Johnson & Johnson to present 25 abstracts on Generalized Myasthenia Gravis at AANEM and MGFA 2024, featuring promising nipocalimab data

Johnson & Johnson announced that 25 abstracts featuring robust research to understand unmet needs in generalized myasthenia gravis (gMG) and evaluate nipocalimab as a potential advanced treatment option will be presented at the 2024 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of America (MGFA) Scientific Session from October 15-18, 2024 in Savannah, Georgia.

16 abstracts will be shared at the MGFA Scientific Session, including three oral presentations about nipocalimab, an investigational product:

• Positive results from the Phase 2/3 Vibrance-MG study of nipocalimab in adolescents living with gMG. (Abstract #MG100)
• New analyses from the Phase 3 Vivacity-MG3 study of nipocalimab in antibody-positive (anti-AChR+, anti-MuSK+ or, anti-LRP4+) adults reporting early improvement in clinical symptoms with nipocalimab after treatment initiation (e.g., 1 week), and sustained response over 8, 16, and 24 weeks. (Abstract #MG102)
• Assessment of nipocalimab as an immunoselective investigational therapy through the analysis of antibody levels detected in the blood after receiving certain vaccines, highlighting the potential ability to maintain a protective immune response even after reduction of IgG autoantibodies is observed. (Abstract #MG111)

The presentations also include real-world data on the patient experience and challenges associated with gMG, including negative impact of the disease on speaking, swallowing and breathing as well as factors associated with exacerbations of gMG, including mental health and challenges in managing the condition during pregnancy.

“The data to be presented at AANEM and MGFA highlight the unmet need that continues to exist for the broad population of people living with gMG as well as the clinical and biological profile of nipocalimab,” said Katie Abouzahr, M.D., Vice President, Autoantibody Portfolio and Maternal Fetal Immunology Disease Area Leader at Johnson & Johnson Innovative Medicine. “We remain committed to deepening our understanding of gMG and of nipocalimab in the potential treatment of this rare disease as we progress the study of this investigational FcRn therapy through a comprehensive clinical program.”

The full list of accepted Johnson & Johnson abstracts is below.

Data presentation highlights: MGFA Special Session – October 15
*Indicates also being presented as a poster at AANEM (Oct. 16-18)

Presenter/Presentation Time (ET) Poster Number	Abstract Name
Oral Session
Jonathan Strober, M.D. 10:24-10:31am* (MG100)	Safety and effectiveness of nipocalimab in adolescent participants in the open label Phase 2/3 Vibrance-MG clinical study
Tuan Vu, M.D. 10:38-10:45am* (MG102)	Efficacy and safety of nipocalimab in patients with generalized myasthenia gravis: topline results from the double-blind, placebo-controlled, randomized Phase 3 Vivacity-MG3 study
Faye Yu, BS 11:32-11:39am* (MG111)	Post-hoc analysis of clinically relevant anti-vaccine antibodies in participants treated with nipocalimab
Poster Session
MG4*	Assessing the suitability of the NeuroQoL Fatigue to evaluate fatigue in patients living with gMG
MG25	A randomized, open-label study on the effect of nipocalimab on vaccine responses in healthy participants
MG31	Disease burden in patients with generalized myasthenia gravis
MG52*	Leveraging AI to characterize mental health experiences throughout the myasthenia gravis diagnosis journey
MG53	Uncontrolled myasthenia gravis can contribute to additional stress burden and adverse mental health experiences
MG54	Sentiment analysis of digital conversations related to myasthenia gravis by race/ethnicity Data presentation highlights: AANEM-only – October 16-18
MG55*	Factors influencing exacerbations and crises in gMG: findings from a claims database study
MG56	Impact of race and social determinants of health on exacerbations in generalized myasthenia gravis
MG60*	Perinatal treatment patterns in myasthenia gravis
MG61*	Adverse pregnancy outcomes in myasthenia gravis: A retrospective cohort study in a US health insurance claims database
MG62	Partnering with patients and caregivers to guide the development of impactful study engagement tools in a generalized myasthenia gravis real world study
MG76	Post-hoc evaluation of the clinical effects of nipocalimab, a new neonatal fragment crystallizable blocker, over time in the Vivacity-MG 3 study
MG82	Symptom severity assessment using MG-ADL items and domains in a 24-week, Phase 3 study (Vivacity) of nipocalimab in gMG

 

Poster Number	Abstract Name
Poster Session
MyReg RWE (#143)	Treatment outcomes among patients with generalized myasthenia gravis in the Czech Republic: results from MYasthenia gravis REGistry (MyReg)
MG-REST Canada (#256)	Interim results for myasthenia gravis-resource utilization, epidemiology, survival & treatment patterns (MG-REST) study in Ontario, Canada

 

About Generalized Myasthenia Gravis (gMG)
Myasthenia gravis (MG) is an autoantibody disease in which the immune system mistakenly makes antibodies (e.g., anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK] or anti-low density lipoprotein-related protein 4 [LRP4]), which target proteins at neuromuscular junction and can block or disrupt normal signaling from nerves to muscles, thus impairing or preventing muscle contraction.^1,2