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Prescribing information

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Cosentyx® (secukinumab): Efficacy in axial spondyloarthritis (axSpA)

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

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.1

In Ireland Cosentyx is reimbursed for the following indications: adult plaque psoriasis (PsO); psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA).

Please refer to the Summary of Product Characteristics (SmPC) for full prescribing information and safety profile.1

Safety profile

Give your patients lasting relief from key symptoms of axSpA2–4

FAST (16 weeks) and LASTING (5 years): see the effects of Cosentyx on the key clinical hallmarks of axSpA: morning stiffness, spinal pain, fatigue and nocturnal back pain.2–4

Mean percentage change from baseline in biologic-naïve patients with AS (as observed data with 150 mg SC load):

Spinal pain3

 
Image representing spinal pain and mean percentage change from baseline of 51% after 16 weeks and 55% after 5 years in biologic-naïve patients with AS treated with Cosentyx 150 mg.

Fatigue*2,3

 
Image representing fatigue and mean percentage change from baseline of 48% after 16 weeks and 47% after 5 years in AS patients treated with Cosentyx 150 mg.

Nocturnal back pain2,4

 
Image representing nocturnal back pain and mean percentage change from baseline of 56% after 16 weeks and 62% after 4 years in AS patients treated with Cosentyx 150 mg.

Morning stiffness3

 
Image representing morning stiffness and mean percentage change from baseline of 44% after 16 weeks and 52% after 5 years in AS patients treated with Cosentyx 150 mg.

Note: There are no comparator/placebo values beyond Year 4/5 where "-" is denoted.

MEASURE 2 trial (N=219) and PREVENT: the primary endpoint of ASAS20 at Week 16 for Cosentyx vs placebo was met (61% vs 28% respectively, p<0.001).5

 

ASAS-EULAR, BSR and BHPR guidelines, based on clinical and real-world experience, continue to support use of an IL-17 inhibitor, such as Cosentyx, in axSpA6,7

Ankylosing spondylitis (AS)

Cosentyx demonstrated reductions in mean ASAS20/40 score in TNFi-naive patients with AS at Week 16 from baseline, with responses observed to be sustained up to Year 5.†5,8–12

 

ASAS20/40 in biologic-naïve patients (responders, %)

AS graph showing 73% of ASAS20 responders and 60% of ASAS40 responders among TNFi-naïve AS patients treated with Cosentyx 150 mg through Year 5 in MEASURE 2 trial.

Adapted from Novartis Data on File.9–12
The primary endpoint of the MEASURE 2 trial, ASAS20 at Week 16 for Cosentyx vs placebo, was met (p<0.001 in TNFi-naïve; p<0.05 in TNFi-inadequate responder).5,9

 

Non-radiographic axial spondyloarthritis (nr-axSpA)

Cosentyx demonstrated reductions in mean ASAS20/40 score in TNFi-naïve patients with nr-axSpA at Week 16 from baseline, with responses observed to be sustained up to Year 2‡2,13

 

Please note that Cosentyx is not reimbursed for nr-axSpA indication in Ireland.

(Data presented are as observed)

nr-axSpA graph showing 82% of ASAS20 responders and 62% of ASAS40 responders among TNFi-naïve nr-axSpA patients treated with Cosentyx 150 mg through Year 2 in PREVENT trial.

Adapted from Novartis Data on File.2 
The primary endpoint of the PREVENT trial (the proportion of patients with ASAS40 at Week 16) was met (p<0.05).13

In biologic-naïve patients with active AS, Cosentyx provides fast (16 weeks) and lasting (5 years) reduction in overall disease activity§3,15

AS graph showing a reduction in mean BASDAI score to 3.7 in biologic-naïve AS patients treated with Cosentyx 150 mg through Year 5 in MEASURE 2 trial.

Adapted from Novartis Data on File.3

BASDAI index includes 6 patient-reported scores of the 5 major symptoms of AS described above.15

  • Score ranges from 0 to 10 on 10-cm VAS, with higher numbers indication greater disease activity15

  • Baseline mean score was 6.73

Most patients who start on Cosentyx, stay on Cosentyx

In the SERENA study:14

 

KM estimated retention rates in patients with r-axSpA14

Graphic showing that 86% of patients with r-axSpA who started on Cosentyx remained on treatment for at least 1 year and 79% for at least 2 years

Adapted from Kiltz U, et al. 2024.14

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 Efficacy in PsA

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 Dosing

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 Mechanism of action

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 Safety profile

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Resources

*These figures show mean baseline improvement at Week 16 with Cosentyx vs placebo, and mean baseline improvement up to Year 5 with Cosentyx without a placebo comparator. Data is in the context of a randomised, double-blind, placebo-controlled Phase III multicenter study of subcutaneous Cosentyx in prefilled syringes designed to demonstrate efficacy at 16 weeks and to evaluate long-term efficacy, safety, and tolerability over 5 years in patients with active AS.3
†MEASURE 2 included patients who did not switch treatment and who switched to open-label or standard of care after Week 20.

‡Patients on Cosentyx 150 mg received a 150 mg loading dose.
§Change in BASDAI was an exploratory endpoint at time points other than Week 16; all data observed.3,16

AS, ankylosing spondylitis; ASAS, Assessment of Spondyloarthritis International Society; axSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; ERA, enthesitis-related arthritis; HS, hidradenitis suppurativa; IL-17, interleukin 17; JPsA, juvenile psoriatic arthritis; KM, Kaplan-Meier; MTX, methotrexate; nr-axSpA, non-radiographic axial spondyloarthritis; PsA, psoriatic arthritis; PsO, plaque psoriasis; r-axSpA, radiographic axial spondyloarthritis; SC, subcutaneous; SmPC, summary of product characteristics; TNF, tumour necrosis factor; TNFi, tumour necrosis factor inhibitor; TNFi-IR, tumour necrosis factor inhibitor-inadequate responder; VAS, visual analogue scale.

Reference

  1. Cosentyx® (secukinumab) Summary of Product Characteristics. Available at: www.medicines.ie.

  2. Novartis Data on File. CAIN457H2315 Data Analysis Report. April 2020. 

  3. Novartis Data on File. CAIN457F2310 Clinical Study Report. May 2019. 

  4. Novartis Data on File. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. January 2020 

  5. Baeten D, et al. N Engl J Med 2015;373(26):2534–2548.

  6. Ramiro S, et al. Ann Rheum Dis 2023;82(1):19–34.

  7. Hamilton L, et al. Rheumatol 2017;56(2):313–316.

  8. Marzo-Ortega H, et al. Lancet Rheumatol 2020 (6);2:e339–e346.

  9. Novartis Data on File. Rheumatology UK 22.

  10. Novartis Data on File. Rheumatology UK 23.

  11. Novartis Data on File. Rheumatology UK 268.

  12. Novartis Data on File. Rheumatology UK 269.

  13. Deodhar A, et al. Arthritis Rheumatol 2021;73(1):110–120. 

  14. Kiltz U, et al. Abstract 1840456. American College of Rheumatology (ACR) Convergence, 14–19 November 2024; Washington, DC, US.

  15. Zochling, J et al. Artrithis Care Res (Hoboken) 2011;63 (suppl 11):S47–S58. 

  16. Novartis Data on File. CAIN457F2310 Clinical Study Report – Week 52 Analysis. November 2014.

IE11579814 | March 2026

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk profile of the medicinal product. All suspected adverse reactions should be reported to HPRA Pharmacovigilance at www.hpra.ie. Adverse events can also be reported to Novartis preferably at www.novartis.com/report, by emailing [email protected] or by calling (01) 2080 612.