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Betaseron (Interferon Beta-1B) - Summary



Betaseron® (Interferon beta-lb) is a purified, sterile, lyophilized protein product produced by recombinant DNA techniques. Interferon beta-1b is manufactured by bacterial fermentation of a strain of Escherichia coli that bears a genetically engineered plasmid containing the gene for human interferon betaser17. The native gene was obtained from human fibroblasts and altered in a way that substitutes serine for the cystine residue found at position 17.

Betaseron (Interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations.

See all Betaseron indications & dosage >>


Published Studies Related to Betaseron (Interferon Beta-1B)

Interferon beta-1b reduces black holes in a randomised trial of clinically isolated syndrome. [2014]
(persistent black holes (PBHs))... CONCLUSIONS: Although the rate of lesions that converted to PBH showed no

Interferon beta for secondary progressive multiple sclerosis. [2012]
CONCLUSIONS: Well designed RCTs, evaluating a high number of patients

Interferon beta-1b-neutralizing antibodies 5 years after clinically isolated syndrome. [2011.08.30]
OBJECTIVE: To determine the frequency and consequences of neutralizing antibodies (NAbs) in patients with a first event suggestive of multiple sclerosis (MS) treated with interferon beta-1b (IFNbeta-1b)... CONCLUSIONS: Although NAb positivity was associated with increased brain MRI activity, no discernible effects on clinical outcomes were found. This finding may reflect the greater power of MRI compared with clinical outcomes to detect the treatment effects of IFNbeta-1b and may also result from temporal changes in NAb titers and biology.

Interferon beta-1b and glatiramer acetate effects on permanent black hole evolution. [2011.04.05]
OBJECTIVE: To compare interferon beta-1b (IFNbeta-1b) and glatiramer acetate (GA) on new lesion (NL) (gadolinium-enhancing, new T2) evolution into permanent black holes (PBH)--a marker of irreversible tissue damage--in patients with relapsing-remitting multiple sclerosis (RRMS)... CONCLUSION: IFNbeta-1b affected PBH development to a similar or better extent than GA. IFNbeta-1b favorably influences an MRI outcome indicative of permanent tissue destruction in the brains of patients with multiple sclerosis. Classification of evidence: This study provides Class III evidence that IFNbeta-1b is associated with a reduction in MRI PBH formation and evolution compared with GA between years 1 and 2 of treatment.

[Interferon beta for multiple sclerosis. How much is good enough?]. [2010.12]
Interferon beta-1b (IFNB-1b, Betaferon(R)) was the first therapy for multiple sclerosis (MS) showing efficacy in a randomized controlled clinical trial... In this review the BEYOND trial is reviewed and placed in the context of advantages and disadvantages of currently available first line therapies for MS.

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Clinical Trials Related to Betaseron (Interferon Beta-1B)

BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose [No longer recruiting]
The purpose of this study is to determine

1. whether treatment with interferon beta-1b 500 micrograms safe, tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms

2. whether treatment with interferon beta-1b tolerable and more efficacious than treatment with Copaxone 20 mg

BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose [Active, not recruiting]
The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and will further investigate the safety and tolerability profile of interferon beta 1b 500µg during longer-term treatment.

BEYOND: Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose [Active, not recruiting]
The purpose of this study is to determine

1. whether treatment with interferon beta-1b 500 micrograms safe, tolerable and more efficacious than treatment with interferon beta-1b 250 micrograms

2. whether treatment with interferon beta-1b tolerable and more efficacious than treatment with Copaxone 20 mg

Betaferon®/ Betaseron® (Interferon Beta-1b) in Patients With Chronic Viral Cardiomyopathy [Completed]
Chronic viral cardiomyopathy is a disease where the cardiac muscle is attacked by a virus and this may result in a reduction in the output of the heart (pump function) thereby causing complaints such as chest pain, shortness of breath and palpitations.

BetaferonĀ® (interferon beta-1b) is marketed for the treatment of Multiple Sclerosis already, but until now, it has not been proven whether it is also effective in patients with chronic viral myocardial disease.

This study will be conducted to examine the efficacy and safety of BetaferonĀ® in patients with this disease. The aim of the treatment is to eliminate the virus from the heart so that the heart function and clinical status can gradually improve.

Follow-up Study of the BENEFIT Study (Betaferon® / Betaseron® in Newly Emerging Multiple Sclerosis for Initial Treatment) [Active, not recruiting]
This study will primarily compare the long-term effects of an early and continued treatment with BetaferonĀ®/BetaseronĀ® (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated after CDMS has been diagnosed (those patients who were treated with placebo during the double-blind BENEFIT study).

Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.

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Reports of Suspected Betaseron (Interferon Beta-1B) Side Effects

Injection Site Pain (146)Influenza Like Illness (124)Injection Site Erythema (115)Depression (110)Pyrexia (103)Pain (98)Fatigue (96)Headache (90)Multiple Sclerosis Relapse (83)Chills (74)more >>


Based on a total of 1 ratings/reviews, Betaseron has an overall score of 8. The effectiveness score is 10 and the side effect score is 4. The scores are on ten point scale: 10 - best, 1 - worst.

Betaseron review by 43 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   multiple sclerosis
Dosage & duration:   0.3mg taken every other night for the period of 4 years and will continue thru life
Other conditions:   DM II, hypertension, splenomegaly, metabolic syndrome, gerd, ibs,edema of lower extremities, seizure
Other drugs taken:   glucophage, omeprazole,paxil, clonazepam,benicar, atenolol,flovent, albuterol, topamax, tretinoin
Reported Results
Benefits:   Storage of a drug may not seem important, but betaseron does not have to be refridgerated, which makes it highly portable. But the main benefit is that the lesions that I was originally diagnosed with DID NOT WORSEN over time. In addition, I have had NO new lesions since beginning betaseron. So this has helped to slow the progress (secondary progressive relapse/remit) and I believe decreased the amount of relapses with residual. Which, if you have ms this is what you aim for.
Side effects:   I do, for some unknown reason, still have side effects from the betaseron. They don't happen every injection, and there is no pattern. I will have a fever and/or chills, and I hurt all over. It feels sometimes like even my hair hurts:) And my injection sites do have a tendency to form large red circles, but they are NOT infections, just a side effect. And for some reason the injections on my legs hurt the worst.
Comments:   I guess the treatment details are how I take it. The injections are deep subcutaneous. Because the drug is very hard on tissue, you can't inject into the same area. Upper arms are divided into 6 imaginary sections, abdomen 6 areas, legs 6 areas, and buttocks 6. So inject into first arm area on one arm, then next injection opposite arm, then abdomen, legs, and buttocks. Then you must start over in the first arm, but a different section and then work your way down again. This keeps tissue necrosis from occuring. The injections are every other night, and come in a pre-measured syringe the must be mixed SLOWLY with the powder immediately before injection. MAKE SURE to NOT agitate the sol'n, as it will foam, then you can't get it in the syringe, and then it's useless.

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Page last updated: 2014-11-30

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