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Cosentyx is indicated for the treatment of active moderate to severe hidradenitis suppurativa (HS; acne inversa) 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
The recommended dose is 300 mg of Cosentyx by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3, and 4, followed by monthly maintenance dosing. Based on clinical response, the maintenance dose can be increased to 300 mg every 2 weeks. Each 300 mg dose is given as one subcutaneous injection of 300 mg or as two subcutaneous injections of 150 mg.1
The chronic, unpredictable nature of HS means even those living with mild HS can suffer significant pain and impairment, which can have a large psychological impact on patients’ lives.2
9 out of 10 patients with HS suffer from pain, interfering with their daily activities (N=1299)3
~40% feel ‘very much/extremely’ embarrassed by their condition (N=1299)3
> 1 in 3 patients report having anxiety or depression, or both (N=1299)3
HS is a skin disease characterised by recurring, painful inflamed nodules, abscesses, tunnelling and scarring. Those with HS experience chronic, painful lesions in sensitive areas.4
SUNSHINE (N=541) and SUNRISE (N=543) were randomised, double-blinded, placebo-controlled Phase III studies assessing the efficacy, safety and tolerability of Cosentyx in patients with moderate to severe HS.4
Observed DLQI response in SUNSHINE and SUNRISE
(exploratory endpoint; no statistical testing)
Adapted from Kimball A, et al. 2023.4
Patients achieve QoL improvement by Week 52 vs placebo4
QoL improvement (exploratory endpoint) was defined as a ≥5-point reduction in dermatology life quality index (DLQI) score from baseline. Improvements in DLQI response rates were observed once patients originally assigned to the placebo group were reassigned to receive Cosentyx 300 mg. Not tested for significance.4
In SUNSHINE, Week 16 DLQI responder rates (observed data; no statistical testing) were 47.8% (n=64/134) for Cosentyx Q2W and 48.4% (n=62/128) for Cosentyx Q4W groups vs 28.9% (n=39/128) for placebo. In SUNRISE, rates were 37.5% (n=54/144) for Cosentyx Q2W and 47.2% (n=67/142) for Cosentyx Q4W groups vs 31.7% (n=46/145) for placebo.4
In SUNSHINE, QoL results at Week 52 for both dosing regimens (observed data; no statistical testing) were 51% (n=96) for Cosentyx Q2W and 48.1% (n=97) for Cosentyx Q4W groups. In SUNRISE rates were 55.2% (n=16) for Cosentyx Q2W and 47.5% (n=101) for Cosentyx Q4W groups.4
For more information on the study design of SUNSHINE & SUNRISE, please see below.
In the SUNSHINE and SUNRISE clinical trials, the primary endpoint of HiSCR50 (decrease in abscess and inflammatory nodule count by ≥50% with no increase in the number of abscesses or draining fistulae compared with baseline) was met in SUNSHINE for Cosentyx 300 mg Q2W (n=181) vs placebo (n=180) (45% vs 34%, respectively; p=0.007) but not met for Cosentyx 300 mg Q4W group (n=180) vs placebo group (n=180) (42% vs 34%, respectively; p=0.042). In SUNRISE, the primary endpoint was met for Cosentyx 300 mg Q2W group (n=180) vs placebo (n=183) (42% vs 31%, respectively; p=0.015) and Cosentyx 300 mg Q4W group vs placebo (46% vs 31%, respectively; p=0.0022). Clinical response was sustained to Week 52 in both trials.4
The most frequently reported adverse reactions with Cosentyx are upper respiratory tract infections (17.1%), most frequently nasopharyngitis, rhinitis.1
Please refer to the Cosentyx SmPC for detailed safety data and full prescribing and administration information.1
SUNSHINE and SUNRISE were randomised, double-blinded, placebo-controlled Phase III studies assessing the efficacy, safety and tolerability of Cosentyx in patients with moderate to severe HS.4
Patients randomised to Cosentyx received 300 mg subcutaneously 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.4
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.
AS, ankylosing spondylitis; DLQI, Dermatology Life Quality Index; ERA, enthesitis-related arthritis; HiSCR50, hidradenitis suppurativa clinical response 50% reduction from baseline; HS, hidradenitis suppurativa; JPsA, juvenile psoriatic arthritis; MTX, methotrexate; nr-axSpA, non-radiographic axial spondyloarthritis; PsA, psoriatic arthritis; PsO, plaque psoriasis; Q2W, every 2 weeks; Q4W, every 4 weeks; QoL, quality of life; SmPC, summary of product characteristics.
References
Cosentyx® (secukinumab) Summary of Product Characteristics.
Van der Zee HH, et al. Br J Dermatol 2022;186(2):355–356.
Garg A, et al. J Am Acad Dermatol 2020;82(2):366–376.
Kimball A, et al. Lancet 2023;401(10378):747–761; and supplementary appendix.
UK | January 2025 | FA-11252569
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.
