Expanding Patient Expectations When Managing Generalized Myasthenia Gravis: A Treating Physician’s Experience with IMAAVY™ (nipocalimab-aahu)

Sponsored by: Johnson & Johnson

The treatment landscape for patients living with generalized myasthenia gravis (gMG) has drastically evolved over the last two and a half decades. This is fantastic news for the roughly 100,000 people in the U.S. living with this chronic neuromuscular disease that causes debilitating symptoms like muscle weakness in the arms and legs, slurred speech, double vision, and can even lead to difficulty swallowing and breathing.

When I started the Myasthenia Program at the University of Minnesota in 1999, the treatment options were primarily corticosteroids and long-term immunosuppressants. Today, there are more than a dozen options available in the US to treat gMG and the advent of newer therapies has revolutionized our approach to caring for people living with this disease. We’ve been able to move toward more targeted treatments that help improve symptoms with fewer side effects and not as broad an impact on the immune system.

Now, the challenge for many providers is adapting their prescribing habits to the rapidly evolving gMG treatment landscape and ensuring that patients who are candidates for safe and effective advanced options do not remain on suboptimal treatments.

FcRn Blockers: Changing the game for MG patients

The introduction of FcRn blockers has been a particular game changer. This class of treatments block the neonatal Fc receptor (FcRn), effectively reducing the body’s levels of circulating pathogenic immunoglobulin G (IgG) autoantibodies by accelerating their degradation. These medications offer a more targeted approach to reducing IgG levels than broad immunosuppressants, with a narrower impact on the body’s immune system, allowing us to better manage both disease and side effect burden. They also come with fewer logistical barriers to treatment initiation, as there are no vaccination requirements like those associated with other targeted treatments.

Continuously innovating within the FcRn class

As treatment options for gMG have grown, so too have my and my patients’ expectations for disease control. While clinically their disease may seem effectively managed, these patients often worry about symptom control. Many of my patients are looking for symptom control options that may better work with their lifestyle or that offer consistent dosing and a schedule they can plan around.

Several of my patients are currently seeing positive results with the latest FcRn blocker, IMAAVY^™ (nipocalimab-aahu), which is approved for the broadest population of people living with gMG—patients who are 12 and older with anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody-positive gMG. This therapy is the only fully human FcRn-blocking monoclonal antibody that is designed for long-lasting, high-affinity and high-specificity binding that enables the reduction of circulating IgG.

In a Phase 3 clinical trial, patients given IMAAVY^™ and standard of care (SOC) therapy consistently every two weeks experienced superior disease control that didn’t fade when compared to placebo and SOC over 24 weeks. Patients also experienced a 4.7-point mean improvement in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score from baseline to Weeks 22, 23, and 24 in comparison to patients taking placebo and SOC who saw a 3.3-point mean improvement.

In the same pivotal study, the safety of IMAAVY^™ plus SOC was evaluated versus placebo and SOC and the most common adverse reactions for patients with gMG treated with IMAAVY^™ were respiratory tract infections, peripheral edema, and muscle spasms.

In my practice, I've had patients start taking IMAAVY^™ who report increased ability to perform everyday activities like chewing, swallowing, and getting up from a chair. These same patients were previously unable to go periods of time without seeing their gMG symptoms return.

The importance of treatment options for gMG patients

With so many treatment options available, my approach to finding the right one for my patients gets personal. I spend a lot of time understanding my gMG patients—their occupations, their lifestyles, their favorite activities—because what at first looks like a mild gMG symptom could be having a major impact on a person’s daily life. It’s important to stay aware of your MG patients’ needs and how their symptoms are impacting them so you can partner to select the right treatment.

We are definitely in the midst of an exciting era where our understanding of gMG and targeted therapies to treat it will only continue to grow. I believe FcRn blockers like IMAAVY^™ will become foundational for patients looking for persistent symptom relief and I encourage clinicians to consider IMAAVY™ as part of a modern, patient-centric gMG treatment strategy.

If you treat gMG patients, visit IMAAVYhcp.com for more information on IMAAVY™.

In consideration of the time spent participating in the development of this article, Dr. Suraj Muley was paid honoraria by Johnson & Johnson.

INDICATION

IMAAVY^™ (nipocalimab-aahu) is a neonatal Fc receptor (FcRn) blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

IMAAVY^™ is contraindicated in patients with a history of serious hypersensitivity reaction to nipocalimab-aahu or to any of the excipients in IMAAVY™. Reactions have included anaphylaxis and angioedema.

WARNINGS AND PRECAUTIONS

Infections

IMAAVY^™ may increase the risk of infection, including serious and severe infections. The most common infections observed in Study 1 and its extension study in patients treated with IMAAVY^™ for gMG were upper respiratory tract infection (46%), respiratory tract infections (28%; including pneumonia, bronchitis, COVID-19), urinary tract infection (15%), herpes (8%; including herpes simplex, herpes zoster, herpes zoster oticus), influenza (8%), oral infection (8%; including candidiasis and dental infections), and skin infection (7%; including cellulitis). Two cases of infections (1%; including cellulitis and urinary tract infection) led to discontinuation of IMAAVY^™. Delay IMAAVY^™ administration in patients with an active infection until the infection is resolved. During treatment with IMAAVY^™, monitor for clinical signs and symptoms of infection. If serious infection occurs, administer appropriate treatment and consider withholding IMAAVY^™ until the infection has resolved.

Patients treated with IMAAVY^™ may be at an increased risk of activation of latent viral infections. Follow standard vaccination guidelines.

Immunization: Evaluate the need to administer age-appropriate vaccinations before initiation of treatment with IMAAVY^™. The safety of immunization with live vaccines and the immune response to vaccination during treatment with IMAAVY^™ are unknown. Live vaccines are not recommended during treatment with IMAAVY^™.

Hypersensitivity Reactions

Administration of IMAAVY^™ may result in hypersensitivity reactions, including angioedema, anaphylaxis, rash, urticaria, and eczema. Management of hypersensitivity reactions depends on the type and severity of the reaction. Monitor the patient during treatment and for 30 minutes after administration. If a hypersensitivity reaction occurs during administration, discontinue IMAAVY^™ infusion and institute appropriate supportive measures if needed.

Infusion-Related Reactions

Administration of IMAAVY^™ may result in infusion-related reactions, including headache, influenza-like illness, rash, nausea, fatigue, dizziness, chills, and erythema. Monitor the patient during treatment and for 30 minutes after each infusion. If a severe infusion-related reaction occurs, discontinue IMAAVY^™ infusion and initiate appropriate therapy. Consider the risks and benefits of readministering IMAAVY^™ following a severe infusion-related reaction. If a mild to moderate infusion-related reaction occurs, patients may be rechallenged with close clinical observation, slower infusion rates, and pre-medication.

ADVERSE REACTIONS

Most common (>10% of patients) adverse reactions associated with IMAAVY^™ include: respiratory tract infection, peripheral edema, and muscle spasms.

Adverse reactions in >5% of patients taking IMAAVY^™ include: urinary tract infection, herpes zoster and simplex infection, oral infection, hypersensitivity reaction, abdominal pain, back pain, pyrexia, diarrhea, cough, anemia, dizziness, nausea, hypertension, and insomnia.

Laboratory Findings

Lipid Increases: In a clinical study, patients treated with IMAAVY^™ had elevations from normal to high of fasting total and LDL cholesterol and decreases from normal to low of fasting HDL cholesterol.

Pediatric Patients 12 Years of Age and Older

Adverse reactions in pediatric patients were consistent with those observed in adult patients with gMG.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are limited data on the use of IMAAVY^™ in pregnant women with gMG. IMAAVY^™ reduces maternal serum IgG concentration and impedes placental IgG transfer to the fetus. Risks and benefits should be considered prior to administering live vaccines to infants exposed to IMAAVY^™ in utero.

Lactation: Nipocalimab-aahu is excreted in human colostrum and breastmilk. There are insufficient data on the effect of IMAAVY^™ in the breastfed infant. There are no data on the effect of nipocalimab-aahu on milk production.

Pediatric Use: The safety and effectiveness of IMAAVY^™ for the treatment of gMG in pediatric patients below the age of 12 years have not been established.

Please see the full Prescribing Information and Medication Guide for IMAAVY^™.
Provide the Medication Guide to your patients and encourage discussion.

Dosage Form and Strengths: IMAAVY^™ is supplied as a 300 mg/1.62 mL(185 mg/mL) and a
1,200 mg/6.5 mL(185 mg/mL) single-dose vial per carton for intravenous use after dilution.

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