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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.2
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.2
In Ireland Cosentyx is reimbursed for the following indications: adult plaque psoriasis (PsO); psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA).
Information on the Cosentyx safety profile may be found on the safety profile page of this website and the Cosentyx Summary of Product Characteristics (SmPC).2
Cosentyx has a well-established efficacy profile characterised by fast and lasting efficacy, a long-term proven safety profile and demonstrated retention rates at 5 years:2–5
FAST and LASTING efficacy for PsO patients with concomitant PsA†3
Consistent safety profile with over 8 years’ experience across licensed indications2,4
Cosentyx retention rates remained high throughout the SERENA study, starting from 88.5% at Year 1 to 58.5% at Year 5‡5
FAST = efficacy at 12 weeks; LASTING = efficacy at 52 weeks.3
FAST = efficacy at 12 weeks3
Results from the CLEAR study.§8
Actual photos taken of a Cosentyx patient by investigators during clinical trials. Individual patient responses may vary.
LASTING = efficacy at 52 weeks7
Head-to-head results.8
Starting at Week 4 and lasting through Year 1, each dose of Cosentyx 300 mg resulted in a statistically significant improvement in PASI 100 response rates compared with ustekinumab 45 mg or 90 mg.7
Adapted from Blauvelt A, et al. 2017.7
LASTING = efficacy at 52 weeks3
PsO | PsA | |
Most common AEs, IR (95% CI) | ||
Nasopharyngitis | 22.6 | 11.6 |
Headache | 7.3 | 3.8 |
Diarrhoea | 4.2 | 3.9 |
Upper respiratory tract infection | 5.3 | 8.8 |
AEs of special interest, IR (95% CI) | ||
Serious injections‡‡ | 1.4 | 1.8 |
Candida infections§§ | 2.9 | 1.5 |
Opportunistic infections¶¶ | 0.19 | 0.18 |
Inflammatory bowel disease‖‖ | 0.01 | 0.03 |
Crohn’s disease‖‖ | 0.1 | 0.1 |
Ulcerative colitis‖‖ | 0.1 | 0.1 |
Major adverse cardiovascular event*** | 0.4 | 0.4 |
Uveitis‖‖ | 0.01 | 0.1 |
Malignancy††† | 0.9 | 1.0 |
Adapted from Gottlieb AB, et al. 2022.18
Treatment discontinuation with TNF inhibitors (TNFis) is common over time.20–22 Up to 50 out of every 100 who start TNFi for PsO or psoriatic disease stop within 3 years of treatment initiation due to lack or loss of effectiveness.20–22
Response rate may diminish with every cycle of biologic therapy23–25
Adapted from Glintborg B, et al. 2013.23
Retention rates over time with Cosentyx
Based on Augustin M, et al. 2024.12
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.2
*‘Patients’ refers to patients who have been prescribed Cosentyx for any indication since launch. Data as of 2025. Please note this is an estimated number.1
†MATURE: a 52-week, multicentre, randomised, double-blind, placebo-controlled Phase III trial (n=122). Co-primary endpoints were PASI 75 and IGA 0/1 response rates at Week 12 vs placebo. PASI 75 was met (95.1% for Cosentyx 300 mg vs 10% for placebo, p<0.0001). IGA mod 2011 0/1 was also met (75.6% for Cosentyx 300 mg vs 7.6% for placebo, p<0.0001). In the MATURE study, both co-primary endpoints and secondary endpoints were met. After Week 12, the response rates were similar and were sustained throughout 52 weeks.3
‡In the core SCULPTURE study, PASI 75 responders at Week 12 continued receiving subcutaneous Cosentyx until Year 1. Thereafter, patients (n=168) entered the extension phase and continued treatment as per the core trial. Treatment was double-blinded until the end of Year 3 and open-label from Year 4.5
§CLEAR: a 52-week, randomised, double-blind, active comparator, parallel-group, phase IIIb study (n=676). Patients (aged ≥18 years) with moderate to severe PsO were randomised 1:1 to receive 300 mg Cosentyx, at baseline and Weeks 1, 2, 3, and then every 4 Weeks from Week 4 to Week 48, or ustekinumab 45 mg or 90 mg at baseline and Week 4, then every 12 weeks from Week 16 to Week 40. The primary endpoint of PASI 90 was met at Week 16 with Cosentyx demonstrating superiority over ustekinumab (79.0% vs 57.6%, respectively; p<0.0001).8
¶FUTURE 5: a randomised, double-blind, placebo-controlled, parallel-group, phase III trial (n=996). Patients (aged ≥18 years) with moderate to severe PsA were randomised 2:2:2:3 to receive 300 mg Cosentyx or 150 mg loading dose (LD), 150 mg without LD or placebo at baseline, weeks 1, 2 and 3 and then every 4 weeks from Week 4. The primary endpoint of the proportion of patients achieving ACR20 at Week 16 was met with significantly more patients achieving an ACR20 response at Week 16 with 300 mg Cosentyx with LD (62.6%), 150 mg with LD (55.5%) or 150 mg without LD (59.5%) vs placebo (27.4%); p<0.0001.11
||SERENA: a large, ongoing, longitudinal, observational study of patients with moderate to severe PsO, PsA, and AS who has received at least 16 weeks of Cosentyx treatment before study enrolment. In an analysis of the 5-year data, the objective was to assess the long-term retention of Cosentyx treatment and the effectiveness of treatment in patients with PsO (n=1740).12
**Neither at every 8 weeks (guselkumab) nor at every 12 weeks (risankizumab) dosage.13,14
††Since first indication in 2015 for eligible adults with moderate to severe PsO.17
‡‡Rates for system organ class.18
§§Rates for high-level terms.18
¶¶Opportunistic infections were bronchopulmonary aspergillosis, cytomegalovirus gastroenteritis, gastrointestinal candidiasis, herpes zoster cutaneous disseminated, herpes zoster infection neurological, mycobacterium avium complex infection, oesophageal candidiasis, pneumocystis jirovecii pneumonia, toxoplasmosis, tuberculosis.18
‖‖Rates for preferred terms.18
***Rates for Novartis Medical Dictionary for Regulatory Activities (MedDRA) query terms.18
†††Rates for standardized MedDRA query terms – ‘malignancies and unspecified tumour’.18
‡‡‡The Getting it Right First Time (GIRFT) programme is a national NHS programme designed to improve the treatment and care of patients.25
ACR, American College of Rheumatology; AE, adverse event; AS, anklyosing spondylitis; axSpA, axial spondyloarthritis; EAIR, exposure-adjusted incidence rate; ERA, enthesitis-related arthritis; GIRFT, getting it right first time; HS, hidradenitis suppurativa; IL-23, interleukin 23; IR, incidence rate; JPsA, juvenile psoriatic arthritis; LD, loading dose; MedDRA, Medical Dictionary for Regulatory Activities; MTX, methotrexate; NAPSI, nail psoriasis severity index; nb-UVB, narrowband ultraviolet B; NHS, National Health Service; nr-axSpA, non-radiographic axial spondyloarthritis; PASI, psoriasis area and severity index; PsA, psoriatic arthritis; PsO, plaque psoriasis; PSSI, psoriasis scalp severity index; PY, patient-years; SmPC, summary of product characteristics; TNF, tumour necrosis factor.
References
Q2 2025 Novartis quarterly financial results. Condensed Interim Financial Report – Supplementary Data. Available at: https://www.novartis.com/investors/financial-data/quarterly-results. [Accessed March 2026].
Cosentyx® (secukinumab) Summary of Product Characteristics. Available at: www.medicines.ie.
Sigurgeirsson B, et al. Dermatol Ther 2022;35(3):e15285.
European Medicines Agency. Medicine overview. Cosentyx (secukinumab). Available at: https://www.ema.europa.eu/en/documents/overview/cosentyx-epar-medicine-overview_en.pdf [Accessed March 2026].
Augustin M, et al. Poster P62689. American Academy of Dermatology Congress. 7–11 March 2025, Orlando, Florida, US.
Iversen L, et al. J Eur Acad Dermatol Venereol 2023;37(5):1004–1016.
Blauvelt A, et al. J Am Acad Dermatol 2017;76(1):60–69.
Thaci S, et al. JAAD 2015;73(3):400–409.
Singh JA, et al. Arthritis Rheumatol 2019;71(1 ):5–32.
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Mease PJ et al. Ann Rheum Dis 2018;77(6):890–897.
Augustin M, et al. Poster P3355. European Academy of Dermatology and Venereology Congress. 25−28 September 2024, Amsterdam, Netherlands.
Tremfya (guselkumab) Summary of Product Characteristics. Available at: www.medicines.ie.
Skyrizi (risankizumab) Summary of Product Characteristics. Available at: www.medicines.ie.
Bagel J, et al. J Am Acad Dermatol 2017;77(4):667–674.
Reich K, et al. Br J Dermatol 2021 ;184(3):425–436.
European Medicines Agency. Summary of positive opinion EMA/CHMP/670/0627/2015. Available at: https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-cosentyx_en.pdf [Accessed March 2026].
Gottlieb AB, et al. Acta Derm Venereol 2022;102:adv00698.
NHS England. Getting It Right First Time (GIRFT). Available at: https://gettingitrightfirsttime.co.uk/ [Accessed March 2026].
Lin P-T, et al. Sci Rep 2018;8(1):16068.
Pina Vegas L, et al. JAMA Dermatol 2022;158(5):513–522.
Rusinol L, et al. Expert Rev Clin Immunol 2024;20(1):71–82.
Glintborg B, et al. Arthritis Rheumatol 2013;65(5):1213–1223.
Iskandar, et al. J Invest Dermatol 2018;138(4):775–784.
Gollins, et al. Skin Health Dis 2024;4(2):e350.
IE11481269 | March 2026