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Johnson & Johnson highlights new data, demonstrating long-term sustained disease control in adults living with generalised myasthenia gravis (gMG)

April 8, 2025 – Clinical Trials, Other, Pharmaceutical – Johnson & Johnson, Johnson & Johnson Innovative Medicine, clinical trials, generalised myasthenia gravis, immunoglobin G antibodies

New compelling results demonstrate 18 months of both sustained reduction in immunoglobulin G antibodies and sustained improvement in gMG symptoms in pivotal Vivacity-MG3 study and open label extension phase
Up to 128 weeks and 180 patient years of follow-up in the open label extension phase demonstrates a safety profile consistent with the Phase 3 Vivacity-MG3 study
45% of the patients receiving steroids at open label extension baseline were able to decrease or discontinue their steroid use
Additionally, the nipocalimab plus standard of care (SOC) group demonstrated four times greater odds of improving and maintaining the strength and function of different muscle groups as measured by QMG response versus placebo plus SOC in the 24-week double blind phase of the study.

8 April 2025 — Beerse, Belgium — Janssen-Cilag International NV, a Johnson & Johnson company, today announced results from additional analyses of the Phase 3 Vivacity-MG3 double-blind study and the ongoing open label extension (OLE), evaluating the long-term efficacy and safety of nipocalimab in a broad population of antibody-positive (anti-AChR+, anti-MuSK+, anti-LRP4+) adults with generalised myasthenia gravis (gMG). Patients treated with nipocalimab plus standard of care (SOC) maintained improvements in their MG-ADL and QMG scores over 84 weeks with sustained reductions in total IgG. These data are included in a presentation (Session 7 #022) and are among 12 abstracts that Johnson & Johnson will present at the American Academy of Neurology (AAN) 2025 Congress in San Diego, California, which includes an oral presentation on QMG score improvements from the double-blind phase of the 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,” said Constantine Farmakidis M.D., Associate Professor of Neurology at University of Kansas Medical Center. “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.”

Nipocalimab demonstrated a mean change in MG-ADL of -5.64 (p<0.001) from double-blind baseline after 60 weeks in the OLE for study participants receiving nipocalimab and SOC, and -6.01 (p<0.001) mean change for study participants who transitioned from placebo and SOC to nipocalimab and SOC. In the antibody-positive population, 45% of patients receiving steroids at the OLE baseline were able to decrease or discontinue steroids at the time of this data cut by more than half of the baseline dose. Among these patients, the mean dose of prednisone decreased from 23 to 10 mg per day. Nipocalimab had a consistent and tolerable safety profile throughout the OLE.

“Estimated to impact between 56,000 and 123,000 people across Europe, there remains a significant unmet need to expand our understanding of gMG and subsequently create additional effective therapies for patients who continue to experience the devastating symptoms of this chronic disease,” said Mark Graham, Senior Director, Therapeutic Area Lead, Immunology, Johnson & Johnson Innovative Medicine EMEA. “The promising results presented at this year’s AAN congress highlight our dedication to broadening the treatment landscape for people affected by autoantibody diseases, including gMG, and could offer a renewed hope for their future care.”

Additional findings from the Phase 3 Vivacity-MG3 double-blind study indicate that patients treated with nipocalimab plus SOC achieved statistically significant improvements in their QMG score by -4.9 versus placebo plus SOC (p<0.001) over weeks 22 and 24. Patients in the nipocalimab plus SOC treatment group were four times more likely to sustain symptom improvement at 20 weeks compared to the placebo plus SOC group, as measured by a three or greater point improvement on the QMG score. Results show significantly more patients treated with nipocalimab (36.4%,) versus placebo (10.5%, p<0.001) spent greater than 75% of study duration demonstrating improvements in the QMG score. A reduction of more than three points in the QMG score indicates a decrease in the severity of the patient’s symptoms as a result of improvements in muscle strength, allowing patients to carry out important daily activities such as swallowing and chewing.

“People living with gMG 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,” said Katie Abouzahr, M.D., Vice President, Autoantibody Portfolio and Maternal Fetal Immunology Disease Area Leader, Johnson & Johnson Innovative Medicine. “These positive data underscore our commitment to helping develop potential innovative therapeutic options for patients living with autoantibody diseases, including gMG.”

ABOUT JOHNSON & JOHNSON

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at www.innovativemedicine.jnj.com/emea/.