When compared to a placebo, Rebif® (interferon beta-1a) was proven effective in treating relapsing multiple sclerosis (RMS) in 3 important ways.
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 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. 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:
The number of lesions represent new or enlarging lesions, per patient per scan.
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 versus placebo for a subset of people who started taking Rebif and had 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 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.
1% of those taking placebo in the PRISMS study stopped taking placebo 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.
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.
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:
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:
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.
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.
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:
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:
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.