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Human interferon beta

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Identification

Summary

Human interferon beta is a polypeptide drug used in the treatment of relapsing forms of Multiple Sclerosis (MS).

Generic Name
Human interferon beta
DrugBank Accession Number
DB14999
Background

Human interferon beta is a polypeptide used in the management of relapsing forms of Multiple Sclerosis (MS), and was initially approved by the FDA in 1992.9 Multiple Sclerosis is a devastating neurodegenerative disease that is usually progressive and significantly debilitating with a profound impact on the quality of life.3

Interferon beta is currently being studied as a possible treatment for COVID-19, which results from infection with the novel 2019 SARS-CoV-2 virus.8 Interferon-beta has been used in the past in clinical studies with other coronaviruses due to its demonstrated activity against the virus causing Middle Eastern Respiratory Syndrome (MERS). It is therefore a potential drug candidate for SARS-CoV-2 based on viral genetic similarity.2,10

Type
Biotech
Groups
Approved, Investigational
Biologic Classification
Protein Based Therapies
Interferons
Protein Chemical Formula
Not Available
Protein Average Weight
40036.0 Da
Sequences
Not Available
Synonyms
  • Fibroblast interferon
  • FIF
  • HUMAN INTERFERON BETA
  • Interferon beta
  • Interferon beta (human)
  • Interferon beta (recombinant)
  • Interferon-beta
External IDs
  • SNG 001
  • SNG-001
  • SNG001
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Pharmacology

Indication

This drug is indicated to treat relapsing forms of Multiple Sclerosis (MS) in adults, which includes clinically isolated syndrome, relapsing-remitting disease, as well as active secondary progressive disease.9

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Treatment ofRelapsing remitting multiple sclerosis (rrms)•••••••••••••••••••••
Contraindications & Blackbox Warnings
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Pharmacodynamics

Interferon-beta has antiviral and immunomodulatory effects. It reduces demyelination, the main component of Multiple Sclerosis pathophysiology, reducing the clinical frequency of MS attacks and slowing disease progression.1,3,12

In vitro studies have shown that beta interferon reduces the replication of certain coronaviruses in lung tissue.7 Retrospective studies using combinations of mycophenolate mofetil and beta interferon showed improved survival against MERS-CoV, the virus that causes Middle Eastern Respiratory Syndrome (MERS). 6

Mechanism of action

Part of the pathophysiology of MS is immune cell activation in addition to degradation of the blood–brain barrier (BBB), resulting in both neural demyelination and axon injury. Immunomodulating drugs such as interferon-beta decrease the inflammation that results in demyelination of nerves. Binding of interferon-beta to type 1 interferon receptors induces a series of beneficial transcriptional JAK/STAT pathway changes. This decreases antigen presentation as well as the proliferation of inflammatory T-cells, reducing the inflammation associated with MS. It also changes the expression of cytokine and matrix metalloproteinase (MMP).1,4

TargetActionsOrganism
AInterferon alpha/beta receptor 1
binder
Humans
Absorption

Beta interferon has a bioavailability of about 30% after subcutaneous or intramuscular administration, demonstrating peak serum concentrations within several hours of a dose. Peak interferon beta-1b concentrations are achieved between 1-8 hours post-dose, measuring about 40 IU/mL.9 After injection, it is absorbed mainly by the lymphatic route.5 Prescribing information for interferon beta-1b indicates a bioavailability of 50%.12 Concentrations of beta interferon are detectable in the circulation 1-2 to days after administration.5

Volume of distribution

The average state volume of distribution for beta interferon is 0.25 L/kg to 2.88 L/kg.9,12 Another reference mentions a volume of distribution of 120 L.5 Beta interferon is distributed throughout the body after extravasation across the vascular wall into the tissue after injection. It likely does not cross the blood-brain barrier, and it is unclear whether beta interferon crosses the placenta.5

Protein binding

Not Available

Metabolism

Data regarding the metabolism of beta interferon is not readily available in the literature.

Route of elimination

Beta interferon is excreted by hepatic and renal pathways, with renal pathways accountable for about 40% of its clearance.5

Half-life

The mean terminal elimination half-life of interferon-beta varies from 8 minutes to about 4 hours.5,9

Clearance

Average serum clearance in a pharmacokinetic study of beta-interferon 1b ranged from 9.4 mL/min•kg-1 to 28.9 mL/min•kg-1.12 Another study revealed a clearance ranging between 0.3 to 1.4 L/h/kg.5

Adverse Effects
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Toxicity

LD50 information for beta interferon is not readily available in the literature.

Overdose information

Following an overdose with a very high dose of beta interferon, one patient described in a case report experienced a modest rise in body temperature with diffuse limb and truncal erythema. The symptoms resolved within 24 hours. Biochemical and hematologic parameters were nonremarkable after the overdose.6 In the case of an overdose, discontinue beta interferon and resume when the patient has returned to baseline function.

Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
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interactions in your software
AminophyllineThe metabolism of Aminophylline can be decreased when combined with Human interferon beta.
BromotheophyllineThe metabolism of Bromotheophylline can be decreased when combined with Human interferon beta.
CaffeineThe metabolism of Caffeine can be decreased when combined with Human interferon beta.
CladribineThe risk or severity of lymphopenia can be increased when Human interferon beta is combined with Cladribine.
DyphyllineThe metabolism of Dyphylline can be decreased when combined with Human interferon beta.
Food Interactions
No interactions found.

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Categories

Drug Categories
Chemical TaxonomyProvided by Classyfire
Description
Not Available
Kingdom
Organic Compounds
Super Class
Organic Acids
Class
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Peptides
Alternative Parents
Not Available
Substituents
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available
Affected organisms
  • SARS-CoV-2

Chemical Identifiers

UNII
V9GU1EM8SF
CAS number
74899-71-1

References

General References
  1. Markowitz CE: Interferon-beta: mechanism of action and dosing issues. Neurology. 2007 Jun 12;68(24 Suppl 4):S8-11. doi: 10.1212/01.wnl.0000277703.74115.d2. [Article]
  2. Al Ghamdi M, Alghamdi KM, Ghandoora Y, Alzahrani A, Salah F, Alsulami A, Bawayan MF, Vaidya D, Perl TM, Sood G: Treatment outcomes for patients with Middle Eastern Respiratory Syndrome Coronavirus (MERS CoV) infection at a coronavirus referral center in the Kingdom of Saudi Arabia. BMC Infect Dis. 2016 Apr 21;16:174. doi: 10.1186/s12879-016-1492-4. [Article]
  3. Huang WJ, Chen WW, Zhang X: Multiple sclerosis: Pathology, diagnosis and treatments. Exp Ther Med. 2017 Jun;13(6):3163-3166. doi: 10.3892/etm.2017.4410. Epub 2017 Apr 28. [Article]
  4. Kasper LH, Reder AT: Immunomodulatory activity of interferon-beta. Ann Clin Transl Neurol. 2014 Aug;1(8):622-31. doi: 10.1002/acn3.84. Epub 2014 Jul 23. [Article]
  5. Hegen H, Auer M, Deisenhammer F: Pharmacokinetic considerations in the treatment of multiple sclerosis with interferon-beta. Expert Opin Drug Metab Toxicol. 2015;11(12):1803-19. doi: 10.1517/17425255.2015.1094055. Epub 2015 Sep 30. [Article]
  6. Falcone NP, Nappo A, Neuteboom B: Interferon beta-1a overdose in a multiple sclerosis patient. Ann Pharmacother. 2005 Nov;39(11):1950-2. doi: 10.1345/aph.1E416. Epub 2005 Oct 4. [Article]
  7. Chan RW, Chan MC, Agnihothram S, Chan LL, Kuok DI, Fong JH, Guan Y, Poon LL, Baric RS, Nicholls JM, Peiris JS: Tropism of and innate immune responses to the novel human betacoronavirus lineage C virus in human ex vivo respiratory organ cultures. J Virol. 2013 Jun;87(12):6604-14. doi: 10.1128/JVI.00009-13. Epub 2013 Apr 3. [Article]
  8. World Health Organization: Landscape analysis of therapeutics as of February 17 2020 [Link]
  9. FDA approved products: Extravia (interferon beta-1b) subcutaneous injection [Link]
  10. Nature Biotechnology: Coronavirus puts drug repurposing on the fast track [Link]
  11. Product monograph: Avonex pen (interferon beta 1a) [Link]
  12. FDA approved products: Betaseron (interferon beta 1b) subcutaneous injection [Link]
  13. EMD Serono MSDS: Interferon beta 1a [Link]
  14. ThPDB: Interferon beta1a [Link]
  15. DailyMed Label: AVONEX (interferon beta-1a) injection, for intramuscular injection [Link]
RxNav
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MSDS
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Clinical Trials

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PhaseStatusPurposeConditionsCountStart DateWhy Stopped100+ additional columns
Unlock 175K+ rows when you subscribe.View sample data
4CompletedTreatmentMultiple Sclerosis1somestatusstop reasonjust information to hide
4CompletedTreatmentRelapsing Remitting Multiple Sclerosis (RRMS)2somestatusstop reasonjust information to hide
4WithdrawnTreatmentRelapsing Multiple Sclerosis (RMS)1somestatusstop reasonjust information to hide
3Active Not RecruitingTreatmentRelapsing Remitting Multiple Sclerosis (RRMS)1somestatusstop reasonjust information to hide
3CompletedTreatmentCoronavirus Disease 2019 (COVID‑19) / Infections, Coronavirus / Severe Acute Respiratory Syndrome (SARS)1somestatusstop reasonjust information to hide

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
SolutionSubcutaneous0.250 mg
Prices
Not Available
Patents
Not Available

Properties

State
Solid
Experimental Properties
PropertyValueSource
hydrophobicity-0.427http://crdd.osdd.net/raghava/thpdb/display_thppid_sub.php?details=Th1049
isoelectric point9.02https://collab.its.virginia.edu/access/content/group/f85bed6c-45d2-4b18-b868-6a2353586804/2/Ch32_Lee_S_Human_Interferon-Beta_--Homo_sapiens-_-/Ch32_Lee_S_Human_Interferon-Beta_--Homo_sapiens_Human_Interferon_beta.html

Targets

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Details1. Interferon alpha/beta receptor 1
Kind
Protein
Organism
Humans
Pharmacological action
Yes
Actions
Binder
General Function
Together with IFNAR2, forms the heterodimeric receptor for type I interferons (including interferons alpha, beta, epsilon, omega and kappa) (PubMed:10049744, PubMed:14532120, PubMed:15337770, PubMed:2153461, PubMed:21854986, PubMed:24075985, PubMed:31270247, PubMed:33252644, PubMed:35442418, PubMed:7813427). Type I interferon binding activates the JAK-STAT signaling cascade, resulting in transcriptional activation or repression of interferon-regulated genes that encode the effectors of the interferon response (PubMed:10049744, PubMed:21854986, PubMed:7665574). Mechanistically, type I interferon-binding brings the IFNAR1 and IFNAR2 subunits into close proximity with one another, driving their associated Janus kinases (JAKs) (TYK2 bound to IFNAR1 and JAK1 bound to IFNAR2) to cross-phosphorylate one another (PubMed:21854986, PubMed:32972995, PubMed:7665574, PubMed:7813427). The activated kinases phosphorylate specific tyrosine residues on the intracellular domains of IFNAR1 and IFNAR2, forming docking sites for the STAT transcription factors (PubMed:21854986, PubMed:32972995, PubMed:7526154, PubMed:7665574, PubMed:7813427). STAT proteins are then phosphorylated by the JAKs, promoting their translocation into the nucleus to regulate expression of interferon-regulated genes (PubMed:19561067, PubMed:21854986, PubMed:32972995, PubMed:7665574, PubMed:7813427, PubMed:9121453). Can also act independently of IFNAR2: form an active IFNB1 receptor by itself and activate a signaling cascade that does not involve activation of the JAK-STAT pathway (By similarity)
Specific Function
Cytokine binding
Gene Name
IFNAR1
Uniprot ID
P17181
Uniprot Name
Interferon alpha/beta receptor 1
Molecular Weight
63524.81 Da
References
  1. Markowitz CE: Interferon-beta: mechanism of action and dosing issues. Neurology. 2007 Jun 12;68(24 Suppl 4):S8-11. doi: 10.1212/01.wnl.0000277703.74115.d2. [Article]
  2. Kasper LH, Reder AT: Immunomodulatory activity of interferon-beta. Ann Clin Transl Neurol. 2014 Aug;1(8):622-31. doi: 10.1002/acn3.84. Epub 2014 Jul 23. [Article]
  3. Haji Abdolvahab M, Mofrad MR, Schellekens H: Interferon Beta: From Molecular Level to Therapeutic Effects. Int Rev Cell Mol Biol. 2016;326:343-72. doi: 10.1016/bs.ircmb.2016.06.001. Epub 2016 Jul 20. [Article]
  4. Kole A, He J, Rivollier A, Silveira DD, Kitamura K, Maloy KJ, Kelsall BL: Type I IFNs regulate effector and regulatory T cell accumulation and anti-inflammatory cytokine production during T cell-mediated colitis. J Immunol. 2013 Sep 1;191(5):2771-9. doi: 10.4049/jimmunol.1301093. Epub 2013 Aug 2. [Article]

Enzymes

Details1. Cytochrome P450 1A2
Kind
Protein
Organism
Humans
Pharmacological action
Unknown
Actions
Downregulator
Curator comments
Data regarding this enzyme action of interferon beta are scarce in the literature. This is unlikely to result in any CYP1A2 mediated drug interactions.
General Function
A cytochrome P450 monooxygenase involved in the metabolism of various endogenous substrates, including fatty acids, steroid hormones and vitamins (PubMed:10681376, PubMed:11555828, PubMed:12865317, PubMed:19965576, PubMed:9435160). Mechanistically, uses molecular oxygen inserting one oxygen atom into a substrate, and reducing the second into a water molecule, with two electrons provided by NADPH via cytochrome P450 reductase (NADPH--hemoprotein reductase) (PubMed:10681376, PubMed:11555828, PubMed:12865317, PubMed:19965576, PubMed:9435160). Catalyzes the hydroxylation of carbon-hydrogen bonds (PubMed:11555828, PubMed:12865317). Exhibits high catalytic activity for the formation of hydroxyestrogens from estrone (E1) and 17beta-estradiol (E2), namely 2-hydroxy E1 and E2 (PubMed:11555828, PubMed:12865317). Metabolizes cholesterol toward 25-hydroxycholesterol, a physiological regulator of cellular cholesterol homeostasis (PubMed:21576599). May act as a major enzyme for all-trans retinoic acid biosynthesis in the liver. Catalyzes two successive oxidative transformation of all-trans retinol to all-trans retinal and then to the active form all-trans retinoic acid (PubMed:10681376). Primarily catalyzes stereoselective epoxidation of the last double bond of polyunsaturated fatty acids (PUFA), displaying a strong preference for the (R,S) stereoisomer (PubMed:19965576). Catalyzes bisallylic hydroxylation and omega-1 hydroxylation of PUFA (PubMed:9435160). May also participate in eicosanoids metabolism by converting hydroperoxide species into oxo metabolites (lipoxygenase-like reaction, NADPH-independent) (PubMed:21068195). Plays a role in the oxidative metabolism of xenobiotics. Catalyzes the N-hydroxylation of heterocyclic amines and the O-deethylation of phenacetin (PubMed:14725854). Metabolizes caffeine via N3-demethylation (Probable)
Specific Function
Aromatase activity
Gene Name
CYP1A2
Uniprot ID
P05177
Uniprot Name
Cytochrome P450 1A2
Molecular Weight
58406.915 Da
References
  1. Delaporte E, Renton KW: Cytochrome P4501A1 and cytochrome P4501A2 are downregulated at both transcriptional and post-transcriptional levels by conditions resulting in interferon-alpha/beta induction. Life Sci. 1997;60(10):787-96. doi: 10.1016/s0024-3205(97)00006-4. [Article]
  2. Christensen H, Hermann M: Immunological response as a source to variability in drug metabolism and transport. Front Pharmacol. 2012 Feb 10;3:8. doi: 10.3389/fphar.2012.00008. eCollection 2012. [Article]

Carriers

Details1. Albumin
Kind
Protein
Organism
Humans
Pharmacological action
Unknown
Actions
Binder
General Function
Binds water, Ca(2+), Na(+), K(+), fatty acids, hormones, bilirubin and drugs (Probable). Its main function is the regulation of the colloidal osmotic pressure of blood (Probable). Major zinc transporter in plasma, typically binds about 80% of all plasma zinc (PubMed:19021548). Major calcium and magnesium transporter in plasma, binds approximately 45% of circulating calcium and magnesium in plasma (By similarity). Potentially has more than two calcium-binding sites and might additionally bind calcium in a non-specific manner (By similarity). The shared binding site between zinc and calcium at residue Asp-273 suggests a crosstalk between zinc and calcium transport in the blood (By similarity). The rank order of affinity is zinc > calcium > magnesium (By similarity). Binds to the bacterial siderophore enterobactin and inhibits enterobactin-mediated iron uptake of E.coli from ferric transferrin, and may thereby limit the utilization of iron and growth of enteric bacteria such as E.coli (PubMed:6234017). Does not prevent iron uptake by the bacterial siderophore aerobactin (PubMed:6234017)
Specific Function
Antioxidant activity
Gene Name
ALB
Uniprot ID
P02768
Uniprot Name
Albumin
Molecular Weight
69365.94 Da
References
  1. FDA approved products: Extravia (interferon beta-1b) subcutaneous injection [Link]

Drug created at May 20, 2019 14:40 / Updated at July 18, 2023 22:57