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{{Short description|Monoclonal antibody against IL-17}}
{{Drugbox
{{Use dmy dates|date=October 2023}}
| Verifiedfields = changed
{{cs1 config |name-list-style=vanc |display-authors=6}}
| Watchedfields = changed
{{Infobox drug
| verifiedrevid = 464388281
| type = mab
| Verifiedfields = changed
| image =
| Watchedfields = changed
| alt =
| verifiedrevid = 464388281
| synonyms = AIN457
| type = mab
| image = Autoinjector with Cosentyx by Novartis (Secukinumab)-0522.jpg
| mab_type = mab
| source = u
| alt =
| target = [[IL17A]]
| caption = Autoinjector with Cosentyx by Novartis (Secukinumab)

| tradename = Cosentyx
<!-- Monoclonal antibody data -->
| Drugs.com = {{Drugs.com|parent|cosentyx}}
| MedlinePlus =
| mab_type = mab
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| source = u
| pregnancy_US = B
| target = [[IL17A]]

| pregnancy_category=
<!-- Clinical data -->
| legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled -->
| pronounce =
| legal_CA = <!-- OTC, Rx-only, Schedule I, II, III, IV, V, VI, VII, VIII -->
| tradename = Cosentyx
| legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM -->
| Drugs.com = {{Drugs.com|monograph|secukinumab}}
| legal_US = Rx-only
| legal_status =
| MedlinePlus = a615011
| DailyMedID = Secukinumab
| routes_of_administration =
| bioavailability =
| pregnancy_AU = C
| pregnancy_AU_comment =
| protein_bound =
| metabolism =
| pregnancy_category =
| routes_of_administration = [[Subcutaneous administration|Subcutaneous]], [[intravenous]]
| class =
| ATC_prefix = L04
| ATC_suffix = AC10
| ATC_supplemental =
| biosimilars =

<!-- Legal status -->
| legal_AU = S4
| legal_AU_comment = <ref>{{cite web | title=Cosentyx (Novartis Pharmaceuticals Australia Pty Ltd) | website=Therapeutic Goods Administration (TGA) | date=7 October 2022 | url=https://www.tga.gov.au/resources/prescription-medicines-registrations/cosentyx-novartis-pharmaceuticals-australia-pty-ltd-2 | access-date=9 April 2023 | archive-date=22 November 2022 | archive-url=https://web.archive.org/web/20221122014843/https://www.tga.gov.au/resources/prescription-medicines-registrations/cosentyx-novartis-pharmaceuticals-australia-pty-ltd-2 | url-status=live }}</ref><ref>{{cite web | title=Prescription medicines: registration of new chemical entities in Australia, 2015 | website=Therapeutic Goods Administration (TGA) | date=21 June 2022 | url=https://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia-2015 | access-date=10 April 2023 | archive-date=10 April 2023 | archive-url=https://web.archive.org/web/20230410065829/https://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia-2015 | url-status=live }}</ref>
| legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F -->
| legal_BR_comment =
| legal_CA = Rx-only
| legal_CA_comment = <ref>{{cite web | title=Health Canada New Drug Authorizations: 2015 Highlights | website=[[Health Canada]] | date=4 May 2016 | url=https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-canada-new-drug-authorizations-2015-highlights.html | access-date=7 April 2024 | archive-date=20 February 2020 | archive-url=https://web.archive.org/web/20200220215421/https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-canada-new-drug-authorizations-2015-highlights.html | url-status=live }}</ref>
| legal_DE = <!-- Anlage I, II, III or Unscheduled -->
| legal_DE_comment =
| legal_NZ = <!-- Class A, B, C -->
| legal_NZ_comment =
| legal_UK = POM
| legal_UK_comment = <ref name="Cosentyx SmPC">{{cite web | title=Cosentyx 150mg and 300mg solution for injection in pre-filled syringe and pre-filled pen - Summary of Product Characteristics (SmPC) | website=(emc) | date=6 June 2022 | url=https://www.medicines.org.uk/emc/medicine/29848 | access-date=9 November 2022 | archive-date=3 October 2017 | archive-url=https://web.archive.org/web/20171003025956/https://www.medicines.org.uk/emc/medicine/29848 | url-status=live }}</ref>
| legal_US = Rx-only
| legal_US_comment = <ref name="Cosentyx FDA label">{{cite web | title=Cosentyx- secukinumab injection | website=DailyMed | date=4 November 2022 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=77c4b13e-7df3-42d4-81db-3d0cddb7f67a | access-date=9 November 2022}}</ref>
| legal_EU = Rx-only
| legal_EU_comment = <ref name="Cosentyx EPAR" />
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment =
| legal_status = Rx-only

<!-- Pharmacokinetic data -->
| bioavailability =
| protein_bound =
| metabolism =
| metabolites =
| onset =
| elimination_half-life =
| elimination_half-life =
| excretion =
| duration_of_action =
| excretion =
| CAS_number_Ref = {{cascite|changed|??}}

| CAS_number = 875356-43-7
<!-- Identifiers -->
| CAS_supplemental = (heavy chain)<br/>{{CAS|875356-44-8}} (light chain)
| CAS_number_Ref = {{cascite|correct|CAS}}
| ATC_prefix = L04
| ATC_suffix = AC10
| CAS_number = 875356-43-7
| CAS_supplemental = (heavy chain)<br/>{{CAS|875356-44-8}} (light chain)
| PubChem =
| PubChem =
| DrugBank_Ref = {{drugbankcite|changed|drugbank}}
| IUPHAR_ligand =
| DrugBank = DB09029
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| DrugBank_Ref = {{drugbankcite|changed|drugbank}}
| DrugBank = DB09029
| ChemSpiderID = none
| ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| C=6584 | H=10134 | N=1754 | O=2042 | S=44
| ChemSpiderID = none
| molecular_weight = 147.94 kg/mol
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = DLG4EML025
| KEGG = D09967
| ChEBI =
| ChEMBL =
| NIAID_ChemDB =
| PDB_ligand =
| synonyms = AIN457

<!-- Chemical and physical data -->| IUPAC_name =
| C = 6584
| H = 10134
| N = 1754
| O = 2042
| S = 44
| SMILES =
| StdInChI =
| StdInChI_comment =
| StdInChIKey =
| density =
| density_notes =
| melting_point =
| melting_high =
| melting_notes =
| boiling_point =
| boiling_notes =
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}}
}}


'''Secukinumab''', [[trade name]] '''Cosentyx''', is a human [[monoclonal antibody]] that binds to the protein [[interleukin 17|interleukin (IL)-17A]],<ref>http://www.psocialsis.com/medicamentos-det.php?recordID=42</ref>
'''Secukinumab''', sold under the brand name '''Cosentyx''' among others, is a human IgG1κ [[monoclonal antibody]] used for the treatment of [[psoriasis]], [[ankylosing spondylitis]], and [[psoriatic arthritis]].<ref name="Cosentyx SmPC" /><ref name="Cosentyx FDA label" /><ref name="Cosentyx EPAR" /> It binds to the protein [[interleukin 17|interleukin (IL)-17A]] and is marketed by [[Novartis]].<ref name="Cosentyx SmPC" /><ref name="Cosentyx FDA label" /><ref name="Cosentyx EPAR" />
and is manufactured by [[Novartis]] Pharma AG for the treatment of [[psoriasis]]. The drug is also being investigated as a treatment for [[uveitis]], [[rheumatoid arthritis]], [[ankylosing spondylitis]], and [[psoriatic arthritis]]. It targets member&nbsp;A form of the [[cytokine]] family of interleukin 17, severely inhibiting its functioning.<ref>{{cite web|title=Statement On A Non-proprietary Name Adopted By The USAN Council: Secukinumab|publisher=[[American Medical Association]]|url=http://www.ama-assn.org/resources/doc/usan/secukinumab.pdf}}</ref><ref name=pmid20926833>{{cite journal |doi=10.1126/scitranslmed.3001107 |pmid=20926833 |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 |year=2010 |last1=Hueber |first1=W. |last2=Patel |first2=D. D. |last3=Dryja |first3=T. |last4=Wright |first4=A. M. |last5=Koroleva |first5=I. |last6=Bruin |first6=G. |last7=Antoni |first7=C. |last8=Draelos |first8=Z. |last9=Gold |first9=M. H. |last10=Durez |first10=P. |last11=Tak |first11=P. P. |last12=Gomez-Reino |first12=J. J. |last13=Foster |first13=C. S. |last14=Kim |first14=R. Y. |last15=Samson |first15=C. M. |last16=Falk |first16=N. S. |last17=Chu |first17=D. S. |last18=Callanan |first18=D. |last19=Nguyen |first19=Q. D. |last20=Rose |first20=K. |last21=Haider |first21=A. |last22=Di Padova |first22=F. |last23=Rose |first23=K |last24=Haider |first24=A |last25=Di Padova |first25=F }}</ref> It is highly specific to the human immunoglobulin G1k (IgG1k) subclass.<ref name=pmid20926833/> On January 21, 2015, the United States, the federal Food and Drug Administration announced that it had 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><ref>http://www.novartis.com/newsroom/media-releases/en/2015/1888645.shtml</ref>


== Medical uses ==
In July 2014 secukinumab established superiority to placebo and to [[etanercept]] for the treatment of chronic plaque psoriasis in Phase III clinical trials.<ref name="NEJM2014">{{cite journal |doi=10.1056/NEJMoa1314258 |pmid=25007392 |title=Secukinumab in Plaque Psoriasis — Results of Two Phase 3 Trials |journal=New England Journal of Medicine |volume=371 |issue=4 |pages=326–38 |year=2014 |last1=Langley |first1=Richard G. |last2=Elewski |first2=Boni E. |last3=Lebwohl |first3=Mark |last4=Reich |first4=Kristian |last5=Griffiths |first5=Christopher E.M. |last6=Papp |first6=Kim |last7=Puig |first7=Lluís |last8=Nakagawa |first8=Hidemi |last9=Spelman |first9=Lynda |last10=Sigurgeirsson |first10=Bárður |last11=Rivas |first11=Enrique |last12=Tsai |first12=Tsen-Fang |last13=Wasel |first13=Norman |last14=Tyring |first14=Stephen |last15=Salko |first15=Thomas |last16=Hampele |first16=Isabelle |last17=Notter |first17=Marianne |last18=Karpov |first18=Alexander |last19=Helou |first19=Silvia |last20=Papavassilis |first20=Charis |last21=Erasure Study |first21=Group |last22=Fixture Study |first22=Group }}</ref> In October 2014, the FDA Dermatologic and Ophthalmic Drugs Advisory Committee unanimously voted to recommend the drug for FDA approval, although this vote in and of itself does not constitute an approval. However, the FDA typically follows recommendations from these committees.<ref>http://www.familypracticenews.com/index.php?id=2934&type=98&tx_ttnews=306073{{Dead link |date=January 2015}}{{full}}</ref> In October 2014, Novartis announced that the drug had achieved a primary clinical endpoint in two phase III clinical trials for [[ankylosing spondylitis]].<ref>[http://inpublic.globenewswire.com/2014/10/23/Novartis+AIN457+secukinumab+meets+primary+endpoint+in+two+Phase+III+studies+in+ankylosing+spondylitis+a+debilitating+joint+condition+of+the+spine+HUG1864939.html]{{full}}</ref> As of 28 October, the relevant FDA committee had not yet responded to these results. In early November 2014, Novartis also released the results of a Phase 3 study on [[psoriatic arthritis]] that yielded promising results.<ref>http://www.medpagetoday.com/MeetingCoverage/ACR/48743{{full}}</ref>
Secukinumab is used to treat [[psoriasis]], [[ankylosing spondylitis]], and [[psoriatic arthritis]].<ref name="Cosentyx SmPC" /><ref name="Cosentyx FDA label" /><ref name="Cosentyx EPAR" /><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="Cosentyx FDA label"/> In October 2023, the FDA approved an intravenous variant of secukinumab.<ref>{{cite web |date=6 October 2023 |title=FDA Approves Intravenous Variant of Secukinumab for Psoriatic Arthritis, Other Arthritis Types |url=https://www.hcplive.com/view/fda-approves-intravenous-variant-secukinumab-psoriatic-arthritis-other-arthritis-types |access-date=9 October 2023 |website=HCP Live |language=en}}</ref>


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="Cosentyx FDA label"/> the [[European Medicines Agency]] (EMA) advises that women should not become pregnant while taking it.<ref name="Cosentyx SmPC"/>
Although the drug was originally intended to treat [[rheumatoid arthritis]], phase II clinical trials for this condition yielded disappointing results.<ref>http://www.medscape.com/viewarticle/806510_6{{full}}</ref> Similarly, while patients in a phase II clinical trial for psoriatic arthritis did show improvement over placebo, the improvement did not meet adequate endpoints.<ref name=pmid23361084>{{cite journal |doi=10.1136/annrheumdis-2012-202646 |pmid=23361084 |title=Efficacy and safety of secukinumab, a fully human anti-interleukin-17A monoclonal antibody, in patients with moderate-to-severe psoriatic arthritis: A 24-week, randomised, double-blind, placebo-controlled, phase II proof-of-concept trial |journal=Annals of the Rheumatic Diseases |volume=73 |issue=2 |pages=349–56 |year=2013 |last1=McInnes |first1=I. B. |last2=Sieper |first2=J. |last3=Braun |first3=J. |last4=Emery |first4=P. |last5=Van Der Heijde |first5=D. |last6=Isaacs |first6=J. D. |last7=Dahmen |first7=G. |last8=Wollenhaupt |first8=J. |last9=Schulze-Koops |first9=H. |last10=Kogan |first10=J. |last11=Ma |first11=S. |last12=Schumacher |first12=M. M. |last13=Bertolino |first13=A. P. |last14=Hueber |first14=W. |last15=Tak |first15=P. P. }}</ref>


In the European Union, secukinumab is indicated for the treatment of:<ref name="Cosentyx EPAR" />
* moderate to severe plaque psoriasis in adults, children and adolescents from the age of six years who are candidates for systemic therapy.<ref name="Cosentyx EPAR" />
* active psoriatic arthritis in adults, alone or in combination with methotrexate (MTX), when the response to previous [[Disease-modifying antirheumatic drug|disease modifying anti rheumatic drug]] (DMARD) therapy has been inadequate.<ref name="Cosentyx EPAR" />
* active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.<ref name="Cosentyx EPAR" />
* active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (NSAIDs).<ref name="Cosentyx EPAR" />
* active moderate to severe hidradenitis suppurativa in adults with an inadequate response to conventional systemic HS therapy.<ref name="Cosentyx EPAR" />
* active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.<ref name="Cosentyx EPAR" />
* active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.<ref name="Cosentyx EPAR" />


== Adverse effects ==
A phase II clinical trial for [[multiple sclerosis]]<ref>{{ClinicalTrialsGov|NCT01874340|Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis}}</ref> completed in 2014 as it had exhibited efficacy in treating [[experimental autoimmune encephalomyelitis]] (EAE), an animal model of MS. Results of this trial have not yet been reported as of April 2015
Very common (greater than 10% of people experience them) adverse effects include upper respiratory tract infections.<ref name="Cosentyx SmPC"/>


Common (between 1% and 10% of people experience them) include oral herpes, runny nose, and diarrhea.<ref name="Cosentyx SmPC"/> [[Injection site reaction]]s are common, occurring in approximately 1.9% of cases.<ref name="PMID37533141">{{cite journal | vauthors = Kim PJ, Lansang RP, Vender R | title = A Systematic Review and Meta-Analysis of Injection Site Reactions in Randomized-Controlled Trials of Biologic Injections | journal = Journal of Cutaneous Medicine and Surgery | volume = 27 | issue = 4 | pages = 358–367 | date = July 2023 | pmid = 37533141 | doi = 10.1177/12034754231188444 | pmc = 10486173 | doi-access = free }}</ref>
== Standard protocol ==
Patients begin treatment with five booster shots of 300&nbsp;mg subcutaneous each one taken a week apart, followed by regular injections once a month thereafter for 5 months.


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.<ref name="Cosentyx FDA label"/> 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.<ref name="pmid22675324">{{cite journal | vauthors = Marwaha AK, Leung NJ, McMurchy AN, Levings MK | title = TH17 Cells in Autoimmunity and Immunodeficiency: Protective or Pathogenic? | journal = Frontiers in Immunology | volume = 3 | issue = | pages = 129 | date = 2012 | pmid = 22675324 | pmc = 3366440 | doi = 10.3389/fimmu.2012.00129 | doi-access = free }}</ref>
== References ==
{{Reflist|35em}}


== 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 | 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 | doi-access = free }}</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 = 1135–1145 | date = July 2016 | pmid = 27299434 | doi = 10.1007/s40265-016-0602-3 | s2cid = 24638664 }}</ref>

It is mostly eliminated by being taken up into cells via [[endocytosis]] and being broken down inside them.<ref name="Cosentyx SmPC"/>

== Chemistry ==
Secukinumab is a recombinant fully human IgG1/kappa monoclonal antibody and is manufactured in [[Chinese hamster ovary cell]]s.<ref name="Cosentyx SmPC"/>

== 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 | 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 = 767–774 | date = October 2010 | pmid = 20811384 | doi = 10.1038/nrd3229 | s2cid = 594719 }}</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 | 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 | s2cid = 10132276 | doi-access = }}</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=15 December 2010|access-date=2 October 2017|archive-date=3 October 2017|archive-url=https://web.archive.org/web/20171003030338/http://www.genengnews.com/gen-news-highlights/novartis-snags-remaining-23-stake-in-alcon-with-12-9b-cash-and-share-deal/81244384|url-status=live}}</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://patents.google.com/patent/US7807155|date=2010|access-date=8 June 2024|archive-date=17 August 2024|archive-url=https://web.archive.org/web/20240817043846/https://patents.google.com/patent/US7807155|url-status=live}}</ref>

In January 2015, secukinumab was approved in the United States and in the European Union to treat adults with moderate-to-severe plaque psoriasis.<ref>{{cite web | title=Drug Approval Package: Cosentyx (secukinumab) NDA #125504 | website=U.S. [[Food and Drug Administration]] (FDA) | date=24 December 1999 | url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125504Orig1s000TOC.cfm | access-date=7 May 2020 | archive-date=3 April 2021 | archive-url=https://web.archive.org/web/20210403020156/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125504Orig1s000TOC.cfm | url-status=live }}</ref><ref name="FDA2015-01-21">{{cite press release| url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm430969.htm| archive-url=https://web.archive.org/web/20150122001418/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm430969.htm| url-status=dead| archive-date=22 January 2015| title=FDA approves new psoriasis drug Cosentyx| date=21 January 2015| publisher=U.S. [[Food and Drug Administration]] (FDA) | access-date=21 January 2015}}</ref><ref name="Cosentyx EPAR">{{cite web | title=Cosentyx EPAR | website=[[European Medicines Agency]] (EMA) | date=17 September 2018 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/cosentyx | access-date=7 May 2020 | archive-date=22 August 2020 | archive-url=https://web.archive.org/web/20200822051102/https://www.ema.europa.eu/en/medicines/human/EPAR/cosentyx | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> It is 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 press release |url=https://www.novartis.com/news/media-releases/novartis-receives-two-new-fda-approvals-cosentyx-treat-patients-ankylosing-spondylitis-and-psoriatic-arthritis-us |title=Novartis receives two new FDA approvals for Cosentyx to treat patients with ankylosing spondylitis and psoriatic arthritis in the US |date=15 January 2016 |publisher=Novartis |access-date=8 May 2020 |archive-date=8 May 2020 |archive-url=https://web.archive.org/web/20200508043159/https://www.novartis.com/news/media-releases/novartis-receives-two-new-fda-approvals-cosentyx-treat-patients-ankylosing-spondylitis-and-psoriatic-arthritis-us |url-status=live }}</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=27 June 2018|archive-date=27 June 2018|archive-url=https://web.archive.org/web/20180627175130/http://www.mdmag.com/medical-news/fda-approves-label-update-for-secukinumab|url-status=live}}</ref>

== References ==
{{Reflist}}


{{Immunosuppressants}}
{{Monoclonals for immune system}}
{{Monoclonals for immune system}}
{{Interleukin receptor modulators}}
{{Interleukin receptor modulators}}
{{Portal bar | Medicine}}
{{Authority control}}


[[Category:Immunosuppressants]]
[[Category:Immunosuppressants]]
[[Category:Novartis]]
[[Category:Drugs developed by Novartis]]
[[Category:Monoclonal antibodies]]
[[Category:Disease-modifying antirheumatic drugs]]

Latest revision as of 14:04, 2 September 2024

Secukinumab
Autoinjector with Cosentyx by Novartis (Secukinumab)
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetIL17A
Clinical data
Trade namesCosentyx
Other namesAIN457
AHFS/Drugs.comMonograph
MedlinePlusa615011
License data
Pregnancy
category
  • AU: C
Routes of
administration		Subcutaneous, intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6584H10134N1754O2042S44
Molar mass147944.37 g·mol−1
 ☒NcheckY (what is this?)  (verify)

Secukinumab, sold under the brand name Cosentyx among others, is a human IgG1κ monoclonal antibody used for the treatment of psoriasis, ankylosing spondylitis, and psoriatic arthritis.[4][5][6] It binds to the protein interleukin (IL)-17A and is marketed by Novartis.[4][5][6]

Medical uses

[edit]

Secukinumab is used to treat psoriasis, ankylosing spondylitis, and psoriatic arthritis.[4][5][6][7] 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.[5] In October 2023, the FDA approved an intravenous variant of secukinumab.[8]

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;[5] the European Medicines Agency (EMA) advises that women should not become pregnant while taking it.[4]

In the European Union, secukinumab is indicated for the treatment of:[6]

  • moderate to severe plaque psoriasis in adults, children and adolescents from the age of six years who are candidates for systemic therapy.[6]
  • active psoriatic arthritis in adults, alone or in combination with methotrexate (MTX), when the response to previous disease modifying anti rheumatic drug (DMARD) therapy has been inadequate.[6]
  • active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.[6]
  • active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to non steroidal anti inflammatory drugs (NSAIDs).[6]
  • active moderate to severe hidradenitis suppurativa in adults with an inadequate response to conventional systemic HS therapy.[6]
  • active enthesitis-related arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.[6]
  • active juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.[6]

Adverse effects

[edit]

Very common (greater than 10% of people experience them) adverse effects include upper respiratory tract infections.[4]

Common (between 1% and 10% of people experience them) include oral herpes, runny nose, and diarrhea.[4] Injection site reactions are common, occurring in approximately 1.9% of cases.[9]

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.[5] 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.[10]

Pharmacology

[edit]

Secukinumab inhibits a member of the cytokine family, interleukin 17A, which is produced mainly by inflammatory T helper 17 cells.[11] 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.[11][12]

It is mostly eliminated by being taken up into cells via endocytosis and being broken down inside them.[4]

Chemistry

[edit]

Secukinumab is a recombinant fully human IgG1/kappa monoclonal antibody and is manufactured in Chinese hamster ovary cells.[4]

History

[edit]

Secukinumab was discovered and developed by Novartis using developmental name AIN457, and the first publication was a Phase I trial published in 2010.[13][14][15][16]

In January 2015, secukinumab was approved in the United States and in the European Union to treat adults with moderate-to-severe plaque psoriasis.[17][18][6] It is the first IL17A inhibiting drug ever approved.[12] 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.[19][20]

References

[edit]
  1. ^ "Cosentyx (Novartis Pharmaceuticals Australia Pty Ltd)". Therapeutic Goods Administration (TGA). 7 October 2022. Archived from the original on 22 November 2022. Retrieved 9 April 2023.
  2. ^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Archived from the original on 10 April 2023. Retrieved 10 April 2023.
  3. ^ "Health Canada New Drug Authorizations: 2015 Highlights". Health Canada. 4 May 2016. Archived from the original on 20 February 2020. Retrieved 7 April 2024.
  4. ^ a b c d e f g h i "Cosentyx 150mg and 300mg solution for injection in pre-filled syringe and pre-filled pen - Summary of Product Characteristics (SmPC)". (emc). 6 June 2022. Archived from the original on 3 October 2017. Retrieved 9 November 2022.
  5. ^ a b c d e f g "Cosentyx- secukinumab injection". DailyMed. 4 November 2022. Retrieved 9 November 2022.
  6. ^ a b c d e f g h i j k l m "Cosentyx EPAR". European Medicines Agency (EMA). 17 September 2018. Archived from the original on 22 August 2020. Retrieved 7 May 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  7. ^ 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.
  8. ^ "FDA Approves Intravenous Variant of Secukinumab for Psoriatic Arthritis, Other Arthritis Types". HCP Live. 6 October 2023. Retrieved 9 October 2023.
  9. ^ Kim PJ, Lansang RP, Vender R (July 2023). "A Systematic Review and Meta-Analysis of Injection Site Reactions in Randomized-Controlled Trials of Biologic Injections". Journal of Cutaneous Medicine and Surgery. 27 (4): 358–367. doi:10.1177/12034754231188444. PMC 10486173. PMID 37533141.
  10. ^ Marwaha AK, Leung NJ, McMurchy AN, Levings MK (2012). "TH17 Cells in Autoimmunity and Immunodeficiency: Protective or Pathogenic?". Frontiers in Immunology. 3: 129. doi:10.3389/fimmu.2012.00129. PMC 3366440. PMID 22675324.
  11. ^ 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.
  12. ^ a b Shirley M, Scott LJ (July 2016). "Secukinumab: A Review in Psoriatic Arthritis". Drugs. 76 (11): 1135–1145. doi:10.1007/s40265-016-0602-3. PMID 27299434. S2CID 24638664.
  13. ^ Nelson AL, Dhimolea E, Reichert JM (October 2010). "Development trends for human monoclonal antibody therapeutics". Nature Reviews. Drug Discovery. 9 (10): 767–774. doi:10.1038/nrd3229. PMID 20811384. S2CID 594719.
  14. ^ 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. S2CID 10132276.
  15. ^ "Novartis Snags Remaining 23% Stake in Alcon with $12.9B Cash and Share Deal". Genetic Engineering News. 15 December 2010. Archived from the original on 3 October 2017. Retrieved 2 October 2017.
  16. ^ Di Padova FE, Gram H, Hofstetter H, Jeschke M, Rondeau JM, Van Den Berg W (2010). "US 7807155: IL-17 antagonistic antibodies". Archived from the original on 17 August 2024. Retrieved 8 June 2024.
  17. ^ "Drug Approval Package: Cosentyx (secukinumab) NDA #125504". U.S. Food and Drug Administration (FDA). 24 December 1999. Archived from the original on 3 April 2021. Retrieved 7 May 2020.
  18. ^ "FDA approves new psoriasis drug Cosentyx" (Press release). U.S. Food and Drug Administration (FDA). 21 January 2015. Archived from the original on 22 January 2015. Retrieved 21 January 2015.
  19. ^ "Novartis receives two new FDA approvals for Cosentyx to treat patients with ankylosing spondylitis and psoriatic arthritis in the US" (Press release). Novartis. 15 January 2016. Archived from the original on 8 May 2020. Retrieved 8 May 2020.
  20. ^ "FDA Approves Label Update for Secukinumab". MD Magazine. Archived from the original on 27 June 2018. Retrieved 27 June 2018.
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