Relapsing MS Clinical Trials | Rebif® (interferon beta‐1a)
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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 treatments available that may sound similar, such as Avonex® (interferon beta-1a) and Plegridy® (peginterferon beta-1a), but they are not the same product. 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

We compared Rebif 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.

A head-to-head study proved Rebif was superior to another relapsing MS treatment. High-dose, high-frequency Rebif was proven superior to low-dose, low-frequency Avonex in 2 important ways: 

1. RELAPSES

2. MRI LESIONS

Rebif was proven to work better than another relapsing MS treatment in a class I clinical trial.|| In fact, the results of this study comparing Rebif with Avonex were one of the reasons that the Food and Drug Administration (FDA) approved Rebif. If you’re currently on Avonex and not doing as well as you expected, talk to your doctor about switching to Rebif.

* Relative differences
The EVIDENCE (EVidence for Interferon Dose-response: European North American Comparative Efficacy) trial was conducted entirely in North America and Western Europe.
Lesions detected with both T1-weighted gadolinium-enhanced and PD/T2-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.
|| 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.

IMPORTANT SAFETY INFORMATION

In the study, side effects between Rebif and Avonex were generally similar. People taking Avonex had more flu-like symptoms than those taking Rebif. People taking Rebif had a greater number of injection site reactions, elevated liver enzymes, and decreased white blood cell counts.

Learn more about safety and tolerability →


Did you know that Rebif further reduced flare-ups 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 chose to take Rebif 44 mcg, whereas 91% of those taking Rebif 44 mcg decided to stay with it.

The people in these photos are not actual Rebif patients.

Avonex® and Plegridy® are registered trademarks of Biogen.


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. Tell your healthcare provider if you become pregnant during your treatment with Rebif
  • you are breastfeeding or plan to breastfeed. It is not known if Rebif passes into your breast milk. You and your healthcare provider should decide if you will use Rebif or breastfeed. You should not do both

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.

Refer to the Instructions for Use that comes with your product.

This information is not intended to replace discussions with your doctor. For additional information about Rebif, please consult the Prescribing Information and Medication Guide and talk to your doctor. You can also visit rebif.com or call, toll-free, 1-877-447-3243. Rebif is available by prescription only.

Rebif, Rebif Rebidose, Rebiject II, MS LifeLines, and the Rebif logo are registered trademarks of  Merck KGaA, Darmstadt, Germany, or its affiliates.

Brought to you by EMD Serono, Inc., the marketer of Rebif in the US.

MS LifeLines is sponsored by EMD Serono, Inc.

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. It is a form of protein called beta interferon that is produced in the body.

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

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. Tell your healthcare provider if you become pregnant during your treatment with Rebif
  • you are breastfeeding or plan to breastfeed. It is not known if Rebif passes into your breast milk. You and your healthcare provider should decide if you will use Rebif or breastfeed. You should not do both

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.

Refer to the Instructions for Use that comes with your product.

This information is not intended to replace discussions with your doctor. For additional information about Rebif, please consult the Prescribing Information and Medication Guide and talk to your doctor. You can also visit rebif.com or call, toll-free, 1-877-447-3243. Rebif is available by prescription only.

Rebif, Rebif Rebidose, Rebiject II, MS LifeLines, and the Rebif logo are registered trademarks of  Merck KGaA, Darmstadt, Germany, or its affiliates.

Brought to you by EMD Serono, Inc., the marketer of Rebif in the US.

MS LifeLines is sponsored by EMD Serono, Inc.