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 adults (alone or in combination with methotrexate [MTX]) who have responded inadequately to disease-modifying anti-rheumatic drug therapy.1

Full indications for Cosentyx can be found here


ALL-IN-ONE relief for eligible adult patients with PsA

The six key clinical manifestations of PsA are joints, axial, skin, enthesitis, dactylitis and nails.1–4 

Download a summary of the key Cosentyx efficacy data here

Interleukin (IL)-17A inhibitors, such as Cosentyx, are recommended across all 6 key manifestations of PsA14–16

Lasting remission could be achievable for your adult patients with PsA

Remission or low disease activity are recommended as targets of therapy in PsA.14–16 The minimal disease activity (MDA) score allows the assessment of low disease activity.16 

Based on observational data; prespecified exploratory endpoint.
 

Image of a pie chart showing 41%

FUTURE 517

of patients achieved MDA at 2 years with Cosentyx 300 mg s.c. (N=51)

The primary endpoint (ACR20 response rate at Week 16) was met (p<0.0001)18

Image of a pie chart showing 40%

FUTURE 119

of patients achieved MDA at 5 years with Cosentyx 150 mg s.c. (N=195)

The primary endpoint (ACR20 response rate at Week 24) was met (p<0.001)20

Most patients who start on Cosentyx, stay on Cosentyx

Real-world data from the UK show the majority of patients with PsA who started on Cosentyx (N=81) remained on treatment for at least 2 years.**21

At Year 1

Interactive graphic showing that 91% of patients with moderate to severe PsA who started on Cosentyx (N=81) remained on treatment for at least 1 year and 78% for at least 2 years.

stayed with Cosentyx
(95% CI: 84–98)

At Year 2

Interactive graphic showing that 91% of patients with moderate to severe PsA who started on Cosentyx (N=81) remained on treatment for at least 1 year and 78% for at least 2 years.

stayed with Cosentyx
(95% CI: 68–88)

 

Full indications

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 non-radiographic 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

*ULTIMATE: non-responder imputation data in biologic-naïve patients originally randomly assigned to Cosentyx (n=83). Patients taking Cosentyx received 150 mg if their body surface area (BSA) was ≤10%, or 300 mg if their BSA was >10% (as assessed by PASI score). The primary endpoint (Global OMERACT-EULAR Synovitis Score [GLOESS] mean change from baseline at Week 12) was met (p=0.004).
MATURE: non-responder imputation data for the 300 mg treatment group of patients with moderate to severe plaque PsO at baseline (n=41). The co-primary endpoint (PASI 75 and Investigator’s Global Assessment [IGA] 0/1 at Week 12) was met (p<0.0001).
TRANSFIGURE: observed data in patients with moderate to severe nail PsO in the 300 mg treatment group (n=66); in the respective 150 mg treatment group (n=67), there was a mean NAPSI improvement of -63.6%. The primary endpoint (percentage change from baseline in mean NAPSI score at Week 16) was met (p<0.0001). Actual photos taken of a Cosentyx patient by investigators during clinical trials. Individual patient responses may vary.
§MAXIMISE: observed data in biologic-naïve patients in the 300 mg treatment group (n=139); in the respective 150 mg treatment group, 65% achieved ASAS40 at Year 1 (n=141). The primary endpoint (ASAS20 response rate at Week 12) was met (p<0.0001);
FUTURE 2: observed data for the 300 mg treatment group of biologic-naïve patients with this symptom at baseline, including those originally randomly assigned to Cosentyx and placebo-switchers (n=51); 75% in the respective 150 mg group maintained complete resolution of enthesitis through Year 5 (n=64). The primary endpoint (the proportion of patients with ACR20 response at Week 24) was met (p<0.0001).
FUTURE 2: observed data for the 300 mg treatment group of biologic-naïve patients with this symptom at baseline, including those originally randomly assigned to Cosentyx and placebo-switchers (n=40); 82% in the respective 150 mg group maintained complete resolution of dactylitis through Year 5 (n=28). The primary endpoint (the proportion of patients with ACR20 response at Week 24) was met (p<0.0001).
**SERENA is an ongoing, longitudinal, non-interventional study across 438 sites in patients with moderate to severe, chronic PsO, active PsA or active AS who were treated with Cosentyx for ≥16 weeks at registration. The primary objective of this 2-year interim analysis was to assess long-term retention of Cosentyx in patients with PsA or AS.

ACR, American College of Rheumatology; AI, autoinjector; AS, ankylosing spondylitis; ASAS, Assessment of Spondyloarthritis international Society; axSpA, axial spondyloarthritis; BSA, body surface area; CI, confidence interval; HS, hidradenitis suppurativa; IGA, investigator’s global assessment; IL, interleukin; JIA, juvenile idiopathic arthritis; MDA, minimal disease activity; MTX, methotrexate; NAPSI, nail psoriasis severity index; PASI, psoriasis area and severity index; PsA, psoriatic arthritis; PsO, psoriasis; s.c., subcutaneous; SmPC, Summary of Product Characteristics; TNFi, tumour necrosis factor inhibitor; TNFi-IR, tumour necrosis factor inhibitor-inadequate responder.

  1. Cosentyx (secukinumab) Summary of Product Characteristics.
  2. Baraliakos X, et al. Ann Rheum Dis 2021;80(5):582–590.
  3. Nash P, et al. Clin Exp Rheumatol 2022;40(5):952–959.
  4. Boers M, et al. EULAR European Congress of Rheumatology. 2–5 June 2021; Virtual Congress. Poster POS0197.
  5. Sigurgeirsson B, et al. Dermatol Ther 2022;35(3):e15285.
  6. Reich K, et al. Br J Dermatol 2021;184(3):425–436.
  7. McInnes IB, et al. Lancet Rheumatol 2020;2(4):e227–e235.
  8. Conaghan PG, et al. Rheumatology 2022;61(Supp 1):keac133.252.
  9. D’Agostino MA, et al. Rheumatology (Oxford) 2022;61(5):1867–1876.
  10. Novartis data on file. CAIN457F3302 (MAXIMISE) Clinical Study Report. August 2020.
  11. Novartis data on file. CAIN457F2312 (FUTURE 2) Interim Clinical Study Report at Week 24. Summary of presence of enthesitis using non-responder imputation–up to Week 24.
  12. Novartis data on file. CAIN457F2312 (FUTURE 2) 5-Year Interim Report 2019. Summary of presence of enthesitis using observed data – Week 260.
  13. McInnes IB, et al. Lancet 2015;386(9999):1137–1146.
  14. Coates LC, et al. Nat Rev Rheumatol 2022;18(8):465–479.
  15. Tucker L, et al. Rheumatology 2022;61(9):e255–e266.
  16. Gossec L, et al. Ann Rheum Dis 2020;79(6):700–712.
  17. Novartis data on file. CAIN457F2342 (FUTURE 5): Week 104 Interim Report. May 2019.
  18. Mease P, et al. Ann Rheum Dis 2018;77(6):890–897.
  19. Mease PJ, et al. ACR Open Rheumatol 2020;2(1):18–25.
  20. Mease P, et al. N Engl J Med 2015;(14)373:1329–1339.
  21. Gaffney K, et al. Rheum Adv Prac 2023;7(2):rkad055.
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UK | January 2024 | 315579

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