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Cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy.1
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.1
Information on the Cosentyx safety profile may be found on the Safety profile page of this website and in the Cosentyx Summary of Product Characteristics.1
This image does not depict a real patient. For illustrative purposes only.
The primary endpoint for both SUNSHINE and SUNRISE studies (SUNNY clinical trial programme) in adult patients with moderate to severe HS was clinical response (HiSCR), defined as a decrease in abscess and inflammatory nodule count by 50% or more with no increase in the number of abscesses or draining fistulae compared with baseline, of Cosentyx versus placebo at Week 16, assessed in the overall population. The primary endpoint was met for Cosentyx 300 mg Q2W in both SUNRISE and SUNSHINE trials (p=0.015 and p=0.007 respectively) and was met for Cosentyx 300 mg Q4W in SUNRISE (p=0.002), but not SUNSHINE. Clinical response was sustained to Week 52 in both trials. Quality of life assessments included NRS30 at Week 16 (pooled data, secondary endpoint) in patients with a baseline rating scale of 3 or more and DLQI (observed data, predefined exploratory endpoint). The proportion of patients with an NRS30 score, defined as ≥30% reduction in patient-reported skin pain and at least a 2-unit reduction from baseline, was significantly higher in Cosentyx 300 mg Q2W and numerically higher in Q4W groups vs placebo at Week 16, with improvements up to Week 52. Cosentyx patients had higher DLQI response rates (improvement by 5 points or more from baseline) at Week 16 vs patients receiving placebo, which was maintained out to Week 52.2
Fast and lasting response in key HS symptoms, including pain and flares (secondary endpoints)2
Flares, a secondary endpoint, are defined as a ≥25% increase in AN count with a minimum increase of 2 in absolute AN count relative to baseline. Significantly fewer patients had flares in the Cosentyx 300 mg Q2W group vs placebo in the SUNSHINE trial (15% of 181 patients vs 29% of 180 patients; p=0.0010) at Week 16. There was no significant difference in the SUNRISE trial. Conversely, in the SUNRISE trial, significantly fewer patients reported flares in the Cosentyx 300 mg Q4W group vs placebo (16% of 180 patients vs 27% of 183 patients; p=0.0049) at Week 16. There was no significant difference in the SUNSHINE trial. Pooled data (observed, no statistical analysis performed) showed a reduction of flares through Week 52 vs placebo.2
QoL improvements seen at Week 16 and sustained through Week 52 in patients with HS vs placebo (predefined exploratory endpoint; based on observed data)2
Cosentyx improved patients’ HRQoL up to 52 weeks in both the SUNSHINE and SUNRISE trials, as assessed by the DLQI response rate (decrease of five points or more from baseline). In the SUNSHINE trial, both the Cosentyx 300 mg Q2W (48%; n=64/134) and Cosentyx 300 mg Q4W (48%; n=62/128) groups had higher DLQI responder rates than the placebo group (29%; n=37/128) at week 16. Likewise, in the SUNRISE trial a higher proportion of patients in the Cosentyx 300 mg Q2W (38%; n=54/144) and Cosentyx 300 mg Q4W groups (67 [47%] of 142 patients) had higher DLQI responder rates than in the placebo group (32%; n=46/145) at Week 16. The differences in both trials were sustained up to Week 52. In addition, improvements in DLQI response rates were observed once patients originally assigned to the placebo group were reassigned to receive Cosentyx 300 mg.2
Consistent safety profile with over 8 years experience, across indications1
Fast response is defined as HiSCR response seen at Week 16.2
Long-lasting response is defined as a reduction in key HS symptoms maintained up to 52 weeks (observed data).2
The most frequently reported adverse reactions are upper respiratory tract infections (17.1%) (most frequently nasopharyngitis, rhinitis). Please refer to the SmPC for more information.1
Please refer to the Cosentyx SmPC for full product information and administration, including dosing in special populations, before prescribing.1
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 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.
SUNSHINE (N=541) and SUNRISE (N=543): Two randomised, double-blind, multicentre, Phase III trials in patients with moderate-to-severe HS were designed to assess efficacy, safety and tolerability of two Cosentyx SC dose regimens at Week 16 (short-term) and up to Week 52 (long- term). Patients were randomised to Cosentyx received 300 mg SC at Weeks 0, 1, 2, 3 and 4, followed by 300 mg every 2 weeks (Q2W; n=361) or every 4 weeks (Q4W; n=360). At Week 16, patients who were randomised to placebo were reassigned to receive Cosentyx 300 mg at Weeks 16, 17, 18, 19 and 20, followed by either Cosentyx 300 mg Q2W or Cosentyx 300 mg Q4W.2
AN, abscess and inflammatory nodule count; AS, ankylosing spondylitis; CI, confidence interval; DLQI, dermatology life quality index; ERA, enthesitis-related arthritis; HiSCR, hidradenitis suppurativa clinical response; HS, hidradenitis suppurativa; JPsA, juvenile psoriatic arthritis; MTX, methotrexate; nr-axSpA, non-radiographic axial spondyloarthritis; NICE, National Institute for Health and Care Excellence; NRS, numeric rating scale; PsA, psoriatic arthritis; PsO, plaque psoriasis; Q2W, every 2 weeks; Q4W, every 4 weeks; QoL, quality of life; SC, subcutaneous; SmPC, summary of product characteristics.
References
Cosentyx® (secukinumab) Summary of Product Characteristics.
Kimball A, et al. Lancet 2023;401(10378):747–761 and supplementary appendix.
National Institute for Health and Care Excellence. Secukinumab for treating moderate to severe hidradenitis suppurativa [TA935]. Available at: https://www.nice.org.uk/guidance/TA935 [Accessed January 2025].
UK | January 2025 | FA-11252340
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.
