Interferon beta-1b
Also known as: Betaferon, Betaseron, Extavia, IFN-β1b, IFN‑β1b, Interferon beta 1b
Source Interferon beta-1b at Peptiology
Save 10% with code PEPTI-BOSSRABBIT-10
Affiliate link: we earn a commission on purchases made through this link, at no extra cost to you.
Tapping Shop Now & Save 10% copies your 10% off code PEPTI-BOSSRABBIT-10 to your clipboard. Paste it at the Peptiology checkout to claim the discount.
Summary
Interferon beta-1b is a recombinant type I interferon cytokine approved for subcutaneous injection. It is primarily prescribed as a disease‑modifying therapy for relapsing‑remitting multiple sclerosis (RRMS), where it reduces inflammatory activity and slows disability accumulation. The drug has also been examined in pharmacogenomic studies of COVID‑19 therapies, although clinical data for that indication are lacking.
Mechanism of Action
Interferon beta‑1b binds the type I interferon receptor (IFNAR) on immune cells, triggering the JAK‑STAT signaling cascade. This leads to transcription of interferon‑stimulated genes that modulate antiviral defenses and dampen pro‑inflammatory cytokine production, thereby altering the immune response that drives multiple sclerosis lesions.
What the Research Shows
Randomised trials and network meta‑analyses show that interferon beta‑1b modestly reduces relapse rates and markedly suppresses MRI‑detected inflammation in RRMS, with benefits evident when treatment starts early. A 2024 Cochrane review reported a probable slight reduction in serious adverse events compared with placebo (OR 0.92) and a modest increase in treatment discontinuations due to adverse events. A 2023 adverse‑effects meta‑analysis found low‑certainty evidence that interferon beta‑1b meets non‑inferiority for serious adverse events (RR 0.94). A pharmacogenomics review identified an IRF6 variant linked to liver toxicity, but clinical relevance remains untested. No direct efficacy data exist for COVID‑19.
Reported Benefits
Evidence from controlled trials indicates interferon beta‑1b lowers the frequency of clinical relapses and substantially reduces new MRI lesions in RRMS, supporting its role as an early disease‑modifying agent. Meta‑analyses suggest it may slightly decrease the risk of serious adverse events relative to placebo, and its antiviral cytokine activity underlies investigation for emerging infections. Overall, the drug provides a modest but clinically meaningful benefit in controlling disease activity.
Limitations of the Evidence
Comparative efficacy appears inferior to newer high‑efficacy agents such as natalizumab or cladribine, with only moderate‑certainty evidence for its impact on relapses. Many trials show risk of bias related to sponsorship and performance factors. Pharmacogenomic signals for liver toxicity lack validation, and no robust data support use in COVID‑19. Long‑term safety beyond two years remains insufficiently studied, and the magnitude of clinical benefit is modest.
Safety Considerations
Interferon beta‑1b is generally well tolerated, but injection‑site reactions and flu‑like symptoms are common in practice. Network meta‑analyses report a slight increase in treatment discontinuations due to adverse events compared with placebo. Low‑certainty evidence suggests it meets non‑inferiority for serious adverse events (RR 0.94). A pharmacogenomic review highlighted a possible association between IRF6 variants and liver toxicity, indicating a need for monitoring liver function, especially in genetically predisposed individuals.
How It Is Administered
The drug is supplied as a recombinant protein for subcutaneous injection. It is typically administered regularly (e.g., every other day) according to the product label, using prefilled syringes or autoinjectors. No oral formulation exists, and dosing schedules are determined by the prescribing clinician.
Routes of Administration
Goals & Uses
- Clinically isolated syndrome (CIS) — delay to definite MSNeurological / PreventiveHigh
- Reduction of MRI lesion burden in MSNeurological / Imaging BiomarkerHigh
- Delay of disability progression in MSNeurological / AutoimmuneHigh
- Treatment of secondary progressive MSNeurological / Disease ModificationModerate
- Relapsing‑Remitting MSDisease ModifyingHigh
- Multiple SclerosisAutoimmune DiseaseHigh
- Reduction of relapse rate in relapsing-remitting MSNeurological / ImmunomodulationHigh
Contraindications
- Current severe depression or suicidal ideationPsychiatricHigh
- Hypersensitivity to interferon beta‑1b or excipientsAllergyHigh
- Severe depression or psychiatric diseasePsychiatricModerate
- PregnancyPopulationHighPotential fetal risk or insufficient safety data
- Severe hepatic impairment or decompensated liver diseaseHepaticHigh
- Hypersensitivity to natural or recombinant interferon-β or human albuminAllergy / ImmunologicHigh
Adverse Effects
- Hepatotoxicity / elevated liver enzymesHepaticCommon
- Injection site reactions (pain, erythema, necrosis)Local / DermatologicCommon
- Flu-like symptoms (fever, chills, myalgia, malaise)Systemic / ImmunologicCommon
- LeukopeniaHematologicRareLow white blood cell count
- Injection site reactionsLocalCommon
- LymphopeniaHematologicCommon
- Flu‑like syndromeSystemicCommon
- Depression and suicidal ideationPsychiatricUncommon
- DepressionPsychiatricUncommon
- Elevated liver enzymesHepaticUncommonIncrease in AST/ALT or other hepatic markers
- Neutralizing antibodies (NAbs)ImmunologicalCommon
Drug Interactions
- Immunosuppressants (e.g., azathioprine)Moderate
- Antidepressants (e.g., SSRIs)Low
- Live vaccinesHigh
- CYP450 substrates (e.g., warfarin, phenytoin)Moderate
- Hepatotoxic drugs (e.g., isoniazid, valproate, statins)Moderate
- Myelosuppressive agents (e.g., azathioprine, methotrexate)Moderate
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patients (<18 years)AgeRelative
- Patients with epilepsyNeurologicalRelative
- Pediatric (≥3 years)AgeRelative
- Patients with thyroid disordersEndocrineRelative
- Patients with pre-existing depression or psychiatric disordersPsychiatricRelative
- Pregnant womenReproductiveRelative
Regulatory Status
- European UnionApprovedApproved: relapsing‑remitting multiple sclerosisMarketed as Extavia.
- United StatesApprovedApproved: relapsing forms of multiple sclerosisMarketed as Betaseron.
- United KingdomApprovedApproved: relapsing forms of multiple sclerosisSame as EU.
Administered by subcutaneous injection; biosimilar versions under investigation.
Evidence & Sources
- Journal ArticleModerateTakahashi T, et al.2020-01-01T00:00:00.000000Z
- Journal ArticleHighGonzalez-Lorenzo M, et al.2024-01-01T00:00:00.000000Z
- Journal ArticleModerateComi G2006-01-01T00:00:00.000000Z
- Journal ArticleHighTramacere I, et al.2023-01-01T00:00:00.000000Z
- Journal ArticleModerateGoodkin DE1994-01-01T00:00:00.000000Z
Frequently Asked Questions
What condition is interferon beta‑1b approved to treat?
It is approved as a disease‑modifying therapy for relapsing‑remitting multiple sclerosis, where it reduces relapse frequency and MRI‑detected disease activity.
What are the most common side effects?
Patients often experience injection‑site reactions and flu‑like symptoms such as fever, chills, and muscle aches. These are usually mild to moderate and tend to lessen with continued use.
How does genetics influence its safety?
A pharmacogenomics review identified an IRF6 gene variant that may increase the risk of liver toxicity with interferon beta‑1b, suggesting that genetic testing could help identify susceptible individuals, although clinical validation is pending.
Is interferon beta‑1b used for COVID‑19?
The drug has been mentioned in pharmacogenomic surveys of COVID‑19 therapies, but no direct clinical trials or efficacy data support its use for COVID‑19 at present.
What is Interferon beta-1b?
Interferon beta-1b is a recombinant type I interferon cytokine approved for subcutaneous injection. It is primarily prescribed as a disease‑modifying therapy for relapsing‑remitting multiple sclerosis (RRMS), where it reduces inflammatory activity and slows disability accumulation. The drug has also been examined in pharmacogenomic studies of COVID‑19 therapies, although clinical data for that indication are lacking.
What is Interferon beta-1b used for?
Interferon beta-1b is educationally associated with: Clinically isolated syndrome (CIS) — delay to definite MS, Reduction of MRI lesion burden in MS, Delay of disability progression in MS, Treatment of secondary progressive MS, Relapsing‑Remitting MS, Multiple Sclerosis, Reduction of relapse rate in relapsing-remitting MS. Educational only — not medical advice.
How is Interferon beta-1b administered?
Recorded routes of administration: Intramuscular, Subcutaneous.
What are the potential side effects of Interferon beta-1b?
Reported adverse effects include: Hepatotoxicity / elevated liver enzymes, Injection site reactions (pain, erythema, necrosis), Flu-like symptoms (fever, chills, myalgia, malaise), Leukopenia, Injection site reactions, Lymphopenia, Flu‑like syndrome, Depression and suicidal ideation, Depression, Elevated liver enzymes, Neutralizing antibodies (NAbs). This list is not exhaustive — consult a qualified clinician.
Who should avoid Interferon beta-1b?
Recorded contraindications: Current severe depression or suicidal ideation, Hypersensitivity to interferon beta‑1b or excipients, Severe depression or psychiatric disease, Pregnancy, Severe hepatic impairment or decompensated liver disease, Hypersensitivity to natural or recombinant interferon-β or human albumin. Consult a qualified clinician before use.