HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) recently reported new Phase 3 data showing sustained symptom improvement and reduced antibody levels in patients with generalized myasthenia gravis treated with its drug IMAAVY, with follow-up extending to 120 weeks.
The findings come from the Vivacity-MG3 study and its ongoing open-label extension, which evaluated antibody-positive adult patients, including those with anti-AChR and anti-MuSK antibodies.
The company said patients treated with IMAAVY experienced sustained reductions in disease severity scores and immunoglobulin G levels, which are associated with the condition.
At 96 weeks in the extension phase, patients showed average reductions of 6.47 points on the MG-ADL scale and 5.97 points on the QMG scale, measures of daily function and muscle strength.
About half of patients achieved minimal symptom expression, with 32 percent maintaining that level for at least eight weeks.
The study also found reductions in corticosteroid use over time, with 57 percent of patients reaching lower dosage levels.
A post-hoc analysis of the double-blind phase found patients who achieved sustained minimal symptom expression reported greater improvements in quality of life compared with those whose symptom control was not maintained.
Constantine Farmakidis, an associate professor of neurology at the University of Kansas Medical Center, said the results support long-term disease management.
“These long-term results … provide further evidence that disease control … can be sustained,” Farmakidis said.
Johnson & Johnson said the data reinforce the drug’s efficacy and safety profile in a broad patient population.
The company is also enrolling participants in a separate study, known as EPIC, which will compare IMAAVY with another FcRn-blocking therapy in patients who have not previously received that class of treatment.
IMAAVY, also known as nipocalimab, is approved for treating generalized myasthenia gravis in adults and adolescents aged 12 and older who test positive for specific antibodies.
Generalized myasthenia gravis is an autoimmune disorder that impairs communication between nerves and muscles, leading to weakness that can affect speech, swallowing and movement.
The condition affects an estimated 100,000 people in the United States and about 700,000 worldwide.
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