Two main goals of the study were to see how VYVGART for IV infusion improved daily abilities and reduced muscle weakness among patients with gMG vs. those who were on placebo.
gMG=generalized myasthenia gravis; IV=intravenous
When added to their current gMG treatment, VYVGART for IV infusion helped patients in the study with anti-AChR antibody positive gMG achieve:
a Patients did not come in for an evaluation at week 9.
MG-ADL=Myasthenia Gravis Activities of Daily Living
Average change in MG-ADL score | ||
---|---|---|
Week | VYVGART for IV infusion + current treatment | Placebo + current treatment |
0 | 0 | 0 |
1 | -2.2 | -1.1 |
2 | -3.7 | -1.4 |
3 | -4.1 | -1.4 |
4 | -4.6 | -1.8 |
5 | -4.4 | -1.8 |
6 | -4.1 | -1.4 |
7 | -3.4 | -1.7 |
8 | -2.2 | -1.7 |
9a | - | - |
10 | -1.6 | -1.0 |
a Patients did not come in for an evaluation at week 9.
VYVGART for IV infusion was determined to be effective if a patient’s MG-ADL score decreased by 2 or more points and stayed at that level for 4 weeks or more in a row, with the first improvement occurring no later than 1 week after the last infusion of treatment cycle 1.
The ADAPT study:
VYVGART for IV infusion was evaluated in a global study of adults with anti-AChR antibody positive gMG. The primary goals of the study were to examine effectiveness (improved daily abilities and reduced muscle weakness) and safety for FDA approval of VYVGART for IV infusion. The study examined the effectiveness and safety of VYVGART for IV infusion in 167 adults (18 years or older) with gMG. In addition to their current treatment, patients received either VYVGART for IV infusion or placebo.
*Improvement maintained for 4 or more weeks was measured by a decrease of 2 or more points on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, with the first reduction occurring no later than 1 week after the last infusion of treatment cycle 1. The MG-ADL scale assesses the impact of gMG on daily functions by measuring 8 signs or symptoms that are commonly affected in gMG. Each item is measured on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents the loss of ability to perform that function. Total scores range from 0 to 24 points, with a higher score showing more severe gMG.
†Improvement maintained for 4 or more weeks was measured by a decrease of 3 or more points on the Quantitative Myasthenia Gravis (QMG) scale, with the first reduction occurring no later than 1 week after the last infusion of treatment cycle 1. The QMG scale assesses muscle weakness in gMG based on 13 items. Each item is assessed on a 4-point scale, where a score of 0 represents no muscle weakness and a score of 3 represents severe muscle weakness. Total scores range from 0 to 39, with a higher score meaning muscle weakness is more severe.
QMG=Quantitative Myasthenia Gravis
VYVGART for IV infusion was evaluated in a global study of adults with anti-AChR antibody positive gMG.
The study examined the effectiveness and safety of VYVGART for IV infusion in 167 adults (18 years or older) with gMG. In addition to their current treatment, patients received either VYVGART for IV infusion or placebo.
Patients in this study needed to meet the following criteria:
Patients represented a range of adults with gMG:
The MG-ADL scale was used to measure gMG symptoms.
MGFA=Myasthenia Gravis Foundation of America
§The MG-ADL scale assesses the impact of gMG on daily functions by measuring 8 signs or symptoms that are commonly affected in gMG. Each item is measured on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents the loss of ability to perform that function. Total scores range from 0 to 24 points, with a score of 0 or 1 meaning minimal or no symptoms.
The following side effects were reported in at least 5% of patients on VYVGART for IV infusion and more frequently than in patients on placebo
Most infections in patients on VYVGART for IV infusion were mild to moderate. Additionally, more patients on VYVGART for IV infusion vs. placebo had lower white blood cell counts that were mild to moderate in severity.
VYVGART for IV infusion may increase the risk of allergic reactions including rash, swelling under the skin, and shortness of breath. It may also increase the risk of serious allergic reactions such as trouble breathing and decrease in blood pressure leading to fainting, as well as infusion-related reactions including increase in blood pressure, chills, shivering, and chest, abdominal, and back pain. These reactions can occur during or after treatment and can cause doctors to pause or, in some cases, stop treatment.
Pregnancy Registry: There is a pregnancy registry for pregnant women who take VYVGART for IV infusion. The purpose of this registry is to collect information about the health of you and your baby if you take VYVGART for IV infusion during pregnancy. To learn more, call 1-855-272-6524 or visit www.VYVGARTpregnancy.com. You may also talk to your healthcare provider about how you can take part in this registry.
||If additional cycles are needed.
IgG=immunoglobulin G
Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. Do not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART and VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART or VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction.
The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.
These are not all the possible side effects of VYVGART and VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.
VYVGART and VYVGART HYTRULO are both prescription medicines, each used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).
Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO, and talk to your doctor.
Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. Do not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART and VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART or VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction.
The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.
These are not all the possible side effects of VYVGART and VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.
VYVGART and VYVGART HYTRULO are both prescription medicines, each used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).
Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO, and talk to your doctor.