Secukinumab Explained

Verifiedfields:changed
Watchedfields:changed
Verifiedrevid:464388281
Type:mab
Mab Type:mab
Source:u
Target:IL17A
Tradename:Cosentyx
Dailymedid:Secukinumab
Pregnancy Au:C
Routes Of Administration:Subcutaneous, intravenous
Atc Prefix:L04
Atc Suffix:AC10
Legal Au:S4
Legal Au Comment:[1] [2]
Legal Ca:Rx-only
Legal Ca Comment:[3]
Legal Uk:POM
Legal Uk Comment:[4]
Legal Us:Rx-only
Legal Us Comment:[5]
Legal Eu:Rx-only
Legal Status:Rx-only
Cas Number:875356-43-7
Cas Supplemental:(heavy chain)
(light chain)
Drugbank:DB09029
Chemspiderid:none
Unii:DLG4EML025
Kegg:D09967
Synonyms:AIN457
C:6584
H:10134
N:1754
O:2042
S:44

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. It binds to the protein interleukin (IL)-17A and is marketed by Novartis.

Medical uses

Secukinumab is used to treat psoriasis, ankylosing spondylitis, and psoriatic arthritis.[6] 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 a intravenous variant of secukinumab.[7]

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:

Adverse effects

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.[8]

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.[9]

Pharmacology

Secukinumab inhibits a member of the cytokine family, interleukin 17A, which is produced mainly by inflammatory T helper 17 cells.[10] 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.[10] [11]

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

Chemistry

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

History

Secukinumab was discovered and developed by Novartis using developmental name AIN457, and the first publication was a Phase I trial published in 2010.[12] [13] [14] [15]

In January 2015, secukinumab was approved in the United States and in the European Union to treat adults with moderate-to-severe plaque psoriasis.[16] [17] [18] It is the first IL17A inhibiting drug ever approved.[11] 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]

Notes and References

  1. Web site: Cosentyx (Novartis Pharmaceuticals Australia Pty Ltd) . Therapeutic Goods Administration (TGA) . 7 October 2022 . 9 April 2023 . 22 November 2022 . https://web.archive.org/web/20221122014843/https://www.tga.gov.au/resources/prescription-medicines-registrations/cosentyx-novartis-pharmaceuticals-australia-pty-ltd-2 . live .
  2. Web site: Prescription medicines: registration of new chemical entities in Australia, 2015 . Therapeutic Goods Administration (TGA) . 21 June 2022 . 10 April 2023 . 10 April 2023 . https://web.archive.org/web/20230410065829/https://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia-2015 . live .
  3. Web site: Health Canada New Drug Authorizations: 2015 Highlights . . 4 May 2016 . 7 April 2024 . 20 February 2020 . 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 . live .
  4. Web site: Cosentyx 150mg and 300mg solution for injection in pre-filled syringe and pre-filled pen - Summary of Product Characteristics (SmPC) . (emc) . 6 June 2022 . 9 November 2022 . 3 October 2017 . https://web.archive.org/web/20171003025956/https://www.medicines.org.uk/emc/medicine/29848 . live .
  5. Web site: Cosentyx- secukinumab injection . DailyMed . 4 November 2022 . 9 November 2022.
  6. Patel NU, Vera NC, Shealy ER, Wetzel M, Feldman SR . A Review of the Use of Secukinumab for Psoriatic Arthritis . Rheumatology and Therapy . 4 . 2 . 233–246 . December 2017 . 28849401 . 5696288 . 10.1007/s40744-017-0076-0 .
  7. Web site: 6 October 2023 . FDA Approves Intravenous Variant of Secukinumab for Psoriatic Arthritis, Other Arthritis Types . 9 October 2023 . HCP Live . en.
  8. Kim PJ, Lansang RP, Vender R . 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 . July 2023 . 37533141 . 10.1177/12034754231188444 . 10486173 . free .
  9. Marwaha AK, Leung NJ, McMurchy AN, Levings MK . TH17 Cells in Autoimmunity and Immunodeficiency: Protective or Pathogenic? . Frontiers in Immunology . 3 . 129 . 2012 . 22675324 . 3366440 . 10.3389/fimmu.2012.00129 . free .
  10. Lubrano E, Perrotta FM . Secukinumab for ankylosing spondylitis and psoriatic arthritis . Therapeutics and Clinical Risk Management . 12 . 1587–1592 . 2016 . 27799780 . 5085310 . 10.2147/TCRM.S100091 . free .
  11. Shirley M, Scott LJ . Secukinumab: A Review in Psoriatic Arthritis . Drugs . 76 . 11 . 1135–1145 . July 2016 . 27299434 . 10.1007/s40265-016-0602-3 . 24638664 .
  12. Nelson AL, Dhimolea E, Reichert JM . Development trends for human monoclonal antibody therapeutics . Nature Reviews. Drug Discovery . 9 . 10 . 767–774 . October 2010 . 20811384 . 10.1038/nrd3229 . 594719 .
  13. 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 . Effects of AIN457, a fully human antibody to interleukin-17A, on psoriasis, rheumatoid arthritis, and uveitis . Science Translational Medicine . 2 . 52 . 52ra72 . October 2010 . 20926833 . 10.1126/scitranslmed.3001107 . 10132276 .
  14. News: Novartis Snags Remaining 23% Stake in Alcon with $12.9B Cash and Share Deal. Genetic Engineering News. 15 December 2010. 2 October 2017. 3 October 2017. 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. live.
  15. Web site: Di Padova FE, Gram H, Hofstetter H, Jeschke M, Rondeau JM, Van Den Berg W. US 7807155: IL-17 antagonistic antibodies. 2010. 8 June 2024. 17 August 2024. https://web.archive.org/web/20240817043846/https://patents.google.com/patent/US7807155. live.
  16. Web site: Drug Approval Package: Cosentyx (secukinumab) NDA #125504 . U.S. Food and Drug Administration (FDA) . 24 December 1999 . 7 May 2020 . 3 April 2021 . https://web.archive.org/web/20210403020156/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125504Orig1s000TOC.cfm . live .
  17. FDA approves new psoriasis drug Cosentyx. https://web.archive.org/web/20150122001418/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm430969.htm. dead. 22 January 2015. 21 January 2015. U.S. Food and Drug Administration (FDA) . 21 January 2015.
  18. Web site: Cosentyx EPAR . European Medicines Agency (EMA) . 17 September 2018 . 7 May 2020 . 22 August 2020 . https://web.archive.org/web/20200822051102/https://www.ema.europa.eu/en/medicines/human/EPAR/cosentyx . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  19. Novartis receives two new FDA approvals for Cosentyx to treat patients with ankylosing spondylitis and psoriatic arthritis in the US . 15 January 2016 . Novartis . 8 May 2020 . 8 May 2020 . 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 . live .
  20. Web site: FDA Approves Label Update for Secukinumab. MD Magazine. 27 June 2018. 27 June 2018. https://web.archive.org/web/20180627175130/http://www.mdmag.com/medical-news/fda-approves-label-update-for-secukinumab. live.

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