Study design

The efficacy and safety of VYVGART Hytrulo for the treatment of adults with CIDP was demonstrated in the ADHERE study1-3

CIDP=chronic inflammatory demyelinating polyneuropathy.

ADHERE: the largest CIDP trial ever conducted, in 322 adult patients with active disease1-3

*The study stopped when 88 events of clinical deterioration occurred for the primary endpoint analysis.

aINCAT=adjusted Inflammatory Neuropathy Cause and Treatment; CIDP=chronic inflammatory demyelinating polyneuropathy; I-RODS=Inflammatory Rasch-built Overall Disability Scale; IVIG=intravenous immunoglobulin; kPa=kilopascals; SC=subcutaneous; SCIG=SC immunoglobulin; QW=once weekly.

Participants eligible to roll over to the open-label extension (OLE) safety study included those who5:

  • Experienced clinical deterioration in the randomized withdrawal period
  • Completed week 48 of the randomized withdrawal period without deterioration
  • Were in the open-label or the randomized withdrawal period and ongoing at the time of the 88th event
  • Were in the run-in period at the time of the 88th event after performing an early discontinuation visit
OLE graphic: Circular infographic depicting a 99% completion rate.

of eligible patients elected to enter ADHERE+ OLE (n=226/228)6

Baseline characteristics of the randomized withdrawal period were similar between treatment groups1

Baseline Characteristics
Baseline Characteristics
BASELINE PATIENT CHARACTERISTICS

VYVGART Hytrulo was studied in a population with a range of treatment histories and disease activities2

Initial treatment period (stage A) patient demographics chart
stage a patient characteristicss vyvgart hytrulo

aINCAT=adjusted Inflammatory Neuropathy Cause and Treatment; CIDP=chronic inflammatory demyelinating polyneuropathy; I-RODS=Inflammatory Rasch-built Overall Disability Scale; IVIG=intravenous immunoglobulin; kPa=kilopascals; SCIG=subcutaneous immunoglobulin.

BASELINE PATIENT CHARACTERISTICS1,2
Randomized withdrawal period (stage B) patient demographics chart
stage paitent

aINCAT=adjusted Inflammatory Neuropathy Cause and Treatment; CIDP=chronic inflammatory demyelinating polyneuropathy; I-RODS=Inflammatory Rasch-built Overall Disability Scale; IVIG=intravenous immunoglobulin; kPa=kilopascals; SCIG=subcutaneous immunoglobulin.

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IMPORTANT SAFETY INFORMATION AND INDICATION
CONTRAINDICATIONS

VYVGART HYTRULO is contraindicated in patients with serious hypersensitivity to efgartigimod alfa products, to hyaluronidase, or to any of the excipients of VYVGART HYTRULO. Reactions have included anaphylaxis and hypotension leading to syncope.

WARNINGS AND PRECAUTIONS
Infection

VYVGART HYTRULO may increase the risk of infection. The most common infections observed in Study 1 in patients with gMG were urinary tract infection (10% of efgartigimod alfa-fcab-treated patients vs 5% of placebo-treated patients) and respiratory tract infections (33% of efgartigimod alfa-fcab-treated patients vs 29% of placebo-treated patients). Patients on efgartigimod alfa-fcab vs placebo had below normal levels for white blood cell counts (12% vs 5%, respectively), lymphocyte counts (28% vs 19%, respectively), and neutrophil counts (13% vs 6%, respectively). The majority of infections and hematologic abnormalities were mild to moderate in severity. Delay VYVGART HYTRULO administration in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding VYVGART HYTRULO until the infection has resolved.

Immunization

Immunization with vaccines during VYVGART HYTRULO treatment has not been studied; the safety with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because VYVGART HYTRULO causes a reduction in immunoglobulin G (IgG) levels, vaccination with live-attenuated or live vaccines is not recommended during VYVGART HYTRULO treatment. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART HYTRULO.

Hypersensitivity Reactions

In clinical trials, hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in patients treated with VYVGART HYTRULO or intravenous efgartigimod alfa-fcab. Urticaria was also observed in patients treated with VYVGART HYTRULO. Hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration, and did not lead to treatment discontinuation in gMG. Anaphylaxis and hypotension leading to syncope have been reported in postmarketing experience with intravenous efgartigimod alfa-fcab. Anaphylaxis and hypotension occurred during or within an hour of administration and led to infusion discontinuation and in some cases to permanent treatment discontinuation. Healthcare professionals should monitor for clinical signs and symptoms of hypersensitivity reactions for at least 30 minutes after administration. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention.

Infusion-Related Reactions

Infusion-related reactions have been reported with intravenous efgartigimod alfa-fcab in postmarketing experience. The most frequent symptoms and signs were hypertension, chills, shivering, and thoracic, abdominal, and back pain. Infusion-related reactions occurred during or within an hour of administration and led to infusion discontinuation. If a severe infusion-related reaction occurs, initiate appropriate therapy. Consider the risks and benefits of readministering VYVGART HYTRULO 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-medications.

ADVERSE REACTIONS

Patients with gMG: In Study 1, the most common (≥10%) adverse reactions in efgartigimod alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. In Study 2, the most common (≥10%) adverse reactions in VYVGART HYTRULO-treated patients were injection site reactions and headache. Injection site reactions occurred in 38% of VYVGART HYTRULO-treated patients, including injection site rash, erythema, pruritus, bruising, pain, and urticaria. In Study 2 and its open-label extension in patients with gMG, all injection site reactions were mild to moderate in severity and did not lead to treatment discontinuation. The majority occurred within 24 hours after administration and resolved spontaneously. Most injection site reactions occurred during the first treatment cycle, and the incidence decreased with each subsequent cycle.

Patients with CIDP: In Study 3 stage B, the overall safety profile observed in patients with CIDP treated with VYVGART HYTRULO was consistent with the known safety profile of VYVGART HYTRULO and of efgartigimod alfa-fcab administered intravenously. In Study 3, injection site reactions occurred in 15% of patients treated with VYVGART HYTRULO compared to 6% of patients who received placebo. The most common of these injection site reactions were injection site bruising and injection site erythema. All injection site reactions were mild to moderate in severity. Most injection site reactions occurred during the first 3 months of treatment.

USE IN SPECIFIC POPULATIONS
Pregnancy

As VYVGART HYTRULO is expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to VYVGART HYTRULO in utero.

Lactation

There is no information regarding the presence of efgartigimod alfa or hyaluronidase, from administration of VYVGART HYTRULO, in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYVGART HYTRULO and any potential adverse effects on the breastfed infant from VYVGART HYTRULO or from the underlying maternal condition.

INDICATION

VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) is indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

Please see the full Prescribing Information.

You may report side effects to the US Food and Drug Administration by visiting http://www.fda.gov/medwatch or calling 1-800-FDA-1088. You may also report side effects to argenx US, Inc, at 1-833-argx411 (1-833-274-9411).

IMPORTANT SAFETY INFORMATION AND INDICATION—CONTRAINDICATIONS

VYVGART HYTRULO is contraindicated in patients with serious hypersensitivity to efgartigimod alfa products, to hyaluronidase, or to any of the excipients of VYVGART HYTRULO. Reactions have included anaphylaxis and hypotension leading to syncope.

WARNINGS AND PRECAUTIONS
Infection

VYVGART HYTRULO may increase the risk of infection. The most common infections observed in Study 1 in patients with gMG were urinary tract infection (10% of efgartigimod alfa-fcab-treated patients vs 5% of placebo-treated patients) and respiratory tract infections (33% of efgartigimod alfa-fcab-treated patients vs 29% of placebo-treated patients). Patients on efgartigimod alfa-fcab vs placebo had below normal levels for white blood cell counts (12% vs 5%, respectively), lymphocyte counts (28% vs 19%, respectively), and neutrophil counts (13% vs 6%, respectively). The majority of infections and hematologic abnormalities were mild to moderate in severity. Delay VYVGART HYTRULO administration in patients with an active infection until the infection has resolved; monitor for clinical signs and symptoms of infections. If serious infection occurs, administer appropriate treatment and consider withholding VYVGART HYTRULO until the infection has resolved.

Immunization

Immunization with vaccines during VYVGART HYTRULO treatment has not been studied; the safety with live or live-attenuated vaccines and the response to immunization with any vaccine are unknown. Because VYVGART HYTRULO causes a reduction in immunoglobulin G (IgG) levels, vaccination with live-attenuated or live vaccines is not recommended during VYVGART HYTRULO treatment. Evaluate the need to administer age-appropriate vaccines according to immunization guidelines before initiation of a new treatment cycle with VYVGART HYTRULO.

Hypersensitivity Reactions

In clinical trials, hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in patients treated with VYVGART HYTRULO or intravenous efgartigimod alfa-fcab. Urticaria was also observed in patients treated with VYVGART HYTRULO. Hypersensitivity reactions were mild or moderate, occurred within 1 hour to 3 weeks of administration, and did not lead to treatment discontinuation in gMG. Anaphylaxis and hypotension leading to syncope have been reported in postmarketing experience with intravenous efgartigimod alfa-fcab. Anaphylaxis and hypotension occurred during or within an hour of administration and led to infusion discontinuation and in some cases to permanent treatment discontinuation. Healthcare professionals should monitor for clinical signs and symptoms of hypersensitivity reactions for at least 30 minutes after administration. If a hypersensitivity reaction occurs, the healthcare professional should institute appropriate measures if needed or the patient should seek medical attention.

Infusion-Related Reactions

Infusion-related reactions have been reported with intravenous efgartigimod alfa-fcab in postmarketing experience. The most frequent symptoms and signs were hypertension, chills, shivering, and thoracic, abdominal, and back pain. Infusion-related reactions occurred during or within an hour of administration and led to infusion discontinuation. If a severe infusion-related reaction occurs, initiate appropriate therapy. Consider the risks and benefits of readministering VYVGART HYTRULO 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-medications.

ADVERSE REACTIONS

Patients with gMG: In Study 1, the most common (≥10%) adverse reactions in efgartigimod alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. In Study 2, the most common (≥10%) adverse reactions in VYVGART HYTRULO-treated patients were injection site reactions and headache. Injection site reactions occurred in 38% of VYVGART HYTRULO-treated patients, including injection site rash, erythema, pruritus, bruising, pain, and urticaria. In Study 2 and its open-label extension in patients with gMG, all injection site reactions were mild to moderate in severity and did not lead to treatment discontinuation. The majority occurred within 24 hours after administration and resolved spontaneously. Most injection site reactions occurred during the first treatment cycle, and the incidence decreased with each subsequent cycle.

Patients with CIDP: In Study 3 stage B, the overall safety profile observed in patients with CIDP treated with VYVGART HYTRULO was consistent with the known safety profile of VYVGART HYTRULO and of efgartigimod alfa-fcab administered intravenously. In Study 3, injection site reactions occurred in 15% of patients treated with VYVGART HYTRULO compared to 6% of patients who received placebo. The most common of these injection site reactions were injection site bruising and injection site erythema. All injection site reactions were mild to moderate in severity. Most injection site reactions occurred during the first 3 months of treatment.

USE IN SPECIFIC POPULATIONS
Pregnancy

As VYVGART HYTRULO is expected to reduce maternal IgG antibody levels, reduction in passive protection to the newborn is anticipated. Risks and benefits should be considered prior to administering live or live-attenuated vaccines to infants exposed to VYVGART HYTRULO in utero.

Lactation

There is no information regarding the presence of efgartigimod alfa or hyaluronidase, from administration of VYVGART HYTRULO, in human milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VYVGART HYTRULO and any potential adverse effects on the breastfed infant from VYVGART HYTRULO or from the underlying maternal condition.

INDICATION

VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) is indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

Please see the full Prescribing Information.

You may report side effects to the US Food and Drug Administration by visiting http://www.fda.gov/medwatch or calling 1-800-FDA-1088. You may also report side effects to argenx US, Inc, at 1-833-argx411 (1-833-274-9411).

INDICATION

VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) is indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).

VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) is indicated for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

References: 1. VYVGART Hytrulo. Prescribing information. argenx US Inc; 2024. 2. Allen JA et al. Presented at: 76th American Academy of Neurology (AAN) Annual Meeting; April 13-18, 2024; Denver, CO. 3. Lewis R et al. Poster presented at: American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting; November 1-4, 2023; Phoenix, AZ. 4. Data on file. REF-02314. argenx US Inc. July 2024. 5. ClinicalTrials.gov. NCT04280718. Accessed April 29, 2024. https://clinicaltrials.gov/study/NCT04280718 6. Data on file. REF-02484. argenx US Inc. July 2024.