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About Rebif

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 Is the Only Self-Injected Relapsing MS Therapy Proven to Achieve All 3 Important Treatment Goals in Relapsing MS

This was shown in the 2-year PRISMS* study that included 560 people to see how they responded to Rebif 22 mcg or Rebif 44 mcg versus placebo, all given under the skin 3 times a week.

Rebif 44 mcg is proven to work on the 3 important aspects of relapsing MS:

Slowing disability progression Rebif 44 mcg was proven to nearly double the time to disability progression (21.3 months with Rebif vs 11.9 months with placebo).
Reducing relapse
rate
Rebif 44 mcg was shown to reduce the frequency of relapses on average by 32% versus placebo (1.73 with Rebif vs 2.56 with placebo).
Reducing active brain lesions on the studied MRI measures †‡ Rebif 44 mcg was proven to reduce the median number of T2 active lesions per patient per scan by 78% versus placebo over 2 years (0.5 with Rebif vs 2.25 with placebo).

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

Before beginning treatment, you should discuss with your doctor the potential benefits and risks associated with Rebif. Let your doctor know if you have a history of depression, seizures, liver disease, thyroid problems, or blood cell count or bleeding problems, or if you have had previous allergic reactions to medications.

*Prevention of Relapses and Disability by Interferon β-1a Subcutaneously in Multiple Sclerosis.
†New or enlarging lesions detected with PD/T2-weighted MRI.
‡Refers to new lesions and total lesion burden or area as defined in the AAN and MS Council guidelines.

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Rebif versus Avonex
The EVIDENCE study

The EVIDENCE* study, a head-to-head trial, compared Rebif® (interferon beta-1a) with Avonex® (interferon beta-1a) for an average of 64 weeks. Rebif 44 mcg was given to 339 people 3 times per week just under the skin, at least 48 hours apart. Avonex 30 mcg was given to 338 people once per week into the muscle.

Over 64 weeks, significantly more people taking Rebif 44 mcg versus Avonex 30 mcg:

  • Were relapse-free (percentage of people remaining relapse-free—Rebif: 56%; Avonex: 48%)
  • Had no new or enlarging lesions detected on MRI (percentage of people with no new or enlarging lesions—Rebif: 58%; Avonex: 38%)

Rebif is the only relapsing MS treatment proven to work better than another in a class I clinical trial.

* EVIDENCE for Interferon Dose-response: European North American Comparative Efficacy.

New or enlarging lesions detected with PD/T2-weighted MRI.

Fewer brain lesions with Rebif

Over 64 weeks, significantly more people taking Rebif 44 mcg versus Avonex 30 mcg had no new or enlarging lesions* detected on MRI (percentage of people with no new or enlarging lesions—Rebif: 58%; Avonex: 38%).

Percentage of people with no new lesion activity as measured by MRI (T2-scan)

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

New or enlarging lesions detected with PD/T2-weighted MRI.

More people were relapse-free with Rebif

In the EVIDENCE study, Rebif reduced the risk of relapses by 30% compared with Avonex.

The data also show that people on Rebif 44 mcg three times per week at least 48 hours apart were more likely to remain relapse-free over the course of the study compared with people on Avonex 30 mcg once per week.

Why change from Avonex to Rebif?

605 people remained at the end of the head-to-head phase of the EVIDENCE study.

A total of 495 people participated in the extension phase of the EVIDENCE study, which lasted an average of 8 months. In the extension phase, all patients were offered the option of either taking Rebif 44 mcg 3 times a week or leaving the study. 73% of those taking Avonex 30 mcg chose to take Rebif 44 mcg, while 91% of those taking Rebif 44 mcg 3 times a week chose to stay on Rebif 44 mcg.

Significant reductions were seen across 2 key treatment measures: 22% reduction in active T2 brain lesions*; 50% reduction in relapses†

*New or enlarging lesions detected with PD/T2-weighted MRI: 0.9 for patients during their last 6 months on Avonex versus 0.7 after transitioning from Avonex to Rebif
(p = 0.222).
†Annualized relapse rate. Rebif: 0.32; Avonex: 0.64.
†New or enlarging lesions detected with PD/T2-weighted MRI.

People who stayed on Rebif experienced continued reductions in relapse rates

People taking Rebif 44 mcg through the extended phase continued to experience significant reductions in relapses over an average of 8 months.

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Compared with Avonex, side effects were generally similar with Rebif despite the higher, more frequent dosing of Rebif


Rebif 44 mcg than with Avonex

Adverse events occurring more frequently with Rebif 44 mcg

  Avonex
30 mcg qw
Rebif
44 mcg tiw
P value
Injection-site disorders 33% 85% <0.001
Hepatic function disorders 10% 18% 0.003
White blood cell disorderss 5% 14% <0.001

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Rebif: An Effective Treatment with a Well Established Safety Profile

You can feel confident that the safety profile of Rebif is backed by 17 years of clinical trial and patient experience.

~17 years clinical trial and patient experience

Most Common Side Effects

The most common side effects with Rebif are injection-site reactions, flu-like symptoms (fever, chills, muscle aches, tiredness), depression, abdominal pain, increased liver enzymes, and blood cell count decreases. Let your doctor know if you have any of these symptoms or feel sad, tired, hot or cold, or experience hives, rashes, bruising, yellowing of the skin, or a change in body weight (gain or loss).

It's important you inform your doctor or health care provider of any side effects or adverse events that you may have. There may be things you can do to help manage them.

You can get helpful tips by calling MS LifeLines® and speaking to a Nurse Support Specialist.

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

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Indication

Rebif 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. Rebif is not approved for treatment of chronic progressive MS. Rebif is available in 22 mcg and 44 mcg prefilled, preassembled syringes and a titration pack.

Important safety information

Before beginning treatment, patients should discuss with their doctor the potential benefits and risks associated with Rebif. Let your doctor know if you have a history of depression, seizures, liver disease, thyroid problems, or blood cell count or bleeding problems, or if you have had previous allergic reactions to medications. Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Rebif and other medicines may affect each other causing serious side effects. Talk to your doctor before you take any new medicines. Rebif is not recommended for women who are or plan to become pregnant.

Potential serious side effects of Rebif include depression and risk of suicide, liver problems, risk to pregnancy, injection-site problems, and severe allergic reactions. Allergic reactions are rare and may be associated with difficulty in breathing and loss of consciousness, which require immediate medical attention.

The most common side effects with Rebif are injection-site reactions, flu-like symptoms (fever, chills, muscle aches, tiredness), depression, abdominal pain, elevated liver enzymes, and blood abnormalities.

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

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

Rebif and MS LifeLines are registered trademarks of EMD Serono, Inc. or its affiliates.

Brought to you by EMD Serono, Inc. and Pfizer Inc, the co-marketers of
Rebif® (interferon beta-1a) in the US.
EMD Serono / Pfizer

Prescribing Information (PDF) - Medication Guide (PDF)

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

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