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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 the Cosentyx Summary of Product Characteristics.1
The efficacy and safety profile of Cosentyx in HS have been studied in two key Phase III clinical trials: SUNSHINE and SUNRISE.2 These were part of the SUNNY Phase III clinical trial program that included 1084 adult patients.2
Explore the data across the key HS domains in the sections below.
Fast relief is defined as HiSCR50 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
Key symptoms of HS are abscesses, inflammatory nodules, flares, pain and tunnels/fistulae.3
of patients achieved HiSCR50 in both trials by Week 16 (primary endpoint)2
of patients achieved HiSCR50 in both trials by Week 52 (exploratory endpoint, observed data)2
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 for Cosentyx 300 mg Q2W vs placebo in both SUNSHINE and SUNRISE trials (p=0.007 and p=0.015 respectively), and for Cosentyx 300 mg Q4W vs placebo in SUNRISE (p=0.002) but not in SUNSHINE.2
Adapted from Kimball A, et al. 2023.4
Data for baseline to Week 16 are based on the primary/secondary estimand and multiple imputation from Week 16. Data for Weeks 18 to 52 are based on observed data after the database lock with no statistical testing.2
Reduction in pain, a secondary endpoint, was defined as an achievement of NRS30 in HS-related skin pain among patients with baseline NRS equal to or more than 3.2
NRS30 was reported using pooled data from both trials, as predefined.2
SUNRISE and SUNSHINE pooled data
FAST: Reduced pain by Week 16 (observed, with no statistical testing)
In Cosentyx patients across SUNRISE & SUNSHINE (Q2W and Q4W groups):2
Q2W: 37% (n=266) in the Cosentyx arm had achieved NRS30 response at Week 16 vs 23% (n=251) in the placebo arm (p=0.0003).2
Q4W: There was no significant difference for the Q4W group vs placebo.2
LASTING: Reduced pain lasted through to Year 1 (observed, with no statistical testing)
Of Cosentyx patients who started with moderate or severe pain:*
had mild or no pain at Week 52.5
Q2W: Out of those patients who started with moderate or severe pain, 65% (n=95) in the Cosentyx arm had mild or no pain.5
Flares, a secondary endpoint, was defined as at least a 25% increase in AN count with a minimum increase of 2 in absolute AN count relative to baseline.2
FAST: Proportion of flare-free patients at Week 16
(pooled data; observed, with no statistical testing)
Q2W: Observed data from full analysis set. 82.3% (n=361) in the Cosentyx arm were flare-free at Week 16 vs 72.0% (n=363) in the placebo arm.2
LASTING: Proportion of flare-free patients at Week 52
(pooled data; observed, with no statistical testing)
Q2W: Observed data from full analysis set. 79.6% (n=361) in the Cosentyx arm were flare-free at Week 52.2
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.2
Tunnels, an element of the prespecified primary endpoint, are also called fistulae or sinus tracts and are defined as raised, tender but fluctuating longitudinal tunnels of variable length and depth, with communications to skin surface, with purulent discharge.2
Proportion of patients with no increase in draining tunnels from baseline at Week 526
(Pooled data; observed)
Observed data from full analysis set (post-hoc analysis). No formal testing comparing Cosentyx and placebo was conducted for draining tunnels at Week 52.6
Fast improvements is defined as a reduction in AN count at Week 16.2
Lasting rates is defined as a reduction in AN count maintained up to 52 weeks (observed data).2
A secondary endpoint in the SUNSHINE and SUNRISE clinical trials was the mean percentage change from baseline in abscess and inflammatory nodule count at Week 16.2
Cosentyx 300 mg Q2W was superior to placebo at reducing abscesses and inflammatory nodules at Week 16 in both SUNSHINE (p<0.0001) and SUNRISE (p=0.0051), and Cosentyx 300 mg Q4W was superior to placebo in the SUNRISE trial (p=0.0001) but not in SUNSHINE.2
Adapted from Kimball A, et al. 2023.2
Data for baseline to Week 16 are based on the primary/secondary estimand and multiple imputation from Week 16. Data for Weeks 18 to 52 are based on observed data after the database lock with no statistical testing.2
In the SUNSHINE and SUNRISE clinical trials, AN50 was assessed as a prespecified exploratory endpoint, defined as a ≥50% decrease from baseline in the number of abscesses and inflammatory nodules.2
of patients originally assigned to Cosentyx achieved AN50 at Week 52 in both trials2
Adapted from Kimball A, et al. 2023.2
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.2
Patients were 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.2
The most frequently reported adverse reactions 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
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.
AN50, decrease in abscess and inflammatory nodule count by 50%; AS, ankylosing spondylitis; CFB, change from baseline; 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; NRS, numeric rating scale; PsA, psoriatic arthritis; PsO, plaque psoriasis; Q2W, every 2 weeks; Q4W, every 4 weeks; 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.
Vinkel C & Thomsen SF. J Clin Aesthet Dermatol 2018;11(10):17–23.
Kimball A, et al. Poster presented at the American Academy of Dermatology (AAD) 2023, March 17–21, New Orleans, USA.
Novartis Data on File. SUNNY Clinical Study Program post-hoc analysis of skin pain severity.
Bechara FG, et al. P144. Poster presented at the European Hidradenitis Suppurativa Foundation e.V. (EHSF); February 8–10, 2023; Florence, Italy.
UK | February 2025 | FA-11252445
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