Adalimumab
1829708
221165713
2008-06-23T09:29:22Z
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{{drugbox-mab
| image = Adalimumab structure.png
| source = Human
| target = TNF
| CAS_number = 331731-18-1
| ATC_prefix = L04
| ATC_suffix = AA17
| PubChem =
| DrugBank = BTD00049
| C = 6428 | H = 9912 | N = 1694 | O = 1987 | S = 46
| molecular_weight = 144190.3 g/mol
| bioavailability = 64%
| protein_bound =
| metabolism =
| elimination_half-life = 10-20 days.
| pregnancy_US = B
| pregnancy_AU = C
| legal_UK = POM
| legal_US = Rx-only
| routes_of_administration = [[Subcutaneous injection|Subcutaneous]]
}}
'''Adalimumab''' (brand name '''HUMIRA''') is the third [[TNF inhibitor]], after [[infliximab]] and [[etanercept]], to be approved in the [[United States]]. Like infliximab and etanercept, adalimumab binds to [[Tumor necrosis factor-alpha|TNFα]], preventing it from activating TNF receptors; adalimumab was constructed from a fully human [[monoclonal antibody]], while infliximab is a [[mouse]]-human [[Chimera (protein)|chimeric]] antibody and etanercept is a TNF receptor-IgG [[fusion protein]]. TNFα inactivation has proven to be important in [[downregulation|downregulating]] the [[inflammation|inflammatory]] reactions associated with [[autoimmune disease]]s. As of 2008 adalimumab has been approved by the [[Food and Drug Administration|FDA]] for the treatment of [[rheumatoid arthritis]], [[psoriatic arthritis]], [[ankylosing spondylitis]], [[Crohn's disease]], moderate to severe chronic [[psoriasis]] and [[juvenile idiopathic arthritis]].
Humira (brand name is an abbreviation of "Human Monoclonal Antibody in Rheumatoid Arthritis") is marketed in both preloaded 0.8 ml [[syringe]]s and also in preloaded [[autoinjector|pen device]]s, both [[injection (medicine)|injected subcutaneously]], typically by the patient at home. It cannot be administered [[route of administration|orally]], because the [[digestive system]] would destroy the drug.
Humira's manufacturer is [[Abbott Laboratories]].
== Indications ==
Adalimumab, like its [[TNF]] inhibitor competitors, [[infliximab]] and [[etanercept]], has proven versatile in proving effectiveness in treating several conditions.
==== Rheumatoid arthritis ====
Adalimumab has been shown to reduce the signs and symptoms of moderate-to-severe [[rheumatoid arthritis]] (RA) in adults, It has also been shown have efficacy in, and be approved for, moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years of age and older. In RA it can be used alone or with methotrexate or similar medicines. can be used alone or with methotrexate or with certain other medicines.
==== Psoriatic arthritis ====
Adalimumab has been shown to reduce the signs and symptoms of [[psoriatic arthritis]] (PsA) in adults, alone or with certain other medicines.
==== Ankylosing spondylitis ====
Adalimumab has been shown to reduce the signs and symptoms of, and is approved for treatment of, [[ankylosing spondylitis]] (AS) in adults.
==== Crohn’s disease ====
Adalimumab has been shown to reduce the signs and symptoms<ref name=Podolsky>{{Cite journal|last=Podolsky|first= Daniel K.|title=Inflammatory bowel disease|journal=New England Journal of Medicine|month=August|year=2002|volume=346|issue=6|pages=417–29
|url=http://content.nejm.org/cgi/content/extract/347/6/417|accessdate=2006-07-02|pmid=12167685|doi=10.1056/NEJMra020831}}</ref> of, and is approved for treatment of, moderate to severe [[Crohn’s disease]] (CD) in adults who have not responded well to conventional treatments and who have lost response to, or are unable to tolerate [[infliximab]].
==== Plaque psoriasis ====
Adalimumab has been shown to treat moderate to severe chronic (lasting a long time) [[plaque psoriasis]] (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or [[phototherapy]] (treatment using ultraviolet light alone or with pills).
== Safety ==
[[Adalimumab]] is an [[immunosuppressant]], and as such has a number of serious safety concerns, potentially fatal, typical of the [[TNF]] class. According to the product labeling, after a number of studies and reports of adverse events in patients receiving [[adalimumab]], including serious and sometimes fatal blood disorders; serious [[infection]]s including include TB ([[tuberculosis]]) and infections caused by viruses, fungi, or bacteria; rare reports of [[lymphoma]] and solid tissue [[cancer]]s; rare reports of serious [[liver]] injury; and rare reports of [[demyelinating]] [[central nervous system]] disorders); rare reports of cardiac failure; the U.S. [[Food and Drug Administration]] issued a [[black box warning]] to doctors appearing in the product labeling of [[adalimumab]] and the other [[TNF]] drugs instructing them to screen and monitor potential patients more carefully<ref> FDA label - http://www.rxabbott.com/pdf/humira_medguide.pdf </ref>.
==History==
* April 1, 1995: Cambridge Antibody Technology Limited signs agreement with Knoll Aktiengesellschaft<ref>[http://www.cambridgeantibody.com/home/news_and_resources/news_archive/2003/cambridge_antibody_technology__humira] Cambridge Antibody Technology website</ref>
* March 2, 2001: Abbott Laboratories acquires Knoll Pharmaceuticals from BASF
* June, 2001: Results from ARMADA, a double-blind, placebo-controlled clinical trial involving 271 patients with active rheumatoid arthritis despite treatment with methotrexate are announced. Among the results are that 50% of patients show a 50% improvement in [[ACR score]].
* December 31, 2002: Humira approved by FDA
==Lawsuit==
In March [[2003]], British company [[Cambridge Antibody Technology]] (CAT), stated its wish to "initiate discussions regarding the applicability of the royalty offset provisions for Humira" [[Abbott Laboratories]] in the [[High Court of Justice|High Court]] of [[London]]. In November 2004, the trial began. In December 2004, the Judge, [[Hugh Laddie|The Hon. Mr Justice Laddie]], ruled for CAT stating "Abbott was in error when it made its first royalty payment to CAT calculated on the basis that only 2% of the Net Sales was due. It should have calculated on the basis of the full royalty of just over 5% and should have paid and continued to pay CAT accordingly." Abbott later paid CAT $23.7 million.
==Similar agents==
* [[Infliximab]]
* [[Etanercept]]
==References==
{{Reflist}}
==External links==
* [http://www.humira.com HUMIRA Official site]
* [http://www.myhumira.com myHUMIRA Official site]
* [http://www.google.com/views?hl=en&safe=off&q=humira++view%3Atimeline&btnG=Search Google Timeline Search]
{{Immunosuppressants}}
{{Humanmonoclonals}}
[[Category:TNF-alpha inhibitors]]
[[Category:Monoclonal antibodies]]
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