| Tuesday, July 04, 2006
|Name: Rebif, interferon beta 1-a
Marketed By: Serono Incorporated
Intended Use: For the treatment of relapsing-remitting (RR) multiple sclerosis (MS).
Profile of User: An individual who has a clinical diagnosis of RRMS and has had two relapses in the last two years.
What It Is: Rebif is virtually the same as Avonex. Rebif (interferon beta 1-a) is almost identical to the natural beta interferon proteins produced in the body. The drug is extracted from Chinese hamster ovary cell using recombinant DNA techniques (cloning).
How it Works: All of the interferons are thought to work in the same way. Rebif is thought to work with the beta interferons that naturally occur in the body when the immune system is activated. It works by blocking immune activating effects of gama interferons (gama interferons increase immune response that attacks myelin in MS patients), and is thought to prevent immuno-cells that attack the myelin from crossing the blood-brain barrier.
- In 1997 the result of two year trial called PRISM (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis)reported that Rebif reduced the number of MS attacks, slowed disability, and reduced the amount of damage in the brain caused by MS shown by an MRI scan. Additional data was made available in 2001.
- The Federal Health Protection Branch approves Rebif for use in Canada in 1998.
- Results of a trial testing the effectiveness of Rebif in treating secondary-progressive MS were published in 1999 and showed fewer relapses and fewer brain lesions as measured by MRI scans. Rebif has not yet been approved for the treatment of secondary-progressive MS.
- In 2000, results of study that examined the early treatment of people without clinically definite MS were released. Those taking Rebif were shown to have delayed progression to clinically definite MS by 25%.
- In 2001, results of the EVIDENCE (Evidence for Interferon Dose-response European-North American Comparative Efficacy) study are made available. This was a 6 month study that did a head to head comparison of Avonex and Rebif. Rebif proved to be more effective in the short-term study and Avonex lost its ‘Orphan’ status, which protected it from competing molecularly identical drugs for seven years in the U.S.
- March 2002 the FDA approves Rebif.
Benefits: Slows the progression of disability in RRMS, decreases relapse rate by approximately 1/3, and decreases the amount of damage (or lesion activity) seen on MRI scans by approximately 1/ 3.
Administration: Subcutaneous injection of 44mcg 3 times a week.
Cost: A base cost between $17,000-$21,000 depending on dosage. In British Columbia, Pharmacare coverage is based on family income; once deductible is reached, Pharmacare pays 70% of costs; when family maximum is reached, Pharmacare pays 100% of costs. Drugs are 100% covered for people in long-term care facilities and those on social assistance. Private insurance coverage varies.
- Flu-like symptoms including fever, muscle ache, nausea, headache, and fatigue.
- Injection site reactions including itching, redness, pain, and swelling.
- All interferons may cause fluctuations of liver enzymes, and lowering of the white
- Some users of interferons develop neutralizing antibodies (NABs) which interfere with or neutralize the effects of interferon treatment
- Depression has been linked to interferon treatment.
- Rare: mild anemia, liver failure, allergic reactions, and heart problems
- (flu-like side effects and injection site reactions should lessen after continued use).
So What do you think? Is this giving you the information you need? Thanks again Steph!x
Hope you are all well!
Tomorrow is smurf blood!erg!
|posted by personallog! @ 11:58 am