Meeting Coverage
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AANEM
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Nipocalimab plus standard of care reduced IgG and was well tolerated
by
Judy George, Deputy Managing Editor, MedPage Today
October 19, 2024
SAVANNAH, Ga. — Investigational nipocalimab plus standard of care achieved sustained reductions in immunoglobulin G (IgG) and appeared to be safe for adolescent patients with generalized myasthenia gravis (gMG), the phase II/III Vibrance-MG study showed.
From baseline to week 24 of the active treatment phase, the mean percentage change in total serum IgG from baseline was -68.98% (95% CI -78.4 to -59.6%), reported Jonathan Strober, MD, of the UCSF Benioff Children’s Hospital in San Francisco.
The median pre-dose total serum IgG reduction from baseline to week 2 was -72%, Strober said. The median reduction to week 24 was -69.87%.
The findings, presented at the Myasthenia Gravis Foundation of America (MGFA) session of the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) annual meeting, show the potential of this investigational therapy for patients, ages 12 to 17 years, with gMG, Strober noted.
“It is encouraging to see these positive results as there are currently no approved advanced treatment options for this adolescent population in the United States,” he said.
The prevalence of gMG increases with age, and few myasthenia gravis patients are children. Some research has suggested that a high percentage of juvenile gMG patients may require hospitalization in an ICU throughout the course of their disease.
Nipocalimab was designed to block the IgG binding site on the neonatal Fc receptor (FcRn) to reduce serum levels of circulating IgG, including pathogenic IgG autoantibodies in gMG. The treatment recently has been tested in a pivotal trial of adult gMG patients.
“These are the first clinical trial data reported with an FcRn blocker in adolescents,” Strober said.
The treatment was well tolerated in adolescents with gMG, he pointed out: there were no serious adverse events (AEs), no AEs leading to discontinuation, and no AEs of special interest through week 24. The most common AE was nasopharyngitis.
Vibrance-MG is an ongoing open-label study of nipocalimab plus standard of care in children and adolescents with gMG, with enrollment open to patients ages 2 years up to age 18.
All participants were diagnosed with gMG MGFA Classification IIa to IVb gMG, were seropositive for anti-acetylcholine receptor (anti-AChR) or muscle-specific kinase (anti-MuSK) autoantibodies, and had an insufficient clinical response to ongoing, stable standard-of-care therapy.
The results presented at AANEM included adolescents, ages 12 years to
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