Johnson & Johnson announces results from Vivacity-MG3 study

Johnson & Johnson announced results from additional analyses of the Phase 3 Vivacity-MG3 double-blind study and the ongoing open-label extensiona, evaluating the long-term efficacy and safety of investigational nipocalimab in a broad population of antibody-positive adults with generalized myasthenia gravis. Patients treated with nipocalimab plus standard of care maintained improvements in their MG-ADLc and QMGb scores over 84 weeks with sustained reductions in total immunoglobulin G (IgG).1 These data are included in a presentation and are among 12 abstracts that Johnson & Johnson will present at the American Academy of Neurology 2025 Meeting in San Diego, California, which includes an oral presentation on QMG score improvements from the double-blind phase of the Phase 3 Vivacity-MG3 study. Nipocalimab demonstrated a mean change in MG-ADL of -5.64 from the double-blind baseline after 60 weeks in the OLE for study participants receiving nipocalimab and SOC, and -6.01 mean change for study participants who transitioned from placebo and SOC to nipocalimab and SOC.1 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.1 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 phase. 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 over weeks 22 and 24.2 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.2 Results show significantly more patients treated with nipocalimab versus placebo 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.