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Encyclopedia > Infliximab
Infliximab
Therapeutic monoclonal antibody
Source chimeric/mouse/human
Target TNF
Identifiers
CAS number 170277-31-3
ATC code L04AA12
DrugBank BTD00004
Chemical data
Formula C6428H9912N1694O1987S46 
Mol. mass 144190.3 g/mol
Pharmacokinetic data
Bioavailability 100% (IV)
Metabolism reticuloendothelial system
Half life 9.5 days
Excretion  ?
Therapeutic considerations
Pregnancy cat.

B Image File history File links Infliximab_structure2. ... Monoclonal antibodies (mAb) are antibodies that are identical because they were produced by one type of immune cell, all clones of a single parent cell. ... Monoclonal antibodies (mAb) are antibodies that are identical because they were produced by one type of immune cell, all clones of a single parent cell. ... An antigen is a molecule that stimulates an immune response. ... CAS registry numbers are unique numerical identifiers for chemical compounds, polymers, biological sequences, mixtures and alloys. ... The Anatomical Therapeutic Chemical Classification System is used for the classification of drugs. ... A section of the Anatomical Therapeutic Chemical Classification System. ... The DrugBank database available at the University of Alberta is a unique bioinformatics and cheminformatics resource that combines detailed drug (i. ... This article does not cite its references or sources. ... General Name, Symbol, Number carbon, C, 6 Chemical series nonmetals Group, Period, Block 14, 2, p Appearance black (graphite) colorless (diamond) Standard atomic weight 12. ... General Name, Symbol, Number hydrogen, H, 1 Chemical series nonmetals Group, Period, Block 1, 1, s Appearance colorless Atomic mass 1. ... General Name, Symbol, Number nitrogen, N, 7 Chemical series nonmetals Group, Period, Block 15, 2, p Appearance colorless gas Standard atomic weight 14. ... General Name, Symbol, Number oxygen, O, 8 Chemical series nonmetals, chalcogens Group, Period, Block 16, 2, p Appearance colorless (gas) very pale blue (liquid) Standard atomic weight 15. ... General Name, Symbol, Number sulfur, S, 16 Chemical series nonmetals Group, Period, Block 16, 3, p Appearance lemon yellow Standard atomic weight 32. ... The molecular mass (abbreviated MM) of a substance, formerly also called molecular weight and abbreviated as MW, is the mass of one molecule of that substance, relative to the unified atomic mass unit u (equal to 1/12 the mass of one atom of carbon-12). ... In pharmacology, bioavailability is used to describe the fraction of an administered dose of unchanged drug that reaches the systemic circulation, one of the principal pharmacokinetic properties of drugs. ... Drug metabolism is the metabolism of drugs, their biochemical modification or degradation, usually through specialized enzymatic systems. ... The reticuloendothelial system (RES), part of the immune system, consists of the phagocytic cells located in reticular connective tissue, primarily monocytes and macrophages. ... It has been suggested that Effective half-life be merged into this article or section. ... Excretion is the process of eliminating waste products of metabolism and other materials that are of no use. ... The pregnancy category of a pharmaceutical agent is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. ...

Legal status
Routes IV

Infliximab (brand name Remicade®) is a drug used to treat auto-immune disorders. Infliximab is known as a "chimeric monoclonal antibody" (the term "chimeric" refers to the use of both mouse (murine) and human components of the drug i.e. murine binding VK and VH domains and human constant Fc domains). The drug blocks the action of TNFα (tumour necrosis factor alpha) by binding to it and preventing it from signaling the receptors for TNFα on the surface of cells. TNFα is one of the key cytokines that triggers and sustains the inflammation response. Remicade was developed by Junming Le and Jan Vilcek at New York University School of Medicine and developed by Centocor, a pharmaceutical company owned by Johnson & Johnson.[1] The regulation of therapeutic goods, that is drugs and therapeutic devices, varies by jurisdiction. ... In pharmacology and toxicology, a route of administration is the path by which a drug, fluid, poison or other substance is brought into contact with the body 1. ... Autoimmune diseases arise from an overactive immune response of the body against substances and tissues normally present in the body. ... Autoimmune diseases arise from an overactive immune response of the body against substances and tissues normally present in the body. ... Monoclonal antibodies (mAb) are antibodies that are identical because they were produced by one type of immune cell, all clones of a single parent cell. ... Species 50 species; see text *Several subfamilies of Muroids include animals called rats. ... In medicine, tumor necrosis factor alpha (TNFα, cachexin or cachectin) is an important cytokine involved in systemic inflammation and the acute phase response. ... In biochemistry, a receptor is a protein on the cell membrane or within the cytoplasm or cell nucleus that binds to a specific molecule (a ligand), such as a neurotransmitter, hormone, or other substance, and initiates the cellular response to the ligand. ... Drawing of the structure of cork as it appeared under the microscope to Robert Hook from Micrographia which is the origin of the word cell. Cells in culture, stained for keratin (red) and DNA (green). ... Cytokines are small protein molecules that are the core of communication between immune system cells, and even between immune system cells and cells belonging to other tissue types. ... An abscess on the skin, showing the redness and swelling characteristic of inflammation. ... Jan T. Vilcek M.D., Ph. ... The New York University School of Medicine was founded in 1841, ten years after the New York Universitys founding, as the University Medical College. ... Centocor is a biotechnology company that was founded in Philadelphia in 1979 with an initial goal of developing new diagnostic assays using monoclonal antibody technology. ... Johnson & Johnson (NYSE: JNJ) is a global American pharmaceutical, medical devices and consumer packaged goods manufacturer founded in 1886. ...


Infliximab has been approved by the U.S. Food and Drug Administration for for the treatment of psoriasis, pediatric Crohn's disease, ankylosing spondylitis, Crohn's disease, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. According to the manufacturer's websites, there are more patients world-wide who have been treated with Remicade (the first commercially available TNF antagonist) than Enbrel and Humira combined. FDA logo The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food, dietary supplements, drugs, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics in the United States. ... Pediatrics (also spelled paediatrics or pædiatrics) is the branch of medicine that deals with the medical care of infants and children. ... Crohns disease (also known as regional enteritis) is a chronic, episodic, inflammatory condition of the gastrointestinal tract characterized by transmural inflammation (affecting the entire wall of the involved bowel) and skip lesions (areas of inflammation with areas of normal lining in between). ... Crohns disease (also known as regional enteritis) is a chronic, episodic, inflammatory condition of the gastrointestinal tract characterized by transmural inflammation (affecting the entire wall of the involved bowel) and skip lesions (areas of inflammation with areas of normal lining in between). ... Psoriatic arthritis (or Arthropathic psoriasis) is a type of inflammatory arthritis that affects around 20% of people suffering from the chronic skin condition Psoriasis. ... Rheumatoid arthritis (RA) is traditionally considered a chronic, inflammatory autoimmune disorder that causes the immune system to attack the joints. ...


Remicade is administered by intravenous infusion, typically at 2-month intervals, and at a clinic or hospital. It cannot be administered orally, because the digestive system would destroy the drug. Intravenous therapy or IV therapy is the administration of liquid substances directly into a vein. ... In pharmacology and toxicology, a route of administration is the path by which a drug, fluid, poison or other substance is brought into contact with the body 1. ... For the Physics term GUT, please refer to Grand unification theory The gastrointestinal or digestive tract, also referred to as the GI tract or the alimentary canal or the gut, is the system of organs within multicellular animals which takes in food, digests it to extract energy and nutrients, and...

Contents

Pharmacology

According to product labeling Infliximab neutralizes the biological activity of TNFα by binding with high affinity to the soluble (free floating in the blood) and transmembrane (located on the outer membranes of T cells and similar immune cells) forms of TNFα and inhibits or prevents the effective binding of TNFα with its receptors. Remicade and Humira (another TNF antagonist) are in the subclass of "anti-TNF antibodies" (they are in the form of naturally occurring antibodies), and are capable of neutralizing all forms (extracellular, transmembrane, and receptor-bound) of TNF alpha.[2] Enbrel, a third TNF antagonist, is in a different subclass (receptor-construct fusion protein), and because of it's modified form, cannot neutralize receptor-bound TNFa.[3] Additionally, the anti-TNF antibodies Humira and Remicade have the capability of lysing cells involved in the inflammatory process, whereas the receptor fusion protein apparently lacks this capability.[4] Although the clinical significance of these differences have not been absolutely proven, they may account for the differential actions of these drugs in both efficacy and side effects. In medicine, tumor necrosis factor alpha (TNFα, cachexin or cachectin) is an important cytokine involved in systemic inflammation and the acute phase response. ... Look up affinity in Wiktionary, the free dictionary. ... T cells are a subset of lymphocytes that play a large role in the immune response. ... Humira is a fully human monoclonal antibody that inhibits TNFα. Together with infliximab and etanercept, it forms the drug class of the biologicals for the treatment of moderate to severe rheumatoid arthritis. ... A transmembrane protein is a protein that spans the entire biological membrane. ... Look up Receptor in Wiktionary, the free dictionary. ... Etanercept (Enbrel®, co-marketed by Amgen and Wyeth) is a recombinant human soluble tumor necrosis factor-alpha (TNFα) receptor. ...


Infliximab has high specificity for TNFα, and does not neutralize TNF beta (TNFβ, also called lymphotoxin α), a related but less inflammatory cytokine that utilizes the same receptors as TNFα. Biological activities that are attributed to TNFα include: induction of proinflammatory cytokines such as interleukin (IL) 1 and IL 6, enhancement of leukocyte movement or migration from the blood vessels into the tissues by increasing the permeability of endothelial layer of blood vessels; and increasing the release of adhesion molecules. Infliximab prevents disease in transgenic mice (a special type of mice that are biologically engineered to produce a human form of TNFα and which are used to test the results of these drugs that might be expected in humans). These experimental mice develop arthritis as a result of their production of human TNFα, and when administered after disease onset, infliximab allows eroded joints to heal. The specificity is a statistical measure of how well a binary classification test correctly identifies the negative cases, or those cases that do not meet the condition under study. ... Lymphotoxin (also known as tumor necrosis factor-beta) is a lymphokine cytokine. ... Look up induction in Wiktionary, the free dictionary. ... An abscess on the skin, showing the redness and swelling characteristic of inflammation. ... Cytokines are a group of proteins and peptides that are used in organisms as signaling compounds. ... Interleukins are a group of cytokines that were first seen to be expressed by white blood cells (leukocytes, hence the -leukin) as a means of communication (inter-). The name is sort of a relic though; it has since been found that interleukins are produced by a wide variety of bodily... White Blood Cells is also the name of a White Stripes album. ... The endothelium is the layer of thin, flat cells that lines the interior surface of blood vessels, forming an interface between circulating blood in the lumen and the rest of the vessel wall. ... Cell Adhesion Molecules (CAMs) are proteins located on the cell surface involved with the binding with other cells or with the extracellular matrix (ECM) in the process called cell adhesion. ... A genetically modified organism is an organism whose genetic material has been deliberately altered. ...


Infliximab in Crohn's disease

There are three phenotypes, or categories of disease presentation in Crohn's disease: stricturing disease (which causes narrowing of the bowel), penetrating disease (which causes fistulae or abnormal connections of the bowel), and inflammatory disease (which causes primarily inflammation.[5] Individuals in the mollusk species Donax variabilis show diverse coloration and patterning in their phenotypes. ... Crohns disease (also known as regional enteritis) is a chronic, episodic, inflammatory condition of the gastrointestinal tract characterized by transmural inflammation (affecting the entire wall of the involved bowel) and skip lesions (areas of inflammation with areas of normal lining in between). ... In medicine, a fistula (pl. ... An abscess on the skin, showing the redness and swelling characteristic of inflammation. ...


Fistulizing disease

Infliximab was first used for closure of fistulae in Crohn's disease in 1999. An initial study showed that it was effective in closing fistulae between the skin and bowel in 56-68% of patients.[6] Further work headed by Bruce Sands, termed the ACCENT 2 trial, showed that it was additionally beneficial in maintaining closure of fistulae, with 36% of patients maintaining closure of fistulae after a year, compared to 19% who received placebo therapy.[7] Crohns disease (also known as regional enteritis) is a chronic, episodic, inflammatory condition of the gastrointestinal tract characterized by transmural inflammation (affecting the entire wall of the involved bowel) and skip lesions (areas of inflammation with areas of normal lining in between). ... 1999 (MCMXCIX) was a common year starting on Friday, and was designated the International Year of Older Persons by the United Nations. ... In zootomy and dermatology, skin is the largest organ of the integumentary system made up of multiple layers of epithelial tissues that guard underlying muscles and organs. ... The intestine is the portion of the alimentary canal extending from the stomach to the anus and, in humans and other mammals, consists of two segments, the small intestine and the large intestine. ... “Placebo effect” redirects here. ...


Inflammatory disease

Inflammatory Crohn's disease, seen here as ulcers on colonoscopy can be treated with infliximab
Inflammatory Crohn's disease, seen here as ulcers on colonoscopy can be treated with infliximab

Infliximab has also been used in order to induce and maintain remission in inflammatory Crohn's disease. The ACCENT 1 trial was a large multicentre trial that showed that 39 to 45% patients treated with infliximab who had an initial response to it, maintained remission after 30 weeks, compared to 21% who received placebo treatment. It also showed a mean maintenance of remission from 38 to 54 weeks compared to 21 weeks for patients who received placebo treatment.[8] Image File history File links CD_colitis. ... Image File history File links CD_colitis. ... Crohns disease (also known as regional enteritis) is a chronic, episodic, inflammatory condition of the gastrointestinal tract characterized by transmural inflammation (affecting the entire wall of the involved bowel) and skip lesions (areas of inflammation with areas of normal lining in between). ... Endoscopic images of a duodenal ulcer. ... Colonoscopy is the minimally invasive endoscopic examination of the large colon and the distal part of the small bowel with a fiber optic camera on a flexible tube passed through the anus. ... Crohns disease (also known as regional enteritis) is a chronic, episodic, inflammatory condition of the gastrointestinal tract characterized by transmural inflammation (affecting the entire wall of the involved bowel) and skip lesions (areas of inflammation with areas of normal lining in between). ...


Crohn's patients have flares of their disease between periods of disease quiescence. These flares are usually treated with steroid medications to obtain remission. However, some gastroenterologists are now advocating for the use of infliximab as the first drug to try to get patients into remission. This has been called the top-down approach to treatment.[9] Steroid skeleton of lanosterol. ... Remission is the state of absence of disease activity in patients with known chronic illness. ...


Infliximab in ulcerative colitis

As infliximab targets TNF, thought to be more related to Th1 cytokines, it was initially thought to be of limited utility in ulcerative colitis, which was thought to be a Th2 disease. However, patients with ulcerative colitis have begun to be treated with infliximab on the basis of two large clinical trials conducted in 2005 by Paul Rutgeerts and William Sandborn. The ACT 1 and ACT 2 (Acute ulcerative Colitis Treatment) trials evaluated the utility of infliximab in ulcerative colitis and showed that 44-45% of patients treated with infliximab for a year maintained a response to the medication, compared to 21% of patients who were treated with placebo medication. At 2 months, the response was 61-69% for patients treated with infliximab, and 31% for those who were treated with placebo.[10] In medicine, tumor necrosis factor alpha (TNFα, cachexin or cachectin) is an important cytokine involved in systemic inflammation and the acute phase response. ... 2005 (MMV) was a common year starting on Saturday of the Gregorian calendar. ...


Safety

According to the product labeling of Infliximab, Etanercept, and Adalimumab, these drugs are in the class of immunosuppressants. After a number of studies and reports of adverse reactions in patients receiving anti-TNFα therapy (including serious and sometimes fatal blood disorders, infections, rare reports of lymphoma and solid tissue cancers, rare reports of serious liver injury, rare reports of drug induced lupus and rare reports of demyelinating central nervous system disorders), the FDA issued a warning to doctors appearing in the respective product labeling of these drugs instructing them to screen and monitor potential patients more carefully ([1]). An infection is the detrimental colonization of a host organism by a foreign species. ... In neuroscience, myelin is an electrically insulating phospholipid layer that surrounds the axons of many neurons. ... A diagram showing the CNS: 1. ...


Other uses

Case studies have been done into other uses of infliximab, such as to treat skin diseases. Remicade (infliximab) has been approved for treating ankylosing spondylitis, Crohn's disease, psoriatic arthritis, psoriasis, rheumatoid arthritis, and ulcerative colitis. Infliximab is also prescribed for the treatment of Behcet's disease.[11] and infusions of infliximab have been used successfully in the treatment of sciatica due to slipped discs.[12] Crohns disease (also known as regional enteritis) is a chronic, episodic, inflammatory condition of the gastrointestinal tract characterized by transmural inflammation (affecting the entire wall of the involved bowel) and skip lesions (areas of inflammation with areas of normal lining in between). ... Psoriatic arthritis (or Arthropathic psoriasis) is a type of inflammatory arthritis that affects around 20% of people suffering from the chronic skin condition Psoriasis. ... Rheumatoid arthritis (RA) is traditionally considered a chronic, inflammatory autoimmune disorder that causes the immune system to attack the joints. ...


There have been numerous case reports of the efficacy of infliximab in various inflammatory skin conditions diseases; psoriasis, in which increased TNFα has been demonstrated, is the most recent indication.[13]


Psoriatic arthritis (PsA), a chronic systemic inflammatory disorder characterized by the association of arthritis and psoriasis, follows a heterogeneous and variable clinical course. Inhibitors of TNF, such as infliximab, substantially improve the signs and symptoms of psoriasis (level 1b, grade A). Several therapies with modest efficacy have been studied in nail psoriasis. Among available agents, higher quality data are available to support the efficacy of cyclosporine and infliximab, a TNF antagonist. Based on studies in AS, the results suggest that infliximab, etanercept, and adalimumab have the potential to reduce the signs and symptoms of moderate to severely active axial involvement in PsA in patients who have had an inadequate response to NSAID (level 1a, grade A).The anti-TNF agents (infliximab and etanercept; level 1b, grade A) are more effective for the treatment of enthesitis than traditional agents.Results suggest that infliximab is effective for the treatment of dactylitis in PsA (level 1b, grade B). KAVANAUGH et al., Systematic Review of Treatments for Psoriatic Arthritis: An Evidence Based Approach and Basis for Treatment Guidelines. 2006; J Rheumatol 2006;33:1417–21)


Availability/Affordability

Like all of the TNF inhibitors, Remicade is an expensive medication, costing about $1000 for a 100mg dose, and is covered by almost every medical insurance plan. It is administered every 6-8 weeks, with an initial startup requiring smaller time frames between infusions. According to the labeling, the current posology is: Pharmacology (in Greek: pharmacon (φάρμακον) is drug, and logos (λόγος) is science) is the study of how chemical substances interact with living systems. ...

Crohns disease (also known as regional enteritis) is a chronic, episodic, inflammatory condition of the gastrointestinal tract characterized by transmural inflammation (affecting the entire wall of the involved bowel) and skip lesions (areas of inflammation with areas of normal lining in between). ... Psoriatic arthritis (or Arthropathic psoriasis) is a type of inflammatory arthritis that affects around 20% of people suffering from the chronic skin condition Psoriasis. ... Rheumatoid arthritis (RA) is traditionally considered a chronic, inflammatory autoimmune disorder that causes the immune system to attack the joints. ...

See also

Adalimumab (Humira®) is the third TNF antagonist (after infliximab and etanercept) to be approved in the US. Like infliximab and etanercept, adalimumab binds to TNFα, preventing it from activating TNF receptors; adalimumab was constructed from a fully human monoclonal antibody, while infliximab is a mouse-human chimeric antibody and etanercept... The anti-tumor necrosis factor α monoclonal antibody infliximab is a mainstay of the biological therapy for inflammatory bowel disease Biological therapy refers to the use of medication that is tailored to specifically target an immune or genetic mediator of disease. ... Etanercept (Enbrel®, co-marketed by Amgen and Wyeth) is a human recombinant, soluble tumor necrosis factor-alpha (TNFα) receptor. ... Monoclonal antibodies (mAb) are antibodies that are identical because they were produced by one type of immune cell, all clones of a single parent cell. ... In medicine, tumor necrosis factor alpha (TNFα, cachexin or cachectin) is an important cytokine involved in systemic inflammation and the acute phase response. ...

External links

Reference

  1. ^ Knight DM, Trinh H, Le J, Siegel S, Shealy D, McDonough M, Scallon B, Moore MA, Vilcek J, Daddona P, et al. Construction and initial characterization of a mouse-human chimeric anti-TNF antibody. Mol Immunol 1993;30:1443-53. PMID 8232330.
  2. ^ Choy EH et al. Cytokine pathways and joint inflammation in rheumatoid arthritis. N Engl J Med. 2001;344:907-916
  3. ^ Etanercept product labeling
  4. ^ Etanercept, Adalimumab and Infliximab product labeling
  5. ^ Dubinsky MC, Fleshner PP. (2003). "Treatment of Crohn's Disease of Inflammatory, Stenotic, and Fistulizing Phenotypes.". Curr Treat Options Gastroenterol 6 (3): 183-200. PMID 12744819. 
  6. ^ Present D, Rutgeerts P, Targan S, Hanauer S, Mayer L, van Hogezand R, Podolsky D, Sands B, Braakman T, DeWoody K, Schaible T, van Deventer S (1999). "Infliximab for the treatment of fistulas in patients with Crohn's disease.". N Engl J Med 340 (18): 1398-405. PMID 10228190. 
  7. ^ Sands B, Anderson F, Bernstein C, Chey W, Feagan B, Fedorak R, Kamm M, Korzenik J, Lashner B, Onken J, Rachmilewitz D, Rutgeerts P, Wild G, Wolf D, Marsters P, Travers S, Blank M, van Deventer S (2004). "Infliximab maintenance therapy for fistulizing Crohn's disease.". N Engl J Med 350 (9): 876-85. PMID 14985485. 
  8. ^
  9. ^ Hanauer S (2003). "Crohn's disease: step up or top down therapy.". Best Pract Res Clin Gastroenterol 17 (1): 131-7. PMID 12617888. 
  10. ^
  11. ^ Sfikakis PP. Behcet's disease: a new target for anti-tumour necrosis factor treatment. Ann Rheum Dis 2002;61 Suppl 2:ii51-3. PMID 12379622.
  12. ^ Korhonen T et al. Efficacy fo infliximab for disc herniation-induced sciatica: a one-year follow-up. Spine 2004;29:2115-9.
  13. ^ Gupta AK, Skinner AR. A review of the use of infliximab to manage cutaneous dermatoses. J Cutan Med Surg 2004;8:77-89. PMID 15685387.

  Results from FactBites:
 
Infliximab - Wikipedia, the free encyclopedia (326 words)
Infliximab (Remicade®) is a powerful drug used to treat auto-immune disorders like Crohn's disease and rheumatoid arthritis.
Infliximab is known as a "chimeric monoclonal antibody" (the term "chimeric" refers to the use of both mouse and human components of the drug i.e.
Before infliximab is administered a test for tuberculosis must be performed, as infliximab has been shown to increase the risk of reactivation of latent tuberculosis.
Patient Education - Drugs - infliximab, Remicade (849 words)
Infliximab belongs to a new class of drugs known as monoclonal antibodies.
Infliximab is used for the treatment of patients with moderate to severe Crohn's disease for whom conventional therapy has not been effective.
The effect of infliximab in pediatric patients and the elderly is unknown.
  More results at FactBites »

 
 

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