Betaseron (interferon beta-1b) for multiple sclerosis
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What is Betaseron for MS?
Betaseron (interferon beta-1b) is an approved injectable medication used to treat adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).
Administered every other day via subcutaneous, or under-the-skin, injections, it has been shown in clinical trials to reduce the frequency of MS relapses, prevent the development of lesions, and delay disability progression.
Betaseron’s active ingredient, interferon beta-1b, is a lab-made version of natural molecules called interferons, which help the body fight infections. While its exact mechanism of action is not completely understood, Betaseron is thought to shift the immune system toward an anti-inflammatory response and to reduce the number of immune cells capable of reaching the brain and spinal cord.
The therapy was originally developed by Chiron, but is now owned and marketed by Bayer. It was the first disease-modifying therapy to be approved in the U.S. for relapsing forms of MS.
Therapy Snapshot
| Brand name: | Betaseron |
| Chemical name: | Interferon beta-1b |
| Usage: | Used to reduce disease activity and delay disability progression in relapsing forms of MS |
| Administration: | Subcutaneous injection |
Who can take Betaseron?
Betaseron is approved in the U.S. for adults with CIS, RRMS, and active SPMS.
The medication should not be taken by people with a history of hypersensitivity reactions (harmful immune responses, including allergic reactions) to natural or lab-made interferon beta, albumin, or mannitol.
Betaseron is approved in more than 100 countries for the same indications. In Europe and other regions outside North America, it is marketed under the brand name Betaferon.
How is Betaseron administered?
Betaseron is administered via subcutaneous injections once every other day.
It is provided as a dry powder that must be diluted in an appropriate liquid solution, supplied in a prefilled syringe. After reconstitution, it is then administered using an autoinjector called Betaconnect. Injections can be done by patients or caregivers after appropriate training.
The recommended dosage is 0.25 mg, or 1 mL of the reconstituted solution, every other day. However, patients typically begin the treatment at a lower dose and then gradually increase their dosage over the course of six weeks.
Betaseron injections should be given in loose and soft skin, such as the stomach region, thigh, buttocks, or upper arms, and injection sites should be rotated to avoid reactions such as infections or tissue death.
A doctor may also recommend taking analgesics or anti-fever medications on treatment days to ease flu-like symptoms, a common side effect associated with the medication.
Betaseron in clinical trials
Betaseron’s approval in the U.S. was supported by data from four clinical trials: one in RRMS, two in SPMS, and one in CIS. The trials tested the medication against a placebo in a combined total of about 2,500 patients.
- The RRMS trial enrolled people who had experienced at least two relapses in the previous two years and aimed to assess differences in relapse rates. Results showed Betaseron led to a significant reduction in the number and severity of relapses after two years of treatment. Significant changes in disability could not be observed in either group, but those on Betaseron also experienced less disease activity on MRI scans.
- The two SPMS trials were conducted in the U.S. and in Europe, and aimed to detect differences in disability progression after up to three years. This goal was met in the European study but rates of progression did not differ significantly in the U.S.-based trial. Still, the treatment also significantly reduced relapse rates and MRI activity in both trials.
- A fourth trial called BENEFIT trial (NCT00185211) enrolled people with CIS who had experienced their first episode of MS-like symptoms in the 60 days prior. In this population, Betaseron significantly reduced the risk of progressing to clinically definite MS after two years. Benefits were sustained for up to 15 years in a long-term study (NCT01795872), with the risk of conversion to clinically definite MS remaining 30.5% lower among those who started Betaseron in the main trial.
Betaseron side effects
The most common side effects of Betaseron reported in clinical trials include:
- injection site reactions
- low counts in blood cells, particularly lymphocytes, leukocytes, and neutrophils
- flu-like symptoms
- muscle pain and increased muscle tone, which can appear as stiffness or spasticity
- elevated levels of liver enzymes
- headache
- pain
- rash
- insomnia
- abdominal pain.
Other less common but serious side effects of Betaseron, some of which may require careful monitoring or adjustments to the treatment plan, include:
- liver injury, which may be severe and lead to liver failure
- serious allergic reactions, including anaphylaxis, which can be life-threatening
- depression and suicidal thoughts
- heart issues
- injection site reactions, some of which may lead to tissue death
- low immune cell levels, which may require dose reductions
- thrombotic microangiopathy, a condition characterized by the formation of blood clots inside small blood vessels, which can be fatal
- pulmonary arterial hypertension, or high blood pressure in the small blood vessels that transport blood through the lungs, which should prompt treatment to be discontinued
- seizures
- drug-induced lupus, an autoimmune condition that may affect multiple organs.
Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
FAQs about Betaseron
Betaseron was the first disease-modifying therapy to be approved by the U.S. Food and Drug Administration for multiple sclerosis (MS). It was first approved in 1993 for relapsing-remitting MS, and its label was later expanded to include clinically isolated syndrome in 2006, and active secondary progressive MS in 2019.
Most observational studies that tracked the outcomes of pregnancies exposed to interferon beta therapies, including Betaseron, did not identify an increased risk of adverse pregnancy outcomes or major birth defects. If clinically needed, Betaseron may be considered during pregnancy, but patients who are or plan to become pregnant should always discuss the benefits and risks with their healthcare providers.
There are no studies reporting an interaction between Betaseron and alcohol. However, alcohol has the potential to cause liver damage, which is also a known side effect of Betaseron, so it should be used with caution while taking this medication. Patients should always discuss safe alcohol use with their healthcare providers.
Because multiple sclerosis presents differently in each individual and responses to treatment vary, it is difficult to determine a standard timeline for when Betaseron starts to work. Patients are advised to talk with their healthcare team about how the medication may help in their specific case.
Both hair loss and weight gain have been reported in clinical trials as potential side effects of Betaseron. Patients should talk with their healthcare team if they experience these or other new symptoms while on the medication.
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