Skip to main content

 

How ULTOMIRIS® May Help

People taking ULTOMIRIS® had ZERO relapses

ULTOMIRIS reduced the risk of relapse by 98.6% compared to placebo, in the clinical trial

The clinical trial included 58 people treated with ULTOMIRIS and 47 people on placebo who had the following*†‡

ULTOMIRIS was studied in people with different treatment histories, races, and ages through ~1.5 years§

52% of people in the clinical trial were on ULTOMIRIS without using any other therapy

48% of people taking ULTOMIRIS were also on certain therapies, like immunosuppressive therapies (ISTs), that help control the immune system

ZERO relapses were seen in the clinical trial

ULTOMIRIS reduced the risk of an attack by 98.6% compared to placebo

Since starting ULTOMIRIS, I have experienced no relapses. As I get farther away from NMOSD relapses, I feel more empowered in managing my health.

Mary Lou Real ULTOMIRIS Patient

Mary Lou, living with NMOSD, has received compensation from Alexion Pharmaceuticals, Inc.

Additional Study Results

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 on before the trials begin.

  • The results below were preplanned parts of the study, but the study was not specifically designed to measure these outcomes and the findings should be interpreted with caution. 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 NMOSD.

No relapse-related hospitalizations were seen in the clinical trial

During the clinical trial, ZERO people treated with ULTOMIRIS were hospitalized due to relapse

Before starting ULTOMIRIS, 74% of people with NMOSD were hospitalized due to relapse

Relapse-related hospitalizations and use of other relapse treatments during the ULTOMIRIS trial

While being treated with ULTOMIRIS, people experienced:

  • ZERO hospitalizations vs 15 (31.9%) with placebo
  • ZERO IV steroids vs 22 (46.8%) with placebo
    •
  • ZERO high-dose oral steroids vs 6 (12.8%) with placebo
  • ONE plasma exchange vs 9 (19.1%) with placebo
    •

Patients previously on rituximab

100% of people taking ULTOMIRIS experienced ZERO relapses regardless of prior therapy

In the ULTOMIRIS clinical trial, 36% of patients were previously on rituximab

In patients with prior rituximab use, ULTOMIRIS helped reduce the risk of relapse by 93.7% compared to placebo

  • 21 out of 58 patients had taken rituximab and had at least 1 relapse in the year before the study. 20 of the 21 patients were treated with rituximab 1 year before the study#
  • 17 people in the placebo group (no active medicine) also had prior rituximab use
  • Patients who took rituximab in the past 3 months were not allowed to join the study

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

*As there are FDA-approved therapies available, the placebo group data were collected as part of a previously conducted trial.

†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.

‡An Expanded Disability Status Scale (EDSS) score of ≤7 was also an inclusion requirement.

§A median of 1.5 years (73.5 weeks) means half the people were studied for less than 1.5 years and were in the study for longer with a range of 13.7-117.7 weeks.

||People who received rituximab during the 3 months before screening were not included in the trial.

As reported by doctors.

#One of the 21 patients had been exposed to rituximab >12 months prior to screening.

The safety of ULTOMIRIS was studied in a clinical trial

The safety of ULTOMIRIS in people with NMOSD is consistent with the established safety profile of ULTOMIRIS in clinical trials of other conditions.

The most common side effects (≥10%) of ULTOMIRIS during the clinical trial for NMOSD were**:

  • headache (24%)
  • COVID-19 infection (24%)
    •
  • back pain (12%)
  • joint pain (10%)
    •
  • urinary tract infection (10%)

Serious adverse reactions were reported in 8 (13.8%) adults with NMOSD receiving ULTOMIRIS. The most common serious adverse events were infections, reported in 5 (8.6%) adults.

**The trial was conducted during the COVID-19 pandemic (Dec 2019-Mar 2022), before approved vaccinations. Please talk to your doctor about any concerns you may have.

COVID-19, coronavirus disease 2019.

 

Talk to your doctor about whether ULTOMIRIS may be right for you

Get the Doctor Discussion Guide

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.UltomirisPregnancyStudy.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 NMOSD are COVID-19 infection, headache, back pain, urinary tract infection, and joint pain (arthralgia).

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 Neuromyelitis Optica Spectrum Disorder (NMOSD) who are anti-aquaporin 4 (AQP4) antibody positive. It is not known if ULTOMIRIS is safe and effective for the treatment of NMOSD in children.

Please see full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious meningococcal infections.