Nipocalimab Shows Sustained Disease Control and Symptom Improvement in 2-Year Extension Study

Researchers presented new data of nipocalimab (Imaavy; Johnson & Johnson) from the phase 3 Vivacity-MG3 study (NCT04951622) and its ongoing open-label extension (OLE) at the recently concluded 2026 American Academy of Neurology (AAN) Annual Meeting, held April 18–22 in Chicago, Illinois. Findings showed that treatment with nipocalimab demonstrated sustained disease control, continued symptom improvement, and a consistent safety profile in adults with antibody-positive generalized myasthenia gravis (gMG) over a 2-year period.¹

At 96 weeks in the OLE, results revealed that treatment with nipocalimab was associated with sustained improvements in clinical outcomes, including Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores, among participants with gMG. Investigators reported that the mean changes from baseline were −6.47 points for MG-ADL (SE, 1.20; P <.001) and −5.97 points for QMG (SE, 1.28; P <.001), consistent with sustained improvement over time.

“For people living with gMG, consistent and durable symptom control is the central goal of treatment,” Constantine Farmakidis, MD, associate professor of neurology at the University of Kansas Medical Center, said in a statement.¹ “These long-term results, now extending to beyond two years, provide further evidence that disease control, as initially observed in the nipocalimab phase 3 pivotal study, can be sustained, and add to the body of evidence that may help guide clinical decision-making.”

In April 2025, FDA approved nipocalimab for the treatment of adults and pediatric patients aged 12 years and older with gMG who are antiacetylcholine receptor or anti-muscle-specific kinase antibody positive. Nipocalimab, an FcRn blocking therapy, is supplied as a 300 mg/1.62 mL and a 1200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection. Findings from the phase 3 VIVACITY-MG3 study, a double-blind, placebo-controlled trial, served as the basis for the approval.²

The Vivacity-MG3 study evaluated the efficacy and safety of a fixed dosing regimen of nipocalimab in adults with gMG. The study enrolled 199 adult patients with gMG who had an inadequate response to standard-of-care (SOC) therapy. Of these participants, 153 were antibody-positive. Patients were randomized in a 1:1 ratio to receive either nipocalimab plus SOC or placebo plus SOC during a 24-week, double-blind, placebo-controlled treatment period. Participants assigned to the active treatment arm received a 30 mg/kg intravenous loading dose of nipocalimab followed by 15 mg/kg administered every 2 weeks, in addition to ongoing SOC therapy.

Coming into the extension, baseline demographic and clinical characteristics were generally balanced between the 2 treatment groups (nipocalimab, n = 77; placebo, n = 76). The primary end point of the study was the difference between treatment groups in mean change from baseline in MG-ADL scores, assessed across weeks 22, 23, and 24. A key secondary end point was the change from baseline in QMG score over the same time period. Following completion of the double-blind phase, patients continued into an ongoing OLE phase, in which long-term safety and efficacy outcomes are being further evaluated.

Regarding patient-reported symptom burden, new findings showed that 50% of patients (n = 153) achieved minimal symptom expression (MSE), and 32% maintained sustained MSE for at least 8 weeks during treatment. In addition, reductions in corticosteroid use were observed, with 57% of patients reaching daily doses of at most 10 mg or at most 5 mg over the course of the OLE.

READ MORE: Cemdisiran Shows Therapeutic Potential in Phase 3 NIMBLE Trial for Generalized Myasthenia Gravis

Pharmacodynamic analyses showed a greater than 64% reduction in total immunoglobulin G, including pathogenic autoantibodies implicated in disease activity (n = 31; SD, 12.91). No unexpected adverse events (AEs) were reported during the OLE. The most frequently observed AEs included muscle spasms, peripheral edema, increased lipid levels, and decreased serum albumin.

A post hoc analysis of the 24-week double-blind portion of the study assessed the relationship between sustained MSE and quality of life outcomes, as measured by the Myasthenia Gravis Quality of Life-15 revised (MG-QoL-15r) instrument. Patients receiving nipocalimab in combination with SOC were more likely to achieve sustained MSE compared with those receiving placebo plus SOC. The likelihood of achieving sustained MSE was approximately 4 times higher in the nipocalimab group (OR, 4.35; 95% CI, 1.37–13.81; P = .013).

Among patients who achieved sustained MSE at 24 weeks, those with maintained symptom control demonstrated greater improvements in day-to-day quality of life compared with other response patterns. Specifically, the mean change in MG-QoL-15r scores was −12.7 (n = 19; P <.001) in patients with sustained MSE, compared with −8.7 (n = 14; P = .016) in those with improvements that were not sustained, and −4.1 (n = 96; P <.001) in patients who did not achieve MSE.

“These long-term findings for nipocalimab reflect continued momentum in transforming the treatment landscape for people living with generalised myasthenia gravis,” Mark Graham, PhD, Therapeutic Area Head, Immunology, Europe, Middle East and Africa Johnson & Johnson, said in a statement.¹ “Evidence demonstrating sustained disease control alongside sustained improvements in quality of life underscores our progress toward more effective treatment options. We remain committed to advancing innovative approaches that address persistent unmet needs and improve long-term outcomes for patients.”

Nipocalimab will also be assessed in the phase 3 head-to-head EPIC trial, will address whether the agent provides superior efficacy to efgartigimod (Vyvgart; argenx) in the latter part of efgartigimod treatment cycles in gMG.³ EPIC, considered the first randomized trial testing advanced therapeutics in patients with gMG, will include 80 FcRn-naïve adult participants who have a MG-ADL score of greater than or equal to 5. In the trial, patients are randomized 1:1 to either nipocalimab every 2 weeks for 12 weeks (arm 1) or efgartigimod weekly at 10 mg/kg for 4 weeks (arm 2).

The study also features an experimental, switching arm, where participants previously treated with efgartigimod in arm 2, as well as those with at least 1 on-label efgartigimod cycle, can crossover to nipocalimab, where they are treated for 12 weeks. This cohort, considered arm 3, excludes those who have a current or recent malignancy, a thymectomry in the past year, or any confirmed, suspected, or familial immunodeficiency unrelated to gMG treatment.

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REFERENCES
1. IMAAVY® (nipocalimab)▼shows over two years of sustained disease control in a broad population with generalised myasthenia gravis (gMG). News release. April 23, 2026. Johnson & Johnson. Accessed April 27, 2026. https://www.jnj.com/innovativemedicine/emea/media-center/press-releases/imaavy-nipocalimab-shows-over-two-years-of-sustained-disease-control-in-a-broad-population-with-generalised-myasthenia-gravis-gmg
2. Johnson & Johnson receives FDA approval for IMAAVY™ (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG). News release. Johnson & Johnson. April 30, 2025. Accessed April 28, 2026. https://www.prnewswire.com/news-releases/johnson--johnson-receives-fda-approval-for-imaavy-nipocalimab-aahu-a-new-fcrn-blocker-offering-long-lasting-disease-control-in-the-broadest-population-of-people-living-with-generalized-myasthenia-gravis-gmg-302442650.html
3. Johnson & Johnson announces first head-to-head study comparing IMAAVY™ with an alternative FcRn blocker in generalized myasthenia gravis (gMG) at AANEM Annual Meeting. News release. Johnson & Johnson. October 29, 2025. Accessed April 27, 2026. https://www.prnewswire.com/news-releases/johnson--johnson-announces-first-head-to-head-study-comparing-imaavy-with-an-alternative-fcrn-blocker-in-generalized-myasthenia-gravis-gmg-at-aanem-annual-meeting-302597514.html