NationMaster - Encyclopedia: 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.^[1] Even for diseases of unknown cause, molecules that are involved in the disease process have been identified, and can be targetted for biological therapy; many of these molecules, which are mainly cytokines, are directly involved in the immune system. Biological therapy has found a niche in the management of cancer,^[2]^[3] autoimmune diseases,^[4] and diseases of unknown cause that cause symptoms due to immune related mechanisms.^[5]^[6] In medicine, tumor necrosis factor alpha (TNFÎ±, cachexin or cachectin) is an important cytokine involved in systemic inflammation and the acute phase response. ... 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. ... It has been suggested that Infliximab (Remicade) be merged into this article or section. ... In chemistry, a molecule is an aggregate of at least two atoms in a definite arrangement held together by special forces. ... Cytokines is a group of proteinaceous signalling compounds that like hormones and neurotransmitters are used extensively for inter-cell communication. ... The Immune System (also known as the Immunlological System) is made up of all the mechanisms through which a multicellular organism defends itself from internal invaders such as bacteria, virus or parasites. ... Immunotherapy is a form of medical treatment based upon the concept of modulating the immune system to achieve a therapeutic goal. ... When normal cells are damaged beyond repair, they are eliminated by apoptosis. ... Autoimmune diseases arise from an overactive immune response of the body against substances and tissues normally present in the body. ...

Inflammatory bowel disease or IBD is a collection of systemic medical diseases of unknown cause that cause inflammation of the gastrointestinal tract.^[7] The three entities usually included in this categorization are Crohn's disease, which can affect the entire bowel, ulcerative colitis, which affects only the large bowel, and indeterminate colitis, which consists of large bowel inflammation that shows elements of Crohn's disease and ulcerative colitis.^[8] The cause of IBD is unknown, but genetic, environmental and immune mechanisms have been theorized, and the latter play a large role in the development of symptoms.^[8] Given this, a variety of biological therapies have been developed for the treatment of IBD. These have dramatically changed the way in which physicians treat Crohn's disease and ulcerative colitis.^[5]^[6] In medicine, inflammatory bowel disease (IBD) is a group of inflammatory conditions of the large intestine and, in some cases, the small intestine. ... Inflammation is the first response of the immune system to infection or irritation and may be referred to as the innate cascade. ... The gastrointestinal tract or digestive tract, also referred to as the GI tract or the alimentary canal, (nourishment canal) or the gut, is the system of organs within multicellular animals which takes in food, digests it to extract energy and nutrients, and expels the remaining waste. ... H&E section of non-caseating granuloma seen in the colon of a patient with Crohns disease. ... Grays Fig. ...

Rationale for biological therapy

Prior to the development of biological therapy as a modality to treat IBD, other medications that modulate the immune system -- including 5-aminosalicylates, steroids, azathioprine, and other immunosuppressants -- were primarily used in treatment.^[7]. Patients with Crohn's disease that developed complications, including fistulae, or abnormal connections to the bowel, were treated with surgery.^[9] Patients with ulcerative colitis that does not respond to medications are still treated with colectomy, or removal of the colon. Cytokines is a group of proteinaceous signalling compounds that like hormones and neurotransmitters are used extensively for inter-cell communication. ... Prednisone is a synthetic corticosteroid drug which is usually taken orally and can be used for a large number of different conditions. ... Azathioprine is a chemotherapy drug, now rarely used for chemotherapy but more for immunosuppression in organ transplantation, autoimmune disease such as rheumatoid arthritis or inflammatory bowel disease such as Crohns disease. ... In medicine, a fistula (pl. ... Colectomy is the surgical procedure by means of which part of the colon is removed. ... In anatomy of the digestive system, the colon, also called the large intestine or large bowel, is the part of the intestine from the cecum (caecum in British English) to the rectum. ...

However, basic science research showed that there were many cytokines that were elevated in both Crohn's disease and ulcerative colitis.^[10] Crohn's disease cytokines, in general were lumped into the Th1 classification of cytokines, and included tumour necrosis factor-α (TNF-α), interleukin-2, and interferon γ.^[11] Ulcerative colitis was less conclusively linked to the Th2 pathway of cytokines.^[12] Cytokines is a group of proteinaceous signalling compounds that like hormones and neurotransmitters are used extensively for inter-cell communication. ... In medicine, tumor necrosis factor alpha (TNFα, cachexin or cachectin) is an important cytokine involved in systemic inflammation and the acute phase response. ... 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... To meet Wikipedias quality standards, this article or section may require cleanup. ...

The monoclonal antibody infliximab is a mouse-human chimeric antibody to TNF-α. It first was used in the treatment of rheumatoid arthritis,^[13] and was the first biological agent used in the treatment of IBD. It is also used in the treatment of psoriasis and ankylosing spondylitis.^[14]^[15] Specifically, it has revolutionized the treatment of Crohn's disease.^[5] 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. ... It has been suggested that Infliximab (Remicade) be merged into this article or section. ... Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disorder that causes the immune system to attack the joints. ...

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.^[16] The phenotype of an individual organism is either its total physical appearance and constitution or a specific manifestation of a trait, such as size, eye color, or behavior that varies between individuals. ... In medicine, a fistula (pl. ... Inflammation is the first response of the immune system to infection or irritation and may be referred to as the innate cascade. ...

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.^[17] 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.^[18] 1999 (MCMXCIX) was a common year starting on Friday, and was designated the International Year of Older Persons by the United Nations. ... A close-up of human skin. ... 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. ... A placebo, from the Latin for I will please, is a medical treatment (operation, therapy, chemical solution, pill, etc. ...

Inflammatory disease

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.^[5] Image File history File links CD_colitis. ... Image File history File links CD_colitis. ... H&E section of non-caseating granuloma seen in the colon of a patient with Crohns disease. ... 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. ...

Crohn's disease 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.^[19] Steroid skeleton. ... Remission is the state of absence of disease activity in patients with known chronic illness. ...

Infliximab in ulcerative colitis

As infliximab targets tumour necrosis factor, thought to be more related to Th1 cytokines, it was intially 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.^[6] 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. ...

Other monoclonal antibodies

Other biological therapy agents and monoclonal antibodies have not showed as much efficacy in the treatment of IBD. These include etanercept (which is the soluble receptor for tumour necrosis factor.^[20]Adalimumab (which is a humanized recombinant antibody to TNF) showed effectiveness in patients with moderate-to-severe Crohn's disease, but less than that of infliximab. ^[21] It however conveys an advantage in that it is given by subcutaneous injection as opposed to infliximab, which is given by intravenous infusion. Etanercept (EnbrelÂ®, co-marketed by Amgen and Wyeth) is a human recombinant, soluble tumor necrosis factor-alpha (TNFÎ±) receptor. ... Receptor may refer to: In telecommunication, a receiver. ... In medicine, tumor necrosis factor alpha (TNFα, cachexin or cachectin) is an important cytokine involved in systemic inflammation and the acute phase response. ... Adalimumab (HumiraÂ®) is the third TNF antagonist (after infliximab and etanercept) to be approved in the US. Like infliximab and etanercept, adalimumab binds to TNFÎ±, 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... Recombinant proteins are proteins that are produced by different genetically modified organisms following insertion of the relevant DNA into their genome. ... Injection has multiple meanings: In mathematics, the term injection refers to an injective function. ... An intravenous drip in a hospital Intravenous therapy or IV therapy is the administration of liquid substances directly into a vein. ...

Side effects and concerns

There have been concerns about the side effects of monoclonal antibodies, and specifically of infliximab, but these are rare. Early side effects include the risk of allergic reactions (including anaphylaxis which may be life-threatening), and reactions to the infusion. These are often treated with medications given before treatement. Infliximab also carries a risk of worsening infection, and can cause reactivation of old infections, like tuberculosis. Over time, there is the risk of serum sickness, which is a delayed hypersensitivity response to the medication. Later complications may include multiple sclerosis and lymphoma. Finally, the medication is quite expensive, with treatment costs ranging from US$3000 to $8000 per infusion.^[22]^[23]^[24] An allergy can refer to several kinds of immune reactions including Type I hypersensitivity in which a persons body is hypersensitised and develops IgE type antibodies to typical proteins. ... It has been suggested that Infliximab (Remicade) be merged into this article or section. ... Side-effect can mean: Side-effect (computer science), a state change caused by a function call Adverse drug reaction, an unintended consequence specifically arising from drug therapy Therapeutic effect (medicine), a desirable consequence of any kind of medical treatment, even though resulting as an unintended, unexpected consequence of the treatment... An allergy can refer to several kinds of immune reactions including Type I hypersensitivity in which a persons body is hypersensitised and develops IgE type antibodies to typical proteins. ... In medicine, anaphylaxis is a severe and rapid systemic allergic reaction. ... Tuberculosis (commonly abbreviated as TB) is an infection caused by the bacterium Mycobacterium tuberculosis, which most commonly affects the lungs (pulmonary TB) but can also affect the central nervous system (meningitis), lymphatic system, circulatory system (Miliary tuberculosis), genitourinary system, bones and joints. ... Serum sickness is a reaction to an antiserum derived from an animal source. ... Hypersensitivity is an immune response that damages the bodys own tissues. ... Lymphoma is a variety of cancer that originates in the lymphatic system. ...

Loss of response to infliximab over time is a concern, due to the development of antibodies to infliximab (termed human anti-chimeric antibodies, or HACA). This can be reduced by concurrent treatment with other immunosuppressant medications (including azathioprine and methotrexate), by maintaining a regular infusion schedule, and by giving patients a pre-treatment dose of steroid medication.^[25] Azathioprine is a chemotherapy drug, now rarely used for chemotherapy but more for immunosuppression in organ transplantation, autoimmune disease such as rheumatoid arthritis or inflammatory bowel disease such as Crohns disease. ... Methotrexate (rINN) (IPA: ), abbreviated MTX and formerly known as amethopterin, is an antimetabolite drug used in treatment of cancer and autoimmune diseases. ...

Organisms

It has been observed that patients in North America and Europe have higher rates of inflammatory bowel disease than patients in developing nations. One thought was that this was due to the protective effects of organisms colonizing the colon in developing countries. On the basis of this, the pig whipworm, Trichuris suis, which causes minimal disease in humans, was evaluated in both Crohn's disease and ulcerative colitis, and showed effect in an open label and randomized control trial respectively.^[26]^[27]The hypothesis is that the whipworm protects against Th1 cytokines, despite its effectiveness in ulcerative colitis (thought to be Th2 mediated). The theory that early exposure to infections protects against IBD has been termed the hygiene hypothesis.^[28] Image File history File links Trichuris_egg. ... Image File history File links Trichuris_egg. ... Binomial name Trichuris trichiura (Linnaeus, 1771) The human Whipworm (Trichuris trichiura or Trichocephalus trichiuris), is a roundworm, which causes trichuriasis when it infects a human large intestine. ... Cytokines is a group of proteinaceous signalling compounds that like hormones and neurotransmitters are used extensively for inter-cell communication. ... World map showing North America A satellite composite image of North America. ... World map showing Europe Political map Europe is one of the seven traditional continents of Earth; the term continent here referring to a cultural and political distinction, rather than a physiographic one, thus leading to various perspectives about Europes precise borders. ... Binomial name Trichuris trichiura (Linnaeus, 1771) The human Whipworm (Trichuris trichiura or Trichocephalus trichiuris), is a roundworm, which causes trichuriasis when it infects a human large intestine. ...

References

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Category: Gastroenterology Health science is the discipline of applied science which deals with human and animal health. ... This article is about the field of medical practice and health care. ... Gastroenterology or gastrology is the medical specialty concerned with the field of digestive diseases. ... The esophagus (also spelled oesophagus/Å“sophagus), or gullet is the muscular tube in vertebrates through which ingested food passes from the mouth area to the stomach. ... In anatomy, the stomach (in ancient Greek ÏƒÏ„ÏŒÎ¼Î±Ï‡Î¿Ï‚) is an organ in the gastrointestinal tract used to digest food. ... Halitosis (medical term, first coined by the Listerine company in 1921), oral malodour (scientific term), breath odour, or most commonly bad breath are terms used to describe noticeably unpleasant odors exhaled in breathing. ... For other uses, see Nausea (disambiguation). ... Vomiting (or emesis) is the forceful expulsion of the contents of ones stomach through the mouth. ... For the webcomic, see Acid Reflux (webcomic). ... Achalasia or acalasia is a failure of a ring of muscle (as a sphincter) to relax (completely). ... Esophageal cancer is malignancy of the esophagus. ... In medicine (gastroenterology), esophageal varices are extreme dilations of sub mucosal veins in the mucosa of the esophagus in diseases featuring portal hypertension, secondary to cirrhosis primarily. ... Peptic ulcer is usually a non-malignant ulcer of the stomach (called gastric ulcer) or duodenum (called duodenal ulcer). ... Abdominal pain can be one of the symptoms associated with transient disorders or serious disease. ... Stomach cancer (also called gastric cancer) can develop in any part of the stomach and may spread throughout the stomach and to other organs, particularly the esophagus, small intestine. ... Dyspepsia is a constant pain in the stomach. ... Gastroparesis, also called delayed gastric emptying, is a disorder in which the stomach takes too long to empty its contents. ... Abdominal angina (a. ... The liver is the largest internal organ of the human body. ... The pancreas is an organ in the digestive system that serves two major functions: exocrine - it produces pancreatic juice containing digestive enzymes. ... Gall bladder Digestive system diagram showing the bile duct The gallbladder (or cholecyst sometimes gall bladder) is a pear-shaped organ that stores about 50 mL of bile (or gall) until the body needs it for digestion. ... A bile duct is any of a number of long tube-like structures that carry bile. ... Hepatitis is a gastroenterological disease, featuring inflammation of the liver. ... Cirrhosis is a consequence of chronic liver disease characterized by replacement of liver tissue by fibrotic scar tissue as well as regenerative nodules, leading to progressive loss of liver function. ... As its name signifies, Non-alcoholic steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) is fatty inflammation of the liver when this is not due to excessive alcohol use. ... Primary biliary cirrhosis is an autoimmune disease of the liver marked by the slow progressive destruction of the small bile ducts within the liver. ... Primary sclerosing cholangitis (PSC) is an inflammatory disease of the bile duct, which leads to cholestasis (blockage of bile transport to the gut). ... In medicine (gastroenterology and hepatology), Budd-Chiari syndrome is the clinical picture caused by occlusion of the hepatic vein. ... Hepatocellular carcinoma (HCC, also called hepatoma or liver cancer) is a primary malignancy (cancer) of the liver. ... Acute pancreatitis is a rapidly-onset inflammation of the pancreas. ... Chronic pancreatitis can present as episodes of acute inflammation in a previously injured pancreas, or as chronic damage with persistent pain or malabsorption. ... Pancreatic cancer (also called cancer of the pancreas) is represented by the growth of a malignant tumour within the small pancreas organ. ... In medicine, gallstones (choleliths) are crystalline bodies formed within the body by accretion or concretion of normal or abnormal bile components. ... Cholecystitis is inflammation of the gallbladder. ... Diagram showing the small intestine In biology the small intestine is the part of the gastrointestinal tract between the stomach and the large intestine (colon). ... Peptic ulcer is usually a non-malignant ulcer of the stomach (called gastric ulcer) or duodenum (called duodenal ulcer). ... An intussusception is a situation in which a part of the intestine has prolapsed into another section of intestine, similar to the way in which the parts of a collapsible telescope slide into one another. ... Malabsorption is the state of impaired absorption of nutrients in the small intestine. ... Coeliac disease or celiac disease is an autoimmune disorder of the small bowel that occurs in genetically-predisposed individuals. ... Lactose intolerance is the name given to the condition (found in the majority of humans) in which lactase, an enzyme needed for proper metabolization of lactose, is not produced in adulthood. ... Fructose malabsorption is a condition in which the fructose carrier in enterocytes is deficient. ... Whipples disease is a rare disease caused by the bacteria Thropheryma whipplei. ... Lymphoma is a variety of cancer that originates in the lymphatic system. ... In anatomy of the digestive system, the colon, also called the large intestine or large bowel, is the part of the intestine from the cecum (caecum in British English) to the rectum. ... Diarrhea or diarrhoea (see spelling differences) is a condition in which the sufferer has frequent watery, loose bowel movements (from the ancient Greek word Î´Î¹Î±ÏÏÎ¿Î® = leakage; lit. ... Appendicitis, or epityphlitis, is a condition characterised by inflammation of the appendix. ... Diverticulitis is a common disease of the bowel, in particular the large intestine. ... Diverticulosis, otherwise known as diverticular disease, is the condition of having diverticula in the large colon which are outpocketings of the colonic mucosa and submucosa through weaknesses of muscle layers in the colon wall. ... In medicine, inflammatory bowel disease (IBD) is a group of inflammatory conditions of the large intestine and, in some cases, the small intestine. ... H&E section of non-caseating granuloma seen in the colon of a patient with Crohns disease. ... Endoscopic image of ulcerative colitis affecting the left side of the colon. ... In gastroenterology, irritable bowel syndrome (IBS) or spastic colon is a functional bowel disorder characterized by abdominal pain and changes in bowel habits that is not associated with any abnormalities seen on routine clinical testing. ... Constipation or irregularity, is a condition of the digestive system where a person (or animal) experiences hard feces that are difficult to eliminate; it may be extremely painful, and in severe cases (fecal impaction) lead to symptoms of bowel obstruction. ... Colorectal cancer, also called colon cancer or bowel cancer, includes cancerous growths in the colon, rectum and appendix. ... Hirschsprungs disease, or congenital aganglionic megacolon, involves an enlargement of the colon, caused by bowel obstruction resulting from an aganglionic section of bowel (the normal enteric nerves are absent) that starts at the anus and progresses upwards. ... Pseudomembranous colitis is a infection of the colon caused by the bacterium Clostridium difficile. ...

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