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Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active enthesitis-related arthritis (ERA) in patients 6 years and older 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
Click on the arrows for supporting data
Click this link for more information on the safety profile of Cosentyx.
*JUNIPERA was a Phase III, double-blind, placebo-controlled, randomised withdrawal study in biologic-naïve paediatric ERA and JPsA patients with active disease (N=86). Patients received Cosentyx 75/150 mg depending on weight <50/≥50 kg respectively, at baseline and Weeks 1, 2, 3 and 4 and then every 4 weeks until Week 100. The primary endpoint was the time to disease flare§ with Cosentyx vs placebo in TP2. Key secondary endpoints included JIA ACR20/50/70/90/100 responses, inactive disease status, JIA ACR CRVs, JADAS-27-C reactive protein and total enthesitis and dactylitis counts. Safety profile analysis was calculated for the entire study period in the overall population. In Treatment Period 1, all patients received open-label treatment with Cosentyx until Week 12. In Treatment Period 2, JIA ACR30 responders at Week 12 were randomised 1:1 to continue Cosentyx or begin placebo in the double-blind period up to Week 100. Patients who experienced a flare received open-label Cosentyx up to Week 104 (Treatment Period 3).4
Therapeutic Indications1
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
†In Treatment Period 1, all patients received Cosentyx until Week 12. Key secondary endpoints included ACR 30/50/70/90 and 100. At Week 1, 33.7%, 22.1%, 8.1%, 2.3% and 1.2% of children with JIA were JIA ACR 30, 50, 70, 90 and 100 responders, respectively.4 At Week 12, 87%, 84%, 67%, 38% and 24% of children with JIA were JIA-ACR 30, 50, 70, 90 and 100 responders, respectively. A total of 34.9% of patients with JIA reached inactive disease status at Week 12.4
‡The JIA ACR30/50/70/90/100 response as per the JIA-ACR response criteria is defined as 30/50/70/90/100% improvement in three or more of six CRVs, with no more than one of the remaining CRVs worsening by >30%.1
§Disease flare was defined as ≥30% worsening from baseline in ≥3 of the 6 JIA ACR response criteria, >30% improvement relative to the end of Week 12.4
ACR, American College of Rheumatology; AS, ankylosing spondylitis; axSpA, axial spondyloarthritis; CI, confidence interval; CRP, C-reactive protein; CRV, core set variable; DMARD, disease modifying anti-rheumatic drug; ERA, enthesitis-related arthritis; HR, hazard ratio; IL-17A, interleukin 17A; JADAS, juvenile arthritis disease activity score; JIA, juvenile idiopathic arthritis; JPsA, juvenile psoriatic arthritis; MoA, mechanism of action; MRI, magnetic resonance imaging; MTX, methotrexate; nr-axSpA, non-radiographic axial spondyloarthritis; NSAID, non-steroidal anti-inflammatory drug; PsA, psoriatic arthritis; PsO, plaque psoriasis; TP2, Treatment Period 2.
References
Cosentyx® (secukinumab) Summary of Product Characteristics.
Taltz (ixekizumab) Summary of Product Characteristics.
Bimzelx (bimekizumab) Summary of Product Characteristics.
Brunner HI, et al. Ann Rheum Dis 2022;82:154–160.
Paroli M, et al. Medicina 2022;58:1552.
Tsukazaki H, et al. Int J Mol Sci 2020;21:6401.
Novartis Data on File. CAIN457F2304. Data Analysis Report. January 2022.
UK | January 2025 | FA-11313556
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.
