Rebif efficacy results

Rebif Ambassador Dave S.
Rebif was proven effective in a clinical study vs placebo

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

slowed the time to disability progression

showed fewer flare-ups

showed fewer new or enlarging 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.

The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

* Lesions detected with both T1-weighted gadolinium-enhanced (T1-Gd+) and PD/T2-weighted MRI.

Refers to new lesions and total lesion burden or area as defined in the AAN and MS Council guidelines.

Prevention of Relapses and Disability by Interferon β-1a Subcutaneously in Multiple Sclerosis.

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 ranged from 0 to 5.0 on the scale.

The 2-year PRISMS study looked at 560 people to see how they responded. One hundred eighty-nine 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:

32%
fewer
flare-ups in 2 years§

2.56 flare-ups, on average, with placebo

1.73 flare-ups, on average, with Rebif

(44 mcg, 3 times a week under the skin)

Rebif, n=184; Placebo, n=187; P<0.0001

Nearly
2×
longer to disability progression||

11.9 months for placebo

21.3 months for Rebif

(44 mcg, 3 times a week under the skin)

Rebif, n=184; Placebo, n=187; P<0.05

§ One hundred eighty-four people took Rebif 44 mcg; 187 took a placebo.

||Progression of disability was defined as an increase of at least 1 point in the EDSS that was sustained for at least 3 months.


84%
fewer T1‐weighted gadolinium-enhanced (T1‐Gd+) brain lesions#**†† at 9 months
8.0 lesions
Placebo
1.3 lesions
Rebif

Rebif (44 mcg, 3 times a week under the skin)

Rebif, n=68; Placebo, n=66; P<0.0001

Median number of lesions, per patient per scan based on comparisons from rank-based ANOVA.‡‡

78%
fewer new or enlarging T2 brain lesions at 2 years (3 times a week under the skin)
2.25 lesions
Placebo
0.5 lesions
Rebif

Rebif (44 mcg, 3 times a week under the skin)

Rebif, n=182; Placebo, n=184; P<0.0001

Median number lesions, per patient per scan based on comparisons from rank-based ANOVA.‡‡

The number of lesions represent new or enlarging lesions, per patient per scan.

The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

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.

# Refers to new lesions and total lesion burden or area as defined in the AAN and MS Council guidelines.

** From a subgroup of 134 patients in the PRISMS study who received 11 consecutive monthly PD/T2 and T1-Gd+ MRI scans beginning 1 month before treatment initiation.

†† Median = a value in an ordered set that has an equal number of values higher and lower.

‡‡ Lesions detected with both T1-Gd+ and PD/T2-weighted MRI.

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

Although people in the PRISMS study had a range of disability, Rebif was also shown to be effective versus placebo for people with greater disability (EDSS scores of 3.5 to 5.0). People with EDSS scores in this range may start to experience mobility and other functional limitations. In this subset of people with greater disability, 31 people took Rebif 44 mcg 3 times a week under the skin and 28 people took a placebo.

Nearly
3×
longer to show disability progression§§

7.3 months for placebo

21.3 months for Rebif

(44 mcg, 3 times a week under the skin)

Rebif, n=31; Placebo, n=28; P<0.05

60%
fewer
flare-ups in 2 years

3.07 flare-ups, on average, with placebo

1.22 flare-ups, on average, with Rebif

(44 mcg, 3 times a week under the skin)

Rebif, n=31; Placebo, n=28; P=0.0002


T2 new or enlarging brain lesions||||¶¶##
74%
fewer at 2 years

Rebif (44 mcg, 3 times a week under the skin)

1.9 lesions
Placebo
0.5 lesions
Rebif

Rebif (44 mcg, 3 times a week under the skin)

Rebif, n=31; Placebo, n=28; P=0.0002

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

The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

In the PRISMS study, 5% of those taking Rebif 44 mcg stopped taking Rebif because of adverse events.

It's important to inform your healthcare provider of any side effects you experience. There may be things you can do to help manage them.

Please see Important Safety Information below and the Rebif Medication Guide and Prescribing Information at the top of this website, and speak with your healthcare provider for more information.

§§Progression of disability 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 PD/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.

Learn more about the head-to-head study involving Rebif
Chrystal’s story: Setting expectations

“I used Rebif for a while, and I began wondering if an oral treatment might be a better fit for me. So, I spoke with my doctor, and we decided to try one.

After about four months on the oral medication, I realized that while it may be a good choice for some people, it wasn’t a good fit for me. At this time I also began to understand that treating relapsing MS is not about instant gratification—it’s about sticking to a routine. And I saw that all treatments aren’t the same. Different people respond differently to various treatments. So, I went back to my doctor and, after discussing it, decided to go back on Rebif.

Rebif Ambassador gardening

With Rebif, I feel like I have a therapy that works for me.

Chrystal R.
Beauty Blogger, Rebif Ambassador, living with relapsing MS Rebif Ambassadors are sponsored by EMD Serono, Inc.

I felt very comfortable going back to Rebif because I knew what to expect. I know there is no cure for MS, but with Rebif, I feel like I have a therapy that works for me.”

This story reflects the personal experience of one person. Results and experiences vary from patient to patient.


MS LifeLines and Rebif Ambassadors are sponsored by EMD Serono, Inc.

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 Rebif® Rebidose® (interferon beta-1a) Autoinjector.

Indication

Rebif® (interferon beta-1a) is used to treat relapsing forms of MS to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS.


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 EMD Serono, Inc. or its affiliates.

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

This information is intended only for residents of the United States.

Copyright © 2019 EMD Serono, Inc. All rights reserved. EMD Serono, Inc., One Technology Place, Rockland, MA 02370

US-INF-1015-0011e(2)

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. 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 Rebif® Rebidose® (interferon beta-1a) Autoinjector.

Indication

Rebif® (interferon beta-1a) is used to treat relapsing forms of MS to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS.


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 EMD Serono, Inc. or its affiliates.

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

This information is intended only for residents of the United States.

Copyright © 2019 EMD Serono, Inc. All rights reserved. EMD Serono, Inc., One Technology Place, Rockland, MA 02370

US-INF-1015-0011e(2)

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