Cosentyx® (secukinumab): Efficacy in psoriatic arthritis (PsA)

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

Cosentyx helps to reduce the risk of irreversible joint damage progression²

An artists impression of early radiographic damage, with the text '90% of patients with PsA taking Cosentyx 300 mg showed no radiographic progression through Year 2 (n=191).2

Artist’s representation of early radiographic damage. These images do not depict real patients. For illustrative purposes only.

FUTURE 5 analysis through 2 years. The primary endpoint of proportion of patients achieving ACR20 response at Week 16 was met (Cosentyx 300 mg 62.6% vs placebo 27.4%, respectively; p<0.0001). The study included 996 patients with active PsA, 222 of whom were taking Cosentyx 300 mg. Radiographic progression, as measured by van der Heijde-modified total Sharp score, was significantly inhibited at Week 24 in all Cosentyx arms vs placebo.⁴

Cosentyx delivers a consistent safety profile^1,5

Adverse reactions from clinical studies and post-marketing analysis reported as very common (≥1/10) and common (≥1/100 to <1/10) frequency:¹

System organ class	Frequency	Adverse reaction
Infections and infestations	Very common	Upper respiratory tract infections
Infections and infestations	Common	Oral herpes
Nervous system disorders	Common	Headache
Respiratory, thoracic and mediastinal disorders	Common	Rhinorrhoea
Gastrointestinal disorders	Common	Diarrhoea, nausea
Skin and subcutaneous tissue disorders	Common	Eczema
General disorders and administration site conditions	Common	Fatigue

Adapted from Cosentyx SmPC.¹

6 manifestations
Sustained efficacy
Persistence
Skin clearance
Axial relief
Patient eligibility

Cosentyx is the FIRST biologic with proven efficacy in all six manifestations^1,6–11

Key clinical manifestations of PsA are joint, axial, skin, enthesitis, dactylitis and nails.⁹

Joints

68%

achieved ACR50  at Year 1 in ULTIMATE^†10

Skin

74%

maintained PASI 90 at Year 5 in FUTURE 2^‡7

Nails

–73%

observed improvement from baseline in mNAPSI at 2.5 years in TRANSFIGURE^§11

Axial

69%

sustained ASAS40 at Year 1 in MAXIMISE^¶9

Dactylitis

94%

achieved resolution at Year 5 in FUTURE 2^||7

Enthesitis

83%

achieved resolution at Year 5 in FUTURE 2**⁷

All the primary endpoints were met in the studies referenced above.^7,9–11

Almost 7 out of 10 patients achieved ACR 20 and 1 in 2 patients achieved ACR 50 by Week 16 and the response was sustained out to Year 5 in FUTURE 1⁸

Graph showing the proportion of ACR20 and ACR50 responders by week of treatment in biologic-naïve Cosentyx-treated patients.

Adapted from Mease PJ, et al. 2020.⁸

of patients completed 5 years of treatment⁸

of patients were biologic naïve⁸

Fast and lasting ACR 20 and ACR 50 response through Year 5⁸

LASTING retention observed to Year 5 with Cosentyx³

Lasting retention: number of patients who responded to Cosentyx and stayed with Cosentyx to Year 5.³

SERENA is the largest prospective, longitudinal, non-interventional study with Cosentyx in adult patients with moderate to severe PsO, active PsA or active AS.^13,14

The primary objective 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.¹³

>2,900 patients 
treated with Cosentyx¹³

19 countries¹³

438
sites across Europe (including the UK), Israel and Russia^13,14

56% of patients who responded to Cosentyx, stayed on Cosentyx³

SERENA real-world data shows that 56% of patients with PsA who responded to Cosentyx* stayed on Cosentyx to Year 5 (n=522)³

Graphic featuring SERENA real-world data showing the proportion of patients with PsA that stay on Cosentyx for up to 5 years (n=522). 67.9% (n=328) of patients remained on Cosentyx at year 3 and 55.7% (n=123) at year 5

Based on Kiltz U, et al. 2024.³

Retention rates were analysed using Kaplan–Meier. 

*The study included patients aged ≥18 years who had received ≥16 weeks of treatment before enrolment.³

With Cosentyx, almost 1 in 2 biologic-naïve patients achieved completely clear skin (PASI 100) at Week 52 in EXCEED¹⁵

Graph showing the proportion of PASI 100 responders by week in patients with PsO vs. placebo.

Adapted from McInnes IB, et al. 2020¹⁵

Fast response seen as early as Week 12¹⁵

Data of randomised patients with PsO≥3% of BSA at baseline: 50% in the Cosentyx® group and 47% in the adalimumab group.¹⁵

Cosentyx® 300 mg is licensed for patients with PsA who have concomitant moderate to severe PsO or who are anti-TNF inadequate responders. For biologic-naïve patients with no or mild PsO, the recommended dose is 150 mg; based on clinical response, the dose can be increased to 300 mg.¹

Baseline PASI score: 10.6 and 10.0 in the Cosentyx and adalimumab groups, respectively.¹⁵

Multiple imputation was used for missing data.¹⁵

The superiority of Cosentyx vs adalimumab was not established for the primary endpoint, therefore key additional endpoints in the hierarchy were not formally tested for statistical significance.¹⁵

FAST and LASTING relief from axial symptoms with Cosentyx⁹

FAST: ASAS40 results seen as early as Week 12 in biologic-naïve patients.⁹
LASTING: ASAS40 results observed to be maintained through to Week 52.⁹

ASAS40 responders in biologic-naïve patients with axial PsA

Graph showing the proportion of ASAS40 responders by week in biologic-naïve patients with axial PsA vs. placebo.

Adapted from Novartis Data on File. 2020.¹⁶

Data from Weeks 12 to 52 are as observed. There is no placebo comparator at Week 52.⁹
MAXIMISE: The primary endpoint (ASAS20 response at Week 12) was met (63% vs 31% for Cosentyx 300 mg vs placebo, respectively; p<0.0001).⁹
ASAS20 and ASAS40 were pre-specified exploratory endpoints at Week 12. No clinical or statistical conclusions can be drawn. 83% and 86% of patients completed the trial in the 300 mg and 150 mg groups, respectively.⁹

Find out more about Cosentyx in eligible patients with axSpA

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Compared with TNF inhibitors, Cosentyx can be used in a broader range of patients^1,17,18

Table showing considerations for choice of therapy and suitability for patients with PsA for Cosentyx, adalimumab and etaneroept.

Efficacy in axSpA

Dosing

Mechanism of action

Safety profile

Resources

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

*Patients had already received at least 16 weeks of Cosentyx prior to enrolment of study.³
^†ULTIMATE: Observed data in biologic-naïve patients with PsA receiving Cosentyx 300 mg or 150 mg who were originally randomly assigned to Cosentyx (n=83).¹⁰
^‡FUTURE 2: Observed data for the 150-mg treatment group of biologic-naïve patients with PsO affecting 3% or more of body surface area at baseline including those originally randomly assigned to Cosentyx and placebo-switchers (n=42); 64% in the respective 300-mg group maintained PASI 90 through Year 5 (n=28).⁷
^§TRANSFIGURE: Observed data in patients with moderate to severe nail PsO in the Cosentyx 300 mg treatment group (n=66; NRI; observed data).¹¹
^¶MAXIMISE: Observed data in biologic-naïve patients with PsA in the Cosentyx 300 mg treatment group (n=139); in the respective Cosentyx 150 mg treatment group, 65% achieved ASAS40 at Year 1 (n=141).⁹
^||FUTURE 2: Observed data for the Cosentyx 300 mg treatment group of biologic-naïve patients with this symptom at baseline, including those originally randomly assigned to Cosentyx and placebo-switchers (n=31); 86% in the respective Cosentyx 150 mg group maintained complete resolution of dactylitis through Year 5 (n=22).⁷
**FUTURE 2: Observed data for the Cosentyx 300 mg treatment group of biologic-naïve patients with this symptom at baseline, including those originally randomly assigned to Cosentyx and placebo-switchers (n=36); 76% in the respective Cosentyx 150 mg group maintained complete resolution of enthesitis through Year 5 (n=45).⁷

ACR, American College of Rheumatology; AS, ankylosing spondylitis; ASAS, Assessment of Spondyloarthritis international Society; axSpA, axial spondyloarthritis; BSA, body surface area; CNS, central nervous system; ERA, enthesitis-related arthritis; HS, hidradenitis suppurativa; JPsA, juvenile psoriatic arthritis; MTX, methotrexate; nr-axSpA, non-radiographic axial spondyloarthritis; NRI, non-responder imputation; PsA, psoriatic arthritis; PsO, plaque psoriasis; SC, subcutaneous; SmPC, summary of product characteristics; TNFi-IR, tumour necrosis factor inhibitor-inadequate responder.

References

Cosentyx® (secukinumab) Summary of Product Characteristics. Available at: www.medicines.ie.
Mease PJ, et al. RMD Open 2021;7(2):e001600.
Kiltz U, et al. Abstract 1840456. American College of Rheumatology (ACR) Convergence. 14–19 November 2024; Washington, DC, US.
Mease P, et al. Ann Rheum Dis 2018;77(6):890–897.
Deodhar A, et al. Arthritis Res Ther 2019;21(1):111.
Baraliakos X, et al. Ann Rheum Dis 2020;0:1–9.
McInnes IB, et al. Lancet Rheumatol 2020;2(4):e227-e235 and supplementary appendix.
Mease PJ, et al. ACR Open Rheumatol 2020;2(1):18–25.
Baraliakos X, et al. Ann Rheum Dis 2021;80(5):582–590.
D’Agostino MA, et al. Semin Arthritis Rheum 2023;63:152259 and supplementary appendix.
Reich K, et al. Br J Dermatol 2021;184(3):425–436.
Sigurgeirsson B, et al. Dermatol Ther 2022;35(3):e15285.
Kiltz U, et al. Adv Ther 2020;37(6):2865–2883.
Kiltz U, et al. Rheumatol Ther 2022;9(4):1129–1142.
McInnes IB, et al. Lancet. 2020;395(10235):1496-1505.
Novartis Data on File. CAIN457F3302 (MAXIMISE) Clinical Study Report. August 2020.
Adalimumab Summary of Product Characteristics Available at: www.medicines.ie.
Etanercept Summary of Product Characteristics. Available at: www.medicines.ie.

IE11481268 | March 2026

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Cosentyx® (secukinumab): Efficacy in psoriatic arthritis (PsA)

Cosentyx helps to reduce the risk of irreversible joint damage progression²

patients with PsO developed PsA after Cosentyx treatment at Year 5 in the SERENA real-world study*³

Cosentyx delivers a consistent safety profile^1,5