Nipocalimab Sustains Disease Control Over 84 Weeks in Patients With gMG

Key Takeaways

Nipocalimab showed sustained improvements in MG-ADL and QMG scores over 84 weeks in gMG patients.
The investigational antibody reduces circulating IgG levels without impacting other immune functions.
The trial demonstrated a reduction in steroid use, with a consistent safety profile comparable to placebo.
Nipocalimab has received FDA priority review, highlighting its potential as a novel gMG treatment.

Nipocalimab with standard of care helped patients with generalized myasthenia gravis (gMG) maintain improvements in daily living and quantitative scores compared with placebo.

Patients with generalized myasthenia gravis (gMG) who were treated with nipocalimab (Johnson & Johnson) plus standard of care had maintained improvements in Myasthenia Gravis Activities of Daily Living (MG-ADL) and quantitative myasthenia gravis (QMG) scores over an 84-week duration, according to updated data presented at the 2025 American Academy of Neurology (AAN) Annual Meeting. These results are from analyses of the phase 3 clinical trial, Vivacity-MG3 (NCT04951622). Additionally, nipocalimab-treated patients also had sustained reductions in total immunoglobulin G (IgG).^1,2

Image credit: sudok1 | stock.adobe.com

Nipocalimab is an investigational monoclonal antibody that is designed to bind with high affinity to block FcRn, reducing levels of circulating IgG antibodies while potentially not impacting other immune functions, including autoantibodies and alloantibodies, which underlie multiple conditions across 3 key segments. Its biologics license application was granted a priority review by the FDA in January 2025, and prior to this action, it received a fast track designation in December 2021 and an orphan drug designation in February 2021.^1,3

MG is an autoantibody disease in which the immune system mistakenly makes antibodies that target proteins at the neuromuscular junction and can block or disrupt normal signaling from nerves to muscles; therefore, impairing or preventing muscle contraction. The disease impacts an estimated 700,000 people worldwide and affects both men and women as well as all ages and racial and ethnic groups; however, MG most frequently begins in young women and older men. Approximately 50% of individuals diagnosed with MG are women, and 10% to 15% of new cases are diagnosed in adolescents aged 12 to 17 years. Among juvenile patients with MG, girls are affected more often than boys, with over 65% of pediatric MG cases in the US diagnosed in girls.^1,3

gMG is specifically characterized by severe muscle weakness of the skeletal muscles and difficulties in speech and swallowing. Vulnerable populations (eg, pediatric patients) have more limited therapeutic options, with current standard-of-care treatments being generalized from adult trials. Outside of symptomatic treatments, there are no FDA-approved FcRn blockers for adolescents with gMG in the US.¹

"People living with gMG around the world endure daily challenges, such as difficulties swallowing, impaired speech, and muscle weakness" said Katie Abouzahr, MD, vice president, leader, Autoantibody Portfolio and Maternal Fetal Immunology Disease Area, Johnson & Johnson Innovative Medicine, in a news release.¹ "They deserve additional, effective treatment options that help address these challenges and provide sustained disease control and stability over time."

Vivacity-MG3 (NCT04951622) is a randomized, double-blind, placebo-controlled phase 3 trial that enrolled adult patients aged 18 years and older with gMG inadequately controlled with standard-of-care therapy. These patients were randomly assigned to receive standard-of-care therapy in addition to either nipocalimab (30 mg/kg loading dose, then 15 mg/kg doses every 2 weeks) or placebo infusions (every 2 weeks). The primary end point of the study was mean change in MG-ADL score from baseline over weeks 22, 23, and 24 in antibody-positive patients. A key secondary end point was change in QMG score, and long-term safety and efficacy were further assessed in an ongoing open-label extension (OLE) phase.^1,4

Nipocalimab demonstrated a mean change in MG-ADL of about –5.64 (P < .001) from the double-blind baseline after 60 weeks in the OLE and a –6.01 (P < .001) mean change for those who transitioned from placebo to nipocalimab. In addition, in the antibody-positive population, approximately 45% of patients receiving steroids at the OLE baseline were able to decrease or discontinue at the time of data cutoff by more than half of the baseline dose. Among these patients, the mean dose of prednisone decreased from about 23 to 10 mg per day. Nipocalimab also demonstrated a consistent and tolerable safety profile throughout the OLE phase.¹

"The sustained disease control seen over 84 weeks for nipocalimab is a key result given the chronic course of gMG and the significant burden on people living with this condition," Constantine Farmakidis, MD, associate professor of neurology at University of Kansas Medical Center, said in the news release. "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."¹

About the Trial

Trial Name: A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

ClinicalTrials.gov ID: NCT04951622

Sponsor: Janssen Research & Development, LLC

Completion Date (Estimated): April 17, 2026

In earlier data⁴, adverse events (AEs) were observed to be similar between the nipocalimab and placebo groups (n = 82; 84% in both groups), with infections (n = 42; 43% in both groups) and headache (nipocalimab: n = 14, 14%; placebo: n = 17; 17%) being the most common. Further, serious AEs were observed in 9 patients (9%) in the nipocalimab group and 14 (14%) in the placebo group, of which 3 had a fatal outcome (nipocalimab: myasthenic crisis; placebo: cardiac arrest and myocardial infarction).⁴

"These positive data underscore our commitment to helping develop potential innovative therapeutic options for patients living with autoantibody diseases, including gMG,” said Abouzahr in the news release.¹

REFERENCES

1. PR Newswire. Johnson & Johnson highlights new data that showcase the strength of nipocalimab, demonstrating long-term sustained disease control in adults living with generalized myasthenia gravis (gMG). News release. April 8, 2025. Accessed April 11, 2025. https://www.prnewswire.com/news-releases/johnson--johnson-highlights-new-data-that-showcase-the-strength-of-nipocalimab-demonstrating-long-term-sustained-disease-control-in-adults-living-with-generalized-myasthenia-gravis-gmg-302422509.html

2. A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis. ClinicalTrials.gov identifier: NCT04951622. Updated April 4, 2025. Accessed April 11, 2025. https://clinicaltrials.gov/study/NCT04951622

3. McGovern G. FDA Grants Priority Review to Nipocalimab as Potential Treatment of Generalized Myasthenia Gravis. Pharmacy Times. January 13, 2025. Accessed April 11, 2025. https://www.pharmacytimes.com/view/fda-grants-priority-review-to-nipocalimab-as-potential-treatment-of-generalized-myasthenia-gravis

4. Antozzi C, Vu T, Ramchandren S, et al. Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. The Lancet Neurology. 2025;24(2):105–116. doi:10.1016/S1474-4422(24)00498-8