3 treatment goals
Chrystal R. MS LifeLines Ambassador, living with relapsing MS

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

1Slowed the time to
disability progression
2Showed fewer
flare-ups
3Showed fewer new or
enlarging MRI brain lesions*†
1Slowed the time to
disability progression
2Showed fewer
flare-ups
3Showed fewer new or
enlarging MRI
brain lesions*†

This was shown in a placebo-controlled study of Rebif for relapsing MS 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. 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 prove that a drug is safe and effective before the Food and Drug Administration (FDA) gives its approval.

The PRISMS study included people with a range of disability in relapsing MS based on their Expanded Disability Status Scale (EDSS) scores. The EDSS is used to track physical disability over time. The scale goes from 0 (least) to 10 (maximum). People in the PRISMS study ranged from 0 to 5.0 on the scale.

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

* Lesions detected with both Gd-enhanced/T1-weighted 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.

Study results showed Rebif was effective for people with relapsing MS with a range of disability

2 year prism study 2 year prism study 2 year prism 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:

Slower time to disability progression§
11.9 months
for placebo
21.3 months for Rebif
44 mcg (3 times a week
under the skin)
Significantly fewer flare-ups in 2 years
2.56 flare-ups on
average with placebo
1.73 flare-ups on
average with Rebif

Significantly fewer new or enlarging MRI brain lesions||¶
Median number of lesions,
per patient per scan**
Median number of lesions,
per patient per scan**

Median number of lesions,
per patient per scan**
Median number of lesions,
per patient per scan**
Placebo
Rebif 44 mcg (3 times a week under the skin)

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.

§ 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 Gd-enhanced/T1-weighted and PD/T2-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 gadolinium-enhanced/T1-weighted (Gd-T1) 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.

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

While 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 some 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.

Disability Progression
7.3 months
for placebo
21.3 months
for Rebif
Flare-ups
3.07 flare-ups
on average
with placebo
1.22 flare-ups
on average
with Rebif
Placebo
Rebif 44 mcg (3 times a week under the skin)
MRI results (brain lesions)
Median number of new or enlarging lesions, per patient per scan
Placebo
Rebif 44 mcg (3 times a week under the skin)

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

The PRISMS study also showed only 26% of people taking Rebif 44 mcg had disability progression||||—as opposed to 37% of those taking a placebo¶¶. The time to progression of disability, which is the permanent worsening of your neurologic examination over time, was also nearly doubled versus placebo (21.3 months vs 11.9 months).

In the PRISMS study, 3% of those taking Rebif 22 mcg and 5% 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 Gd-enhanced/T1-weighted 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.
¶¶ 189 people took Rebif 22 mcg; 184 people took Rebif 44 mcg; and 187 took a placebo.

Learn more about the head-to-head study involving Rebif

Chrystal’s story: Setting expectations

"Once I realized that my treatment wasn’t about instant gratification, I adjusted my expectations."

I used Rebif for a while and I began wondering if other treatments might be a better fit for me. I was also curious about how my body would respond to an oral medication. So I spoke with my doctor, and we decided to try it.

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.

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.

Chrystal R. Beauty blogger, MS LifeLines Ambassador, living with relapsing MS

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

Talk to someone who understands
living with MS

Talk to someone who understands relapsing MS, through the Peer Connection Program. Call 1-866-783-5189.

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Next: Rebif offers options
Important Safety Information and Indication

Important Safety Information

7.07

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.