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词条 Secukinumab
释义

  1. Medical uses

  2. Adverse effects

  3. Pharmacology

  4. Chemistry

  5. History

  6. References

{{short description|Monoclonal antibody against IL-17 used for treatment of psoriasis}}{{Drugbox
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| type = mab
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| synonyms = AIN457
| mab_type = mab
| source = u
| target = IL17A
| tradename = Cosentyx
| Drugs.com = {{Drugs.com|parent|cosentyx}}
| MedlinePlus =
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| pregnancy_US = B
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| legal_CA =
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| legal_US = Rx-only
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| routes_of_administration =
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| CAS_number_Ref = {{cascite|changed|??}}
| CAS_number = 875356-43-7
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{{CAS|875356-44-8}} (light chain)
| ATC_prefix = L04
| ATC_suffix = AC10
| PubChem =
| KEGG = D09967
| DrugBank_Ref = {{drugbankcite|changed|drugbank}}
| DrugBank = DB09029
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
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| C=6584 | H=10134 | N=1754 | O=2042 | S=44
| molecular_weight = 147.94 kg/mol
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Secukinumab, trade name Cosentyx, is a human IgG1κ monoclonal antibody that binds to the protein interleukin (IL)-17A,

and is marketed by Novartis for the treatment of psoriasis, ankylosing spondylitis, and psoriatic arthritis.[1][2]

It inhibits a member of the cytokine family, interleukin 17A.[1]

Medical uses

It is used to treat psoriasis, ankylosing spondylitis, and psoriatic arthritis.[1][2][3] It is given by subcutaneous injection and is sold in a pre-filled syringe or autoinjector that can be used at home and as a lyophilized powder for use in hospitals and clinics.[2]

Secukinumab was not tested in pregnant women; animal studies did not show harm at relevant doses. The US Food and Drug Administration advises that the drug should be used in pregnant women only if the risk to the fetus is justified by the potential benefit;[2] the European Medicines Agency advises that women should not become pregnant while taking it.[1]

Secukinumab should not be given to people with active infections since it suppresses the immune system.[1]

Adverse effects

Very common (greater than 10% of people experience them) adverse effects include upper respiratory tract infections.[1]

Common (between 1% and 10% of people experience them) include oral herpes, runny nose, and diarrhea.[1]

In clinical trials there were rare instances of hypersensitivity reactions, severe infections, and some cases of serious inflammatory bowel disease, some of which were new and some of which were exacerbations of existing conditions.[2]

Pharmacology

Secukinumab inhibits a member of the cytokine family, interleukin 17A, which is produced mainly by inflammatory T helper 17 cells.[4] IL17A is upregulated in serum of people with psoriasis and in the synovial fluid of people with psoriatic arthritis, and promotes inflammation when it binds to the interleukin-17 receptor which is expressed in various types of cells, including keratinocytes in skin.[4][5]

It is mostly eliminated by being taken up into cells via endocytosis and being broken down inside them.[1]

Chemistry

Secukinumab is a recombinant fully human IgG1/kappa monoclonal antibody and is manufactured in Chinese hamster ovary cells.[1]

History

Secukinumab was discovered and developed by Novartis using developmental name AIN457, and the first publication was a Phase I trial published in 2010.[6][7][8][9]

In January 2015, the FDA approved secukinumab to treat adults with moderate-to-severe plaque psoriasis.[10] It was the first IL17A inhibiting drug ever approved.[5] In January 2016, the FDA approved it to treat adults with ankylosing spondylitis, and psoriatic arthritis and in February 2018 a label update was approved to include the treatment for moderate-to-severe scalp psoriasis.[11][12]

References

1. ^{{cite web|title=Cosentyx 150 mg solution for injection in pre-filled syringe and pre-filled pen - Summary of Product Characteristics|url=https://www.medicines.org.uk/emc/medicine/29848|publisher=UK Electronic Medicines Compendium|accessdate=2 October 2017|language=en|date=15 August 2017}}
2. ^{{cite web|title=Cosentyx (secukinumab) injection|url=https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125504s016lbl.pdf|publisher=FDA|date=September 2017}} For label updates see [https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=125504 FDA index page for BLA 125504]
3. ^{{cite journal|last1=Patel|first1=NU|last2=Vera|first2=NC|last3=Shealy|first3=ER|last4=Wetzel|first4=M|last5=Feldman|first5=SR|title=A Review of the Use of Secukinumab for Psoriatic Arthritis.|journal=Rheumatology and therapy|date=28 August 2017|doi=10.1007/s40744-017-0076-0|pmid=28849401|volume=4|pmc=5696288|pages=233–246}}
4. ^{{cite journal|last1=Lubrano|first1=E|last2=Perrotta|first2=FM|title=Secukinumab for ankylosing spondylitis and psoriatic arthritis.|journal=Therapeutics and Clinical Risk Management|date=2016|volume=12|pages=1587–1592|doi=10.2147/TCRM.S100091|pmid=27799780|pmc=5085310}}
5. ^{{cite journal|last1=Shirley|first1=M|last2=Scott|first2=LJ|title=Secukinumab: A Review in Psoriatic Arthritis.|journal=Drugs|date=July 2016|volume=76|issue=11|pages=1135–45|doi=10.1007/s40265-016-0602-3|pmid=27299434}}
6. ^{{cite journal|last1=Nelson|first1=AL|last2=Dhimolea|first2=E|last3=Reichert|first3=JM|title=Development trends for human monoclonal antibody therapeutics.|journal=Nature Reviews. Drug Discovery|date=October 2010|volume=9|issue=10|pages=767–74|doi=10.1038/nrd3229|pmid=20811384}}
7. ^{{cite journal|last1=Hueber|first1=W|last2=Patel|first2=DD|last3=Dryja|first3=T|last4=Wright|first4=AM|last5=Koroleva|first5=I|last6=Bruin|first6=G|last7=Antoni|first7=C|last8=Draelos|first8=Z|last9=Gold|first9=MH|last10=Psoriasis Study|first10=Group.|last11=Durez|first11=P|last12=Tak|first12=PP|last13=Gomez-Reino|first13=JJ|last14=Rheumatoid Arthritis Study|first14=Group.|last15=Foster|first15=CS|last16=Kim|first16=RY|last17=Samson|first17=CM|last18=Falk|first18=NS|last19=Chu|first19=DS|last20=Callanan|first20=D|last21=Nguyen|first21=QD|last22=Uveitis Study|first22=Group.|last23=Rose|first23=K|last24=Haider|first24=A|last25=Di Padova|first25=F|title=Effects of AIN457, a fully human antibody to interleukin-17A, on psoriasis, rheumatoid arthritis, and uveitis.|journal=Science Translational Medicine|date=6 October 2010|volume=2|issue=52|pages=52ra72|doi=10.1126/scitranslmed.3001107|pmid=20926833|url=http://stm.sciencemag.org/content/2/52/52ra72.full}}
8. ^{{cite news|title=Novartis Snags Remaining 23% Stake in Alcon with $12.9B Cash and Share Deal|url=http://www.genengnews.com/gen-news-highlights/novartis-snags-remaining-23-stake-in-alcon-with-12-9b-cash-and-share-deal/81244384|work=Genetic Engineering News|date=December 15, 2010}}
9. ^{{cite web|last1=Padova|first1=Franco E. Di|last2=Gram|first2=Hermann|last3=Hofstetter|first3=Hans|last4=Jeschke|first4=Margit|last5=Rondeau|first5=Jean-Michel|last6=Berg|first6=Wim Van Den|title=US 7807155: IL-17 antagonistic antibodies|url=https://www.google.com/patents/US7807155|date=2010}}
10. ^{{cite press release| url=http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm430969.htm| title=FDA approves new psoriasis drug Cosentyx| date=January 21, 2015| publisher=United States Food and Drug Administration| accessdate=January 21, 2015}}
11. ^{{Cite web|url=https://www.novartis.com/news/media-releases/novartis-receives-two-new-fda-approvals-cosentyx-treat-patients-ankylosing|title=Press release: Novartis receives two new FDA approvals for Cosentyx to treat patients with ankylosing spondylitis and psoriatic arthritis in the US |last=|first=|date=2016-01-15|publisher=Novartis}}
12. ^{{Cite web|url=http://www.mdmag.com/medical-news/fda-approves-label-update-for-secukinumab|title=FDA Approves Label Update for Secukinumab|website=MD Magazine|access-date=2018-06-27}}
{{Immunosuppressants}}{{Monoclonals for immune system}}{{Interleukin receptor modulators}}

3 : Immunosuppressants|Novartis|Novartis brands

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