Secukinumab

Secukinumab
Autoinjector of secukinumab by Novartis
Monoclonal antibody
TypeWhole antibody
SourceHuman
TargetIL17A
Names
Trade namesCosentyx
Other namesAIN457
Clinical data
Drug classMonoclonal antibody
Main usesPsoriasis, ankylosing spondylitis, psoriatic arthritis[1]
Side effectsRunny nose, diarrhea, cold sores, hives[2]
Pregnancy
category
  • AU: C
  • US: B (No risk in non-human studies)
    Routes of
    use    		Subcutaneous
    External links
    AHFS/Drugs.comMonograph
    MedlinePlusa615011
    Legal
    License data
    Legal status
    • AU: S4 (Prescription only)
    • UK: POM (Prescription only)
    • US: ℞-only
    • EU: Rx-only [3]
    • In general: ℞ (Prescription only)
    Chemical and physical data
    FormulaC6584H10134N1754O2042S44
    Molar mass147944.37 g·mol−1

    Secukinumab, sold under the brand name Cosentyx, is a medication used to treat psoriasis, ankylosing spondylitis, and psoriatic arthritis.[1] It is given by injection under the skin.[2]

    Common side effects include a runny nose, diarrhea, cold sores, and hives.[2] Other side effects may include anaphylaxis and infection.[2] Use during pregnancy or breastfeeding is not recommended.[4] It is a monoclonal antibody that binds to and inhibits interleukin (IL)-17A.[2]

    Secukinumab was approved for medical use in the United States and Europe in 2015.[2][1] In the United Kingdom 150 mg costs the NHS about £600 as of 2021.[4] This amount in the United States costs about 6,200 USD.[5]

    Medical uses

    Secukinumab is used to treat psoriasis, ankylosing spondylitis, and psoriatic arthritis.[6][7][8] 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.[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;[7] the European Medicines Agency (EMA) advises that women should not become pregnant while taking it.[6]

    Secukinumab should not be given to people with active infections since it suppresses the immune system.[6]

    In the European Union, secukinumab is indicated for the treatment of:[9]

    • moderate to severe plaque psoriasis in adults, children and adolescents from the age of six years who are candidates for systemic therapy.[9]
    • 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.[9]
    • active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.[9]
    • 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).[9]

    Dosage

    It is generally given at a dose of 150 to 300 mg.[4] Initially it is given weekly and than it is given monthly.[4]

    Side effects

    Very common (greater than 10% of people experience them) adverse effects include upper respiratory tract infections.[6]

    Common (between 1% and 10% of people experience them) include oral herpes, runny nose, and diarrhea.[6]

    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.[7] 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

    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.[6]

    Chemistry

    Secukinumab is a recombinant fully human IgG1/kappa monoclonal antibody and is manufactured in Chinese hamster ovary cells.[6]

    History

    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][9] It was 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

    1. 1 2 3 "Cosentyx". Archived from the original on 22 August 2020. Retrieved 11 October 2021.
    2. 1 2 3 4 5 6 "Secukinumab Monograph for Professionals". Drugs.com. Archived from the original on 4 March 2021. Retrieved 11 October 2021.
    3. ↑ "Cosentyx EPAR". European Medicines Agency (EMA). Archived from the original on 22 August 2020. Retrieved 23 September 2020.
    4. 1 2 3 4 BNF (80 ed.). BMJ Group and the Pharmaceutical Press. September 2020 – March 2021. p. 1162. ISBN 978-0-85711-369-6.{{cite book}}: CS1 maint: date format (link)
    5. ↑ "Cosentyx Prices, Coupons & Patient Assistance Programs". Drugs.com. Archived from the original on 22 June 2021. Retrieved 11 October 2021.
    6. 1 2 3 4 5 6 7 "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. Archived from the original on 3 October 2017. Retrieved 2 October 2017.
    7. 1 2 3 4 "Cosentyx (secukinumab) injection" (PDF). FDA. September 2017. Archived (PDF) from the original on 2021-04-02. Retrieved 2021-05-17. For label updates see FDA index page for BLA 125504 Archived 2021-08-02 at the Wayback Machine
    8. ↑ 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.
    9. 1 2 3 4 5 6 "Cosentyx EPAR". European Medicines Agency (EMA). Archived from the original on 22 August 2020. Retrieved 7 May 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
    10. ↑ Front Immunol. 2012 Jun 4;3:129
    11. 1 2 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. 1 2 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. S2CID 24638664.
    13. ↑ Nelson AL, Dhimolea E, Reichert JM (October 2010). "Development trends for human monoclonal antibody therapeutics". Nature Reviews. Drug Discovery. 9 (10): 767–74. 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. Archived from the original on 2019-08-26. Retrieved 2021-05-17.
    15. ↑ "Novartis Snags Remaining 23% Stake in Alcon with $12.9B Cash and Share Deal". Genetic Engineering News. December 15, 2010. Archived from the original on October 3, 2017. Retrieved May 17, 2021.
    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 2021-08-29. Retrieved 2021-05-17.
    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). January 21, 2015. Archived from the original on January 22, 2015. Retrieved January 21, 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. 2016-01-15. Archived from the original on 2020-05-08. Retrieved 2021-05-17.
    20. ↑ "FDA Approves Label Update for Secukinumab". MD Magazine. Archived from the original on 2018-06-27. Retrieved 2018-06-27.
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