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Results With ULTOMIRIS®

ULTOMIRIS Was Proven to Provide Lasting
Control Over gMG Symptoms

Symptom improvements over 26 weeks:

More than 2x greater improvement in activities of daily living such as*:

  • Seeing
  • Chewing
  • Breathing
  • Brushing teeth
  • Combing hair
  • Rising from a chair
and

More than 3x greater reduction in muscle weakness, improving physical functions such as†:

  • Eye and facial movements
  • Swallowing
  • Speaking
  • Hand gripping
  • Head lifting
  • Limb stretching

*Versus placebo from baseline to Week 26 of the clinical trial, according to the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale. The MG-ADL scale is a patient-reported symptom improvement scale that was used in the ULTOMIRIS study to measure the difficulty of everyday activities. MG-ADL total scores range from 0 to 24, with higher scores indicating more severe gMG symptoms. In the study, the average baseline total score for the 86 people receiving ULTOMIRIS was 9.1; for the 89 people receiving placebo, it was 8.9. At Week 26, the average change in score from baseline was -3.1 for people receiving ULTOMIRIS and -1.4 for those receiving placebo. Many patients continued taking other medicines throughout the study.

†Versus placebo from baseline to Week 26 of the clinical trial, according to the Quantitative Myasthenia Gravis (QMG) scale. The QMG scale is a doctor-reported symptom improvement scale. It was used in the ULTOMIRIS study to measure muscle weakness and the difficulty of certain movements. QMG total scores can range from 0-39, with higher scores indicating more severe gMG symptoms. In the study, the average baseline total score for the 86 people receiving ULTOMIRIS was 14.8; for the 89 people receiving placebo, it was 14.5. At Week 26, the average change in score from baseline was -2.8 for people receiving ULTOMIRIS and -0.8 for those receiving placebo. Many patients continued taking other medicines throughout the study.

ULTOMIRIS was studied in a 26-week clinical trial that included adults with varying degrees of severity of anti-AChR antibody-positive gMG

See How ULTOMIRIS Was Studied

The trial (CHAMPION-MG) measured the impact of ULTOMIRIS (ravulizumab-cwvz) on daily activities and muscle weakness. It included 175 people who were randomly split into 2 groups: those taking ULTOMIRIS (86 people) and those receiving placebo (89 people)*

  • A patient-reported questionnaire measured the effects of gMG symptoms on activities of daily living and physical functions
  • A doctor-reported questionnaire measured muscle weakness
  • After Week 26 of the trial, all study participants were eligible to receive ULTOMIRIS for up to an additional 4 years
  • Over 90% of people in the trial had mild or moderate gMG†
  • Study participants were allowed to continue taking immunosuppressive therapies if they were receiving them prior to the start of the initial study period. In fact, at their first dose of ULTOMIRIS, most people were taking an immunosuppressive therapy. If people were receiving immunosuppressive therapies at the start of the study, they were required to continue taking them throughout the initial study period

*Placebo is an inactive substance or treatment that looks the same as, and is given in the same way as, the investigational medication being studied.

†As defined by Myasthenia Gravis Foundation of America (MGFA) clinical classification.

Ask your doctor about managing your gMG symptoms with ULTOMIRIS

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IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING

What is the most important information I should know about ULTOMIRIS?
ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections.

  • ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early.
  1. You must receive meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS if you are not vaccinated.
  2. If your healthcare provider decided that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible.
  3. If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations.
  4. If you had a meningococcal vaccine in the past, you might need additional vaccination. Your healthcare provider will decide if you need additional vaccination.
  5. Meningococcal vaccines reduce but do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection: headache with nausea or vomiting, headache and fever, headache with a stiff neck or stiff back, fever, fever and a rash, confusion, muscle aches with flu-like symptoms and eyes sensitive to light.

Your healthcare provider will give you a Patient Safety Card about the risk of meningococcal infection. Carry it with you at all times during treatment and for 8 months after your last ULTOMIRIS dose. It is important to show this card to any healthcare provider or nurse to help them diagnose and treat you quickly.

ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. Before you can receive ULTOMIRIS, your healthcare provider must: enroll in the ULTOMIRIS REMS program; counsel you about the risk of meningococcal infection; give you information and a Patient Safety Card about the symptoms and your risk of meningococcal infection (as discussed above); and make sure that you are vaccinated with a meningococcal vaccine, and if needed, get revaccinated with the meningococcal vaccine. Ask your healthcare provider if you are not sure if you need to be revaccinated.

ULTOMIRIS may also increase the risk of other types of serious infections. Call your healthcare provider right away if you have any new signs or symptoms of infection.

Who should not receive ULTOMIRIS?
Do not receive ULTOMIRIS if you have a meningococcal infection or have not been vaccinated against meningococcal infection unless your healthcare provider decides that urgent treatment with ULTOMIRIS is needed.

Before you receive ULTOMIRIS, tell your healthcare provider about all of your medical conditions, including if you: have an infection or fever, are pregnant or plan to become pregnant, and are breastfeeding or plan to breastfeed. It is not known if ULTOMIRIS will harm your unborn baby or if it passes into your breast milk. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS.

Tell your healthcare provider about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment.

What are the possible side effects of ULTOMIRIS?
ULTOMIRIS can cause serious side effects including infusion-related reactions. Symptoms of an infusion-related reaction with ULTOMIRIS may include lower back pain, tiredness, feeling faint, discomfort in your arms or legs, bad taste, or drowsiness. Stop treatment of ULTOMIRIS and tell your healthcare provider or nurse right away if you develop these symptoms, or any other symptoms during your ULTOMIRIS infusion that may mean you are having a serious infusion reaction, including: chest pain, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, and feel faint or pass out.

The most common side effects of ULTOMIRIS in people with gMG are diarrhea and upper respiratory tract infections.

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of ULTOMIRIS. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider right away if you miss an ULTOMIRIS infusion or for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

INDICATION
What is ULTOMIRIS?
ULTOMIRIS is a prescription medicine used to treat adults with a disease called generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

It is not known if ULTOMIRIS is safe and effective for the treatment of gMG in children.

Please see the full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections/sepsis.

Questions? Call us at 1-877-GMG-ULTO (877-464-8586)