Betaferon is a powder and solvent, which is made into a solution for injection. It contains 250 micrograms (8 million international units - MIU) per ml of the active substance interferon beta-1b.
|Table of Contents|
|What is it used for?|
|How is it used?|
|How does it work?|
|How has it been studied?|
|What benefits has it shown during the studies?|
|What is the risk associated?|
|Why has it been approved?|
Betaferon is used to treat adult patients who have multiple sclerosis (MS).
It is used in patients:
- who have experienced the signs of MS for the first time, and these are severe enough to justify treatment with injected corticosteroids (anti-inflammatory medicines). It is used when the patient is considered to be at high risk of developing MS. Before using it, doctors need to exclude other causes for the symptoms.
- who have MS of the type known as relapsing remitting, when the patient has attacks (relapses) within periods with no symptoms (remissions), in patients with at least 2 relapses within the last two years.
- who have secondary progressive MS (the type of MS that comes after relapsing remitting MS), when their disease is active. The medicine can only be obtained with a prescription.
Betaferon treatment should be started by a doctor who has experience in the treatment of MS. The treatment should start with 62.5 micrograms (a quarter of the dose) every other day, increasing progressively over 2 and a half weeks to reach the recommended dose of 250 micrograms (8 MIU) given every other day. Betaferon is given by a subcutaneous (under the skin) injection. The patients can inject Betaferon themselves, provided that they have been trained. Betaferon treatment should be stopped in patients who fail to respond.
MS is a disease of the nerves, where inflammation destroys the protective sheath around the nerves (demyelination). The active substance in Betaferon, interferon beta-1b, belongs to the group of the interferons. Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses. The exact way that Betaferon works in MS is not yet known but beta-interferon seems to calm the immune system and prevents the relapses of MS. Interferon beta-1b is produced by a method known as ?recombinant DNA technology?. The interferon beta-1b is made by a bacterium that has received a gene (DNA), which makes it able to produce it. The replacement interferon beta-1b acts in the same way as naturally produced interferon beta.
Betaferon was studied over 2 years in 338 patients with relapsing remitting MS and able to walk unaided, where its effectiveness was compared to that of a placebo (dummy treatment. The main measure of effectiveness was the reduction in the number of relapses.
Betaferon has also been studied in 1,657 patients in two studies of secondary progressive MS patients who were able to walk, where it was compared with a placebo. The main measure of effectiveness was the delay to progression of disability.
The study of Betaferon in patients with a single demyelinating event involved 487 patients, who received either Betaferon or a placebo for two years. The study measured the time it took for a patient to develop clinically defined MS.
In patients with relapsing remitting MS, Betaferon was more effective than placebo in reducing the number of annual relapses: patients receiving the medicine had on average 0.84 relapses a year, when patients on placebo had 1.27.
One of the two studies in patients with secondary progressive MS showed a significant delay in the time to disability progression (31% risk reduction due to Betaferon) and in the time to becoming wheelchair bound (39%). In the second trial, no delay in the time to disability progression was seen. In both trials, Betaferon showed a reduction in the number (30%) of clinical relapses. In the study of patients with a single demyelinating event, Betaferon was shown to reduce the risk of developing clinically defined MS: 28% of the patients who received Betaferon developed MS, against 45% of those who received placebo.
Very common side effects are flu-like symptoms (fever, chills, arthralgia [joint pain, malaise [feeling ill], headache or myalgia [muscle pain]) and injection site reactions. For the full list of all side effects reported with Betaferon, see the Package Leaflet.
Betaferon should not be used in people who have a history of hypersensitivity (allergy) to natural or recombinant interferon beta, human albumin or any of the other ingredients. Betaferon treatment should not be started during pregnancy. If a woman becomes pregnant while taking the medicine, she should consult her doctor. Betaferon should not be used in patients who are currently suffering from severe depression and/or have thoughts of suicide. Betaferon should not be used in patients who have decompensated liver disease (when the liver does not function normally).
The Committee for Medicinal products for Human Use (CHMP) decided that Betaferon?s benefits are greater than its risks for the treatment of patients with relapsing remitting multiple sclerosis, secondary progressive multiple sclerosis, and in patients with a single episode of demyelination, severe enough to justify treatment with injected corticosteroids. They recommended that Betaferon be given marketing authorisation.
Betaferon was originally authorised under "Exceptional Circumstances", because, for scientific reasons, limited information was available at the time of approval. As the company had supplied the additional information requested, the "Exceptional Circumstances" ended on 3 April 2001.