J3247: Permanent J-code for the IV formulation of COSENTYX^®*

Effective July 1, 2024, for all sites of care

IV dosing calculator Provider and Co-pay Portal - IV IV Billing & Coding Guide

*If COSENTYX is administered on or after July 1, 2024, the permanent J-code replaces the miscellaneous J-code J3590.
It is the sole responsibility of the healthcare provider to select the proper codes and ensure the accuracy of all statements used in seeking coverage and reimbursement for an individual patient. Novartis cannot guarantee insurance coverage or reimbursement.

Reference: CMS, HCPCS Quarterly Update, April 2024.

ALL-IN-ONE relief

Here with you with results in all key clinical manifestations of psoriatic arthritis (PsA) for up to 2 years^7-11

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

COSENTYX 300 mg

COSENTYX 150 mg

Results Up to 2 Years Across Multiple Manifestations for 300 mg

Results Up to 2 Years Across Multiple Manifestations for 150 mg

In FUTURE 5, ACR50, dactylitis, enthesitis, mNAPSI, and PASI 90 were prespecified exploratory end points at 2 years, and PASI 100 was a post hoc analysis based on PASI 90. In MAXIMISE, ASAS20 at 1 year was a prespecified exploratory end point. No clinical or statistical conclusions can be drawn.^7‑9,11,12

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. MAXIMISE primary end point: 63% experienced relief on COSENTYX 300 mg at Week 12 vs 31% with placebo, as measured by ASAS20 (P<0.0001) (n=164) (MI).⁸

Nail data in PsA from FUTURE 5 at Week 16 (mixed population) were consistent with those in the dedicated nail PsO study, TRANSFIGURE. Improvement from baseline NAPSI at Week 16 (primary end point) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).¹³

At baseline in FUTURE 5 (mixed population), 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.¹²

Here for your community

*FDA approved for active PsA and AS in 2016.

Dr. Suzanne Gharib PsA has many manifestations

Hear what matters to patients

A patient's experience:

"I was talking to my doctor about treatment options, and before he could finish his sentence, we both said COSENTYX."

Meet Darren
Darren, an actual patient with PsA on COSENTYX, was compensated for his time. Individual results may vary.

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

COSENTYX clinical trial end points

FUTURE 2

FUTURE 2 studied a mixed population of patients with PsA: 2/3 biologic-naive and 1/3 anti–TNF-α inadequate responders¹⁵

ACR20 responses at Week 16 (NRI) in the mixed population were 57% (P<0.0001), 60% (P<0.0001), and 18%, respectively, for COSENTYX 300 mg (n=100), 150 mg (n=100), and placebo (n=98)^1,15
The primary end point of ACR20 responses at Week 24 (NRI) was achieved by 54% of patients on COSENTYX 300 mg (n=100) (P<0.0001), 51% on COSENTYX 150 mg (n=100) (P<0.0001), and 15% on placebo (n=98)^1,15
Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI^1,15
Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 24¹

FUTURE 5

FUTURE 5 studied a mixed population of patients with PsA: more than 2/3 biologic-naive and less than 1/3 anti–TNF-α inadequate responders¹²

JOINT¹²

ACR20 response rates (NRI) (primary end point) 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)

ENTHESITIS¹²

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)

DACTYLITIS¹²

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)

SKIN¹²

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)

NAIL¹²*

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

MAXIMISE studied biologic-naive patients with PsA¹⁶

The primary end point (ASAS20 responses at Week 12) was achieved by 63% of patients on COSENTYX 300 mg (n=164) compared with 31% for placebo (n=164) (MI; P<0.0001)¹⁶
The key secondary end point, ASAS20 responses at Week 12 in patients on COSENTYX 150 mg, was achieved by 66% (n=157) (MI; P<0.0001)¹⁶

TRANSFIGURE

TRANSFIGURE studied patients with nail psoriasis^13,17

The primary end point, improvement from baseline NAPSI at Week 16 (repeated measures analysis), was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001)^13,17

*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) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).¹³

^†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.¹²

Study designs

FUTURE 2 study design

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: 2/3 of patients were biologic-naive and 1/3 were anti–TNF-α inadequate responders.^1,15,18

FUTURE 5 study design

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 2/3 of patients were biologic-naive and less than 1/3 were anti–TNF-α inadequate responders (individual patients could have been exposed to up to 3 TNF-α inhibitors).^12,19

MAXIMISE study design

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.¹⁶

TRANSFIGURE study design

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 132.¹⁷

ACR, American College of Rheumatology; ASAS, Assessment of SpondyloArthritis international Society criteria; BASDAI, Bath Ankylosing Spondylitis Activity Index; BSA, body surface area; DMARDs, disease-modifying antirheumatic drugs; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; MI, multiple imputation; mNAPSI, modified Nail Psoriasis Severity Index; mTSS, modified Total Sharp Score; NAPSI, Nail Psoriasis Severity Index; NRI, nonresponder imputation; NSAIDs, nonsteroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; TNF, tumor necrosis factor; VAS, visual analog scale.

Definitions and references

Definitions

ACR, American College of Rheumatology; AS, ankylosing spondylitis; ASAS, Assessment of SpondyloArthritis international Society criteria; FDA, US Food and Drug Administration; IL, interleukin; IV, intravenous; MI, multiple imputation; mNAPSI, modified Nail Psoriasis Severity Index; NAPSI, Nail Psoriasis Severity Index; nr-axSpA, non-radiographic axial spondyloarthritis; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; SC, subcutaneous.

References

Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
Remicade. Prescribing information. Janssen Biotech Inc.
Simponi Aria. Prescribing information. Janssen Biotech Inc.
Orencia. Prescribing information. Bristol-Myers Squibb Co.
Taltz. Prescribing information. Eli Lilly & Co.
Siliq. Prescribing information. Bausch Health US LLC.
Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.
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.
Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.
Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 100 Tender/Swollen Joints Pain Biologic-Naive. Novartis Pharmaceuticals Corp; April 2020.
Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.
Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.
Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015.
Data on file. Novartis press release. Novartis Pharmaceuticals Corp; January 2016.
Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.
Data on file. CAIN457F3302 (MAXIMISE) Data Analysis Report. Novartis Pharmaceuticals Corp; June 2016.
Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2017.
Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.
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.

a. 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.

b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.

c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.

d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.

e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.

f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.

g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.

h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.

i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.

j. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.

k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.

l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.

m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.

o. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.

p. Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.

q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.

r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.

s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.

t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.

Here with you because relief can’t come soon enough

Dr. Asad Eraser As clinicians, we aim for fast relief of symptoms

In FUTURE 5

Fast relief of joint symptoms as early as Week 2¹

ACR20 response at Week 2 in a mixed population¹

31% for COSENTYX 300 mg (n=222)
26% for COSENTYX 150 mg (n=220)
15% for placebo (n=332)

In FUTURE 5, ACR20 was a prespecified exploratory end point at Week 2. No clinical or statistical conclusions can be drawn.¹

^{Relief for your biologic-naive patients with PsA}

COSENTYX 300 mg

COSENTYX 150 mg

41 Percent of Patients Achieved ACR50 on 300 mg at Week 16

ASAS20 and ASAS40 Responses at 1 Year for 150mg

In FUTURE 5, ACR50 was a prespecified exploratory end point at Week 16 in a subgroup of biologic-naive patients. No clinical or statistical conclusions can be drawn.¹

Please see FUTURE 2 (pivotal trial) and FUTURE 5 primary end points and study design details

COSENTYX clinical trial end points

FUTURE 2

FUTURE 2 studied a mixed population of patients with PsA: 2/3 biologic-naive and 1/3 anti–TNF-α inadequate responders²

ACR20 responses at Week 16 (NRI) in the mixed population were 57% (P<0.0001), 60% (P<0.0001), and 18%, respectively, for COSENTYX 300 mg (n=100), 150 mg (n=100), and placebo (n=98)^2,3
The primary end point of ACR20 responses at Week 24 (NRI) was achieved by 54% of patients on COSENTYX 300 mg (n=100) (P<0.0001), 51% on COSENTYX 150 mg (n=100) (P<0.0001), and 15% on placebo (n=98)^2,3
Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI^2,3
Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 24³

FUTURE 5

FUTURE 5 studied a mixed population of patients with PsA: more than 2/3 biologic-naive and less than 1/3 anti–TNF-α inadequate responders¹

JOINT¹

ACR20 response rates (NRI) (primary end point) 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)

ENTHESITIS¹

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)

DACTYLITIS¹

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)

SKIN¹

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)

NAIL¹*

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)

*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) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).^4

†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.¹

Study designs

FUTURE 2 study design

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: 2/3 of patients were biologic-naive and 1/3 were anti–TNF-α inadequate responders.^2,3,5

FUTURE 5 study design

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 2/3 of patients were biologic-naive and less than 1/3 were anti–TNF-α inadequate responders (individual patients could have been exposed to up to 3 TNF-α inhibitors).^1,6

ACR, American College of Rheumatology; DMARDs, disease-modifying antirheumatic drugs; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; mNAPSI, modified Nail Psoriasis Severity Index; mTSS, modified Total Sharp Score; NAPSI, Nail Psoriasis Severity Index; NRI, nonresponder imputation; NSAIDs, nonsteroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; TNF, tumor necrosis factor.

Definitions and references

Definitions

ACR, American College of Rheumatology; PsA, psoriatic arthritis.

References

1. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.

2. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.

3. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

4. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015.

5. Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.

6. 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.

a. 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.

b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.

c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.

d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.

e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.

f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.

g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.

h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.

i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.

j. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.

k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.

l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.

m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.

o. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.

p. Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.

q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.

r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.

s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.

t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.

Here with you for the long term

Dr. Sudhakar Tumuluri Reducing the patient's inflammation

In FUTURE 2, as observed in biologic-naive patients with psoriatic arthritis (PsA)

Lasting joint results at 5 years¹

COSENTYX 300 mg

COSENTYX 150 mg

As with other uncontrolled studies, this phase of the study has limitations (eg, no placebo comparisons, and patients responding better are more likely to stay in the study over time).
At baseline, n=67 and n=63 were biologic-naive in the 300 mg and 150 mg arms, respectively.²
In the mixed population: 74% of patients in the 300 mg arm and the 150 mg arm achieved an ACR20 response; 48% of patients in the 300 mg arm and 42% in the 150 mg arm achieved an ACR50 response; 28% of patients in the 300 mg arm and 29% in the 150 mg arm achieved an ACR70 response.

*73% and 76% completed the extension treatment period in the 300 mg arm and 150 mg arm, respectively.¹

In FUTURE 2, ACR20, ACR50, and ACR70 were prespecified exploratory end points from baseline through 5 years in a subgroup of biologic-naive patients. No clinical or statistical conclusions can be drawn.²

Please see FUTURE 2 (pivotal trial) primary end point and study design details

Definitions and references

Definitions

ACR, American College of Rheumatology; PsA, psoriatic arthritis; TNF, tumor necrosis factor.

References

1. Data on file. CAIN457F2312 (FUTURE 2): 5-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.

2. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.

3. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

4. Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.

a. 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.

b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.

c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.

d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.

e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.

f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.

g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.

h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.

i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.

j. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.

k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.

l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.

m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.

o. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.

p. Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.

q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.

r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.

s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.

t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.

Tried and tested specifically for axial symptoms of PsA

Dr. Sudhakar Tumuluri PSA axial involvement is underdiagnosed

In MAXIMISE, as observed in biologic-naive patients with PsA

Demonstrated improvement in axial symptoms^1,2

ASAS20 responses at Week 12 (MI) were¹:

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

COSENTYX 300 mg

COSENTYX 150 mg

ASAS20 and ASAS40 Responses at 1 Year for 300 mg

In MAXIMISE, ASAS20 and ASAS40 were prespecified exploratory end points at 1 year. No clinical or statistical conclusions can be drawn.²

ASAS components are relevant to your patients with PsA and include⁴:

Data from the MAXIMISE trial, whose study design, patient population, and dosing regimen were consistent with those of FUTURE 2. In FUTURE 2, 20% of patients had spondylitis with peripheral arthritis.

*85% and 90% of patients completed the trial in the 300 mg and 150 mg arms, respectively.²

Please see MAXIMISE primary end point and study design details

Definitions and references

Definitions

ASAS, Assessment of SpondyloArthritis international Society criteria; BASFI, Bath Ankylosing Spondylitis Functional Index; MI, multiple imputation; PsA, psoriatic arthritis.

References

1. Data on file. CAIN457F3302 (MAXIMISE) Data Analysis Report. Novartis Pharmaceuticals Corp; June 2016.

2. Data on file. CAIN457F3302 (MAXIMISE): 1-Year Clinical Study Report. Novartis Pharmaceuticals Corp; August 2020.

3. 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.

4. Data on file. CAIN457F2310 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2014.

a. 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.

b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.

c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.

d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.

e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.

f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.

g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.

h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.

i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.

j. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.

k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.

l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.

m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.

o. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.

p. Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.

q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.

r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.

s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.

t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.

Here with you to reduce the burden of enthesitis

Dr. Joseph Huffstutter Adequate control of enthesitis is critical

In FUTURE 5, as observed in biologic-naive patients

Complete resolution of enthesitis¹

COSENTYX 300 mg

COSENTYX 150 mg

Complete Resolution of Enthesitis with 300 mg

Complete Resolution of Enthesitis with 150 mg

*Patients with no enthesitis are defined as having an LEI score of 0 among patients with a score of 1 or more at baseline.³

^†91% of patients completed the study in both the 300 mg and 150 mg arms.¹

Complete resolution of enthesitis at Week 16 in a mixed population (prespecified secondary end point) using NRI analysis: 56% for COSENTYX 300 mg (n=140) and 55% for COSENTYX 150 mg (n=141) vs 35% for placebo (n=192)²
82% of patients achieved complete resolution of enthesitis at 2 years in the 150 mg arm¹
Among patients with enthesitis, 40% of biologic-naive patients in the COSENTYX 150 mg arm were up-titrated to 300 mg starting at Week 52, at the investigator’s discretion¹

In FUTURE 5, complete resolution of enthesitis was a prespecified exploratory end point at 2 years in a subgroup of biologic-naive patients with LEI >0 at baseline. No clinical or statistical conclusions can be drawn.³

As with other uncontrolled studies, this phase of the FUTURE 5 study has limitations (eg, no placebo comparisons, and patients responding better are more likely to stay in the study over time).

At baseline, 97 patients and 93 patients in FUTURE 5 had enthesitis in the 300 mg and 150 mg arms, respectively (biologic-naive).³

Please see FUTURE 2 (pivotal trial) and FUTURE 5 primary end points and study design details

COSENTYX clinical trial end points

FUTURE 2

FUTURE 2 studied a mixed population of patients with PsA: 2/3 biologic-naive and 1/3 anti–TNF-α inadequate responders⁴

ACR20 responses at Week 16 (NRI) in the mixed population were 57% (P<0.0001), 60% (P<0.0001), and 18%, respectively, for COSENTYX 300 mg (n=100), 150 mg (n=100), and placebo (n=98)^4,5
The primary end point of ACR20 responses at Week 24 (NRI) was achieved by 54% of patients on COSENTYX 300 mg (n=100) (P<0.0001), 51% on COSENTYX 150 mg (n=100) (P<0.0001), and 15% on placebo (n=98)^4,5
Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI^4,5
Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 24⁵

FUTURE 5

FUTURE 5 studied a mixed population of patients with PsA: more than 2/3 biologic-naive and less than 1/3 anti–TNF-α inadequate responders³

JOINT³

ACR20 response rates (NRI) (primary end point) 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)

ENTHESITIS³

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)

DACTYLITIS³

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)

SKIN³

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)

NAIL³*

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)

*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) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).^6

†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.³

Study designs

FUTURE 2 study design

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: 2/3 of patients were biologic-naive and 1/3 were anti–TNF-α inadequate responders.^4,5,7

FUTURE 5 study design

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 2/3 of patients were biologic-naive and less than 1/3 were anti–TNF-α inadequate responders (individual patients could have been exposed to up to 3 TNF-α inhibitors).^2,3

ACR, American College of Rheumatology; DMARDs, disease-modifying antirheumatic drugs; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; mNAPSI, modified Nail Psoriasis Severity Index; mTSS, modified Total Sharp Score; NAPSI, Nail Psoriasis Severity Index; NRI, nonresponder imputation; NSAIDs, nonsteroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; TNF, tumor necrosis factor.

Definitions and references

Definitions

LEI, Leeds Enthesitis Index; NRI, nonresponder imputation.

References

1. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.

2. 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.

3. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.

4. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.

5. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

6. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015.

7. Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.

a. 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.

b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.

c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.

d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.

e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.

f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.

g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.

h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.

i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.

j. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.

k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.

l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.

m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.

o. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.

p. Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.

q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.

r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.

s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.

t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.

Here with you to help your patients with “sausage digits”

In FUTURE 5, as observed in biologic-naive patients

Complete resolution of dactylitis¹

COSENTYX 300 mg

COSENTYX 150 mg

Complete Resolution of Dactylitis with 300 mg

Complete Resolution of Dactylitis with 150 mg

*Patients with no dactylitis are deﬁned as having a LDI score of 0 among patients with a score of 1 or more at baseline.²

^†87% and 84% of patients completed the study in the 300 mg and 150 mg arms, respectively.¹

Complete resolution of dactylitis at Week 16 in a mixed population (prespecified secondary end point) using NRI analysis: 66% for COSENTYX 300 mg (n=82) and 57% for COSENTYX 150 mg (n=80) vs 32% for placebo (n=124)²
86% of patients achieved complete resolution of dactylitis at 2 years in the 150 mg arm¹
Among patients with dactylitis, 56% of biologic-naive patients in the COSENTYX 150 mg arm were up-titrated to 300 mg starting at Week 52, at the investigator’s discretion¹

In FUTURE 5, complete resolution of dactylitis was a prespecified exploratory end point at 2 years in a subgroup of biologic-naive patients with LDI >0 at baseline. No clinical or statistical conclusions can be drawn.²

As with other uncontrolled studies, this phase of the FUTURE 5 study has limitations (eg, no placebo comparisons, and patients responding better are more likely to stay in the study over time).

At baseline, 55 patients and 52 patients had dactylitis in the 300 mg and 150 mg arms, respectively (biologic-naive).²

Please see FUTURE 2 (pivotal trial) and FUTURE 5 primary end points and study design details

COSENTYX clinical trial end points

FUTURE 2

FUTURE 2 studied a mixed population of patients with PsA: 2/3 biologic-naive and 1/3 anti–TNF-α inadequate responders³

ACR20 responses at Week 16 (NRI) in the mixed population were 57% (P<0.0001), 60% (P<0.0001), and 18%, respectively, for COSENTYX 300 mg (n=100), 150 mg (n=100), and placebo (n=98)^3,4
The primary end point of ACR20 responses at Week 24 (NRI) was achieved by 54% of patients on COSENTYX 300 mg (n=100) (P<0.0001), 51% on COSENTYX 150 mg (n=100) (P<0.0001), and 15% on placebo (n=98)^3,4
Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI^3,4
Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 24⁴

FUTURE 5

FUTURE 5 studied a mixed population of patients with PsA: more than 2/3 biologic-naive and less than 1/3 anti–TNF-α inadequate responders²

JOINT²

ACR20 response rates (NRI) (primary end point) 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)

ENTHESITIS²

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)

DACTYLITIS²

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)

SKIN²

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^2*

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)

*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) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).^5

†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.²

Study designs

FUTURE 5 study design

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 2/3 of patients were biologic-naive and less than 1/3 were anti–TNF-α inadequate responders (individual patients could have been exposed to up to 3 TNF-α inhibitors).^2,7

ACR, American College of Rheumatology; DMARDs, disease-modifying antirheumatic drugs; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; mNAPSI, modified Nail Psoriasis Severity Index; mTSS, modified Total Sharp Score; NAPSI, Nail Psoriasis Severity Index; NRI, nonresponder imputation; NSAIDs, nonsteroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; TNF, tumor necrosis factor.

Definitions and references

Definitions

LDI, Leeds Dactylitis Index; NRI, nonresponder imputation.

References

1. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.

2. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.

3. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.

4. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

5. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015.

6. Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.

7. 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.

a. 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.

b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.

c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.

d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.

e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.

f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.

g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.

h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.

i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.

j. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.

k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.

l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.

m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.

o. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.

p. Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.

q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.

r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.

s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.

t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.

Here with you to help clear their skin

Real treatment success with COSENTYX

Skin clearance through 2 years

COSENTYX-Baseline-skin-clearance-PsO-baseline

Actual patient photos representative of the average response taken by investigators during PsO clinical trials. Individual results may vary.

In FUTURE 5, as observed in biologic-naive patients

Your patients with PsA can achieve clearer skin¹

COSENTYX 300 mg

COSENTYX 150 mg

Baseline and PASI 100 at 2 Years with 300 mg

*91% and 90% of patients completed the two-year clinical trial in the 300 mg and 150 mg arms, respectively.¹

Baseline and PASI 100 at 2 Years with 150 mg

*91% and 90% of patients completed the two-year clinical trial in the 300 mg and 150 mg arms, respectively.¹

In FUTURE 5, PASI 100 is a post hoc analysis in a subgroup of biologic-naive patients with PsA and PsO based on PASI 75 and PASI 90 as prespecified exploratory end points at 2 years. No clinical or statistical conclusions can be drawn.²

66% PASI 90 response, 150 mg (n=84)³
38% of patients with PsA and PsO in the COSENTYX 150 mg arm were up-titrated to 300 mg starting at Week 52, at the investigator's discretion¹

In FUTURE 5, PASI 90 was a prespecified exploratory end point at 2 years. Results were as observed in a subgroup of biologic-naive patients with PsA and plaque psoriasis. No clinical or statistical conclusions can be drawn.

Please see FUTURE 2 (pivotal trial) and FUTURE 5 primary end points and study design details

COSENTYX clinical trial end points

FUTURE 2

FUTURE 2 studied a mixed population of patients with PsA: 2/3 biologic-naive and 1/3 anti–TNF-α inadequate responders⁴

ACR20 responses at Week 16 (NRI) in the mixed population were 57% (P<0.0001), 60% (P<0.0001), and 18%, respectively, for COSENTYX 300 mg (n=100), 150 mg (n=100), and placebo (n=98)^4,5
The primary end point of ACR20 responses at Week 24 (NRI) was achieved by 54% of patients on COSENTYX 300 mg (n=100) (P<0.0001), 51% on COSENTYX 150 mg (n=100) (P<0.0001), and 15% on placebo (n=98)^4,5
Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI^4,5
Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 24⁵

FUTURE 5

FUTURE 5 studied a mixed population of patients with PsA: more than 2/3 biologic-naive and less than 1/3 anti–TNF-α inadequate responders²

JOINT²

ACR20 response rates (NRI) (primary end point) 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)

ENTHESITIS²

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)

DACTYLITIS²

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)

SKIN²

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^2*

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)

*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) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).^6

†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.²

Study designs

FUTURE 5 study design

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 2/3 of patients were biologic-naive and less than 1/3 were anti–TNF-α inadequate responders (individual patients could have been exposed to up to 3 TNF-α inhibitors).^2,8

ACR, American College of Rheumatology; DMARDs, disease-modifying antirheumatic drugs; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; mNAPSI, modified Nail Psoriasis Severity Index; mTSS, modified Total Sharp Score; NAPSI, Nail Psoriasis Severity Index; NRI, nonresponder imputation; NSAIDs, nonsteroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; TNF, tumor necrosis factor.

Definitions and references

Definitions

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 100 Tender/Swollen Joints Pain Biologic-Naive. Novartis Pharmaceuticals Corp; April 2020.

2. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.

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. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.

5. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

6. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015.

7. Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.

8. 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.

a. 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.

b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.

c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.

d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.

e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.

f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.

g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.

h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.

i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.

j. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.

k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.

l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.

m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.

o. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.

p, Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.

q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.

r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.

s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.

t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.

Here with you for relief of stubborn nail symptoms

Real treatment success with COSENTYX

Patient photos taken from a dedicated nail PsO trial

Relief of nail symptoms baseline — Baseline

Relief of nail symptoms on week 16 — Week 16

Relief of nail symptoms on week 32 — Week 32

Relief of nail symptoms on week 80 — Week 80

Actual patient photos representative of the average response taken by investigators during PsO clinical trials. Individual results may vary.

Look between the cuticle and the new nail to see treatment success. It can take on average about 24 weeks to 1 year for the nail to grow out.¹

Dr. Joseph Huffstutter Patients may not connect complaints to their PsA

In FUTURE 5, as observed in biologic-naive patients

Nail clearance through 2 years²

COSENTYX 300 mg

COSENTYX 150 mg

Nail Disease Improvement at 2 Years with 300 mg

Nail Disease Improvement at 2 Years with 150 mg

*79% and 83% of patients completed the trial in the 300 mg and 150 mg arms, respectively.²

46% of patients with nail psoriasis were up-titrated from 150 mg to 300 mg starting at Week 12, at the investigator’s discretion²

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.³

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) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).⁴

At baseline, 66% and 61% of biologic-naive patients had nail psoriasis in the 300 mg and 150 mg arms, respectively. Mean baseline and 2-year mNAPSI values were 19.2 and 3.1, and 19.7 and 2.2, in the 300 mg and 150 mg arms, respectively.^2,3

Look deeper—help inhibit progression of joint structural damage^b

Take a look

A robust safety profile^m

Explore our safety data

Support to help offices help patients

Get support

Please see FUTURE 2 (pivotal trial) and FUTURE 5 primary end points and study design details

COSENTYX clinical trial end points

FUTURE 2

FUTURE 2 studied a mixed population of patients with PsA: 2/3 biologic-naive and 1/3 anti–TNF-α inadequate responders⁵

ACR20 responses at Week 16 (NRI) in the mixed population were 57% (P<0.0001), 60% (P<0.0001), and 18%, respectively, for COSENTYX 300 mg (n=100), 150 mg (n=100), and placebo (n=98)^5,6
The primary end point of ACR20 responses at Week 24 (NRI) was achieved by 54% of patients on COSENTYX 300 mg (n=100) (P<0.0001), 51% on COSENTYX 150 mg (n=100) (P<0.0001), and 15% on placebo (n=98)^5,6
Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI^5,6
Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 24⁶

FUTURE 5

FUTURE 5 studied a mixed population of patients with PsA: more than 2/3 biologic-naive and less than 1/3 anti–TNF-α inadequate responders³

JOINT³

ACR20 response rates (NRI) (primary end point) 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)

ENTHESITIS³

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)

DACTYLITIS³

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)

SKIN³

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^3*

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)

*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) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).^4

†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.³

Study designs

FUTURE 2 study design

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: 2/3 of patients were biologic-naive and 1/3 were anti–TNF-α inadequate responders.^5-7

FUTURE 5 study design

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 2/3 of patients were biologic-naive and less than 1/3 were anti–TNF-α inadequate responders (individual patients could have been exposed to up to 3 TNF-α inhibitors).^3,8

ACR, American College of Rheumatology; DMARDs, disease-modifying antirheumatic drugs; LDI, Leeds Dactylitis Index; LEI, Leeds Enthesitis Index; mNAPSI, modified Nail Psoriasis Severity Index; mTSS, modified Total Sharp Score; NAPSI, Nail Psoriasis Severity Index; NRI, nonresponder imputation; NSAIDs, nonsteroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; TNF, tumor necrosis factor.

Definitions and references

Definitions

mNAPSI, modified Nail Psoriasis Severity Index; NAPSI, Nail Psoriasis Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis.

References

1. National Psoriasis Foundation. Managing nail psoriasis. https://www.psoriasis.org/about-psoriasis/specific-locations/hands-feet-nails/managing-nail-psoriasis. Accessed January 8, 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 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.

4. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015.

5. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.

6. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

7. Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.

8. 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.

a. 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.

b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.

c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.

d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.

e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.

f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.

g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.

h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.

i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.

j. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341.

k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.

l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.

m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.

o. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47.

p. Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.

q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.

r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.

s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.

t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.

Tap to see IMPORTANT SAFETY INFORMATION and INDICATIONS

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
COSENTYX^® (secukinumab) is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis and angioedema have been reported during treatment with COSENTYX...

CONTRAINDICATIONS

COSENTYX^® (secukinumab) is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis and angioedema have been reported during treatment with COSENTYX.

WARNINGS AND PRECAUTIONS

Infections

COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in COSENTYX treated subjects compared to placebo-treated subjects. In placebo-controlled clinical trials in subjects with moderate to severe PsO, higher rates of common infections, such as nasopharyngitis (11.4% versus 8.6%), upper respiratory tract infection (2.5% versus 0.7%) and mucocutaneous infections with candida (1.2% versus 0.3%) were observed in subjects treated with COSENTYX compared to placebo-treated subjects. A similar increase in risk of infection in subjects treated with COSENTYX was seen in placebo-controlled trials in subjects with PsA, AS and nr-axSpA. The incidence of some types of infections, including fungal infections, appeared to be dose-dependent in clinical trials.

In the postmarketing setting, serious bacterial, viral, and fungal opportunistic infections, and some fatal infections have been reported in patients receiving IL-17 inhibitors including COSENTYX. Cases of Hepatitis B virus reactivation have been reported.

Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, monitor the patient closely and discontinue COSENTYX until the infection resolves.

If signs of Hepatitis B virus reactivation occur, consult a hepatitis specialist. COSENTYX is not recommended for use in patients with active viral hepatitis.

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Avoid administration of COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX. Consider anti-TB therapy prior to initiation of COSENTYX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients closely for signs and symptoms of active TB during and after treatment.

Inflammatory Bowel Disease

Inflammatory Bowel Disease (IBD) exacerbations, in some cases serious and/or leading to discontinuation of COSENTYX, occurred in COSENTYX treated subjects during clinical trials in PsO, PsA, AS, nr-axSpA, and HS. In adult subjects with HS, the incidence of IBD was higher in subjects who received COSENTYX 300 mg every 2 weeks (Ulcerative Colitis [UC] 1 case, EAIR 0.2/100 subject-years; Crohn’s Disease [CD] 1 case, EAIR 0.2/100 subject-years) compared to subjects who received COSENTYX 300 mg every 4 weeks (IBD 1 case, EAIR 0.2/100 subject-years). In addition, new onset IBD cases occurred in subjects treated with COSENTYX in clinical trials. In an exploratory trial in 59 subjects with active Crohn’s disease [COSENTYX is not approved for the treatment of Crohn’s disease], there were trends toward greater disease activity and increased adverse reactions in subjects treated with COSENTYX as compared to placebo-treated subjects.

Exercise caution when prescribing COSENTYX to patients with IBD. Patients treated with COSENTYX should be monitored for signs and symptoms of IBD.

Eczematous Eruptions

In postmarketing reports, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma, were reported in patients receiving COSENTYX; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of COSENTYX.

Treatment may need to be discontinued to resolve the eczematous eruption. Some patients were successfully treated for eczematous eruptions while continuing COSENTYX.

Hypersensitivity Reactions

Serious hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in COSENTYX treated subjects in clinical trials and in the post-marketing setting. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of COSENTYX and initiate appropriate therapy.

The removable caps of the COSENTYX Sensoready^® pen and the COSENTYX 1 mL and 0.5 mL prefilled syringes contain natural rubber latex, which may cause an allergic reaction in latex-sensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied.

Immunizations

Prior to initiating therapy with COSENTYX, consider completion of all age-appropriate immunizations according to current immunization guidelines. COSENTYX may alter a patient’s immune response to live vaccines. Avoid use of live vaccines in patients treated with COSENTYX.

MOST COMMON ADVERSE REACTIONS

Most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.

Please see Full Prescribing Information, including Medication Guide.

10/24 FA-11289065

J3247: Permanent J-code for the IV formulation of COSENTYX®*

ALL-IN-ONE relief

Here with you with results in all key clinical manifestations of psoriatic arthritis (PsA) for up to 2 years7-11

A robust safety profilem

Convenient once-a-month maintenance dosing (every 4 weeks)m

Support to help offices help patients

Here for your community

Novartis commitment to rheumatology is ongoing:

Hear what matters to patients

A patient's experience:"I was talking to my doctor about treatment options, and before he could finish his sentence, we both said COSENTYX."

Meet DarrenDarren, an actual patient with PsA on COSENTYX, was compensated for his time. Individual results may vary.

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

Definitions and references

Here with you because relief can’t come soon enough

Fast relief of joint symptoms as early as Week 21

Relief for your biologic-naive patients with PsA

Please see FUTURE 2 (pivotal trial) and FUTURE 5 primary end points and study design details

Definitions and references

Here with you for the long term

Lasting joint results at 5 years1

Please see FUTURE 2 (pivotal trial) primary end point and study design details

Definitions and references

Tried and tested specifically for axial symptoms of PsA

Demonstrated improvement in axial symptoms1,2

ASAS components are relevant to your patients with PsA and include4:

Please see MAXIMISE primary end point and study design details

Definitions and references

Here with you to reduce the burden of enthesitis

Complete resolution of enthesitis1

Please see FUTURE 2 (pivotal trial) and FUTURE 5 primary end points and study design details

Definitions and references

Here with you to help your patients with “sausage digits”

Complete resolution of dactylitis1

Please see FUTURE 2 (pivotal trial) and FUTURE 5 primary end points and study design details

Definitions and references

Here with you to help clear their skin

Skin clearance through 2 years

Your patients with PsA can achieve clearer skin1

Please see FUTURE 2 (pivotal trial) and FUTURE 5 primary end points and study design details

Definitions and references

Here with you for relief of stubborn nail symptoms

Patient photos taken from a dedicated nail PsO trial

Baseline

Week 16

Week 32

Week 80

Nail clearance through 2 years2

Look deeper—help inhibit progression of joint structural damageb

A robust safety profilem

Support to help offices help patients

Please see FUTURE 2 (pivotal trial) and FUTURE 5 primary end points and study design details

Definitions and references

J3247: Permanent J-code for the IV formulation of COSENTYX^®*

Here with you with results in all key clinical manifestations of psoriatic arthritis (PsA) for up to 2 years^7-11

A robust safety profile^m

Convenient once-a-month maintenance dosing (every 4 weeks)^m

A patient's experience:

"I was talking to my doctor about treatment options, and before he could finish his sentence, we both said COSENTYX."

Meet Darren
Darren, an actual patient with PsA on COSENTYX, was compensated for his time. Individual results may vary.

Fast relief of joint symptoms as early as Week 2¹

^{Relief for your biologic-naive patients with PsA}

Lasting joint results at 5 years¹

Demonstrated improvement in axial symptoms^1,2

ASAS components are relevant to your patients with PsA and include⁴:

Complete resolution of enthesitis¹

Complete resolution of dactylitis¹

Your patients with PsA can achieve clearer skin¹

Nail clearance through 2 years²

Look deeper—help inhibit progression of joint structural damage^b

A robust safety profile^m