This article preserves historical trial summaries, dosing descriptions and product information. It has not been reviewed against current prescribing information and should not be used to choose or change treatment.
Betaseron, known as Betaferon in Europe, is manufactured by Schering and its US associate Berlex. It is a form of beta interferon (interferon beta, IFN-β) used to modify the course of multiple sclerosis.
While not a cure, Betaseron has been shown in clinical trials to reduce the average relapse rate in people with the relapsing-remitting multiple sclerosis form of the disease. That doesn't mean that it reduces the relapse rate for all the trial volunteers, just that averaged over the entire volunteer population, the relapse rate is reduced.
Betaseron/Betaferon has also been shown to reduce EDSS progression and relapse rate in people with secondary progressive MS who are still experiencing relapses.
Betaseron is a form of beta interferon known as interferon beta-1b. It is administered via subcutaneous self-injection every other day.
Here is a table of clinical trials of Betaseron.
Trial Name | Brief Description | Results | Reference |
|---|---|---|---|
IFNB Multiple Sclerosis Study Group - IFNβ-1b (Betaseron / Betaferon) trial of relapsing remitting MS | Multicenter, randomized, double-blind, placebo-controlled trial with 372 people. One-third received placebo, one-third 1.6 MIU of IFNβ-1b and one-third 8 MIU of IFNβ-1b - all self-administered by subcutaneous injections every other day. Study over 2 years extended for 5 years | Annual relapse rate for patients receiving placebo was 1.27; for 1.6 MIU IFNβ-1b, 1.17; and for 8 MIU IFNβ-1b, 0.84 after 2 years. Based on 52 people at one study centre, new MRI lesion formation was reduced by 80% |
Trial Name | Brief Description | Results | Reference |
|---|---|---|---|
Comparative trial between interferon beta-1b (Betaseron regime) and interferon beta-1a (Avonex regime) (INCOMIN). | 2-year, prospective, randomised, multicentre study. 188 patients with RRMS were assigned to interferon beta-1b (n=96) or interferon beta-1a (n=92). Interferon beta-1a 30 microg was administered once a week, interferon beta-1b 250 microg was administered on alternate days. Primary outcome measures were the proportion of patients free from relapses and free from new MRI T2 lesions. | 51% on interferon beta-1b remained relapse-free compared with 36% on interferon beta-1a. 55% on interferon beta-1b had no new T2 lesions compared 26% on interferon beta-1a. | |
Open-label treatment trial to compare the effect of IFNβ-1a (Avonex), IFNβ-1b (Betaseron), and glatiramer acetate (Copaxone) on the relapse rate in RRMS | 12 month (18 months of follow-up) prospective, non-randomized, open-label trial with 156 volunteers (33 no treatment, 40 Avonex, 41 Betaseron and 42 Copaxone | Average relapses per year: Copaxone - 0.49; Betaseron 0.55; Avonex - 0.81; Untreated - 1.02. The Avonex reduction was not statistically significant | |
Comparison of Copaxone and Betaferon (Betaseron) in people with MS : an open-label 2-year follow-up | 58 people with RRMS divided into: (a) Copaxone 20 mg subcutaneously daily - 20 people (b) Copaxone 20 mg alternate-days - 18 people (c) Betaseron 8 MIU subcutaneously alternate days - 20 patients | All groups showed a reducton in relapse rate over 2 years: (a) Copaxone daily 1.1 (b) Copaxone alternate day, 0.9 (c) Betaseron 1.2. All 3 groups deteriorated on EDSS: (a)Copaxone daily by 0.5 points (b) Copaxone alternate by 0.4 points (c) Betaseron by 0.2 points |
Trial Name | Brief Description | Results | Reference |
|---|---|---|---|
European Study Group on interferon beta-1b (IFNβ-1b, Betaferon) in secondary progressive MS | Placebo-controlled, multicentre, randomised, double-blinded trial involving 718 people (358 on placebo, 360 on IFNβ-1b at 250 µg subcutaneously every other day for up to three years) | Betaferon reduced the confirmed 1-point EDSS progression rate, reduced the relapse rate by 31% and new MRI lesions by 78%. | Lancet. 1998 Nov 7;352(9139):1491-7 |
Neutralising antibodies:
More information about Betaseron/Betaferon including comparative information between the various disease modifying treatments for multiple sclerosis can be found by following this link:
Betaseron links:
NMSS - Room temperature Betaseron approved
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Author: Paul Jones
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