Cosentyx® (secukinumab) heritage
Cosentyx® (secukinumab) 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 moderate to severe hidradenitis suppurativa (HS; acne inversa) in adults with an inadequate response to conventional systemic HS therapy.1,2
The Cosentyx legacy
patients treated globally and counting, across indications3
150+
clinical trials across indications*4
8 years
of real-world experience, worldwide across indications5
8
indications1,2
Cosentyx has 5-years of a consistent safety profile across 24 studies in PsO and PsA6
Confidence to prescribe Cosentyx to your eligible patients – Cosentyx real-world evidence (RWE)
RWE shows a consistent safety profile with long-term use of Cosentyx over 6 years7
Please refer to the Cosentyx Summary of Product Characteristics (SmPC) for full safety information, and the safety profile page here.
No trend towards increased AE rates over time (pooled AS, PsA, PsO):7
<1% incidence rate of IBD, which is within expected background incidence rate (per 100 PY).6
For further adverse events, please refer to the Cosentyx SmPC.
No new safety signals in clinical trials, including those for paediatric juvenile idiopathic arthritis (JIA, n=81) and PsO (n=162) patients as young as 6 years old†1,2,4
No new safety signals have been identified in more than 680,000 PY across AS, PsA and PsO indications7
No trend towards increased rates of major adverse cardiovascular events (MACE), or malignancy reported in clinical trials and RWE‡7,8
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 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.1,2
*Not limited to licensed indications.
†In paediatric PsO, JPsA and ERA.
‡The pooled clinical trial safety data for Cosentyx involved 7300+ 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 Periodic Safety Update Report (PSUR) submitted to global health authorities.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; JPsA, juvenile psoriatic arthritis; MACE, major adverse cardiovascular event; MTX, methotrexate; PsA, psoriatic arthritis; PsO, psoriasis; PSUR, Periodic Safety Update Report; PY, patient-years; RWE, real-world evidence.
References
Cosentyx® (secukinumab) GB Summary of Product Characteristics.
Cosentyx® (secukinumab) NI Summary of Product Characteristics
Novartis Data on File. Secukinumab (Sec008). February 2023.
ClinicalTrials.gov. Search results for ‘secukinumab’, completed, terminated and active, not recruiting trials. Available at: https://clinicaltrials.gov/search?term=Secukinumab,&aggFilters=status:com [Accessed July 2024].
European Medicines Agency. European public assessment report. Medicine overview. Cosentyx (secukinumab). https://www.ema.europa.eu/en/documents/overview/cosentyx-epar-medicine-o.... [Accessed July 2024].
Gottlieb AB, et al. Acta Derm Venereol 2022;102:adv00698.
Novartis data on file. Cosentyx PSUR; 26 December 2019–25 December 2020. February 2021.
Deodhar A et al. Arthritis Res Ther 2019;21(1):111.
UK | October 2024 | 451965
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.