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Cosentyx® (secukinumab) heritage

Cosentyx® (secukinumab) 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 moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy.1

Full indications for Cosentyx can be found here.

Cosentyx Summary of Product Characteristics (SmPC) can be found here.

Cosentyx heritage

1.6 million plus.

patients treated globally and counting, across indications2

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150+

clinical trials across indications*3

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10 years

of real-world clinical experience, worldwide across indications†4

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8

indications1

†Since first indication in 2015 for eligible adults with moderate to severe PsO.4

Confidence to prescribe Cosentyx to your eligible patients – Cosentyx real-world evidence (RWE)

RWE shows a consistent safety profile across indications with long-term use of Cosentyx over 9 years5

Please refer to the Cosentyx Summary of Product Characteristics (SmPC) for full safety information, and the safety profile page here.

No trend towards increased AE rates over time (pooled data in a PSUR including exposure in clinical trials and marketing experience):5

 
Table showing consistent safety profile in AS, PsA, plaque PsO over 9 years.

Adapted from Novartis Data on File, 2025.5

Successive time periods of PSUR shown with cumulative rate: 26 Dec 2014 to 25 June 2015; 26 June 2015 to 25 Dec 2015; 26 Dec 2015 to 25 June 2016; 26 June 2016 to 25 Dec 2016; 26 Dec 2016 to 25 Dec 2017; 26 Dec 2017 to 25 Dec 2018; 26 Dec 2018 to 25 Dec 2019; 26 Dec 2019 to 25 Dec 2020; 26 Dec 2020 to 25 Dec 2023.5

The most frequently reported adverse reactions are upper respiratory tract infections (17.1%) (most frequently nasopharyngitis, rhinitis).1

Caution should be exercised when considering the use of Cosentyx in patients with a chronic infection or a history of recurrent infection. If a patient develops a serious infection, the patient should be closely monitored and Cosentyx should not be administered until the infection resolves.1

Patients should be evaluated for tuberculosis infection prior to initiating treatment with Cosentyx. Cosentyx should not be given to patients with active tuberculosis. In patients with latent tuberculosis, anti‑tuberculosis therapy should be considered prior to initiation of Cosentyx.1

Cosentyx is not recommended in patients with IBD. If a patient develops signs and symptoms of IBD or experiences an exacerbation of pre-existing inflammatory bowel disease, Cosentyx should be discontinued and appropriate medical management should be initiated.1

Please refer to the SmPC for full safety information before prescribing.1

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Consistent safety profile in clinical trials, including those for paediatric JIA (n=86) and PsO (n=162) patients as young as 6 years old‡1

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Consistent safety profile in more than 1.8 million PY across AS, PsA and PsO indications5

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No trend towards increased rates of major adverse cardiovascular events (MACE), or malignancy reported in clinical trials and RWE5

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 Cosentyx

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 Cosentyx in PsO

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 Cosentyx in HS

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 Safety profile

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 Mechanism of action

Therapeutic indications1
Cosentyx is indicated for the treatment of moderate to severe PsO in adults, children and adolescents from the age of 6 years who are candidates for systemic therapy; active PsA in adult patients (alone or in combination with MTX) when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate; active AS in adults who have responded inadequately to conventional therapy; active 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 HS (acne inversa) in adults with an inadequate response to conventional systemic HS therapy; active 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 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

*Not limited to licensed indications.
†Since first indication in 2015 for eligible adults with moderate to severe PsO.4
‡In paediatric PsO, JPsA and ERA.

AE, adverse event; AS, ankylosing spondylitis; axSpA, axial spondyloarthritis; EAIR, exposure-adjusted incidence rate; HS, hidradenitis suppurativa; IBD, inflammatory bowel disease; JIA, juvenile idiopathic arthritis; JPsA, juvenile psoriatic arthritis; MACE, major adverse cardiovascular event; MTX, methotrexate; PsA, psoriatic arthritis; PsO, psoriasis; PSUR, Periodic Safety Update Report; PY, patient-years; RWE, real-world evidence.

References

  1. Cosentyx® (secukinumab) Summary of Product Characteristics.

  2. Novartis Data on File. Secukinumab (SEC018). February 2025.

  3. ClinicalTrials.gov. Search results for ‘secukinumab’, completed, terminated and active, not recruiting trials. Available at: https://clinicaltrials.gov/search?term=Secukinumab,&aggFilters=status:com [Accessed September 2025].

  4. European Medicines Agency. Summary of positive opinion EMA/CHMP/670627/2015. Available at: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cosentyx_en.pdf [Accessed September 2025].

  5. Novartis Data on File. Secukinumab (SECO20). April 2025.

UK | September 2025 | FA-11386176-1

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 online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.