Psoriatic Arthritis Efficacy | COSENTYX® (secukinumab)

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Only COSENTYX has long-term results in all 6 key clinical manifestations of PsA^1-4

Unlike IL-23is, IL-17is, like COSENTYX, are recommended across all key clinical manifestations of PsA⁵

Skin

71% achieved PASI 90 at Year 2 in FUTURE 5 (n=68)¹

Nail

84% reduction in mNAPSI at Year 2 in FUTURE 5 (n=81)²

Joint

78% achieved joint relief at Year 2 in FUTURE 5 (n=137)³

Enthesitis

80% achieved complete resolution at Year 2 in FUTURE 5 (n=88)³

Dactylitis

88% achieved complete resolution at Year 2 in FUTURE 5 (n=48)³

Axial

81% achieved axial relief at Year 1 in MAXIMISE (n=139)⁴

In FUTURE 5, mNAPSI, a measure used to assess psoriatic nail involvement, was a prespecified exploratory end point in a subgroup of biologic-naive patients with PsA and nail psoriasis. No clinical or statistical conclusions can be drawn.⁶
Exploratory results at Year 2 (FUTURE 5) and Year 1 (MAXIMISE) with COSENTYX 300 mg in biologic-naive patients with PsA (as observed). No clinical or statistical conclusions can be drawn.^1,4,6,7

Please see FUTURE 5 and MAXIMISE primary end points and study design details

COSENTYX clinical trial end points

FUTURE 5 in adults with PsA¹
Primary end point was ACR20 at Week 16

Two-thirds biologic-naive and one-third anti–TNF-α-exposed
More than half (52%) of patients also had PsO affecting ≥3% of BSA

For COSENTYX 300 mg

63% (n=222) (P<0.0001)

For COSENTYX 150 mg with LD

56% (n=220) (P<0.0001)

vs 27% for placebo (n=332)

MAXIMISE in biologic-naive adults with PsA²

Primary end point was ASAS20 at Week 12
91% of patients also had PsO

For COSENTYX 300 mg

63% (n=164) (multiple imputation; P<0.0001)

vs 31% for placebo (n=164)

Study designs

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).^1,3

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.⁴

ACR, American College of Rheumatology; ASAS, Assessment of SpondyloArthritis International Society criteria; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BSA, body surface area; LD, loading dose; mTSS, modified Total Sharp Score; NSAIDs, nonsteroidal anti-inflammatory drugs; PsA, psoriatic arthritis; PsO, plaque psoriasis; TNF-α, tumor necrosis factor alpha.

References

1. 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.
2. 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.
3. Data on file. CAIN457F2342 (FUTURE 5): Clinical Study Report. Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
4. Data on file. CAIN457F3302 (MAXIMISE): Data Analysis Report. Novartis Pharmaceuticals Corp; June 2016.

Proven to help stop the progression of irreversible joint damage in PsA

At Year 2, 84% of patients* had no radiographic progression^3†
COSENTYX 300 mg (n=139)

No approved IL-23 inhibitor has been shown to stop further radiographic joint damage at 2 years^8,9

In FUTURE 5, mTSS was a prespecified exploratory end point at Year 2 in a subgroup of biologic-naive patients. No clinical or statistical conclusions can be drawn.^3,6
*Biologic-naive patients.³
^†No radiographic progression was defined as a change from baseline in mTSS ≤0.0.³

Please see FUTURE 5 primary end points and study design details

The only dedicated trial with proven results in axial manifestations⁴

MAXIMISE in biologic-naive patients with PsA^4‡

ASAS20 responses at Week 12 (multiple imputation) were:

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)

^‡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.¹⁰

Explore our safety data >

Please see MAXIMISE primary end point and study design details

Definitions and references

Definitions

IL, interleukin; IL-17i, interleukin-17 inhibitor; IL-23i, interleukin-23 inhibitor; mNAPSI, modified Nail Psoriasis Severity Index; mTSS, modified Total Sharp Score; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis.

References

1. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.
2. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.
3. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
4. 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.
5. Gossec L, Kerschbaumer A, Ferreira RJO, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update. Ann Rheum Dis. 2024;83(6):706-719.
6. Data on file. CAIN457F2342 Clinical Study Report. Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
7. Data on file. CAIN457F3302 (MAXIMISE): 1-Year Clinical Study Report. Novartis Pharmaceuticals Corp; August 2020.
8. Clinicaltrials.gov. Absence of radiographic progression data at 2 years for IL-23 inhibitors in PsA. Completed March 24, 2025.
9. Clinicaltrials.gov. A study of guselkumab in participants with active Psoriatic arthritis (APEX). NCT04882098. Accessed September 24, 2025. https://clinicaltrials.gov/study/NCT04882098
10. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

Only COSENTYX has long-term results in all 6 key clinical manifestations of PsA^1-4

Unlike IL-23is, IL-17is, like COSENTYX, are recommended across all key clinical manifestations of PsA⁵

Skin

Nail

Joint

Enthesitis

Dactylitis

Axial

Please see FUTURE 5 and MAXIMISE primary end points and study design details

COSENTYX clinical trial end points

Study designs

Proven to help stop the progression of irreversible joint damage in PsA

Gary, actual patient with PsO and PsA on COSENTYX, was compensated for his time. Individual results may vary.

No approved IL-23 inhibitor has been shown to stop further radiographic joint damage at 2 years^8,9

Please see FUTURE 5 primary end points and study design details

COSENTYX clinical trial end points

Study design

The only dedicated trial with proven results in axial manifestations⁴

MAXIMISE in biologic-naive patients with PsA^4‡

Please see MAXIMISE primary end point and study design details

COSENTYX clinical trial end points

Study design

Definitions and references

Important Safety Information

Indications

Only COSENTYX has long-term results in all 6 key clinical manifestations of PsA1-4

Unlike IL-23is, IL-17is, like COSENTYX, are recommended across all key clinical manifestations of PsA5

Skin

Nail

Joint

Enthesitis

Dactylitis

Axial

Please see FUTURE 5 and MAXIMISE primary end points and study design details

Proven to help stop the progression of irreversible joint damage in PsA

Gary, actual patient with PsO and PsA on COSENTYX, was compensated for his time. Individual results may vary.

No approved IL-23 inhibitor has been shown to stop further radiographic joint damage at 2 years8,9

Please see FUTURE 5 primary end points and study design details

The only dedicated trial with proven results in axial manifestations4

MAXIMISE in biologic-naive patients with PsA4‡

Please see MAXIMISE primary end point and study design details

Definitions and references

Only COSENTYX has long-term results in all 6 key clinical manifestations of PsA^1-4

Unlike IL-23is, IL-17is, like COSENTYX, are recommended across all key clinical manifestations of PsA⁵

No approved IL-23 inhibitor has been shown to stop further radiographic joint damage at 2 years^8,9

The only dedicated trial with proven results in axial manifestations⁴

MAXIMISE in biologic-naive patients with PsA^4‡