Secukinumab

Secukinumab
Monoclonal antibody
Type Whole antibody
Source Human
Target IL17A
Clinical data
Trade names Cosentyx
AHFS/Drugs.com entry
Pregnancy
category
  • US: B (No risk in non-human studies)
Legal status
Legal status
Identifiers
CAS Number 875356-43-7 (heavy chain)
875356-44-8 (light chain)
ATC code L04AC10 (WHO)
DrugBank DB09029 N
ChemSpider none
Synonyms AIN457
Chemical data
Formula C6584H10134N1754O2042S44
Molar mass 147.94 kg/mol
 NYesY (what is this?)  (verify)

Secukinumab, trade name Cosentyx, is a human monoclonal antibody that binds to the protein interleukin (IL)-17A,[1] 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 A form of the cytokine family of interleukin 17, severly inhibiting its funcitoning.[2][3] It is highly specific to the human immunoglobulin G1k (IgG1k) subclass.[3] 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.[4][5]

In July 2014 secukinumab established superiority to placebo and to etanercept for the treatment of chronic plaque psoriasis in Phase III clinical trials.[6] 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.[7] In October 2014, Novartis announced that the drug had achieved a primary clinical endpoint in two phase III clinical trials for ankylosing spondylitis.[8] 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.[9]

Although the drug was originally intended to treat rheumatoid arthritis, phase II clinical trials for this condition yielded disappointing results.[10] Similarly, while patients in a phase II clinical trial for psoriatic arthritis did show improvement over placebo, the improvement did not meet adequate endpoints.[11]


A phase II clinical trial for multiple sclerosis[12] 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

Standard protocol

Patients begin treatment with five booster shots of 300 mg subcutaneous each one taken a week apart, followed by regular injections once a month thereafter for 5 months.

References

  1. ↑ http://www.psocialsis.com/medicamentos-det.php?recordID=42
  2. ↑ "Statement On A Nonproprietary Name Adopted By The USAN Council: Secukinumab" (PDF). American Medical Association.
  3. 1 2 Hueber, W.; Patel, D. D.; Dryja, T.; Wright, A. M.; Koroleva, I.; Bruin, G.; Antoni, C.; Draelos, Z.; Gold, M. H.; Durez, P.; Tak, P. P.; Gomez-Reino, J. J.; Foster, C. S.; Kim, R. Y.; Samson, C. M.; Falk, N. S.; Chu, D. S.; Callanan, D.; Nguyen, Q. D.; Rose, K.; Haider, A.; Di Padova, F.; Rose, K; Haider, A; Di Padova, F (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.
  4. ↑ "FDA approves new psoriasis drug Cosentyx" (Press release). United States Food and Drug Administration. January 21, 2015. Retrieved January 21, 2015.
  5. ↑ http://www.novartis.com/newsroom/media-releases/en/2015/1888645.shtml
  6. ↑ Langley, Richard G.; Elewski, Boni E.; Lebwohl, Mark; Reich, Kristian; Griffiths, Christopher E.M.; Papp, Kim; Puig, Lluís; Nakagawa, Hidemi; Spelman, Lynda; Sigurgeirsson, Bárður; Rivas, Enrique; Tsai, Tsen-Fang; Wasel, Norman; Tyring, Stephen; Salko, Thomas; Hampele, Isabelle; Notter, Marianne; Karpov, Alexander; Helou, Silvia; Papavassilis, Charis; Erasure Study, Group; Fixture Study, Group (2014). "Secukinumab in Plaque Psoriasis — Results of Two Phase 3 Trials". New England Journal of Medicine 371 (4): 326–38. doi:10.1056/NEJMoa1314258. PMID 25007392.
  7. ↑ http://www.familypracticenews.com/index.php?id=2934&type=98&tx_ttnews=306073[][]
  8. ↑
  9. ↑ http://www.medpagetoday.com/MeetingCoverage/ACR/48743[]
  10. ↑ http://www.medscape.com/viewarticle/806510_6[]
  11. ↑ McInnes, I. B.; Sieper, J.; Braun, J.; Emery, P.; Van Der Heijde, D.; Isaacs, J. D.; Dahmen, G.; Wollenhaupt, J.; Schulze-Koops, H.; Kogan, J.; Ma, S.; Schumacher, M. M.; Bertolino, A. P.; Hueber, W.; Tak, P. P. (2013). "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". Annals of the Rheumatic Diseases 73 (2): 349–56. doi:10.1136/annrheumdis-2012-202646. PMID 23361084.
  12. ↑ Clinical trial number NCT01874340 for "Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis" at ClinicalTrials.gov
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