Lasting benefits seen with Imaavy treatment in gMG, per trial analyses
Approved therapy boosts life quality, cuts symptoms during infections
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Treatment with Imaavy for gMG leads to lasting cuts in symptoms and improvements in life quality, post-trial analyses found.
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Significant benefits were seen for those with early or less severe gMG, and during infection-triggered symptom worsening.
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A new study dubbed PETUNIA will track Imaavy's safety and outcomes for gMG patients during pregnancy.
Use of the approved therapy Imaavy (nipocalimab-aahu) leads to a lasting drop in symptoms and related gains in quality of life for adults with generalized myasthenia gravis (gMG) treated early in their disease course, with significant benefits also seen among patients with less severe symptoms at diagnosis.
Further, these improvements — both in reduced symptoms and their associated daily life impact — were sustained during periods of infection.
That’s according to post-hoc analyses of data from the global Phase 3 Vivacity-MG3 clinical trial (NCT04951622), whose top-line data supported Imaavy’s approvals for certain gMG patients. Post-hoc analyses are those conducted after a study has been designed and its data collected.
These new findings were presented via three posters at the 2026 Congress of the European Academy of Neurology, held June 27-30 in Geneva.
“People living with generalized myasthenia gravis often face unpredictable symptoms that can interfere with everyday life, underscoring the need for continued innovation grounded in disease biology,” David Lee, MD, PhD, global immunology therapeutic area head at Johnson & Johnson, Imaavy’s developer, said in a company press release detailing the new data.
“We are continuing to explore the potential of IMAAVY in supporting sustained disease control across key moments in patients’ lives,” Lee said
At the congress, researchers also presented the design of PETUNIA, fully known as Pregnancy Enhanced Tracking with Neonatal and Infant Assessment, a study that will collect data on maternal and infant outcomes with exposure to Imaavy immediately before and/or during pregnancy.
gMG is an autoimmune disease in which self-reactive antibodies attack proteins needed for communication between nerves and muscles. This disrupts muscle contractions, leading to symptoms such as fluctuating muscle weakness across multiple muscle groups and fatigue.
Imaavy works to reduce levels of disease-driving antibodies by blocking the activity of the neonatal Fc receptor (FcRn), a protein that normally helps prevent circulating antibodies from being broken down.
Imaavy approvals in US, Europe based on Vivacity trial data
The therapy is approved in the U.S. and the European Union for adults and adolescents, ages 12 and older, with gMG associated with self-reactive antibodies against the acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) — the most common types of MG-driving antibodies.
Regulatory approvals were based on top-line results from Vivacity-MG3, in which six months of Imaavy treatment led to greater reductions in disease severity compared with a placebo when given alongside standard care in adults with gMG.
This was mainly assessed with the Myasthenia Gravis Activities of Daily Living (MG-ADL) score, a patient-reported measure of how symptoms affect eight daily activities. Higher scores indicate more severe disease.
In one poster, researchers shared data from Vivacity-MG3 participants who had been diagnosed with gMG no more than five years before enrollment.
Data from this subgroup showed that, after six months, MG-ADL scores decreased by a mean of 4.9 points among those treated with Imaavy, compared with a 2.7-point drop in those given the placebo. The difference between the groups was statistically significant.
Scores on the Quantitative Myasthenia Gravis (QMG) scale, a clinician-administered assessment of muscle weakness, also fell significantly more with Imaavy than with the placebo (by 5.1 vs. 2.3 points).
The Imaavy group was significantly more likely to experience clinically meaningful MG-ADL score reductions, by about four times, and to maintain these for at least 20 weeks, or about 4.5 months (56.8% vs. 24.1%). Similar trends were seen for QMG scores.
Imaavy “may provide meaningful and substantial clinical benefit, even in patients in early stages of gMG,” the researchers wrote.
Treatment remains effective when infections occur
The therapy was also superior to the placebo in a subgroup of participants who entered the trial with lower MG-ADL scores — of 6-9 — which was below the trial population’s median score and indicated less symptom burden at diagnosis. This was the focus of a second poster also showing benefits with Imaavy.
After six months, treatment with Imaavy was associated with a significantly greater mean drop in MG-ADL scores (4.5 vs. 2.3 points) and QMG scores (5.2 vs. 1.9 points) relative to the placebo. Those on the therapy were also significantly more likely to achieve clinically meaningful MG-ADL score drops and to maintain them for at least 20 weeks.
These data add “further insights for healthcare professionals into the use of IMAAVY in patients with less severe disease,” the release stated.
For many people living with generalized myasthenia gravis, achieving and maintaining sustained disease control is an important goal throughout the course of their disease, from the moment they are diagnosed and across the different stages of their journey.
In a third poster, scientists examined changes in MG-ADL and QMG scores shortly before and during infection episodes — which are known to trigger worsening gMG symptoms — in Vivacity-MG3 participants.
Infections were reported in similar proportions of patients treated with Imaavy or the placebo (42.9% vs. 41.8%) and lasted about the same in both groups (10 vs. 12 days). The most commonly reported infections were COVID-19, the common cold, and upper respiratory tract infections.
Among participants who developed infections, MG-ADL scores remained unchanged with Imaavy but increased (worsened) by a mean of one point with the placebo. The same pattern was seen for QMG scores.
According to Johnson & Johnson, Imaavy’s safety and tolerability were consistent across the patient subgroups examined.
“For many people living with generalized myasthenia gravis, achieving and maintaining sustained disease control is an important goal throughout the course of their disease, from the moment they are diagnosed and across the different stages of their journey,” said Carlo Antozzi, MD, of the Neurological Institute Foundation C. Besta in Milan, Italy, who noted that “these post-hoc analyses add to the growing body of evidence on Imaavy” for use in gMG.
New PETUNIA trial to assess therapy’s safety in women
In Switzerland, researchers also shared the design of the PETUNIA study, which will collect real-world safety data on exposure to at least one Imaavy dose during pregnancy or within two weeks before the last menstrual period.
To date, the therapy’s safety has not been studied in pregnant people with gMG. PETUNIA’s goal is to determine the frequency of pregnancy outcomes, including gMG disease severity, among patients. It also will assess maternal complications and neonatal and infant health outcomes.
The study is expected to collect information on at least 162 pregnancies over approximately 10 years. It will be noninterventional, the researchers noted, and will involve both prospective and retrospective reports on pregnant patients.
“Insights gained from this study will support clinical decision-making for pregnant individuals with gMG,” the researchers wrote.
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