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For US Healthcare Professionals

RESULTS IN PRIMARY PROGRESSIVE MS (PPMS)

OCREVUS IS THE ONLY APPROVED TREATMENT FOR PPMS.

Find out why OCREVUS may be the right choice for treating your primary progressive multiple sclerosis (PPMS). See results and understand how OCREVUS was evaluated in a clinical trial.

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OCREVUS WAS PROVEN TO DELAY DISABILITY PROGRESSION OF PPMS.

People taking OCREVUS® (ocrelizumab) were 24% less likely to have disability progression than those taking placebo.

*OCREVUS was studied against a placebo. A placebo is a substance or treatment that has no active medicine. It is common for treatment to be compared with a placebo when there are no existing approved treatments to compare it with. Disability progression was measured using a tool called the Expanded Disability Status Scale (EDSS). Disability progression was confirmed 3 months after the initial neurological worsening.

†Disability progression was also confirmed after 6 months.

WHAT IS DISABILITY PROGRESSION AND WHY DOES IT MATTER?

 

Disability progression is the increase in physical disability that happens over time for people with MS. How and when it happens is different for everyone. It can also vary in severity.

Some people may find they struggle with walking or remembering their “to-do” list. Others may experience tingling or numbness or blurred vision. While some may dismiss or overlook these symptoms, they may be a sign of disability progression—and over time, decreased mobility.

How is disability progression measured in clinical studies?

Disability progression is measured using a tool called the Expanded Disability Status Scale (EDSS). It assesses your functionality or changes to function in the areas listed below. OCREVUS was not proven to individually reduce each of these measured endpoints.

Visual function - problems with sight

Visual functions - problems with sight or involuntary eye movements

Muscle weakness or difficulty moving limbs

Muscle weakness or difficulty moving limbs and walking

Cerebral functions - problems with thinking and memory

Cerebral functions - problems with thinking or memory

Tremor or loss of coordination

Tremor or loss of coordination

Numbness or loss of sensations

Numbness or loss of sensations

Bowel and bladder function

Bowel or bladder function

Problems with speech, swallowing, or involuntary eye movements

Problems with speech or swallowing

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SELECT IMPORTANT SAFETY INFORMATION

Infections are a common side effect. OCREVUS increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Serious infections can happen with OCREVUS, which can be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or painful urination. Signs of herpes infection include: cold sores, shingles, genital sores, skin rash, pain, and itching. Signs of more serious herpes infection include: changes in vision, eye redness or eye pain, severe or persistent headache, stiff neck, and confusion. Signs of infection can happen during treatment or after you have received your last dose of OCREVUS. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with OCREVUS until your infection is gone. Please visit Safety & Side Effects for more information.

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OCREVUS SAW SUPERIOR RESULTS IN LESION VOLUME.

OCREVUS® (ocrelizumab) saw a 3% reduction in T2 lesion volume. Placebo saw a 7% increase in T2 lesion volume.

OCREVUS reduced the volume of T2 hyperintense lesions, while T2 lesion volume increased in people taking placebo.

The average change in volume of T2 lesions was -0.39 cm3 for OCREVUS compared with 0.79 cm3 for placebo.‡

‡OCREVUS was evaluated in a study including 732 people who were treated with OCREVUS or placebo for at least 120 weeks.

 

Lesions in MS

  • Lesion volume is the total amount of lesion area, including both old and new lesions, and is measured using magnetic resonance
  • T2 hyperintense lesions may reflect new inflammation or older, chronic lesions which are a sign of scarring from previous MS activity

Why is this important?

While you may not see them, MS can cause lesions to develop in the central nervous system (CNS). Over time, if these lesions progress, some of them may lead to a variety of symptoms that may be more noticeable. Reducing the development of new lesions is an important step in slowing MS progression.

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BY THE NUMBERS

Here are the people included in the study:

  • 732 people (488 taking OCREVUS, 244 taking placebo)
  • 18-55 years of age
  • Average time since people experienced the start of symptoms was about 7 years
  • Had not previously received MS disease-modifying treatment (88%) and those who had (12%)

Why this is important:

  • Studied in a large group of people
  • Studied in a variety of people who have MS
  • Study included people who had not been taking a treatment and those who had
Katrina, an MS patient, using OCREVUS® since 2017

Now that I’ve seen the results, what’s next?

After reviewing the results and safety, having an honest conversation with your doctor is the next step. Our Doctor Discussion Guide can help shape the conversation around your symptoms, lifestyle, and goals so that you might find a treatment that is right for you.
Click below to either create a personalized list of questions to ask at your appointment or view a guide with commonly asked questions.
Personalize My Guide
View Common Questions
Alex, an MS patient, using OCREVUS® since 2019

What can I expect while taking OCREVUS?

OCREVUS is an infusion that is given twice a year. Your first dose will be split between 2 treatments for a total of 3 treatments your first year. Your treatment may be given at an infusion center, your doctor's office, or at home depending on what you and your doctor decide is right for you.
Learn About Infusions

Important Safety Information & Indications

What is OCREVUS?

OCREVUS is a prescription medicine used to treat:

  • Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
  • Primary progressive MS, in adults.

It is not known if OCREVUS is safe and effective in children.

Who should not receive OCREVUS?

Do not receive OCREVUS if you have an active hepatitis B virus (HBV) infection.

Do not receive OCREVUS if you have had a life-threatening allergic reaction to OCREVUS. Tell your healthcare provider if you have had an allergic reaction to OCREVUS or any of its ingredients in the past.

What is the most important information I should know about OCREVUS?

OCREVUS can cause serious side effects, including:

  • Infusion reactions: Infusion reactions are a common side effect of OCREVUS, which can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion of OCREVUS for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you get any of these symptoms:
    • itchy skin
    • rash
    • hives
    • tiredness
    • coughing or wheezing
    • trouble breathing
    • throat irritation or pain
    • feeling faint
    • fever
    • redness on your face (flushing)
    • nausea
    • headache
    • swelling of the throat
    • dizziness
    • shortness of breath
    • fatigue
    • fast heart beat

These infusion reactions can happen for up to 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion. If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.

  • Infection:
    • Infections are a common side effect. OCREVUS increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Serious infections can happen with OCREVUS, which can be life-threatening or cause death. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or painful urination. Signs of herpes infection include: cold sores, shingles, genital sores, skin rash, pain, and itching. Signs of more serious herpes infection include: changes in vision, eye redness or eye pain, severe or persistent headache, stiff neck, and confusion. Signs of infection can happen during treatment or after you have received your last dose of OCREVUS. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with OCREVUS until your infection is gone.
    • Hepatitis B virus (HBV) reactivation: Before starting treatment with OCREVUS, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with OCREVUS. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving OCREVUS.
    • Weakened immune system: OCREVUS taken before or after other medicines that weaken the immune system could increase your risk of getting infections.
  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability, and has been reported with OCREVUS. Symptoms of PML get worse over days to weeks. It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with:
    • thinking        
    • eyesight
    • strength
    • balance
    • weakness on 1 side of your body
    • using your arms or legs
  • Decreased immunoglobulins: OCREVUS may cause a decrease in some types of immunoglobulins. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

Before receiving OCREVUS, tell your healthcare provider about all of your medical conditions, including if you:

  • have ever taken, take, or plan to take medicines that affect your immune system, or other treatments for MS.
  • have ever had hepatitis B or are a carrier of the hepatitis B virus.
  • have a history of inflammatory bowel disease or colitis.
  • have had a recent vaccination or are scheduled to receive any vaccinations. 
    • You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment with OCREVUS. You should not receive ‘live’ or ‘live attenuated’ vaccines while you are being treated with OCREVUS and until your healthcare provider tells you that your immune system is no longer weakened.
    • When possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with OCREVUS. If you would like to receive any non-live (inactivated) vaccines, including the seasonal flu vaccine, while you are being treated with OCREVUS, talk to your healthcare provider.
    • If you have a baby and you received OCREVUS during your pregnancy, it is important to tell your baby’s healthcare provider about receiving OCREVUS so they can decide when your baby should be vaccinated.
  • are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if OCREVUS will harm your unborn baby. You should use birth control (contraception) during treatment with OCREVUS and for 6 months after your last infusion of OCREVUS. Talk with your healthcare provider about what birth control method is right for you during this time.
  • are breastfeeding or plan to breastfeed. It is not known if OCREVUS passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take OCREVUS.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of OCREVUS?

OCREVUS may cause serious side effects, including:

  • Risk of cancers (malignancies) including breast cancer. Follow your healthcare provider’s instructions about standard screening guidelines for breast cancer.
  • Inflammation of the colon, or colitis: Tell your healthcare provider if you have any symptoms of colitis, such as:
    • Diarrhea (loose stools) or more frequent bowel movements than usual
    • Stools that are black, tarry, sticky or have blood or mucus
    • Severe stomach-area (abdomen) pain or tenderness

These are not all the possible side effects of OCREVUS.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at (888) 835-2555.

For more information, go to www.OCREVUS.com or call 1-844-627-3887.

Please see additional Important Safety Information throughout and click here for full Prescribing Information and Medication Guide.

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