Betaseron (Interferon Beta-1B) - Summary

BETASERON 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 beta_ser17. 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.

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NEWS HIGHLIGHTS

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

A single-centre, randomized, double-blind, placebo-controlled study of interferon beta-1b on primary progressive and transitional multiple sclerosis. [2009.09.29]
Inflammation and neurodegeneration may have differential impacts on disease evolution in the different forms of multiple sclerosis. However, a beneficial effect of immunomodulatory drugs should not be ruled out in primary progressive multiple sclerosis... Positive effects of interferon beta on secondary clinical and magnetic resonance imaging outcomes were observed, but a beneficial effect on Expanded Disability Status Scale progression was not demonstrated.

Biological response genes after single dose administration of interferon beta-1b to healthy male volunteers. [2008.08.13]
Treatment with interferon beta-1b (IFNB-1b) is clinically effective in multiple sclerosis patients. However, the mechanism of action is only partially understood, and validated biological response markers are lacking.This panel may become a valuable tool for development of new IFNB-1b formulations and assessment of clinical drug effects.

Biological response genes after single dose administration of interferon beta-1b to healthy male volunteers. [2008.06.17]
Treatment with interferon beta-1b (IFNB-1b) is clinically effective in multiple sclerosis patients. However, the mechanism of action is only partially understood, and validated biological response markers are lacking.This panel may become a valuable tool for development of new IFNB-1b formulations and assessment of clinical drug effects.

Subgroups of the BENEFIT study: risk of developing MS and treatment effect of interferon beta-1b. [2008.04]
BACKGROUND : The BENEFIT study examined interferon beta (IFNB)-1b treatment in patients with clinically isolated syndrome (CIS) and > or = 2 clinically silent brain MRI lesions. METHODS : Subgroups of 468 patients (IFNB-1b: n = 292; placebo: n = 176) were created for demographics, clinical, laboratory, and MRI findings at onset...

Magnetic resonance imaging effects of interferon beta-1b in the BENEFIT study: integrated 2-year results. [2007.09]
BACKGROUND: In the Betaseron/Betaferon in Newly Emerging Multiple Sclerosis for Initial Treatment (BENEFIT) study, interferon beta-1b delayed conversion to multiple sclerosis in patients with a first clinical event and at least 2 clinically silent brain magnetic resonance imaging (MRI) lesions. OBJECTIVE: To examine detailed MRI findings from the first 2 years of this trial... CONCLUSIONS: Interferon beta-1b treatment had a robust effect on MRI measures, supporting its value as an early intervention in this patient group. This effect was maintained despite including patients who switched from placebo to interferon beta-1b in the active treatment group. Trial Registration clinicaltrials.gov Identifier: NCT00185211.

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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.

Betaferon® (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 Betaferon® 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 Betaferon®/Betaseron® (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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PATIENT REVIEWS / RATINGS / COMMENTS

Betaseron review by 43 year old female patient
		Rating
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.