Vyvgart tied to symptom relief, corticosteroid reductions in gMG study

Treatment with Vyvgart (efgartigimod) was associated with rapid and sustained symptom easing, lower corticosteroid use, and no unexpected safety concerns in a small real-world study of adults with generalized myasthenia gravis (gMG).

The findings suggest the therapy may be a useful option in individualized treatment plans, although larger, longer-term studies are needed to confirm its long-term safety and effectiveness, the researchers noted.

The study, “Real-world evidence on utilization and clinical outcomes of efgartigimod in patients with generalized myasthenia gravis,” was published in the Journal of Neuroimmunology.

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How Vyvgart works in gMG

gMG is an autoimmune disease driven by self-reactive antibodies that disrupt signals at the neuromuscular junction, where nerves communicate with muscles. In most cases, these antibodies target the acetylcholine receptor (AChR) protein.

Argenx’s Vyvgart is a therapy approved in Europe and other regions for adults with gMG and anti-AChR antibodies. In the U.S., Vyvgart and its subcutaneous formulation, Vyvgart Hytrulo, were recently approved for all adults with gMG, regardless of antibody status.

Given in treatment cycles that typically involve once-weekly doses for four weeks, Vyvgart works by blocking the neonatal Fc receptor, a protein that helps stabilize and prevent the breakdown of circulating antibodies. It is, therefore, expected to lower levels of disease-driving self-reactive antibodies.

While clinical trials have shown Vyvgart can ease symptoms in people with gMG, more real-world data are needed to understand how the therapy is used in everyday clinical practice.

Here, a team of researchers in Belgium retrospectively reviewed real-world data from 27 adults with AChR antibody-positive gMG who were treated with Vyvgart at a single neuromuscular center between February 2024 and February 2026.

Real-world study tracked seven treatment cycles

Participants’ mean age was 61.7, they had lived with the disease for a median of seven years, and their disease was classified as moderate or severe based on MG-ADL scores when they started Vyvgart. Most of them (85.2%) had previously experienced impending myasthenic crises that required rescue treatment, while three (11.1%) had experienced manifest myasthenic crises requiring mechanical ventilation.

The analysis focused on the first seven cycles of treatment and looked at several outcomes, including changes in the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale — a measure of how the disease affects daily activities — corticosteroid use, treatment cycle timing, and safety.

Results showed that Vyvgart was associated with rapid and sustained symptom easing, as reflected by statistically significant and clinically meaningful reductions in MG-ADL scores at all time points assessed. A clear therapeutic effect was seen by the second treatment cycle and it was sustained through seven cycles. The largest score reduction was seen by cycle six.

When researchers looked at changes within each treatment cycle, the biggest drop in MG-ADL scores occurred during the first one, with smaller changes in later cycles. This suggested that Vyvgart quickly reduced symptom burden, then helped maintain a more stable level of disease control over time.

The proportion of participants classified as having MG-ADL-based moderate or severe disease also fell substantially with treatment. For severe disease specifically, this proportion dropped from 41% of patients at treatment start to 0% from cycle five onward. By cycle seven, two-thirds of evaluable patients had either mild disease or minimal symptom expression, meaning little to no symptom burden in daily activities.

Vyvgart also helped reduce daily dosages of corticosteroids, whose long-term or high-dose use is associated with serious side effects. Among the 19 patients who were taking corticosteroids at the start of Vyvgart, nine lowered their daily dose and four stopped taking them during Vyvgart treatment. The average daily dose of corticosteroids fell significantly by the third treatment cycle, with the largest drop seen in cycle five.

Treatment responses varied among patients

Treatment intervals remained generally stable, with only a slight increase in the time between cycles. “Partial symptom recurrence between the fourth administration and the subsequent first administration of the following cycle was generally modest,” the researchers wrote.

Individual responses varied. About half of the participants showed reductions in MG-ADL scores with each treatment cycle, followed by partial symptom recurrence, while 18.5% experienced a return to initial MG-ADL scores between treatment cycles.

Sustained improvement with little or no worsening between cycles was observed in 11% of patients, while no clinically meaningful improvement was seen in 15%. Four patients were switched to Zilbrysq (zilucoplan), another gMG-approved therapy, because of insufficient disease control.

During advanced therapy, three patients had impending myasthenic crises requiring plasma exchange, a rescue treatment, including two while receiving Vyvgart and one during Zilbrysq treatment after switching therapies. All had a history of frequent impending myasthenic crises. This suggested that patients with previous crises may need closer monitoring even while on advanced therapy.

Vyvgart was generally well tolerated. The most commonly reported adverse events were headache (33%), upper respiratory tract infections (22%), and skin changes (15%). No unexpected safety concerns were reported.

“Although limited by the small sample size, this real-world analysis indicates that [Vyvgart] may be a valuable option within individualized treatment strategies for gMG,” the researchers wrote. “Multicenter studies [following patients over time] are required to confirm these observations and further assess long-term effectiveness and safety.”