Rheumatology | COSENTYX® (secukinumab)

All-In-One relief gets it done. Results in all key clinical manifestations of PsA and the hallmarks of disease that matter to patients with AS and nr-axSpA. Darren, an actual patient with PsA on Cosentyx, was compensated for his time. Individual results may vary. Child is not a patient and not Darren's actual child. Trust the efficacy and safety you know in both SC and IV formulations.

Please see clinical trial primary end points, key data, and study designs

Years of clinical experience

A robust safety profile⁹
10+ years on the market^9‡
NO Boxed WARNING or routine lab monitoring, including liver enzymes⁹

See PsA efficacy >See PsA safety >

#1 covered IL-17 antagonist across all insurance types.

Better first- and second-line coverage than any other IL-17 inhibitor in rheumatology.

Cosentyx in IV form is well covered across insurance types. ~70% of privately insured. 78% of Medicare Advantage. 100% of Medicare Part B FFS.

*All trials used SC administration.
^†The effectiveness and safety of COSENTYX IV formulation are based on the pharmacokinetic exposure and extrapolation of the established effectiveness and safety of SC COSENTYX in adult patients with active PsA, AS, or nr-axSpA.⁹
^‡COSENTYX was originally approved by the FDA in 2015.⁹
^§For SC privately insured patients and IV Medicare Part B FFS patients.
^||COSENTYX for SC use is present on formularies as either a first-, second-, third-, fourth-, or fifth-line biologic. Novartis does not guarantee payments or coverage for any product or service. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. Coverage information is subject to change by the relevant payer.
^¶Based on the total number of covered lives across commercial, Medicare, and Medicaid health plans.
^#Medicare Part B FFS typically covers outpatient prescription drugs that are administered incident to a physician service and that are not usually self-administered. For drugs that are available in both oral and injectable forms, the MACs are responsible for determining whether the drug and the route of administration are both medically necessary. Novartis does not guarantee payment or coverage for any product or service. Actual coverage and reimbursement decisions are made by individual payers following the receipt of claims. Coverage information is subject to change by the relevant payer.
**No step therapy or prior authorizations are required.

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Please see FUTURE 2 (pivotal trial), FUTURE 5, MAXIMISE, MATURE, MEASURE 2 (pivotal trial), PREVENT (pivotal trial), and TRANSFIGURE primary end points and study design details

COSENTYX clinical trial end points

FUTURE 2* (PsA)
(Two-thirds biologic-naive and one-third anti–TNF-α inadequate responders)¹²
ACR20 responses at Week 16 (NRI) were^9,12:

57% for COSENTYX 300 mg (n=100) (P<0.0001)
60% for COSENTYX 150 mg (n=100) (P<0.0001)
18% for placebo (n=98)

ACR20 responses at Week 24 (primary end point) (NRI) were^9,12:

54% for COSENTYX 300 mg (n=100) (P<0.0001)
51% for COSENTYX 150 mg (n=100) (P<0.0001)
15% for placebo (n=98)
Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI^9,12
Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 24¹²

FUTURE 5* (PsA)
(Two-thirds biologic-naive and one-third anti–TNF-α inadequate responders)¹³
Results at Week 16¹³

JOINT
FUTURE 5 primary end point
ACR20 response rates (NRI) were:

63% for COSENTYX 300 mg (n=222) (P<0.0001)
56% for COSENTYX 150 mg (n=220) (P<0.0001)
27% for placebo (n=332)

ENTHESITIS
Complete resolution (LEI=0) in patients with enthesitis at baseline (NRI):

56% for COSENTYX 300 mg (n=140)
55% for COSENTYX 150 mg (n=141)
35% for placebo (n=192)

DACTYLITIS
Complete resolution (LDI=0) in patients with dactylitis at baseline (NRI):

66% for COSENTYX 300 mg (n=82)
57% for COSENTYX 150 mg (n=80)
32% for placebo (n=124)

SKIN
Patients who achieved PASI 90 (NRI):

54% for COSENTYX 300 mg (n=110)
37% for COSENTYX 150 mg (n=125)
9% for placebo (n=162)

NAIL^†
Reduction in nail disease (mNAPSI as observed) response rates were^‡:

51% for COSENTYX 300 mg (n=125)
53% for COSENTYX 150 mg (n=128)
11% for placebo (n=203)

MAXIMISE*^§ (PsA)
ASAS20 responses at Week 12 (MI) in biologic-naive patients with PsA were¹:

63% for COSENTYX 300 mg (n=164) (primary end point) (P<0.0001)
66% for COSENTYX 150 mg (n=157) (key secondary end point) (P<0.0001)
31% for placebo (n=164)

MATURE* (PsO)
Coprimary end points in patients with moderate to severe PsO¹⁴
PASI 75 response at Week 12 (LRM) was:

95% for COSENTYX 300-mg UnoReady^® pen (n=41) (P<0.0001)
10% for placebo (n=40)

IGA mod 2011 0/1 response at Week 12 (LRM) was:

76% for COSENTYX 300-mg UnoReady pen (n=41) (P<0.0001)
8% for placebo (n=40)

MEASURE 2* (AS)

61% of patients achieved ASAS20 in a mixed population at Week 16 on COSENTYX 150 mg (n=72) vs 28% on placebo (n=74) (NRI; P=0.0001) (primary end point)^9,15

PREVENT* (nr-axSpA)

40% of biologic-naive patients achieved ASAS40 at 1 year on COSENTYX 150 mg no load (n=166) vs 20% on placebo (n=171) (NRI; P<0.05) (primary end point)¹⁶

TRANSFIGURE* (nail PsO)
NAPSI improvement at Week 16 in patients with moderate to severe nail PsO (primary end point) (MMRM)^17,18:

46% NAPSI improvement for COSENTYX 300 mg (n=63) (P<0.0001)
38% for COSENTYX 150 mg (n=64) (P<0.0001)
12% for placebo (n=56)

*All trials used SC administration.
^†Nail data in PsA were consistent with those in the dedicated nail PsO study, TRANSFIGURE. Improvement from baseline NAPSI at Week 16 (primary end point) (MMRM) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).¹⁷
^‡At baseline, mNAPSI scores were 18.0 and 17.8 in the 300-mg and 150-mg arms, respectively. At Week 16, mNAPSI scores were 8.8 and 8.4 in the 300-mg and 150-mg arms, respectively.¹³
^§Data from the MAXIMISE trial, whose study design, patient population, and dosing regimen are consistent with those of FUTURE 2. In FUTURE 2, 20% of patients had spondylitis with peripheral arthritis.⁹

Study designs

FUTURE 2 was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 397 adult patients with active PsA (≥3 swollen and ≥3 tender joints) despite use of NSAIDs, corticosteroids, or DMARDs. Patients had a diagnosis for ≥5 years and received subcutaneous COSENTYX 75 mg (n=99), 150 mg (n=100), 300 mg (n=100), or placebo (n=98) at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks thereafter. Patients who received placebo were rerandomized to COSENTYX 150 mg or 300 mg every 4 weeks at Week 16 or Week 24 based on responder status. Primary end point was the percentage of patients with ACR20 response at Week 24. Study population was mixed: two-thirds of patients were biologic-naive and one-third were anti–TNF-⍺ inadequate responders.^9,12,19

FUTURE 5 was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that evaluated 996 adult patients with active PsA. Patients were randomized to receive subcutaneous COSENTYX 150 mg without load (n=222), 150 mg with load (n=220), 300 mg with load (n=222), or placebo (n=332). Patients who received placebo were rerandomized to receive COSENTYX 150 mg or 300 mg every 4 weeks, based on responder status at Week 16 (nonresponders) or Week 24 (responders). Primary end point was the percentage of patients with ACR20 response at Week 16. Secondary end points included change in mTSS at Week 24 from baseline. Study population was mixed: more than two-thirds of patients were biologic-naive and less than one-third were anti–TNF-⍺ inadequate responders (individual patients could have been exposed to up to 3 TNF-⍺ inhibitors).^13,20

MAXIMISE was a randomized, double-blind, placebo-controlled, multicenter, 52-week study that evaluated 498 patients with active PsA and axial skeleton involvement (defined by BASDAI score ≥4, spinal pain VAS ≥40 [0 to 100-mm scale]) who had inadequate response to at least 2 NSAIDs for at least 4 weeks. Patients were randomized to receive subcutaneous COSENTYX 150 mg (n=165), COSENTYX 300 mg (n=167), or placebo (n=166) at Weeks 0, 1, 2, 3, 4, and 8. Primary end point was the proportion of patients with ASAS20 response at Week 12. After Week 12, patients who were placed in the placebo group at baseline were rerandomized to active treatment with COSENTYX 150 mg or 300 mg, administered every 4 weeks from Week 12 to Week 52 (last dose on Week 48) but remained blinded to dose.²¹

MATURE was a 52-week, multicenter, randomized, double-blind, placebo-controlled, parallel group study of the efficacy, safety, and tolerability of the 300-mg COSENTYX UnoReady pen in 122 adult patients with moderate to severe PsO. After screening, for Treatment Period 1 (randomization through Week 12 predose), patients were randomized 2:2:1:1 to either COSENTYX 300-mg (2 mL) UnoReady pen, COSENTYX 300-mg 2 × 150-mg (2 × 1 mL) prefilled syringes (PFS), placebo UnoReady pen (2 mL), or placebo (2 × 1 mL) PFS. For Treatment Period 2 (Week 12 through Week 52), PASI 90 nonresponders were rerandomized to the respective COSENTYX 300-mg autoinjector or COSENTYX 300-mg 2 x 1 mL PFS group. All arms started with 4 once-weekly loading doses, followed by dosing every 4 weeks. Patients switched from placebo to active drug repeated the loading doses. Primary end point was the efficacy of the COSENTYX 300-mg UnoReady pen vs placebo, with respect to both PASI 75 and IGA mod 2011 0 or 1 response (coprimary end point) at Week 12.²²

MEASURE 2 was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 219 adult patients with active AS who received COSENTYX 75 mg, 150 mg, or placebo subcutaneous treatment at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks. At Week 16, patients who received placebo were rerandomized to either COSENTYX 75 mg or 150 mg every 4 weeks. After 16 weeks, patients knew they were taking active medication, but were blinded to the dose. After 1 year, patients continued to receive the same active dose as open-label treatment and were assessed every 8 weeks through 2 years, then every 12 weeks through 5 years. The primary end point was the percentage of patients who achieved ASAS20 response at Week 16.^6,9,15

PREVENT was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial evaluating 555 adult patients with active nr-axSpA who met the ASAS classification criteria for axSpA and had abnormal hsCRP and/or evidence of sacroiliitis on MRI. Participants were randomized to receive 1 of 3 treatments subcutaneously: COSENTYX 150 mg load, COSENTYX 150 mg no load, or placebo. Patients were treated with COSENTYX 150 mg with load or placebo (Weeks 0, 1, 2, 3, and 4) or COSENTYX 150 mg without load (Weeks 0 and 4), followed by the same dose every 4 weeks thereafter. Starting at Week 16, dose adjustment or addition of concomitant NSAIDs and DMARDs was permitted. Starting at Week 20, patients were allowed to switch to open-label COSENTYX 150 mg monthly or local standard of care if the patient was considered an inadequate responder for 2 consecutive visits by the discretion of the investigator and patient. The primary end point was the percentage of biologic-naive patients who achieved ASAS40 response at Week 52 in the no-load arm. The core phase of the trial ran through Week 104, with an extension phase through Week 208. Most patients (90%) were biologic-naive in this study.^8,9,16

TRANSFIGURE was a double-blind, randomized, placebo-controlled study examining the safety and efficacy of COSENTYX in patients with moderate to severe nail PsO. Patients were randomized to COSENTYX 300 mg (n=66), COSENTYX 150 mg (n=67), or placebo (n=65). All patients were adults with moderate to severe PsO (PASI score ≥12 and BSA ≥10%) and significant nail involvement (fingernail NAPSI score of ≥16 and ≥4 fingernails involved) who were candidates for systemic therapy. Primary end point: NAPSI assessment at Week 16. Secondary end points included NAPSI response over time up to Week 132.¹⁸

ACR, American College of Rheumatology; AS, ankylosing spondylitis; ASAS, Assessment of SpondyloArthritis International Society criteria; axSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BSA, body surface area; DMARDs, disease-modifying antirheumatic drugs; hsCRP, high-sensitivity C-reactive protein; IGA mod 2011, Investigator’s Global Assessment modified 2011; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; LRM, logistic regression model; MI, multiple imputation; MMRM, mixed model for repeated measures; mNAPSI, modified Nail Psoriasis Severity Index; MRI, magnetic resonance imaging; mTSS, modified Total Sharp Score; NAPSI, Nail Psoriasis Severity Index; nr-axSpA, non-radiographic spondyloarthritis; NRI, nonresponder imputation; NSAIDs, nonsteroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; SC, subcutaneous; TNF, tumor necrosis factor; VAS, visual analog scale.

Definitions and references

Definitions

AS, ankylosing spondylitis; FFS, fee-for-service; IL, interleukin; IV, intravenous; MAC, Medicare administrative contractor; nr-axSpA, non-radiographic axial spondyloarthritis; PsA, psoriatic arthritis; SC, subcutaneous.

References

1. Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021:80(5):582-590.
2. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
3. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.
4. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.
5. Data on file. CAIN457H2315 (PREVENT): Data Analysis Report. Novartis Pharmaceuticals Corp; August 2021.
6. Data on file. CAIN457F2310 (MEASURE 2): Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.
7. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.
8. Data on file. CAIN457H2315 (PREVENT): Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.
9. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
10. Data on file. IL-17 PsA Pharmacy Payer Coverage Data. Novartis Pharmaceuticals Corp; March 2025.
11. Data on file. PsA Medical Payer Coverage Data. Novartis Pharmaceuticals Corp; July 2024.
12. Data on file. CAIN457F2312 (FUTURE 2): Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.
13. Data on file. CAIN457F2342 (FUTURE 5): Clinical Study Report. Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
14. Sigurgeirsson B, Browning J, Tyring S, et al. Secukinumab demonstrates efficacy, safety, and tolerability upon administration by 2 ml autoinjector in adult patients with plaque psoriasis: 52-week results from MATURE, a randomized, placebo-controlled trial. Dermatol Ther. 2022;35(3):e15285. doi:10.1111/dth.15285
15. Data on file. CAIN457F2310 (MEASURE 2): Clinical Study Report. Novartis Pharmaceuticals Corp; November 2014.
16. Deodhar A, Blanco R, Dokoupilová E, et al. Improvement of signs and symptoms of nonradiographic axial spondyloarthritis in patients treated with secukinumab: primary results of a randomized, placebo-controlled phase III study. Arthritis Rheumatol. 2021;73(1):110-120 and Supplementary Material.
17. Data on file. CAIN457A2313 (TRANSFIGURE): Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015.
18. Data on file. CAIN457A2313 (TRANSFIGURE): Clinical Study Report. Novartis Pharmaceuticals Corp; October 2017.
19. Data on file. CAIN457F2312 (FUTURE 2): Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.
20. Mease P, van der Heijde D, Landewé R, et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018;77(6):890-897.
21. Data on file. CAIN457F3302 (MAXIMISE): Data Analysis Report. Novartis Pharmaceuticals Corp; June 2016.
22. Data on file. CAIN457A2325 (MATURE): Clinical Study Report. Novartis Pharmaceuticals Corp; August 2020.

Years of clinical experience

Please see FUTURE 2 (pivotal trial), FUTURE 5, MAXIMISE, MATURE, MEASURE 2 (pivotal trial), PREVENT (pivotal trial), and TRANSFIGURE primary end points and study design details

Definitions and references

Important Safety Information

Indications