Long-term follow-up of the phase 3 Vivacity-MG3 trial has shown nipocalimab’s benefits in antibody-positive generalised myasthenia gravis (gMG) are sustained over time, researchers told the European Academy of Neurology 2026 Congress.
Post-hoc analyses also showed symptom improvements held up even when patients caught common infections, offering reassurance about using the monoclonal antibody during periods when disease exacerbations are more likely.
A key advantage of nipocalimab, and the broader neonatal Fc receptor (FcRn) class of drugs it belongs to, is how quickly it works, said Professor Heinz Wiendl, a neurologist and director of the Department of Neurology and Neurophysiology at University Hospital Freiburg.
“Fast onset immune therapies act within days or weeks, which is usually only seen with corticosteroids or plasma exchange,” he told delegates, noting this makes it easier for clinicians to judge efficacy quickly.
“You are seeing the consequences of what you are doing quite nicely and fast. You can have readouts within weeks.”
Professor Wiendl said another benefit was that nipocalimab kept working reliably over time. Unlike some other therapies, he said, it did not disrupt the body’s broader immune regulation. It also bound more tightly to its target than comparable treatments, meaning a lower dose could still deliver strong, lasting effects.
“It reduces immunoglobulins extremely fast but also in a very sustainable way, because it is given every two weeks,” he said.
Nipocalimab was highly efficient, sharply curtailed symptom expression, allowed patients to reduce corticosteroids, and had a strong safety profile, said Dr Carl Antozzi, lead investigator of Vivacity-MG3 and head of the functional neuroimmunology department at the IRCCS Neurological Institute Foundation in Milan.
Up to 75% of patients saw a reduction in immunoglobulin G (IgG) levels after the first dose, he told the EAN audience, while half of all patients achieved minimal symptom expression during the study. Long-term improvements on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale persisted through week 96 of the open-label extension.
Among patients taking corticosteroids at the open-label baseline, 45% were able to decrease or discontinue their use by the data cut-off, Dr Antozzi said, with the mean prednisone-equivalent dose falling from 23mg to 10mg per day.
“gMG remains a severe disease, underscoring the need for treatment goals grounded in patient experience,” Dr Antozzi said, adding that nipocalimab was best given as early as possible in the disease course.