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'''Secukinumab''', [[trade name]] '''Cosentyx''', is a human IgG1κ [[monoclonal antibody]] that binds to the protein [[interleukin 17|interleukin (IL)-17A]],
'''Secukinumab''', [[trade name]] '''Cosentyx''', is a human IgG1κ [[monoclonal antibody]] that binds to the protein [[interleukin 17|interleukin (IL)-17A]],
and is marketed by [[Novartis]] for the treatment of [[psoriasis]], [[ankylosing spondylitis]], and [[psoriatic arthritis]].<ref name=UKlabel>{{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}}</ref><ref name=USlabel>{{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]</ref>
and is marketed by [[Novartis]] for the treatment of [[psoriasis]], [[ankylosing spondylitis]], and [[psoriatic arthritis]].<ref name=UKlabel>{{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|access-date=2 October 2017|language=en|date=15 August 2017}}</ref><ref name=USlabel>{{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]</ref>


It inhibits a member of the [[cytokine]] family, [[IL17A|interleukin 17A]].<ref name=UKlabel/>
It inhibits a member of the [[cytokine]] family, [[IL17A|interleukin 17A]].<ref name=UKlabel/>


== Medical uses ==
== Medical uses ==
It is used to treat [[psoriasis]], [[ankylosing spondylitis]], and [[psoriatic arthritis]].<ref name=UKlabel/><ref name=USlabel/><ref>{{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}}</ref> 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.<ref name=USlabel/>
It is used to treat [[psoriasis]], [[ankylosing spondylitis]], and [[psoriatic arthritis]].<ref name=UKlabel/><ref name=USlabel/><ref>{{cite journal | vauthors = Patel NU, Vera NC, Shealy ER, Wetzel M, Feldman SR | title = A Review of the Use of Secukinumab for Psoriatic Arthritis | journal = Rheumatology and Therapy | volume = 4 | issue = 2 | pages = 233–246 | date = December 2017 | pmid = 28849401 | pmc = 5696288 | doi = 10.1007/s40744-017-0076-0 }}</ref> 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.<ref name=USlabel/>


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;<ref name=USlabel/> the [[European Medicines Agency]] advises that women should not become pregnant while taking it.<ref name=UKlabel/>
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;<ref name=USlabel/> the [[European Medicines Agency]] advises that women should not become pregnant while taking it.<ref name=UKlabel/>
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== Pharmacology ==
== Pharmacology ==
Secukinumab inhibits a member of the [[cytokine]] family, [[IL17A|interleukin 17A]], which is produced mainly by inflammatory [[T helper 17 cell]]s.<ref name=Lubrano2016>{{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}}</ref> 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.<ref name=Lubrano2016/><ref name=Shirley2016>{{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}}</ref>
Secukinumab inhibits a member of the [[cytokine]] family, [[IL17A|interleukin 17A]], which is produced mainly by inflammatory [[T helper 17 cell]]s.<ref name=Lubrano2016>{{cite journal | vauthors = Lubrano E, Perrotta FM | title = Secukinumab for ankylosing spondylitis and psoriatic arthritis | journal = Therapeutics and Clinical Risk Management | volume = 12 | pages = 1587–1592 | date = 2016 | pmid = 27799780 | pmc = 5085310 | doi = 10.2147/TCRM.S100091 }}</ref> 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.<ref name=Lubrano2016/><ref name=Shirley2016>{{cite journal | vauthors = Shirley M, Scott LJ | title = Secukinumab: A Review in Psoriatic Arthritis | journal = Drugs | volume = 76 | issue = 11 | pages = 1135–45 | date = July 2016 | pmid = 27299434 | doi = 10.1007/s40265-016-0602-3 }}</ref>


It is mostly eliminated by being taken up into cells via [[endocytosis]] and being broken down inside them.<ref name=UKlabel/>
It is mostly eliminated by being taken up into cells via [[endocytosis]] and being broken down inside them.<ref name=UKlabel/>
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== History ==
== History ==
Secukinumab was discovered and developed by Novartis using developmental name AIN457, and the first publication was a Phase I trial published in 2010.<ref>{{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}}</ref><ref>{{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}}</ref><ref>{{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}}</ref><ref>{{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}}</ref>
Secukinumab was discovered and developed by Novartis using developmental name AIN457, and the first publication was a Phase I trial published in 2010.<ref>{{cite journal | vauthors = Nelson AL, Dhimolea E, Reichert JM | title = Development trends for human monoclonal antibody therapeutics | journal = Nature Reviews. Drug Discovery | volume = 9 | issue = 10 | pages = 767–74 | date = October 2010 | pmid = 20811384 | doi = 10.1038/nrd3229 }}</ref><ref>{{cite journal | vauthors = Hueber W, Patel DD, Dryja T, Wright AM, Koroleva I, Bruin G, Antoni C, Draelos Z, Gold MH, Durez P, Tak PP, Gomez-Reino JJ, Foster CS, Kim RY, Samson CM, Falk NS, Chu DS, Callanan D, Nguyen QD, Rose K, Haider A, Di Padova F | display-authors = 6 | title = Effects of AIN457, a fully human antibody to interleukin-17A, on psoriasis, rheumatoid arthritis, and uveitis | journal = Science Translational Medicine | volume = 2 | issue = 52 | pages = 52ra72 | date = October 2010 | pmid = 20926833 | doi = 10.1126/scitranslmed.3001107 | url = http://stm.sciencemag.org/content/2/52/52ra72.full }}</ref><ref>{{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}}</ref><ref>{{cite web| vauthors = Di Padova FE, Gram H, Hofstetter H, Jeschke M, Rondeau JM, Van Den Berg W |title=US 7807155: IL-17 antagonistic antibodies|url=https://www.google.com/patents/US7807155|date=2010}}</ref>


In January 2015, the FDA approved secukinumab to treat adults with moderate-to-severe plaque psoriasis.<ref name="FDA2015-01-21">{{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}}</ref> It was the first IL17A inhibiting drug ever approved.<ref name=Shirley2016/> 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.<ref>{{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}}</ref><ref>{{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}}</ref>
In January 2015, the FDA approved secukinumab to treat adults with moderate-to-severe plaque psoriasis.<ref name="FDA2015-01-21">{{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| access-date=January 21, 2015}}</ref> It was the first IL17A inhibiting drug ever approved.<ref name=Shirley2016/> 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.<ref>{{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}}</ref><ref>{{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}}</ref>


== References ==
== References ==

Revision as of 14:29, 7 September 2019

Secukinumab
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetIL17A
Clinical data
Trade namesCosentyx
Other namesAIN457
AHFS/Drugs.comcosentyx
License data
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
KEGG
Chemical and physical data
FormulaC6584H10134N1754O2042S44
Molar mass147.94 kg/mol g·mol−1
 ☒NcheckY (what is this?)  (verify)

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] Caution should be used when starting secukinumab in patients with inflammatory bowel disease, and patients being treated with secukinumab should be monitored for signs and symptoms of inflammatory bowel disease. [4]

Pharmacology

Secukinumab inhibits a member of the cytokine family, interleukin 17A, which is produced mainly by inflammatory T helper 17 cells.[5] 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.[5][6]

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.[7][8][9][10]

In January 2015, the FDA approved secukinumab to treat adults with moderate-to-severe plaque psoriasis.[11] It was the first IL17A inhibiting drug ever approved.[6] 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.[12][13]

References

  1. ^ a b c d e f g h i "Cosentyx 150 mg solution for injection in pre-filled syringe and pre-filled pen - Summary of Product Characteristics". UK Electronic Medicines Compendium. 15 August 2017. Retrieved 2 October 2017.
  2. ^ a b c d e "Cosentyx (secukinumab) injection" (PDF). FDA. September 2017. For label updates see FDA index page for BLA 125504
  3. ^ Patel NU, Vera NC, Shealy ER, Wetzel M, Feldman SR (December 2017). "A Review of the Use of Secukinumab for Psoriatic Arthritis". Rheumatology and Therapy. 4 (2): 233–246. doi:10.1007/s40744-017-0076-0. PMC 5696288. PMID 28849401.
  4. ^ Front Immunol. 2012 Jun 4;3:129
  5. ^ a b Lubrano E, Perrotta FM (2016). "Secukinumab for ankylosing spondylitis and psoriatic arthritis". Therapeutics and Clinical Risk Management. 12: 1587–1592. doi:10.2147/TCRM.S100091. PMC 5085310. PMID 27799780.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  6. ^ a b Shirley M, Scott LJ (July 2016). "Secukinumab: A Review in Psoriatic Arthritis". Drugs. 76 (11): 1135–45. doi:10.1007/s40265-016-0602-3. PMID 27299434.
  7. ^ Nelson AL, Dhimolea E, Reichert JM (October 2010). "Development trends for human monoclonal antibody therapeutics". Nature Reviews. Drug Discovery. 9 (10): 767–74. doi:10.1038/nrd3229. PMID 20811384.
  8. ^ Hueber W, Patel DD, Dryja T, Wright AM, Koroleva I, Bruin G, et al. (October 2010). "Effects of AIN457, a fully human antibody to interleukin-17A, on psoriasis, rheumatoid arthritis, and uveitis". Science Translational Medicine. 2 (52): 52ra72. doi:10.1126/scitranslmed.3001107. PMID 20926833.
  9. ^ "Novartis Snags Remaining 23% Stake in Alcon with $12.9B Cash and Share Deal". Genetic Engineering News. December 15, 2010.
  10. ^ Di Padova FE, Gram H, Hofstetter H, Jeschke M, Rondeau JM, Van Den Berg W (2010). "US 7807155: IL-17 antagonistic antibodies".
  11. ^ "FDA approves new psoriasis drug Cosentyx" (Press release). United States Food and Drug Administration. January 21, 2015. Retrieved January 21, 2015.
  12. ^ "Press release: Novartis receives two new FDA approvals for Cosentyx to treat patients with ankylosing spondylitis and psoriatic arthritis in the US". Novartis. 2016-01-15.
  13. ^ "FDA Approves Label Update for Secukinumab". MD Magazine. Retrieved 2018-06-27.
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