What is Rebif?
Rebif is a solution for injection in syringes and pre-filled cartridges. The syringes contain 8.8, 22 or 44 micrograms of the active substance interferon beta-1a. The cartridges contain a total of 66 or 132 micrograms of interferon beta-1a and are designed for multiple dosing using an electronic injector which releases 8.8, 22 or 44 micrograms per dose.
What is Rebif used for?
Rebif is indicated for the treatment of multiple sclerosis (MS) with relapses. It is a type of multiple sclerosis in which the patient suffers from attacks (relapses), followed by periods without symptoms. The efficacy of the medicine has not been demonstrated in patients with secondary progressive MS (the MS occurring after MS with relapses) in the absence of exacerbations. Rebif should not be used in children under the age of 12 due to a lack of information on the use of the medicine in this population.
The medicine can only be obtained with a prescription.
How is Rebif used?
Treatment with Rebif should be started under the supervision of a physician experienced in the treatment of MS. The recommended dose of Rebif is 44 micrograms three times a week by subcutaneous injection (under the skin). The 22 micrograms dose is recommended for patients who cannot tolerate the highest dose and for adolescents aged 12 to 16 years.
When starting treatment with Rebif for the first time, the dosage should gradually increase to avoid adverse reactions, starting with 8.8 micrograms three times a week in the first two weeks, then continuing with 22 micrograms three times a week in the next two weeks. To start the treatment, special packs with the correct number of syringes or cartridges are available. The electronic injector used with the cartridges is programmed to release the correct doses of Rebif at the beginning of the treatment and during the intake phase of the standard dose.
The patient can inject himself Rebif, if he has received appropriate instructions. The doctor may advise the patient to take an antipyretic analgesic before each injection and 24 hours after the injection in order to mitigate flu-like symptoms that may occur as an adverse reaction to the treatment. All patients should be monitored at least once every two years.
How does Rebif work?
MS is a disease of the nerves in which inflammation destroys the protective sheath that covers the nerves. This phenomenon is called "demyelination". The active substance in Rebif, interferon beta-1a, belongs to the group of interferons. Interferons are natural substances produced by the body to help it cope with attacks such as viral infections. The mechanism of action of Rebif in MS is not yet fully known; however, interferon beta appears to calm the immune system and prevent MS relapses.
Interferon beta-1a is produced by a method known as "recombinant DNA technique": that is, it is obtained from a cell in which a gene (DNA) has been inserted which allows it to produce interferon beta-1a. The analogue interferon beta-1a acts in the same way as natural interferon beta.
How has Rebif been studied?
Rebif has been studied in 560 patients with relapsing MS. Patients had suffered at least two relapses in the previous 2 years. Patients were treated with Rebif (22 or 44 micrograms) or placebo (a dummy treatment) for two years. The study was subsequently extended to four years.
The number of recurrences of the patient was considered as the main measure of effectiveness.
Rebif has also been studied in patients with secondary progressive MS. This study evaluated the effectiveness of the drug in preventing disability progression over three years.
The company did not carry out formal studies on patients under the age of 16. However, it has presented information from published studies on the use of Rebif in adolescents aged 12 to 18 years.
What benefit has Rebif shown during the studies?
Rebif was more effective than placebo in reducing the number of relapsing-remitting MS relapses. Recurrence decreased about 30% over two years with both Rebif 22 micrograms and Rebif 44 micrograms compared to placebo, and 22% (Rebif 22 micrograms) and 29% (Rebif 44 micrograms) over the course of four years.
In the study of patients with progressive MS, no significant effect on disability progression was observed, but the recurrence rate decreased by approximately 30%. Some effects on disability progression were found only in patients who reported relapses in the two years prior to the start of the study.
Published studies have shown, with regard to patients aged 12 to 18, a decrease in the recurrence rate. This decrease may be related to treatment with Rebif.
What is the risk associated with Rebif?
The most common side effects (seen in more than 1 patient in 10) with Rebif are flu-like symptoms, neutropenia, lymphopenia and leukopenia (reduced number of white blood cells), thrombocytopenia (reduced number of platelets), anemia (reduced number of globules reds), headache, inflammation and other reactions at the injection site, as well as increased transaminases (liver enzymes). Similar undesirable effects have been observed in minors. For the full list of all side effects reported with Rebif, see the Package Leaflet.
Rebif should not be used in patients with a history of hypersensitivity (allergy) to natural or recombinant interferon beta or any of the other components. Treatment with Rebif should not be started during pregnancy. Patients who begin pregnancy during therapy should consult their doctor. Furthermore, Rebif should not be taken by patients with severe depression or suicidal ideation.
Why was Rebif approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Rebif's benefits are greater than its risks for treating MS patients with relapses and therefore recommended that they be given marketing authorization.
Other information on Rebif:
On 4 May 1998, the European Commission granted a marketing authorization valid throughout the European Union for Rebif to Serono Europe Limited. The marketing authorization was renewed on 4 May 2003 and 4 May 2008.
For the full EPAR of Rebif, click here.
Last update of this summary: 01-2009
