized myasthenia gravis.

“Efgartigimod is an Fc receptor that recycles IgG, including those pathogenic IgG autoantibodies,” Mamatha Pasnoor, MD, FAAN, professor in the department of neurology at the University of Kansas Medical Center, told attendees at the American Academy of Neurology annual meeting.

picture of a pile of pills
Results of a phase 3 trial demonstrated Vyvgart was well-tolerated, improved clinical outcomes in generalized myasthenia gravis. Image: Adobe Stock

Pasnoor and colleagues evaluated the long-term safety and efficacy of Vyvgart (efgartigimod, argenx) in the ADAPT study, a 26-week multicenter, randomized, controlled, phase 3 trial of 167 adults with generalized myasthenia gravis, of whom 151 completed ADAPT and enrolled in the ADAPT+ open-label extension study.

Participants were given 10 mg/kg of IV efgartigimod as once-weekly infusions for 4 weeks and were evaluated for subsequent cycles. Researchers assessed long-term efficacy using the Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scales, and also monitored patients for safety and tolerability.

According to results, 145 participants enrolled in ADAPT+ received at least one cycle as of January 2022, of whom 111 were anti-acetylcholine receptor-antibody positive (AChR-Ab+) and 34 were anti-AChR-Ab–.

Data showed that all 111 anti-AChR-Ab+ participants had consistent and repeatable improvements in MG-ADL (mean change week 3 of cycle 1 = –5; up to 14 cycles) and QMG scores (–4.7; up to 7 cycles) during each cycle, with similar results reported across the overall study population.

Further, researchers reported repeatable reductions in total IgG (mean reduction = –55.9%; up to 7 cycles) and anti-AChR autoantibody levels (–56.1%; up to 7 cycles), and no reductions in albumin or increases in LDL cholesterol.

Incidence of adverse events was similar in ADAPT and ADAPT+ and were mostly mild to moderate, with headache (25%), COVID-19 infection (15%), nasopharyngitis (14%), diarrhea (10%) and urinary tract infections (9%) most commonly reported. Adverse events did not increase in frequency with subsequent treatment cycles, researchers noted.

“Treatment is well-tolerated and efficacious in patients with [generalized myasthenia gravis],” Pasnoor said.