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Cosentyx® (secukinumab): Safety profile and side effects
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; 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 or older (alone or in combination with MTX) whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.1,2
A consistent safety profile with over 8 years of real-world evidence (RWE) across indications
Cosentyx offers a consistent, generally well-tolerated safety profile across all indications3–6
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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 age1,2
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No trend towards increased rates of major adverse cardiovascular event (MACE) or malignancy reported in clinical trials or RWE*7
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No discontinuations in pooled clinical trial data and RWE 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 severe7
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<1% of patients with PsO had immunogenicity over 5 years8
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No lab monitoring required for neutropenia, lymphopenia, anaemia, lipids1,2
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No warning in SmPC about use in patients with a history of smoking1,2
Please read full warnings and precautions (found in the SmPC) when prescribing Cosentyx.
Learn more about the safety profile of Cosentyx in our summary
Summary from clinical trials and post-marketing experience1,2
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Adapted from Cosentyx SmPC. Please refer to the SmPC for full information on adverse events.
Clinical trials and RWE show a consistent safety profile over 6 years‡9
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)9
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Adapted from Cosentyx PSUR 2021.9
No trend towards increased rates of malignancy, MACE or IBD over time9
Safety considerations1,2
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Cosentyx is contraindicated in:
Patients with hypersensitivity to active substance or to any of the excipients
Clinically important, active infection, e.g., active tuberculosis
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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.
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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.
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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.
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If an anaphylactic or other serious allergic reaction occurs, administration of Cosentyx should be discontinued immediately and appropriate therapy initiated.
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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.
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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.
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Live vaccinations should not be given concurrently with Cosentyx. Please see the SmPC for full information regarding vaccinations.
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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.
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Please refer to the SmPC for detailed safety data and full prescribing and administration information, including dosing in special populations and warnings/precautions.
Therapeutic Indications1,2
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 nonradiographic 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.1,2
*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.7
†Cases were reported in patients with PsO diagnosis.1,2
‡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 2020.9
AE, adverse event; AS, ankylosing spondylitis; axSpA, axial spondyloarthritis; EAIR, exposure-adjusted incidence rate; ERA, enthesitis-related arthritis; HS, hidradenitis suppurativa; IBD, inflammatory bowel disease; JIA, juvenile idiopathic arthritis; JPsA, juvenile psoriatic 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) GB Summary of Product Characteristics.
Cosentyx® (secukinumab) NI 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.
UK | October 2024 | 449397
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.
