Prescribing information (external link)

Image
Top banner. Cosentyx® (secukinumab) logo.
Image
Top banner. Cosentyx® (secukinumab) logo.

Sustained remission in psoriatic arthritis (PsA)

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 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 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

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.


Cosentyx may help your eligible patients with PsA achieve sustained remission2,3

 

Current guidelines recommend aiming for low disease activity or remission in PsA*4

    Help move toward sustained remission†2

    Sustained remission was defined as achieving minimal disease activity (MDA) between Weeks 24 and 52 and maintaining this response in at least 2 of the next 6 visits (scheduled every 8 weeks) through Week 104.2

    Image
    ""

    Clinical trial data

    55.5% of patients achieved sustained remission (MDA) with Cosentyx 300 mg SC at Year 2 
    (n=191; observational, no statistical testing)†2,5

    Image
    ""

    Real-world evidence

    66.2% of patients previously treated with one or more biologic were observed to achieve remission (MDA) with Cosentyx at Year 4  
    (n=136)‡3

    Fictional patient and HCP imagery, for illustrative purposes only.

    Cosentyx may help your eligible patients with PsA achieve sustained remission2,3,5

    MDA is a validated clinical measure used to assess disease control in PsA6,7

     

    A patient achieves MDA by meeting 5 of the 7 criteria below:6

    Image
    Tick icon

    ≤1 tender joint count

    Image
    Tick icon

    ≤1 swollen joint count

    Image
    Tick icon

    PASI score ≤1 or BSA ≤3%

    Image
    Tick icon

    ≤1 tender entheseal point(s)

    Image
    Tick icon

    VAS ≤15

    Image
    Tick icon

    Patient global disease activity ≤20

    Image
    Tick icon

    HAQ-DI ≤0.5

     

    Lasting retention observed up to 5 years in the real world8

     

    Real-world data show that 56% of patients who responded to Cosentyx stayed on Cosentyx to Year 5 (n=522).8

    Number of patients who have stayed on Cosentyx up to 5 years8

    Image
    Graphic showing lasting retention observed up to 5 years in the real world with Cosentyx.8

    Based on Kiltz U, et al. 2025.9

    At Year 5, in patients with PsA who initially responded to Cosentyx (observed data):8

    Image
    Graphic showing the percentage of patients with PsA at year 5, who initially responded to Cosentyx:

    SERENA is the largest prospective, longitudinal, non-interventional study with Cosentyx in adult patients with moderate to severe PsO, active PsA or active AS.
    The study included patients aged ≥18 years who had received ≥16 weeks of treatment before enrolment. Patients in the 5-year analysis had received Cosentyx for an average of 1 year before enrolment. The primary objective of this study was to assess the long-term retention of Cosentyx in routine clinical practice. Secondary objectives of the study were to describe the long-term effectiveness of Cosentyx for the treatment of PsA and AS. Patients received Cosentyx according to the local label. Retention rates were analysed using Kaplan–Meier.8,9

    Efficacy profile across the 6 key manifestations of PsA2,5,10–16

     

    55.5% achieved sustained remission (MDA)§ with Cosentyx 300 mg SC at Year 2¶2 (n=191; observed data; no statistical testing)

    Image
    ""

    Joints

    67.7% achieved ACR50 at Year 1‖10,11
    (n=44/65; observed data; secondary endpoint)

    Enthesitis

    76.5% had complete resolution at Year 5**12
    (n=39/51; observed data; secondary endpoint)

    Dactylitis

    87.5% had complete resolution at Year 5††12
    (n=35/40; observed data; secondary endpoint)

    Skin

    69.6% achieved PASI 90 at  Year 2‡‡13,14
    (n=41; NRI; secondary endpoint)

    Nails

    76.5% mean change in mNAPSI score at Year 2§§15
    (n=220; post-hoc analysis, pooled data)

    Axial

    69.1% achieved ASA40 at Year 1¶¶16
    (n=96/139; observed data; secondary endpoint)

    Fictional patient and HCP imagery, for illustrative purposes only.

    What could achieving sustained remission mean for your patients?


Real-world evidence shows a consistent safety profile over 9 years17

Learn about the safety profile of Cosentyx


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 hidradenitis suppurativa (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

*There is no consensus definition of remission. Here, remission is defined as achieving MDA.4,18
The primary endpoint (proportion of patients with ACR20 response at Week 16) was met; Cosentyx 300 mg 62.6% vs placebo 27.4%, N=996; p<0.0001.5
Real-world prospective multicentre study exploring the four-year effectiveness, safety profile and drug retention rate of patients with PsA receiving Cosentyx (150 mg or 300 mg, as needed) between 2016 and 2023 (N=685).3
§Sustained remission was defined as achieving MDA between Weeks 24 and 52 and maintaining this response in at least 2 of the next 6 visits (scheduled every 8 weeks) through Week 104.2
FUTURE 5 study. Data in patients randomly assigned to Cosentyx 300 mg. 47.8% of patients in the Cosentyx 150 mg group achieved MDA (n=184). At baseline, approximately 70% of patients were biologic-naïve.2,5
ULTIMATE study. Patients taking Cosentyx 150 mg and 300 mg were pooled into a single arm (n=83) and were biologic-naïve. Patients taking Cosentyx received 150 mg if their BSA was ≤10% or 300 mg if their BSA was >10% (as assessed by PASI score).10,11
**FUTURE 2 study. Results are reported in patients with this symptom at baseline receiving Cosentyx 300 mg. 75% of patients in the 150 mg group (n=48/64) achieved complete resolution of enthesitis. Approximately 65% were TNFi-naïve. Cosentyx dose was escalated from 150 to 300 mg starting at Week 128, if active signs of PsA were observed based on the physician’s assessment; the dose was maintained thereafter.12
††FUTURE 2 study. Results are reported in patients with this symptom at baseline receiving Cosentyx 300 mg. 82% of patients in the 150 mg group (n=23/28) achieved complete resolution of dactylitis. Approximately 65% were TNFi-naïve. Cosentyx dose was escalated from 150 to 300 mg starting at Week 128, if active signs of PsA were observed based on the physician’s assessment; the dose was maintained thereafter.12
‡‡FUTURE 2 study. Results are reported in patients with >3% of BSA affected by psoriatic skin involvement receiving Cosentyx 300 mg. 52.5% of patients in the 150 mg group (n=58) achieved PASI 90 at Year 2. Approximately 65% were TNFi-naive. Cosentyx dose was escalated from 150 to 300 mg starting at Week 128, if active signs of PsA were observed based on the physician’s assessment; the dose was maintained thereafter.12,14
§§Post hoc analysis across pooled FUTURE 2–5 datasets. Data presented are from the Cosentyx 300 mg group. A 76% change in mNAPSI was achieved by patients receiving Cosentyx 150 mg (n=307).15
¶¶MAXIMISE study. ASAS20 and ASAS40 were prespecified exploratory endpoints at 1 year. No clinical or statistical conclusions can be drawn. Results are reported in biologic-naïve patients receiving Cosentyx 300 mg; 65% of patients in the Cosentyx 150 mg group (n=141) achieved ASAS40 at Year 1.16

ACR, American College of Rheumatology; AS, ankylosing spondylitis; ASAS, Assessment in SpondyloArthritis International Society; BSA, body surface area; ERA; enthesitis-related arthritis; HAQ-DI, health assessment questionnaire-disability index; HCP, healthcare professional; HS, hidradenitis suppurativa; JPsA, juvenile psoriatic arthritis; MDA, minimal disease activity; mNAPSI, modified nail psoriasis severity Index; MTX, methotrexate; nr-axSpA, nonradiographic axial spondyloarthritis; PASI, psoriasis area and severity index; PsA, psoriatic arthritis; PsO, plaque psoriasis; SC, subcutaneous; SmPC, summary of product characteristics; TNFi, tumour necrosis factor inhibitor; VAS, visual analogue scale.

References

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

  2. Coates LC, et al. RMD Open 2023;9(2):e002939.

  3. Ramonda R, et al. Arthritis Res Ther 2024;26(1):172.

  4. Gossec L, et al. Ann Rheum Dis 2024;83(6):706–719.

  5. Mease PJ, et al. Ann Rheum Dis 2018;77(6):890–897.

  6. Coates LC, et al. Ann Rheum Dis 2010;69(1):48–53.

  7. Coates LC, et al. RMD Open 2019;5(2):e001002.

  8. Kiltz U, et al. Abstract 2344. Arthritis Rheumatol 2024;76(Suppl 9).

  9. Kiltz U, et al. Poster 1462. American College of Rheumatology Convergence; 6–11 November 2025; Washington, DC, US.

  10. D'Agostino MA, et al. Rheumatology (Oxford) 2022;61(5):1867–1876 and supplementary materials.

  11. Conaghan PG, et al. P253. Rheumatology 2022;61(Supp 1):keac133.252.

  12. McInnes IB, et al. Lancet Rheumatol 2020;2(4):e227–e235.

  13. McInnes IB, et al. Lancet 2015;386(9999):1137–1146.

  14. McInnes IB, et al. Rheumatology (Oxford) 2017;56(11):1993–2003.

  15. Reich K, et al. Br J Dermatol 2022;187(3):438 441.

  16. Baraliakos X, et al. Ann Rheum Dis 2021;80(5):582–590.

  17. Novartis Data on File. Secukinumab (SEC020). April 2025.

  18. Almodovar R, et al. Reumatol Clin (Engl Ed) 2021;17(6):343–350

UK | April 2026 | FA-11625076-1

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.