Johnson & Johnson Reports Positive Long-Term Data For Nipocalimab in Phase 3 Vivacity-MG3 Study

Today, Johnson & Johnson shared new findings from the Phase 3 Vivacity-MG3 clinical trial and its ongoing open-label extension (OLE). The trial evaluated nipocalimab in adults with generalised myasthenia gravis (gMG) who are positive for specific antibodies (anti-AChR, anti-MuSK, or anti-LRP4). Patients who received nipocalimab in combination with standard care (SOC) showed a sustained improvement in MG-ADL (activities of daily living) and QMG (quantitative myasthenia gravis) scores for up to 84 weeks, along with an ongoing reduction in total IgG levels, indicating long-term clinical benefit and durable response. 

This data will be included in a presentation-Session 7 #022. It is among 12 abstracts that Johnson & Johnson will present at the American Academy of Neurology (AAN) 2025 Meeting in San Diego, California, which includes an oral presentation on QMG score improvements from the double-masked phase of the Phase 3 Vivacity-MG3 study.

"The sustained disease control seen over 84 weeks for nipocalimab is a key result given the chronic course of generalised MG and the significant burden on people living with this condition. Overall, I am encouraged by these results that show improvement in disease control as measured by the MG-ADL and QMG scores across a broad population seropositive for AChR, MuSK, or LRP4 autoantibodies," said Constantine Farmakidis, M.D., Associate Professor of Neurology at the University of Kansas Medical Centre. "

Results also highlighted a notable steroid-sparing effect, as 45% of patients on corticosteroids at the start of the OLE could reduce or discontinue their steroid dose by more than half. In this group, prednisone use dropped from 23 mg/day to 10 mg/day, suggesting that nipocalimab may reduce dependence on immunosuppressants. The treatment maintained a consistent and tolerable safety profile throughout the extension phase.

Katie Abouzahr, M.D., Vice President, Autoantibody Portfolio and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson Innovative Medicine, commented, "People living with generalised MG around the world endure daily challenges, such as difficulties swallowing, impaired speech and muscle weakness. They deserve additional, effective treatment options that help address these challenges and provide sustained disease control and stability over time. These positive data underscore our commitment to helping develop potential innovative therapeutic options for patients living with autoantibody diseases, including gMG." 

In the double-masked portion of the study, patients treated with nipocalimab plus SOC showed a statistically significant QMG score improvement of -4.9 compared to placebo (p<0.001), with four times greater likelihood of sustained symptom improvement at 20 weeks. Notably, 36.4% of nipocalimab-treated patients spent more than 75% of the trial period with symptom improvements, versus only 10.5% in the placebo group. These improvements reflect better muscle strength, enabling patients to perform critical daily functions like swallowing and chewing.