Is Rebif Right for You?

Rebif for Multiple Sclerosis Treatment

Rebif is known as a disease-modifying therapy for multiple sclerosis. Let me say upfront: This article is not about why disease-modifying therapy is a good idea, rather I have tried to put together as many facts as I could about Rebif in plain language. Why? When I was trying to choose my treatment, I know that it was hard to find information about these drugs that was from a neutral source. I watched the videos (with numerous smiling people gleefully giving themselves injections) from each company and would think, “that’s the one for me” – until I watched the next video.

Having set my goal as giving you the information that I was interested in when I was trying to make a decision about which MS treatment to start, I will start with my “Bottom Line,” summarizing my take on Rebif.

Bottom Line: With small variations, the treatment's effectiveness is about the same for all of the "CRAB" (Copaxone, Rebif, Avonex, Betaseron) drugs – about one-third reduction in relapses when compared to a placebo over two years in people with relapsing-remitting MS (RRMS). People with RRMS usually make their decisions about MS treatment based on their doctor’s advice and experience with similar patients. Other factors come into play for each patient, such as convenience, injection considerations, side effects and cost.

Rebif is basically the same formulation as Avonex (also Interferon beta-1a), but at a higher dose. Rebif has been shown to be slightly more effective than Avonex at preventing relapses.

However, it is given three times a week (as opposed to Avonex’s once-a-week dosing), and people experience more injection site reactions (85% compared to 33% Avonex), more liver disorders (18% vs. 10% Avonex) and white blood cell disorders (13.6% vs. 5.3% Avonex). However, people experience fewer flu-like symptoms over time than Avonex (45% vs.

53% Avonex), and they seem to last for a shorter period after dosing.

Patients like the fact that Rebif needles are the tiniest of all and injections are subcutaneous (injected into the fat right under the skin), meaning the needle is easily inserted. However, injections can be more painful than others, due to lower pH of Rebif (which makes it acidic). Rebif is the most convenient of all to travel with, as it can be unrefrigerated, and requires no mixing (it comes in prefilled syringes). Rebif is the most expensive of all of the CRAB drugs. Like all of the interferons, patients on Rebif need to have bloodwork done regularly and be monitored closely for depression.

More Detailed Information on Rebif

Type of MS and Severity: Rebif is for people with RRMS.

Efficacy: Similar to all the CRAB drugs - decreased relapses by 33% in initial trial of patients with mild to moderate RRMS.

Necessary Monitoring: Blood tests need to be done every three months to check white blood cell count and liver function for the first year.

After a year, they can be reduced to once every four months. People with known thyroid problems should be monitored every six months for thyroid dysfunction.

Injection Considerations: Rebif is given three times a week (12 times a month) as a subcutaneous (under the skin) injection, usually done by the patient themselves or a family member. The needle is shorter than for intramuscular therapies (.5 inch versus 1 – 1.25 inches), and is 29-gauge (which is the thinnest needle available for any MS therapies). However, Rebif is acidic (pH 3.8), which means injections often sting.

Side Effects: The side effects of Rebif are similar to those of the other interferon-based therapies (with the exception of Avonex, which doesn’t cause as many injection-site reactions).

  • Flu-Like Symptoms: The most important side effect is the flu-like symptoms, which are experienced by about 69% of patients. These include: fever, chills, sweating, muscle aches and fatigue (but not nausea or stomach upset), and they last for 8 or more hours. This side effect is usually the worst after the first injection and progressively lessens with each injection, so that most people do experience it (or it is tolerable) after six months – it can also be reduced by starting with a low dose and increasing to a full dose gradually (over several weeks). Taking ibuprofen or acetaminophen a couple hours before and after can help with some of these side effects.
  • Red Spots: Red spots usually occur at the site of injections (in 71% of patients), which may last several weeks. These can break down into sores (injection-site necrosis) in 5% of all cases.
  • Liver Damage: Hepatic injury including elevated serum hepatic enzyme levels and hepatitis has been reported. Regular monitoring is required to prevent such damage from occurring or progressing. If you notice that you begin bruising easily or that your skin or the whites of your eyes begins to look yellow, go see your doctor immediately.
  • Blood Counts: Rebif can cause a decrease in the numbers of red and white blood cells, as well as a reduction in the number of platelets in the blood.
  • Depression: Rebif should be used with caution in patients with depression.
  • Allergic Reactions: Although rare, some people have experienced an allergic reaction to Rebif (which can happen after the first dose or after several doses), which has caused difficulty breathing and loss of consciousness.
  • Thyroid Abnormalities: Rebif should be used with caution in people with thyroid dysfunction, who should be monitored for thyroid function every six months while on Rebif.

Click here to read the second page on Rebif.

History: Rebif has an interesting history. In 1996, Avonex was granted 7-year market exclusivity under the terms of the Orphan Drug Act (until May 2003). In order to market Rebif before that expired, it had to be shown that Rebif had superior efficacy or was safer than Avonex. In a head-to-head study, Rebif was shown to work better than Avonex in reducing the frequency of relapses, and was granted the first exception in history to the exclusivity rule of the Orphan Drug Act by the FDA.

Storage: Needs refrigeration for long-term storage, although can be kept at room temperature for up to 30 days.

Ease of Use: Rebif is provided in prefilled syringes. An automatic injection device (Rebiject II) is provided for patients who prefer to use it, although can also be injected without the device.

Contraindications/Precautions: Not contraindicated for use with any drug, including high-dose steroids (Solu-Medrol). People with a history of depression should be monitored closely while on Rebif – even though there is no link with Rebif in clinical trials, people have reported depression in conjunction with use of interferons.

Pregnancy: Pregnancy category C, meaning that it caused some harm to fetuses in animal studies, but the effect in humans is unknown. Rebif should not be used by women who are pregnant and should be stopped before trying to conceive for some time (usually one to three months – discuss this with your doctor).

Rebif should not be used by women who are breastfeeding.

Safety: Rebif has a comparable safety record to the other interferon-based drugs, which are considered safe for long-term use, as long as appropriate monitoring for liver function and blood cell count are maintained.

Cost: Rebif costs between 25,000 and 31,000 dollars a year.

(Check exact prices at DestinationRx.com).Rebif is covered by most insurance plans. For assistance in figuring out reimbursement, patients can call the MS LifeLines Support Program at 1-877-447-3243 and speak to a “Reimbursement Specialist.” According to the MS LifeLines website: “If you have trouble paying for Rebif, MS LifeLines may be able to help. A review of your situation will be conducted and you will be referred to the appropriate state or federal programs.” Your doctor’s office or local chapter of the National MS Society should also be able to assist you in determining financial options for affording treatment.

More information: Rebif is made by Serono, Inc. (a Swiss company) and comarketed in the United States by Pfizer, Inc. The patient support program for Rebif is called MS LifeLines. They can be reached by phone at 1-877-447-3243.

Sources:

PRISMS Study Group. PRISMS-4: long-term efficacy of interferon-beta-1a in relapsing MS. Neurology 2001;56: 1628-1636.

Panitch H, Goodin DS, Francis G, et al. Randomized, comparative study of interferon beta-1a treatment regimens in MS: the EVIDENCE Trial. Neurology 2002;59:1496-1506.

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