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 adults (alone or in combination with methotrexate [MTX]) who have responded inadequately to disease-modifying anti-rheumatic drug therapy; 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.1
Full indications for Cosentyx can be found here
Please refer to the Summary of Product Characteristics (SmPC) for further information. The GB SmPC can be found here, and the NI SmPC can be found here.
A consistent safety profile with over 8 years of real-world evidence (RWE)
Cosentyx offers a consistent, generally well-tolerated safety profile across all indications2–5
No new safety signals in clinical trials, including those for paediatric patients with PsO (n=162) and juvenile idiopathic arthritis (JIA) (n=86) as young as 6 years of age1
No trend towards increased rates of major adverse cardiovascular event (MACE) or malignancy reported in clinical trials or RWE*6
No discontinuations due to Candida infections, with all being non-serious and mild to moderate in severity, except four cases in the PsO pool that were considered severe6
No warnings in SmPC about venous thromboembolism, blood clots, stroke, cancer or death1
<1% of patients had immunogenicity over 5 years†7
No lab monitoring required for neutropenia, lymphopenia, anaemia, lipids or liver enzyme elevations1
No warning in SmPC about use in patients with a history of smoking1
Please read full warnings and precautions (found in the SmPC) when prescribing Cosentyx.
Download a summary of the Cosentyx safety profile here
Summary from clinical trials and post-marketing experience1
Adapted from Cosentyx SmPC. Please refer to the SmPC for full information on adverse events.
RWE shows a consistent safety profile over 6 years§8
No trend toward increased adverse event (AE) rates over time (pooled AS, PsA, plaque PsO in a Periodic Safety Update Report [PSUR], including exposure in clinical trials and marketing experience)8
No trend towards increased rates of malignancy, MACE or IBD over time8
Cosentyx safety considerations1
Cosentyx is contraindicated in:
- Patients with hypersensitivity to active substance or to any of the excipients
- Clinically important, active infection, e.g., active tuberculosis
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.
Cases of new or exacerbations of inflammatory bowel disease have been reported with Cosentyx. Cosentyx is not recommended in patients with IBD. If a patient develops signs or symptoms of IBD or experiences an exacerbation of pre-existing IBD, Cosentyx should be discontinued and appropriate medical management should be initiated.
Cosentyx has the potential to increase the risk of infections. Serious infections have been observed in patients receiving Cosentyx in the post-marketing setting. Caution should be exercised when considering the use of Cosentyx in patients with a chronic infection or a history of recurrent infection. Please see the SmPC for the full information.
If an anaphylactic or other serious allergic reaction occurs, administration of Cosentyx should be discontinued immediately and appropriate therapy initiated.
The removable needle cap of Cosentyx 150 mg in pre-filled syringe and 150 mg pre-filled pen contains a derivative of natural rubber (latex). Use in latex-sensitive individuals has not been studied and there is therefore a potential risk of hypersensitivity reactions which cannot be completely ruled out.
Women of childbearing potential should use an effective method of contraception during treatment and for at least 20 weeks after treatment. As a precautionary measure, it is preferable to avoid the use of Cosentyx during pregnancy. Because of the potential for adverse reactions in nursing infants from Cosentyx, a decision on whether to discontinue breastfeeding during treatment and up to 20 weeks after treatment, or to discontinue therapy with Cosentyx, must be made, taking into account the benefit of breastfeeding to the child and the benefit of therapy to the woman.
Live vaccinations should not be given concurrently with Cosentyx.
Cosentyx was administered concomitantly with MTX, sulfasalazine and/or corticosteroids in arthritis studies (including in patients with PsA and AS). Caution should be exercised when considering concomitant use of other immunosuppressants and secukinumab.
Please refer to the SmPC for detailed safety data and full prescribing and administration information, including dosing in special populations and warnings/precautions.
Full indications
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
*The pooled clinical trial safety data for Cosentyx involved 7, 300+ patients and 21 randomised controlled clinical trials, including long-term exposure of up to 5 years in PsO and PsA and up to 4 years in AS. The post-marketing data are from the Cosentyx PSUR submitted to global health authorities.6
†Data are for patients with PsO.7
‡Cases were reported in patients with PsO diagnosis.1
§Successive time periods of PSUR shown with cumulative rate: 26 Dec 2014 to 25 Dec 2015; 26 Dec 2015 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 2020.8
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; MACE, major adverse cardiovascular event; MTX, methotrexate; nr-axSpA, non-radiographic axial spondyloarthritis; PsA, psoriatic arthritis; PsO, psoriasis; PSUR, periodic safety update report; PY, patient-years; RWE, real world evidence; SmPC, Summary of Product Characteristics.
References
- Cosentyx (secukinumab) Summary of Product Characteristics.
- Baraliakos X, et al. RMD Open 2019;5(2):e001005.
- Marzo-Ortega H, et al. Ann Rheum Dis 2019;78(suppl 2):873. Abstract FRI0379.
- Mease PJ, et al. ACR Open Rheumatol 2020;2(1):18–25.
- McInnes IB, et al. Lancet Rheumatol 2020;2(4):e227–e235.
- Deodhar A, et al. Arthritis Res Ther 2019;21(1):111.
- Reich K, et al. J Eur Acad Dermatol Venereol 2019;33(9):1733–1741.
- Novartis data on file. Cosentyx PSUR; 26 December 2019–25 December 2020. 22 February 2021.