Do you have questions about getting a COVID-19 vaccine?

If you are on treatment for multiple sclerosis (MS) and have questions about COVID-19 or the COVID-19 vaccines, contact your healthcare provider for answers and guidance. It is very important to continue taking your MS medicine as prescribed and to follow your healthcare provider’s treatment directions.

For additional information, there are helpful online resources that address the question of whether people with MS should get a COVID-19 vaccine, including the National MS Society and the The Consortium of Multiple Sclerosis Centers. To learn more about your vaccination options, talk with your healthcare provider.

US-REB-00324 04/2021

PROVEN RESULTS

Rebif® was proven effective in a clinical study vs placebo

When compared to placebo, Rebif® (interferon beta-1a) was proven effective in treating relapsing multiple sclerosis (RMS) in 3 important ways.

  1. Slowed the time to disability progression

  2. Showed fewer relapses

  3. Showed fewer new or enlarging magnetic resonance imaging (MRI) brain lesions*

This was shown in a placebo-controlled study of Rebif® for RMS called PRISMS. A placebo, which is an inactive substance, is used for comparison against the active ingredient of the drug to determine its effectiveness and safety profile. As part of this type of clinical trial, people understand that they may or may not get the drug as part of the study. Many clinical trials are performed this way. This type of study is commonly used to determine whether the drug is effective and to evaluate its safety profile.

*Lesions detected with both T1-weighted gadolinium-enhanced (T1-Gd+) and T2-weighted MRI.
†Refers to new lesions and total lesion burden or area as defined in the American Academy of Neurology (AAN) and MS Council guidelines.
Prevention of Relapses and Disability by Interferon β-1a Subcutaneously in Multiple Sclerosis.

 

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Rebif® was effective for people with a range of disability

The PRISMS study included people with a range of disability in RMS based on their Expanded Disability Status Scale (EDSS) scores. The EDSS is used to track physical disability over time. The scale goes from 0 (minimum) to 10 (maximum). People in the PRISMS study had EDSS scores ranging from 0 to 5.0 on the scale when they entered the study.

The 2-year PRISMS study looked at 560 people to see how they responded. 189 people took Rebif® 22 mcg, 184 took Rebif® 44 mcg, and 187 took a placebo, all given under the skin 3 times a week. The overall results for people taking Rebif® 44 mcg showed:

 

fewer relapses in 2 years

1.73 relapses, on average, with Rebif®
2.56 relapses, on average, with placebo
Rebif®: n=184; placebo: n=187

 

fewer T1 lesions at 9 months

1.3 lesions with Rebif®
8.0 lesions with placebo
T1-weighted gadolinium-enhanced* brain lesions†‡§
Rebif®: n=68; placebo: n=66

 

longer to disability progression||

21.3 months for Rebif®
11.9 months for placebo
Rebif®: n=184; placebo: n=187

 

78% fewer new or enlarging T2 brain lesions¶# at 2 years

0.5 lesions with Rebif®
2.25 lesions with placebo
Rebif®: n=182; placebo: n=187

 

*Gadolinium is a contrast medium injected prior to MRI scans. It passes through breaches in the blood-brain barrier and is therefore used to highlight new and active lesions. The usage of gadolinium greatly enhances the sensitivity of a T1-weighted MRI.
†Lesions detected with both T1-weighted gadolinium-enhanced (T1-Gd+) and T2-weighted MRI.
‡Refers to new lesions and total lesion burden or area as defined in the American Academy of Neurology (AAN) and MS Council guidelines.
§From a subgroup of 134 patients in the PRISMS study who received 11 consecutive monthly T2- and T1-weighted gadolinium-enhanced MRI scans beginning 1 month before treatment initiation.
||Disability progression was defined as an increase of at least 1 point in the EDSS that was sustained for at least 3 months.
¶Median number of lesions, per patient per scan, based on comparisons from rank-based analysis of variance (ANOVA). Lesions detected with both T1-Gd+ and T2-weighted MRI. Median = a value in an ordered set that has an equal number of values higher and lower.
#The number of lesions represents new or enlarging lesions, per patient per scan.

 

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A subset of people from this study with greater levels of disability at study entry showed significant results at 2 years*

Although people in the PRISMS study had a range of disability at the beginning of the study, Rebif® was also shown to be effective vs placebo for a subset of people who started taking Rebif® and had greater disability (scores of 3.5 to 5.0 on the EDSS). People with EDSS scores in this range may start to experience mobility and other functional limitations.

Expanded Disability Status Scale and Disability Progression

 

Graphic of four people at different stages of disability from Fully Ambulatory to Impaired Walking Ability

 

*Disability progression was defined in a Rebif® clinical trial as an increase of at least 1 point on the EDSS that was sustained for at least 3 months.

In this subset of people with greater disability at the beginning of the study, 31 people took Rebif® 44 mcg 3 times a week under the skin, and 28 people took a placebo.

 

longer to disability progression*

21.3 months with Rebif®
7.3 months for placebo

Rebif®: n=31; placebo: n=28

 

fewer relapses in 2 years

1.22 relapses, on average, with Rebif®
3.07 relapses, on average, with Placebo

Rebif®: n=31; placebo: n=28

 

fewer T2 new or enlarging brain lesions†‡§

0.5 lesions with Rebif®
1.9 lesions with Placebo

Rebif®: n=31; placebo: n=28

Median number of new or enlarging lesions, per patient per scan, based on comparisons from rank-based ANOVA||

 

*Disability progression was defined as an increase of at least 1 point in the EDSS that was sustained for at least 3 months.
†Lesions detected with both T1-Gd+ and T2-weighted MRI.
‡Refers to new lesions and total lesion burden or area as defined in the AAN and MS Council guidelines.
§Based on comparisons from rank-based ANOVA.
||Median = a value in an ordered set that has an equal number of values higher and lower.

 

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MOST FREQUENTLY REPORTED AEs IN PRISMS

PRISMS: REBIF® 44 mcg AND 22 mcg VS PLACEBO

  • Injection site reactions (92% and 89% vs 39%)

  • Headache (70% and 65% vs 63%)

  • Influenza-like symptoms (59% and 56% vs 51%)

  • Leukopenia (36% and 28% vs 14%)

  • Serum glutamic pyruvic transaminase increased (27% and 20% vs 4%)

  • Abdominal pain (20% and 22% vs 17%)

  • Serum glutamic-oxaloacetic transaminase increased (17% and 10% vs 4%)

 

 

HEAD-TO-HEAD STUDY

Not all interferons are the same

Rebif® (interferon beta-1a) is in the class of drugs called interferons. There are other types of interferon treatment available that may sound familiar, such as Avonex® (interferon beta-1a) and Plegridy® (peginterferon beta-1a), but they are not the same types of interferon. They may differ in many ways, including formulation, method of delivery, frequency, and dose. 

Head-to-head is the only way to compare

The only way to know if one drug is more effective than another is to evaluate them in the same study.

Rebif® was proven superior to another relapsing MS treatment

Rebif® was compared to Avonex® in a head-to-head study called EVIDENCE.* For an average of 64 weeks, Rebif® 44 mcg was given to 339 people 3 times a week under the skin, with injections at least 48 hours apart. Avonex® 30 mcg was given to 338 people once a week into the muscle.

In this head-to-head study, high-dose, high-frequency Rebif® was proven superior to low-dose, low-frequency Avonex®† in 2 important ways:

 


Relapses


More people on Rebif® remained free from relapses

 


on Rebif® (n=339)

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VS

 


on Avonex® (n=338)

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Average of 24 weeks on treatment


MRI lesions


More people on Rebif® showed no new or enlarging T2-brain lesions

 


on Rebif® (n=325)

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VS

 


on Avonex® (n=325)

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Average of 24 weeks on treatment

More people on Rebif® were free of T1-weighted gadolinium-enhanced§ lesions

 


on Rebif® (n=325)

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VS

 


on Avonex® (n=325)

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Average of 24 weeks on treatment

 

Rebif® was proven to work better than another relapsing MS treatment in a class I clinical trial.|| If you’re currently on Avonex® and not doing as well as you expected or you’re considering an interferon therapy, talk to your doctor about Rebif®.

 

*The EVIDENCE (EVidence of Interferon Dose-response: European North American Comparative Efficacy) trial was conducted entirely in North America and Western Europe.
†The approved Avonex® dose is 30 mcg per week.
‡Lesions detected with both T1-weighted gadolinium-enhanced and PD/T2-weighted MRI.
§Gadolinium is a contrast medium injected prior to MRI scans. It passes through breaches in the blood-brain barrier and is therefore used to highlight new and active lesions. The usage of gadolinium greatly enhances the sensitivity of a T1-weighted MRI.
||According to the American Academy of Neurology, data from class I studies are collected under the highest scientific standards and are thought to be the most valid.

 

 

Rebif® further reduced relapses after the head-to-head (comparative) phase of the study ended

At the end of the head-to-head (comparative) phase of the EVIDENCE study, the 605 remaining people were asked if they wanted to leave the study or keep going in the extension phase. In this phase of the study, which lasted an average of 8 months, 495 people chose to participate; 73% of those taking Avonex® 30 mcg once weekly chose to take Rebif® 44 mcg three times weekly, whereas 91% of those taking Rebif® 44 mcg three times weekly decided to stay with it.

 

 

Patients who started on Avonex® then moved to Rebif®

additional reduction in relapses

0.64 annualized relapse rate for Avonex® at the end of the head-to-head phase

0.32 annualized relapse rate after moving to Rebif® at the end of the extension phase*


*Average of 8 months on treatment with Rebif®
Transitioned from Avonex® to Rebif®, n=223

 

 

Patients who started on Rebif® and continued on Rebif®

additional reduction in relapses

0.46 annualized relapse rate for Rebif® at the end of the head-to-head phase

0.34 relapse rate after continuing on Rebif® at the end of the extension phase*


*Average of 8 additional months on treatment with Rebif®
Continued with Rebif®, n=272

 

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Side effects of Rebif® and Avonex®

In the study, fewer people taking Rebif® had flu-like symptoms compared with people taking Avonex® (45% vs 53%). This may be due to the ability to titrate with Rebif®.

Titration means starting at a lower dosage and gradually building up to the full dosage. Your healthcare provider may offer this to help your body adjust to Rebif when you’re just starting treatment.

In the EVIDENCE study, the side effects of Rebif® and Avonex® were generally similar, with the following exceptions:

 

Side effects % of people taking Rebif® 44 mcg three times weekly % of people taking Avonex® 30 mcg once weekly
Flu-like symptoms 45% 53%
Injection site reactions 85% 33%
Liver disorders 18% 10%
White blood cell disorders 14% 5%

Represents adverse events reported over an average of 64 weeks.

 

Avonex® and Plegridy® are registered trademarks of Biogen.

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Rebif® in the body

See how Rebif® is thought to work in treating RMS. 

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Rebif® gives you options

Learn more about different injection devices and dosing with Rebif®.


IMPORTANT SAFETY INFORMATION AND INDICATION

Important Safety Information

Before beginning treatment, you should discuss the potential benefits and risks associated with Rebif with your healthcare provider.

Rebif can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking Rebif.

  • Behavioral health problems including depression and suicidal thoughts. You may have mood problems including depression (feeling hopeless or feeling bad about yourself), and thoughts of hurting yourself or suicide
  • Liver problems or worsening of liver problems including liver failure. Symptoms may include nausea, loss of appetite, tiredness, dark colored urine and pale stools, yellowing of your skin or the white part of your eye, bleeding more easily than normal, confusion, and sleepiness. During your treatment with Rebif you will need to see your healthcare provider regularly and have regular blood tests to check for side effects
  • Serious allergic and skin reactions. Symptoms may include itching, swelling of your face, eyes, lips, tongue or throat, trouble breathing, anxiousness, feeling faint, skin rash, hives, sores in your mouth, or skin blisters and peels
  • Injection site problems. Symptoms at the injection site may include redness, pain, swelling, color changes (blue or black), and drainage of fluid
  • Blood problems. Rebif can affect your bone marrow and cause low red and white blood cell and platelet counts. In some people, these blood cell counts may fall to dangerously low levels. If your blood cell counts become very low, you can get infections and problems with bleeding and bruising. Your healthcare provider may ask you to have regular blood tests to check for blood problems
  • Seizures. Some people have had seizures while taking Rebif

Rebif will not cure your MS but may decrease the number of flare-ups of the disease and slow the occurrence of some of the physical disability that is common in people with MS.

Do not take Rebif if you are allergic to interferon beta, human albumin, or any of the ingredients in Rebif.

Before you take Rebif, tell your healthcare provider if you have or have had any of the following conditions:

  • mental illness, including depression and suicidal behavior
  • liver problems, bleeding problems or blood clots, low blood cell counts, seizures (epilepsy), or thyroid problems
  • you drink alcohol
  • you are pregnant or plan to become pregnant. It is not known if Rebif will harm your unborn baby
  • you are breastfeeding or plan to breastfeed. Rebif may pass into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take Rebif

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

The most common side effects of Rebif include:

  • flu-like symptoms. You may have flu-like symptoms when you first start taking Rebif. You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers. For many people, these symptoms lessen or go away over time. Symptoms may include muscle aches, fever, tiredness, and chills
  • stomach pain
  • change in liver blood tests

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Rebif. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. 

You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Indication

Rebif® (interferon beta-1a) is a prescription medicine used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.