Spotlight on Relapsing MS

Why Rebif?

Have you recently been diagnosed with relapsing MS and are looking to start treatment? Or have you been living with relapsing MS, and researching available treatments? Either way, you've come to the right place. This is your guide to Rebif^® (interferon beta-1a).

Rebif is proven to significantly slow the progression of relapsing forms of multiple sclerosis (MS). First approved in Europe in 1998, Rebif has been available in the United States since 2002, and is currently the most prescribed treatment outside the United States for relapsing forms of MS. In fact, Rebif is currently being used by more than 93,000 patients worldwide and has more than 13 years of clinical trial and patient experience, so you can be confident when your physician prescribes it to treat your relapsing MS.

The Benefits of Rebif Therapy

These are the three key measures of treatment effectiveness in many MS clinical studies.

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

Rebif has a well-established safety profile supported by more than 13 years of worldwide patient and clinical trial experience.

Rebif Also Has Many Features Designed for Convenience

• The thinnest needle of any MS therapy to reduce discomfort.
• The only product with a "starter" pack, the Rebif "Titration" kit was designed to help with dosing accuracy as you start increasing the doses in the first month of treatment. The gradual increase may help reduce the initial side effects.
• Rebif syringes come as ready-to-use, pre-filled AND pre-assembled doses, so no pre-mixing or assembly is required on your end.
• 3-times weekly dosing, which maintains a consistent therapeutic effect of interferon beta-1a in your body.
• Free travel kit available through MS LifeLines.
• The freedom to choose between either manual injection, or using Rebiject II^®, an auto-injector device, which may help ease you into using Rebif.

"I would tell someone considering Rebiject II to just do it. All of us who live with MS want a full and productive life, and if we can simplify it, why not? I mean, who really likes pain? Or needles? For me this device causes less pain, and you feel less stressed about injecting. I'm all for that!"
–Louise, MS LifeLines Ambassador

Rebif is Supported by the MS LifeLines^® Program

MS LifeLines is more than an educational support service — it's a community. Their mission is to offer connections, understanding, and support to people with MS, people on or considering Rebif therapy for their relapsing MS, and the family and friends who care for them.

Through MS LifeLines, you can reach MS-certified nurses, Monday to Friday, from 8am to 10pm, Eastern time and you can reach Reimbursement Specialists Monday through Friday, from 8am-8pm Eastern time.

You can also access the MS LifeLines community anytime at www.MSLifeLines.com

How Does Rebif Work?

Interferons, like Rebif, have many actions that affect the immune system. Some of these properties are thought to maintain and preserve nerve function. In this way, Rebif may help reduce the damage to the vital components of the central nervous system. Although there is no cure for MS, Rebif has been proven to slow the course of the disease.

How Well Does Rebif Work in Relapsing MS?

Comparing Rebif vs. Placebo

• A placebo is a drug that is administered in the same way as the test drug (Rebif) but does not contain any active ingredients (interferon beta-1a)
• The PRISMS† study compared Rebif and placebo over 2 years

PRISMS showed that Rebif works better than placebo at:

• Reducing brain lesions seen on MRI* scans (the exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown).
• Reducing the frequency of relapses
• Slowing the progression of disability

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

†PRISMS: Prevention of Relapses and Disability by Interferon Beta-1a Subcutaneously in Multiple Sclerosis. PRISMS Study Group. Lancet. 1998;352:1498-1504.

How Does Rebif Compare With Other Therapies for Relapsing MS?

Only a head-to-head study can scientifically compare one treatment with another. Few head-to-head studies have been performed in MS. But a clinical trial called EVIDENCE† (short for Evidence of Interferon Dose-response: European North American Comparative Efficacy) compared Rebif and Avonex^® (interferon beta-1a).

In the EVIDENCE study, Rebif at a dose of 44 micrograms three times a week, given just under the skin, was compared with Avonex at a dose of 30 micrograms once a week, given into the muscle. This study compared Rebif and Avonex over an average of 64 weeks. EVIDENCE showed that Rebif reduced brain lesions seen on MRI* scans and reduced the frequency of relapses to a greater extent than did Avonex.

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

†EVIDENCE: Evidence of Interferon Dose-response: European North American Comparative Efficacy. Panitch H, et al. J Neurol Sci. 2005;239:67-74.

Avonex is a registered trademark of Biogen Idec.

Rebif Reduced MRI* Activity Compared With Avonex

Rebif reduced MRI lesion activity more than Avonex in the EVIDENCE study. About 58% of patients taking Rebif, and only 38% of patients taking Avonex, had no T2 active lesions after an average of 64 weeks of treatment.

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

Rebif Reduced Relapses Better Than Avonex

Rebif also reduced the risk of relapse more than Avonex in the EVIDENCE study. Stated another way, there was a higher probability of having a relapse over the course of the EVIDENCE study for patients taking Avonex than for those taking Rebif.

Compared to Avonex, side effects were generally similar despite the higher, more frequent dosing of Rebif 44 mcg three times per week with some exceptions. As to be expected with higher, more frequent dosing, people taking Rebif had a greater number of injection-site reactions (85% Rebif vs. 33% Avonex), liver disorders (18% Rebif vs. 10% Avonex), and white blood cell disorders (13.6% Rebif vs. 5.3% Avonex). However, flu-like symptoms were significantly higher for people taking Avonex than for people taking Rebif (45% Rebif vs. 53% Avonex). It is important to note that the rate of discontinuation or serious adverse events was similar for the two drugs.

FDA Changes Rebif Labeling

Following the outcome of the EVIDENCE trial, which compared Rebif and Avonex (both interferon beta-1a), the FDA added the following information to the labeling of Rebif:

*EVIDENCE Study: Evidence of Interferon Dose-response: European North American Comparative Efficacy.

Side Effects with Rebif

What Are the Common Side Effects of Rebif?

Like all medications for relapsing MS, there are side effects with Rebif as well. Before you start taking Rebif, talk with your doctor about the possible side effects.

The most common ones, injection-site reactions and flu-like symptoms, are generally expected with any injectable interferon. With Rebif, flu-like symptoms can last for a few hours and for many people, lessen or diminish with continued use, over time.

What Can I Do About Flu-like Symptoms?

With a little planning and guidance from your healthcare professional, you should be able to manage flu-like symptoms. These tend to be more obvious when you first start taking Rebif. Then they might taper off, or disappear over time, as your body becomes more accustomed to treatment.

• Nighttime injections are recommended to allow you to sleep through many of these symptoms.
• Take a non-prescription pain reliever/fever reducer recommended by your doctor before or after injecting Rebif to help reduce symptoms.

What Can I Do about Injection-site Reactions?

Swelling, redness, and irritation may occur at the injection site. Talk to your doctor about how to minimize these reactions. Some suggestions include:

• Bring Rebif^® (interferon beta-1a) to room temperature to reduce irritation by removing from the refrigerator 1 to 4 hours before injection.
• Use the proper injection technique.
• If using an alcohol swab, let the area dry to minimize stinging.
• Gently massage area after injection with a dry cotton ball or gauze for at least 2 minutes. This helps disperse medicine and reduce irritation.
• Some people prefer to apply a warm cloth or cold pack after injecting.
• Inject only into healthy tissue.
• Wait at least 7 days before injecting in the same spot.

Check the site for redness, tenderness, or swelling. Contact your healthcare provider about any skin reaction that does not clear up in a few days.

What Are the Serious Side Effects with Rebif?

Depression: This is not uncommon in people with MS. However, if you are feeling noticeably sadder or helpless, or feel like hurting yourself or others, you should tell a family member or friend right away and call your doctor as soon as possible. Inform your doctor if you have ever had any mental illness, including depression, and if you take any medications for depression.

Liver problems: Your liver may be affected by taking Rebif and a few patients have developed severe liver injury. Your healthcare provider may ask you to have regular blood tests to make sure that your liver is working properly. If your skin or the whites of your eyes become yellow or if you are bruising easily you should call your doctor right away.

Risk to pregnancy: Be sure to tell your healthcare provider if you are or plan to become pregnant. If you become pregnant while taking Rebif you should stop using Rebif immediately and call your doctor. Rebif may cause you to lose your baby (miscarry) or may cause harm to your unborn child. You and your doctor will need to decide whether the potential benefit of taking Rebif is greater than the risks are to your unborn child.

A pregnancy registry has been established to monitor pregnancy outcomes of women exposed to Rebif while pregnant. Patients are encouraged to have their health care provider register them at rebifpregnancyregistry.com or by calling MS LifeLines at 1-877-447-3243 Monday through Friday 8am to 8pm ET.

Allergic reactions: Some patients taking Rebif have had severe allergic reactions leading to difficulty in breathing and loss of consciousness. If you think you are having an allergic reaction, you should stop therapy immediately and contact your doctor. Allergic reactions can happen after the first dose or after you have taken Rebif many times.

Injection-site reactions: Rebif may cause redness, pain, or swelling at the injection site. A few patients have developed infections or an area of severe skin damage (necrosis). If one of your injection sites becomes swollen, painful, or infected and does not heal within a few days, call your doctor. You may also view the brief injection training video on this website for proper technique.

Are There Any Other Possible Side Effects of Rebif?

You should also be aware of other potential but less common side effects that have been reported by some people taking Rebif. Contact your healthcare provider for these and other symptoms you may be experiencing. They include:

Thyroid problems: Your thyroid function may change, and you may be asked to have regular blood tests to monitor your thyroid function. Symptoms of thyroid change include feeling cold or hot all the time and/or an unexplained change in your weight.

Less severe allergic reactions: Some patients have had hives, rash, skin bumps, or itching while they were taking Rebif. If you think you are having an allergic reaction, stop using Rebif immediately.

Other side effects include abdominal pain and blood cell count decreases. Contact your doctor about these and any other side effects you may be experiencing, and consult the Rebif Medication Guide.

Avonex is a registered trademark of Biogen Idec.