Prescribing information

 

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults, children and adolescents from the age of 6 years who are candidates for systemic therapy; active psoriatic arthritis (PsA) in adult patients (alone or in combination with methotrexate [MTX]) when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate; active ankylosing spondylitis (AS) in adults who have responded inadequately to conventional therapy; active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs; active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy; active enthesitis-related arthritis (ERA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy; active juvenile psoriatic arthritis (JPsA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.1,2


The Cosentyx mechanism of action works by blocking IL-17A, a key proinflammatory cytokine associated with inflammation in axSpA, PsA, PsO and HS1–14

Animated graphic showing the production of IL-17A via both adaptive and innate immune pathways.

Increased levels of IL-17A are found in the affected tissues of patients with axSpA, PsA, PsO and HS1,2,8,15,16

How does Cosentyx work?

The active ingredient, secukinumab, mechanism of action works by targeting IL-17A, preventing it from binding to the IL-17A receptor.1,2 It acts downstream of several other biologics and inhibits IL-17A cytokines irrespective of adaptive or innate immunity origin.17,18

Cosentyx mechanism of action video

Watch the short video below to discover the mode of action of Cosentyx.

 

 

Through blocking IL-17A, Cosentyx works across the key manifestations of axSpA, PsA, PsO and HS1–9

Graphic highlighting that Cosentyx works across the key manifestations of axSpA, PsA, PsO and HS.

 

Cosentyx’s mechanism of action may provide an alternative option for patients with an inadequate response to IL-12/231,2,4,18,19

 

Consider IL-17 MoA as an alternative for prior inadequate response to IL-12/231–9

CLEAR study: PASI 100 over 52 weeks (secondary endpoint)19

Graph from the CLEAR study showing PASI 100 Over 52 weeks (secondary endpoint)

Graph adapted from Blauvelt A, et al. 2017.19

  • Starting at Week 4 and lasting through to Week 52, each dose of Cosentyx 300 mg resulted in a statistically significant improvement in PASI 100 response rates compared with ustekinumab 45 mg or 90 mg19
  • CLEAR primary endpoint: The proportion of patients achieving PASI 90 at Week 16 for Cosentyx 300 mg vs ustekinumab 45 mg or 90 mg was met by 79% vs 58%, respectively; p<0.000119
  • Cosentyx and ustekinumab exhibited comparable safety and tolerability profiles with no new or unexpected safety signals. The most common AEs for both were nasopharyngitis and headache19

In the CLEAR study, Cosentyx demonstrated superior long-lasting skin clearance vs ustekinumab over 1 year19

BAD recommends a TNF antagonist or an IL‐17 inhibitor such as Cosentyx as a first‐line biologic for adult patients with psoriasis and PsA20

 

Cosentyx is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Cosentyx is indicated.  Please refer to the Cosentyx SmPC for full product information before prescribing.1,2

 

Therapeutic indications1,2

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults, children and adolescents from the age of 6 years who are candidates for systemic therapy; active psoriatic arthritis (PsA) in adult patients (alone or in combination with methotrexate [MTX]) when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate; active ankylosing spondylitis (AS) in adults who have responded inadequately to conventional therapy; active nonradiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging evidence in adults who have responded inadequately to non-steroidal anti-inflammatory drugs; active moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy; active enthesitis-related arthritis (ERA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy; active juvenile psoriatic arthritis (JPsA) in patients 6 years and older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.1,2

CLEAR was a Phase IIIb randomised, double-blind, head-to-head study comparing Cosentyx 300 mg (n=337) to ustekinumab 45 mg or 90 mg (n=339) over 52 weeks in patients with moderate to severe PsO. The primary endpoint was PASI 90 at Week 16. The main secondary endpoint was PASI 90 at Year 1. PASI 75/90/100 over time were also evaluated.19

AS, ankylosing spondylitis; axSpA, axial spondyloarthritis; BAD, British Association of Dermatologists; BSR, British Society for Rheumatology; ERA, enthesitis-related arthritis; GRAPPA, Group for Research and Assessment of Psoriatic Arthritis; HS, hidradenitis suppurativa; IL-17A, interleukin 17A; IL-23, interleukin 23; JPsA, juvenile psoriatic arthritis; MTX, methotrexate; NK, natural killer; PASI, psoriasis area and severity index; PsA, psoriatic arthritis; PsO, plaque psoriasis; SmPC, summary of product characteristics; TNF, tumour necrosis factor.

References

  1. Cosentyx® (secukinumab) GB Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/3669/smpc [Accessed February 2024].
  2. Cosentyx® (secukinumab) NI Summary of Product Characteristics. Available at: https://www.emcmedicines.com/en-gb/northernireland/medicine?id=ecdc7f05-... [Accessed February 2024].
  3. Zeichner JA, et al. J Clin Aesthet Dermatol 2016;9(suppl 6):S3–S6.
  4. Lynde CW, et al. J Am Acad Dermatol 2014;71(1):141–150.
  5. Keijsers RR, et al. Exp Dermatol 2014;23(11):799–803.
  6. Mease PJ, et al. N Engl J Med 2015;373(14):1329–1339.
  7. McInnes IB, et al. Lancet 2015;386(9999):1137–1146.
  8. Mills KHG. Nat Rev Immunol 2023;23(1):38–54.
  9. Fletcher JM, et al. Clin Exp Immunol 2020;201(2):121–134.
  10. Lories RJ, et al. Nat Med 2012;18(7):1018–1019.
  11. Smith JA, et al. Arthritis Rheumatol 2014;66(2):231–241.
  12. Kehl AS, et al. Arthritis Rheumatol 2016;68(2):312–322.
  13. McGonagle D, et al. Nat Rev Rheumatol 2015;11(12):731–740.
  14. Baeten D, et al. N Engl J Med 2015;373(26):2534–2548.
  15. Constantinou CA, et al. Ther Adv Musculoskelet Dis 2019;11:1759720X19895488.
  16. Schön M & Erpenbeck L. Front Immunol 2018;9:1323.
  17. Gorelick J, et al. Practical Dermatol 2016;12:35–50.
  18. Krueger J, et al. Exp Dermatol 2023;00:1–14.
  19. Blauvelt A, et al. J Am Acad Dermatol 2017;76(1):60–69.
  20. Smith CH, et al. Br J Dermatol 2020;183(4):628–637.
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UK | February 2024 | 406840

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via uk.patientsafety@novartis.com or online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at medinfo.uk@novartis.com