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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
Please refer to the Cosentyx Summary of Product Characteristics for full safety information, and the safety profile page here.
Artist’s representation of early radiographic damage.
Red flags indicating PsA risk include:
Artist’s representation of early radiographic damage.
FUTURE 5 was a 2-year, randomised, double-blind, placebo-controlled, parallel-group, Phase 3 study in patients with active PsA. The primary endpoint of proportion of patients achieving ACR20 response at Week 16 was met (Cosentyx 300 mg 62.6% vs placebo 27.4%, p<0.0001). The study included 996 patients with active PsA, 222 of whom were taking Cosentyx 300 mg. No structural progression responders are those subjects who have a change in van der Heijde modified total Sharp score relative to baseline of ≤0.5 during the analysis period.10
Observed and NRI endpoints; not statistically tested.
sustained reduction in mNAPSI at 2.5 years (observed; n=66)†,14,15
TRANSFIGURE: primary endpoint of percentage change from baseline in mean NAPSI score at Week 16 for Cosentyx 300 mg or 150 mg vs placebo was met (−45% for 300 mg, −38% for 150 mg vs −11% for placebo, p<0.001)
achieved ACR50 at Week 24
(NRI; n=81)II,16,17
ULTIMATE: primary endpoint of GLOESS score for Cosentyx vs placebo at Week 12 was met (−9 vs −6 respectively, p=0.004)
sustained complete resolution at Year 5 (observed; n=51)#,18,19
FUTURE 2: primary endpoint of ACR20 response at Week 24 for Cosentyx 300 mg or 150 mg vs placebo was met (54% in 300 mg; 51% in 150 mg; 15% in placebo; p<0.0001)
sustained PASI 100 at Year 1
(observed; n=41)‡,20
MATURE: co-primary endpoints of PASI 75 and IGA 0/1 mod 2011 at Week 12 for Cosentyx Al 300 mg vs placebo were met (95% vs 10% and 76% vs 8% respectively, p<0.0001)
• Scalp PsO 53% sustained PSSI 90 clearance at Week 12 (NRI; n=51)§,13
SCALP: primary endpoint of PSSI 90 response at Week 12 for Cosentyx 300 mg vs placebo was met (53% vs 2.0% respectively, p<0.001)
sustained ASAS40 at Year 1 (observed; n=139)¶,11
MAXIMISE: primary endpoint of ASAS20 response at Week 12 for Cosentyx 300 mg vs placebo was met (63% vs 31%, respectively, p<0.0001)
sustained complete resolution at Year 5 (observed; n=40)#,18,19
FUTURE 2: primary endpoint of ACR20 response at Week 24 for Cosentyx 300 mg or 150 mg vs placebo was met (54% in 300 mg; 51% in 150 mg; 15% in placebo; p<0.0001)
Rheumatological clinical societies and associations recommend IL-17 inhibitors:
✔ GRAPPA 2021 guidance strongly recommends an IL-17 inhibitor as a first-line biologic following inadequate response to DMARDs, across all 6 key manifestations of PsA21
✔ IL-17 inhibitors are recommended as a first-line biologic option by BSR for key manifestations of PsA22
Please note Cosentyx is recommended for patients with PsA when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Please see the SmPC for full information.1,2
✔ BAD recommends an IL-17 inhibitor as a first-line biologic for adult patients with PsO and PsA23
✔ Cosentyx is the first and only biologic with demonstrated efficacy in a clinical study designed to assess axial PsA as of July 202411
Cosentyx is only licensed in adults with PsA (alone or in combination with methotrexate) if there is an inadequate response to a previous DMARD1,2
In the MATURE clinical trial, results showed FAST and LONG-LASTING skin clearance with Cosentyx (FAST = efficacy at 12 weeks and LASTING = efficacy at 52 weeks).20
PASI 100 skin clearance rates over time in biologic-naïve and -experienced patients20
p<0.0001 vs placebo at Week 12.
Adapted from Sigurgeirsson et al. 2022.20
PASI 90 and 100 were key secondary endpoints. Co-primary endpoints: PASI 75 and IGA 0/1 response rates at Week 12 were met (p<0.0001).20
5.5 out of 10 patients taking Cosentyx 300 mg achieved PASI 100 at 1 year20
MATURE was a 52-week, multicentre, randomised, double-blind, placebo-controlled, Phase 3 trial (n=122). PASI 75 response rates with Cosentyx via the UnoReady® 300 mg pen were superior to placebo at Week 12 (co-primary endpoint; 95.1% vs 10%, respectively, p<0.0001). IGA 0/1 response rates with Cosentyx via the UnoReady® 300 mg pen were also superior to placebo at Week 12 (co-primary endpoint; 75.6% vs 7.6%, respectively, p<0.0001).20
The SCULPTURE extension study showed long-term persistence for up to 5 years. The SCULPTURE core study did not reach primary end point of non-inferiority of re-treatment as needed vs fixed interval dosing with Cosentyx.24,25
Out of 168 patients receiving Cosentyx in the SCULPTURE study at Year 1, 75% (n=126) of plaque PsO patients remained on Cosentyx at Year 5 in the SCULPTURE extension study24
Absolute PASI results showed that at Year 1, 73% of patients reported no impact of PsO on their life, with 66% still reporting this at Year 5.24
Sustained results24
At Year 1 and through to Year 5, Cosentyx provided an average of 90% change in the a PASI response rate vs baseline (observed).24 Statistical significance not tested.
Adapted from Bissonette et al. 2018.24
SCULPTURE extension was a multicentre trial, double-blind from Year 1 through 3, and then open-label through Year 5. The primary endpoint of the core Phase 3 trial was non-inferiority of retreatment as needed vs fixed interval (every 4 weeks) for maintaining PASI 75 to Week 52, which was not established. aPASI ≤5/≤3/≤2/≤1 responses sustained from Year 1 (87.7%, 74.1%, 67.9% and 58.6%, respectively) through to Year 5 (84.4%, 75.4%, 66.4% and 53.3%, respectively).24,25
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
*The 6 key manifestations of PsA are joints, axial, skin, enthesitis, dactylitis, and nails.1,2,11,12
†TRANSFIGURE: the primary endpoint of NAPSI improvement score vs placebo at Week 16 was met (−45.3% for Cosentyx 300 mg vs −10.8% for placebo, p<0.001). Observed data in patients with moderate to severe nail PsO in the 300 mg treatment group (n=66); in the respective 150 mg treatment group (n=67), there was a mean NAPSI improvement of −63.3% sustained at Year 2.14,15
‡MATURE: MATURE was a 52-week, multicentre, randomised, double-blind, placebo-controlled Phase 3 trial (n=122). Co-primary endpoints were PASI 75 and IGA 0/1 response rates at Week 12 vs placebo. PASI 75 was met (95.1% for Cosentyx 300 mg vs 10% for placebo, p<0.0001). IGA 0/1 was also met (75.6% for Cosentyx 300 mg vs 7.6% for placebo, p<0.0001).20
§SCALP (n=102) was a 24-week randomised, double-blind, placebo-controlled, parallel-group, multicentre, Phase 3b study. Patients with moderate to severe scalp PsO received Cosentyx 300 mg or placebo at baseline, Weeks 1, 2, and 3, and then every 4 weeks from Weeks 4 to 20. The final efficacy and safety evaluations were performed at Week 24. The primary endpoint of PSSI 90 vs placebo at Week 12 was met (52.9% for Cosentyx 300 mg vs 2% for placebo, p<0.001).13
IIULTIMATE: nonresponder imputation data in biologic-naïve patients originally randomly assigned to Cosentyx. The primary endpoint of GLOESS score vs placebo at Week 12 was met (−9% for Cosentyx 300 mg vs −6% for placebo, p=0.004).17
¶MAXIMISE: observed data in biologic-naïve patients in the 300 mg treatment group (n=139); in the respective 150 mg treatment group, 65% achieved ASAS40 at Year 1 (n=141). The primary endpoint of ASAS20 vs placebo at Week 12 was met (63% for Cosentyx 300 mg vs 31% for placebo, p<0.0001).11
#FUTURE 2: observed data for the 300 mg treatment group of biologic-naïve patients with this symptom at baseline; 82% in the respective 150 mg group maintained complete resolution of dactylitis through Year 5 (n=28); 75% in the respective 150 mg group maintained complete resolution of enthesitis through Year 5 (n=64). The primary endpoint of ACR20 vs placebo at Week 24 was met (54% for Cosentyx 300 mg vs 15.3% with placebo, p<0.0001).18,19
ACR, American College of Rheumatology; AS, ankylosing spondylitis; ASAS, Assessment of Spondyloarthritis International Society; BAD, British Association of Dermatologists; BSR, British Society for Rheumatology; DMARD, disease-modifying anti-rheumatic drug; ERA, enthesitis-related arthritis; GLOESS, Global OMERACT/EULAR ultrasound synovitis score; GRAPPA, Group for Research and Assessment of Psoriasis and Psoriatic Arthritis; HS, hidradenitis suppurativa; IGA, investigator’s global assessment; IL, interleukin; JPsA, juvenile psoriatic arthritis; mNAPSI, mean nail psoriasis severity index; MTX, methotrexate; NAPSI, nail psoriasis severity index; nr-axSpA, non-radiographic axial spondyloarthritis; NRI, non-responder imputation; PASI, psoriasis area and severity index; PsA, psoriatic arthritis; PsO, plaque psoriasis; PSSI, psoriasis scalp severity index; QoL, quality of life.
References
Cosentyx (secukinumab) GB Summary of Product Characteristics.
Cosentyx (secukinumab) NI Summary of Product Characteristics.
Singh JA, et al. Arthritis Rheumatol 2019;71(1):5–32.
Haroon M, et al. Ann Rheum Dis 2015;74(6):1045–1050.
Menter A, et al. Am J Manag Care 2016;22(Suppl 8):S216–S224.
Gladman DD, et al. Ann Rheum Dis 2005;64(Suppl II):ii14–ii17.
Cigolini C, et al. Clin Exp Rheumatol 2022;40(9):1611–1619.
Wilson FC, et al. Arthritis Rheum 2009;61(2):233–239.
Mease PJ, et al. RMD Open 2021;7(2):e001600.
Mease P, et al. Ann Rheum Dis 2018;77(6):890–897.
Baraliakos X, et al. Ann Rheum Dis 2021;80(5):582–590.
Nash P, et al. Clin Exp Rheumatol 2022;40(5):952–959.
Bagel J, et al. J Am Acad Dermatol 2017;77(4):667–674.
Reich K, et al. Br J Dermatol 2019;181(5):954–966.
Reich K, et al. Br J Dermatol 2021;184(3):425–436.
Boers M, et al. EULAR European Congress of Rheumatology. 2–5 June 2021; Virtual Congress. Poster POS0917.
D’Agostino MA, et al. Rheumatology 2022;61(5):1867–1876.
McInnes IB, et al. Lancet Rheumatol 2020;2(4):e227–e235.
McInnes IB, et al. Lancet 2015;386(9999):1137–146.
Sigurgeirsson B, et al. Dermatol Ther 2022;35(3):e15285.
Coates LC, et al. Nat Rev Rheumatol 2022;18(8):465–479.
Tucker L, et al. Rheumatology 2022(9);61:e255–e266.
Smith CH, et al. Br J Dermatol 2020(4);183:628–637.
Bissonnette R, et al. J Eur Acad Dermatol Venereol 2018;32(9):1507–1514.
Mrowietz U, et al. J Am Acad Dermatol 2015;73(1):27–36.
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