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Clinical Results

ULTOMIRIS® Was Proven to Provide
Continuous Control Over gMG Symptoms

After the first 26 weeks of a clinical trial, people on ULTOMIRIS saw:

2 times improvement in activities of daily living

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

Seeing

Chewing

Breathing

Brushing teeth

Combing hair

Rising from a chair

3 times reduction in muscle weakness

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. In the study, the baseline MG-ADL total score for the 86 people on ULTOMIRIS was 9.1; for the 89 people on placebo, it was 8.9. Many people 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. In the study, the average baseline QMG total score for the 86 people on ULTOMIRIS was 14.8; for the 89 people on 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 people continued taking other medicines throughout the study.

ULTOMIRIS demonstrated effectiveness vs placebo at Week 26, and some people showed earlier improvement

See the results

ULTOMIRIS demonstrated effectiveness vs placebo at Week 26, and some people showed earlier improvement ULTOMIRIS demonstrated effectiveness vs placebo at Week 26, and some people showed earlier improvement

Study Details and Limitations

  • On the scale used to measure these results, lower scores indicate improved gMG symptoms
  • Clinical trials are designed to make sure results are meaningful and not due to chance. Comparisons between ULTOMIRIS and placebo at any time point before Week 26 were part of the planned study of ULTOMIRIS, but the primary goal of the study was to measure them at Week 26, so no conclusions should be drawn from the data prior to Week 26
    • Placebo is an inactive substance or treatment that looks the same and is given the same way as the medication being studied
  • Individual results may vary. Not everyone who takes ULTOMIRIS will experience the same results

How were these results measured?

The Myasthenia Gravis Activities of Daily Living (MG-ADL) scale is a patient-reported symptom improvement questionnaire that was used in the ULTOMIRIS study to measure the impact of gMG symptoms on 8 key daily activities and functions. MG-ADL total scores range from 0 to 24, with higher scores indicating more severe gMG symptoms.

Another questionnaire called the Quantitative Myasthenia Gravis (QMG) scale was also used in the ULTOMIRIS study. The QMG scale is a 13-item doctor-reported symptom improvement scale that assesses muscle weakness. QMG total scores can range from 0 to 39, with higher scores indicating more severe gMG symptoms.

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

The CHAMPION-MG trial 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)

  • The MG-ADL scale measured the effects of gMG symptoms on activities of daily living and physical functions
  • The QMG scale measured muscle weakness
  • Over 90% of people in the trial had mild or moderate gMG‡
  • 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 at stable doses throughout the initial study period of 26 weeks
  • After Week 26 of the trial, all study participants were eligible to receive ULTOMIRIS for an extension period of up to 4 additional years

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

Additional Data for ULTOMIRIS

Medicines are studied in clinical trials to find out if they can help people effectively and safely

Clinical trials—like the one in which ULTOMIRIS was studied—have a few specific goals that are decided before they begin.

  • The results below were not preplanned study goals, so no conclusions can be drawn. Talk with your healthcare team about any questions you may have

Alexion is committed to the continued analysis of trial data to better understand the treatment of gMG.

People who started ULTOMIRIS within 2 years of gMG diagnosis experienced 4.3 points of improvement in MG-ADL total score at Week 26, vs 2.9 points for people who started ULTOMIRIS more than 2 years after diagnosis.

Of 175 people in the study, 35 started the study within 2 years of gMG diagnosis (19 received ULTOMIRIS) and 140 started more than 2 years after diagnosis (67 received ULTOMIRIS).

82% of people experienced at least 3 points of improvement with ULTOMIRIS by Week 60 of the clinical trial.

At Week 60 (34 weeks after people who received placebo in the initial 26 weeks of the clinical trial had switched to ULTOMIRIS, and after those receiving ULTOMIRIS had continued to take it for an additional 34 weeks), their data up to that point were collected for analysis. Of the 139 people who stayed in the study until that time point, 82% had at least 3 points of improvement in MG-ADL total score. The extension period was designed to measure safety, so no conclusions should be drawn.

Individual results may vary. Not everyone who takes ULTOMIRIS will experience the same results.

I did notice a change with ULTOMIRIS. I notice that I don't slur my words as long. I don't choke as much.

Mike
Real ULTOMIRIS Patient

Mike, living with gMG, has received compensation from Alexion Pharmaceuticals, Inc.

Mike has a family member who is employed by Alexion, including at the time Mike started treatment.

Download this helpful discussion guide full of information and ideas for talking to your doctor about ULTOMIRIS

Download The Doctor Discussion Guide

ULTOMIRIS has been used by people across 30 countries

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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 may lower the ability of your immune system to fight infections.

  • ULTOMIRIS increases your chance of getting serious meningococcal infections that may quickly become life-threatening or cause death if not recognized and treated early.
  1. You must complete or update meningococcal vaccine(s) at least 2 weeks before your first dose of ULTOMIRIS.
  2. If you have not completed your meningococcal vaccines and ULTOMIRIS must be started right away, you should receive the required vaccine(s) as soon as possible.
  3. If you have not been vaccinated and ULTOMIRIS must be started right away, you should also receive antibiotics for as long as your healthcare provider tells you.
  4. If you had a meningococcal vaccine in the past, you might need additional vaccines before starting ULTOMIRIS. Your healthcare provider will decide if you need additional meningococcal vaccines.
  5. Meningococcal vaccines 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: fever, fever with high heart rate, headache and fever, confusion, muscle aches with flu-like symptoms, fever and a rash, headache with nausea or vomiting, headache with a stiff neck or stiff back, or eyes sensitive to light.

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

ULTOMIRIS is only available through a program called the ULTOMIRIS and SOLIRIS Risk Evaluation and Mitigation Strategy (REMS). Before you can receive ULTOMIRIS, your healthcare provider must: enroll in the REMS program; counsel you about the risk of serious meningococcal infections; give you information about the signs and symptoms of serious meningococcal infection; make sure that you are vaccinated against serious infections caused by meningococcal bacteria, and that you receive antibiotics if you need to start ULTOMIRIS right away and are not up to date on your vaccines; give you a Patient Safety Card about your risk of meningococcal infection.

ULTOMIRIS may also increase the risk of other types of serious infections, including Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae. Certain people may be at risk of serious infections with gonorrhea.

Who should not receive ULTOMIRIS?
Do not receive ULTOMIRIS if you have a serious meningococcal infection when you are starting ULTOMIRIS.

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, abdominal pain, muscle spasms, changes in blood pressure, tiredness, feeling faint, shaking chills (rigors), discomfort in your arms or legs, bad taste, or drowsiness. Stop treatment of ULTOMIRIS and tell your healthcare provider right away if you develop these symptoms, or any other symptoms during your ULTOMIRIS infusion that may mean you are having a serious infusion-related 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 meningococcal infections.

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