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Clinical Results

In adults with anti-AChR antibody-positive generalized myasthenia gravis (gMG) ULTOMIRIS® Was Proven to Provide
Continuous Control Over gMG Symptoms*

After the first 26 weeks of a clinical trial, people on ULTOMIRIS (ravulizumab-cwvz) saw:

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

Seeing

Chewing

Breathing

Brushing teeth

Combing hair

Rising from a chair

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

AChR=acetylcholine receptor.

*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 average baseline MG-ADL total score for the 86 people on ULTOMIRIS was 9.1; for the 89 people on placebo, it was 8.9. At Week 26, the average change in total score from baseline was -3.1 for people receiving ULTOMIRIS and -1.4 for those receiving placebo. 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 total 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.

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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

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 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

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

  • Below you’ll see additional data from a clinical trial extension that are related to the main results included above
  • Since the data below were not preplanned trial goals and the extension period was designed to measure safety, no conclusions should be drawn about the effectiveness or safety of ULTOMIRIS based on the below data points. Talk to 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.

Additional data from an extension of the clinical trial

  • The data from the extension§ of the clinical trial were analyzed among participants for up to 164 weeks
    • This included 26 weeks of the initial trial period followed by 138 weeks of the extension period
  • Of the 175 people in the initial trial period, 78 people who received ULTOMIRIS and 83 people who received placebo entered the extension period. All participants received ULTOMIRIS in the extension period
  • The median|| duration of treatment with ULTOMIRIS for the initial trial period and extension period was ~108 weeks (range of 2-180.71 weeks)

§An extension study is a follow-up to the initial clinical trial. It's designed to gather more information about the treatment over a longer period of time.

||Median is defined as the middle value in a set of numbers.

8 out of every 10 people (128 out of 160) saw a ≥3-point reduction from baseline in their MG-ADL total score by Week 164.

43% of people (55 out of 128) who had a ≥3-point reduction in MG-ADL total score from baseline by Week 164 experienced minimal symptom expression (MSE).

  • MSE means that their MG-ADL total score had gone down to either 0 or 1

Of the 160 people assessed for ≥3-point reduction in MG-ADL total score from baseline, 86 people received ULTOMIRIS in the initial trial period and the extension period, while 74 people received placebo in the initial trial period and ULTOMIRIS in the extension period.

At Week 164:

  • People who started taking ULTOMIRIS from the beginning of the clinical trial saw an average reduction of 4 points in their MG-ADL total score from when they first began the trial
  • People who first took placebo and then switched to ULTOMIRIS in the extension period experienced an average reduction of 2.1 points in their MG-ADL total score from the time they started taking ULTOMIRIS

Out of 113 patients who received steroids during the extension period:

  • 63% (71/113) of patients were taking 10 mg or less per day of steroids at the last reported dose
  • 31% (35/113) of patients were taking 5 mg or less per day of steroids at the last reported dose

At the beginning of the clinical trial, steroid use was not a measured outcome. The study was not designed to assess steroid use or dosage.

A measured outcome in a study is the specific data point(s) that researchers are looking at in order to understand more about a treatment.

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

Side effect profile in the study extension

In the study extension, side effects reported in ≥10% of patients were COVID-19, headache, diarrhea, arthralgia (joint pain), nausea, back pain, urinary tract infection, nasopharyngitis (common cold), fatigue, and dizziness.

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.

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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. It is not known if ULTOMIRIS will harm your unborn baby.
    • Pregnancy Registry: There is a registry for pregnant women who take ULTOMIRIS to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking ULTOMIRIS, talk to your healthcare provider about how you can join this registry or you may contact the registry at 1-833-793-0563 or www.UltomirisPregnancy
      Study.com       to enroll.
  • are breastfeeding or plan to breastfeed. It is not known if ULTOMIRIS 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, stomach (abdominal) pain, muscle spasms, changes in blood pressure, tiredness, feeling faint, shaking chills (rigors), discomfort in your arms or legs, or bad taste. 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)