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Please see pivotal trial results

Primary end points in pivotal trials

ERASURE: Adults with moderate to severe PsO¹
Coprimary end points were PASI 75 and IGA 0/1 at Week 12¹

For COSENTYX 300 mg (n=245)¹

82% achieved PASI 75
65% achieved IGA 0/1

Adult patients on COSENTYX 150 mg (n=245) or placebo (n=248) achieving PASI 75 (71% vs 4%) and IGA 0/1 (51% vs 2%) at Week 12, respectively. P<0.001 for all comparisons.^1,2

FIXTURE trial in adults with moderate to severe PsO¹
Coprimary end points were PASI 75 and IGA 0/1 at Week 12¹

For COSENTYX 300 mg (n=327)¹

76% achieved PASI 75
62% achieved IGA 0/1

Adult patients on COSENTYX 150 mg (n=327) or placebo (n=326) achieving PASI 75 (67% vs 5%) and IGA 0/1 (51% vs 3%) at Week 12, respectively. P<0.001 for all comparisons.^1,2

Study design

ERASURE and FIXTURE were multicenter, randomized, double-blind, placebo-controlled trials. ERASURE evaluated 738 adult patients who received subcutaneous COSENTYX 150 mg (n=245), COSENTYX 300 mg (n=245), or placebo (n=248). FIXTURE evaluated 1306 adult patients who received COSENTYX 150 mg (n=327), COSENTYX 300 mg (n=327), placebo (n=326), or a biologic active control: etanercept (n=323). All patients were adults with moderate to severe plaque psoriasis who had BSA ≥10%, PASI score ≥12, and IGA mod 2011 score ≥3 and were candidates for systemic therapy or phototherapy. Patients received treatment at Weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter. Patients randomized to receive placebo who were nonresponders at Week 12 and did not achieve PASI 75 were then rerandomized to receive COSENTYX 300 mg or 150 mg. Coprimary end points were PASI 75 and IGA 0 or 1 (clear or almost clear).^1,3,4

Definitions

IGA, Investigator’s Global Assessment modified 2011; PASI, Psoriasis Area and Severity Index; PsO, plaque psoriasis.

References:

1. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
2. Langley RG, Elewski BE, Lebwohl M, et al. Secukinumab in plaque psoriasis—results of two phase 3 trials. N Engl J Med. 2014;371(4):326-338.
3. Data on file AIN457A2302 (ERASURE): Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013.
4. Data on file AIN457A2303 (FIXTURE): Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013.

Complete clearance is achievable¹

PASI 100 achieved by 55% of patients with the UnoReady^® Pen at Week 52 in MATURE.

Observation of higher COSENTYX exposure was an exploratory end point. No clinical or statistical conclusions can be drawn

Baseline

Week 52

Actual patient image from the FIXTURE trial representing the average response achieving PASI 100 at Week 52 on 300 mg. Individual results may vary.

PASI 75 and IGA mod 2011 0/1 data at Week 12 in MATURE

Please see MATURE primary end points and study design details

Early, strong, and sustained clearance in nail psoriasis^2,3

Nail psoriasis results seen as early as Week 2^2*

Baseline^†

Week 16

Year 2.5

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

improvement in NAPSI^2‡

COSENTYX 300 mg (n=66) vs 12% with placebo (n=65) (MI)

improvement in NAPSI³

COSENTYX 300 mg (n=66) (as observed)

First IL-antagonist with a dedicated trial in nail psoriasis⁴

NAPSI at Week 2 and through Year 2.5 was a prespecified exploratory end point. No statistical or clinical conclusions can be drawn.²
*Mean reduction in NAPSI from baseline was 5% with COSENTYX 300 mg (n=66) vs 2% with placebo (n=29).³
^†Mean baseline NAPSI score was 43.²
^‡Improvement was defined as mean reduction in NAPSI from baseline.²

Early, strong, and sustained visible results in hard-to-treat scalp psoriasis^5,6

Scalp psoriasis results seen as early as Week 3^5§

Baseline^||

Week 12

Week 24

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

achieved PSSI 90

COSENTYX 300 mg (n=51) vs 2% with placebo (n=51) (NRI)^5,6

achieved PSSI 90

COSENTYX 300 mg (n=51) (NRI)^5,6

First IL-antagonist with a dedicated trial in scalp psoriasis⁷

Please see TRANSFIGURE and Scalp primary end points and study design details

COSENTYX clinical trial end points

TRANSFIGURE¹
Primary end point was mean percentage change from baseline in NAPSI at Week 16
For COSENTYX 300 mg:

-46% (n=66) vs -12% for placebo (n=65) (repeated measure analysis; P<0.0001)

Dedicated Scalp study in adults with moderate to severe scalp psoriasis²
Primary end point was PSSI 90 at Week 12

For COSENTYX 300 mg: 53% (n=51) vs 2% for placebo (n=51) (NRI; P<0.001)

Study designs

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 plaque 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. At Week 16, patients initially receiving placebo were rerandomized 1:1 to COSENTYX 150 mg or COSENTYX 300 mg; initial dosing: once weekly for 5 weeks followed by once every 4 weeks. Primary end point was NAPSI assessment at Week 16. Secondary end points included NAPSI response over time up to Week 132.³

Scalp was a multicenter, double-blind, randomized, placebo-controlled study in adult patients with moderate to severe scalp psoriasis for at least 6 months prior to randomization with PSSI score ≥12 and IGA mod 2011 (scalp only) ≥3 and ≥30% scalp surface area affected. At baseline, patients were randomized to COSENTYX 300 mg (n=51) or placebo (n=51). During the initial treatment period (from baseline to Week 12), patients in both treatment groups received subcutaneous treatment weekly at baseline and Weeks 1, 2, 3, and 4, followed by treatment every 4 weeks. Primary end point was the proportion of patients who achieved PSSI 90 at Week 12. At Week 12, patients initially receiving placebo who did not achieve a PSSI 90 response were switched to COSENTYX 300 mg (n=46): doses at Weeks 12, 13, 14, 15, 16, and 20. Patients who achieved response while receiving placebo continued receiving placebo (n=1) through Week 20.²

BSA, body surface area; IGA, Investigator’s Global Assessment modified 2011; NAPSI, Nail Psoriasis Severity Index; NRI, non-responder imputation; PASI, Psoriasis Area and Severity Index; PsO, plaque psoriasis; PSSI, Psoriasis Scalp Severity Index.

References

1. Reich K, Sullivan J, Arenberger P, et al. Effect of secukinumab on the clinical activity and disease burden of nail psoriasis: 32-week results from the randomized placebo-controlled TRANSFIGURE trial. Br J Dermatol. 2019;181(5):954-966.
2. Bagel J, Duffin KC, Moore A, et al. The effect of secukinumab on moderate-to-severe scalp psoriasis: results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study. J Am Acad Dermatol. 2017;77(4):667-674.
3. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2017.

PSSI 90 at Week 3 was not powered to evaluate statistical significance. No statistical or clinical conclusions can be drawn.⁵
^§12% achieved PSSI 90 with COSENTYX 300 mg vs 0% with placebo (n=51).^5,6
^||Mean baseline PSSI score was 33.⁵

Fast and long-lasting skin clearance in adult patients with PsO

Faster onset vs IL-12/23 targeting agent in CLARITY⁸

achieved PASI 75

COSENTYX 300 mg (n=550) vs 16% with ustekinumab 45/90 mg (n=552) (key secondary end point; multiple imputation, P<0.0001)

5-year skin clearance in SCULPTURE Extension⁹

achieved PASI 90

COSENTYX 300 mg (as observed, N=122)
75% of patients who entered the extension study at Year 1 completed the study at Year 5

COSENTYX is the first
IL-17A antagonist with
5-year PsO efficacy and safety data in a phase 3 study.^10,11

Please see CLARITY and SCULPTURE Extension primary end points and study design details

COSENTYX clinical trial end points

CLARITY head-to-head superiority study against ustekinumab in adults with moderate to severe PsO.¹
Coprimary end points were PASI 90 and IGA 0/1 at Week 12.*
For COSENTYX 300 mg (n=550):

67% achieved PASI 90 vs 48% with ustekinumab 45/90 mg^† (n=552) (P<0.0001)
72% achieved IGA 0/1 vs 55% with ustekinumab 45/90 mg^† (n=552) (P<0.0001)

*Multiple imputation (full analysis set).
^†Ustekinumab dose was based on body weight at baseline: 45 mg for patients ≤100 kg; 90 mg for patients >100 kg.

SCULPTURE Core and SCULPTURE Extension in adults with moderate to severe PsO²

SCULPTURE Core: The primary end point was noninferiority of the retreatment at SoR regimen vs the FI regimen for maintaining PASI 75 at Week 52 in patients who were PASI 75 responders at Week 12.^2‡

5-year results for patients treated with COSENTYX 300 mg FI (n=168)²:

75% of patients who entered the extension study at Year 1 completed the study at Year 5
89% had PASI 75 at Year 5 (89% at Year 1)
41% had PASI 100 at Year 5 (44% at Year 1)

In the COSENTYX 300-mg FI group of the core study, patients received COSENTYX 300 mg every 4 weeks. At Week 12, 90% of patients in the 300-mg FI arm achieved PASI 75. PASI 75 responders at Week 12 were eligible to enter the maintenance period. 78% of patients who continued COSENTYX 300-mg FI maintained PASI 75 and 60% achieved PASI 90 at Week 52. At Week 52, patients could continue in the extension study regardless of PASI 75 response and received the same blinded maintenance regimen and dose up to the end of Year 3. Extension study was unblinded from Year 3 through Year 5.^2,3

Data presented are as observed—patients with missing data at a specific time point are not included in the analysis. The as-observed analysis included patients who completed an assessment at each visit only²
As with open-label extensions, patients who lose response or are unable to tolerate treatment are likely to discontinue treatment, which may raise the proportion of responders in the overall population

^‡Maintenance of PASI 75 response was assessed at Week 52 for patients on the FI regimen. For patients on the retreatment-as-needed regimen, PASI 75 response was assessed at Week 52 for those who required active treatment at Week 40, or at Week 40 for those who did not require active treatment at Week 40.²

Study designs

CLARITY was a 52-week, multicenter, randomized, double-blind study in adults with moderate to severe PsO who had a BSA ≥10%, PASI score ≥12, IGA mod 2011 ≥3, and were candidates for systemic therapy or phototherapy. Efficacy and safety were assessed in 550 patients on COSENTYX  300 mg (administered at Weeks 0, 1, 2, 3, and 4, and once every 4 weeks thereafter up to Week 48) vs 552 patients on ustekinumab 45 mg (for patients ≤100 kg) or 90 mg (for patients >100 kg) administered at Weeks 0, 4, 16, 28, and 40. Coprimary end points were PASI 90 and IGA 0/1 at Week 12. Key secondary end points included PASI 75 at Week 4 and PASI 100 at Week 16.¹

SCULPTURE Core was a randomized, double-blind, multicenter trial assessing PASI response and maintenance of response in patients with moderate to severe plaque psoriasis on either an FI regimen (every 4 weeks) or on a retreatment at SoR regimen. All patients had a BSA of ≥10%, PASI score ≥12, and IGA mod 2011 score ≥3 and were candidates for systemic therapy or phototherapy. Primary end point was noninferiority of the retreatment at SoR regimen vs the FI regimen for maintaining PASI 75 at Week 52 in patients who were PASI 75 responders at Week 12. Initial dosing (weekly) was at baseline and Weeks 1, 2, 3, 4, and 8. In the SoR arms, patients received COSENTYX at Week 12 and then every 4 weeks from the start of relapse (≥20% loss of maximum PASI improvement vs baseline and a loss of PASI 75 response) until they achieved PASI 75 again.⁴

SCULPTURE Extension was a multicenter, double-blind, and open-label (from Week 156 through Week 260) extension study. Patients who completed 52 weeks of the SCULPTURE Core study were eligible to continue the same COSENTYX dose and regimen in the extension to Week 156. At Week 156, the study was unblinded and, based on investigator judgment, patients could switch dosing regimens (from SoR to FI regimen and from COSENTYX 150 mg to 300 mg). Primary objective was to assess long-term safety and tolerability of COSENTYX in patients who completed treatment in the core studies. Other objectives included efficacy over time with respect to PASI 50/75/90.⁵

BSA, body surface area; FI, fixed interval; IGA, Investigator’s Global Assessment modified 2011; PASI, Psoriasis Area and Severity Index; PsO, plaque psoriasis; SoR, start of relapse.

References

1. Bagel J, Nia J, Hashim PW, et al. Secukinumab is superior to ustekinumab in clearing skin in patients with moderate to severe plaque psoriasis (16-week CLARITY results). Dermatol Ther (Heidelb). 2018;8(4):571-579.
2. Mrowietz U, Leonardi CL, Girolomoni G, et al. Secukinumab retreatment-as needed versus fixed-interval maintenance regimen for moderate to severe plaque psoriasis: a randomized, double-blind, noninferiority trial (SCULPTURE). J Am Acad Dermatol. 2015;73(1):27-36.
3. Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32(9):1507-1514.
4. Data on file. CAIN457A2304 Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013.
5. Data on file. 4-Year Interim Report. Study CAIN457A2304E1. Novartis Pharmaceuticals Corp; December 2016.

Definitions and references

Definitions

IL, interleukin; IGA, Investigator’s Global Assessment modified 2011; MI, multiple imputation; NAPSI, Nail Psoriasis Severity Index; NRI, nonresponder imputation; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; PsO, plaque psoriasis; PSSI, Psoriasis Scalp Severity Index.

References

1. 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
2. Reich K, Sullivan J, Arenberger P, et al. Effect of secukinumab on the clinical activity and disease burden of nail psoriasis: 32-week results from the randomized placebo-controlled TRANSFIGURE trial. Br J Dermatol. 2019;181(5):954-966.
3. Reich K, Sullivan J, Arenberger P, et al. Secukinumab shows high and sustained efficacy in nail psoriasis: 2.5-year results from the randomized placebo-controlled TRANSFIGURE study. Br J Dermatol. 2021;184(3):425-436.
4. Novartis’ Cosentyx^® is first biologic to show long-term efficacy in nail and palmoplantar psoriasis, which can impact up to 90% of psoriasis patients [press release]. Basel, Switzerland: Novartis; November 30, 2017. Accessed October 10, 2024. https://www.novartis.com/news/media-releases/novartis-cosentyx-first-biologic-show-long-term-efficacy-nail-and-palmoplantar-psoriasis-which-can-impact-90-psoriasis-patients
5. Bagel J, Duffin KC, Moore A, et al. The effect of secukinumab on moderate-to-severe scalp psoriasis: results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study. J Am Acad Dermatol. 2017;77(4):667-674.
6. Data on file. CAIN457AUS01 Clinical Study Report. Novartis Pharmaceuticals Corp; February 2017.
7. Novartis receives FDA approval for Cosentyx^® label update to include moderate to severe scalp psoriasis [press release]. Basel, Switzerland: Novartis; February 8, 2018. Accessed October 10, 2024. https://www.novartis.com/us-en/news/media-releases/novartis-receives-fda-approval-cosentyx-label-update-include-moderate-severe-scalp-psoriasis
8. Bagel J, Nia J, Hashim PW, et al. Secukinumab is superior to ustekinumab in clearing skin in patients with moderate to severe plaque psoriasis (16-week CLARITY results). Dermatol Ther (Heidelb). 2018;8(4):571-579.
9. Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32(9):1507-1514.
10. Data on file. CAIN457A2304E1 Clinical Study Report. Novartis Pharmaceuticals Corp; March 2018.
11. Novartis announces FDA approval for first IL-17A antagonist Cosentyx^™ (secukinumab) for moderate-to-severe plaque psoriasis [press release]. Basel, Switzerland: Novartis; January 21, 2015. Accessed May 3, 2023. https://www.novartis.com/news/media-releases/novartis-announces-fda-approval-first-il-17a-antagonist-cosentyxtm-secukinumab-moderate-severe-plaque-psoriasis-patients

Please see pivotal trial results

Complete clearance is achievable1

Baseline

Week 52

PASI 75 and IGA mod 2011 0/1 data at Week 12 in MATURE

Please see MATURE primary end points and study design details

Early, strong, and sustained clearance in nail psoriasis2,3

Nail psoriasis results seen as early as Week 22*

Baseline†

Week 16

Year 2.5

improvement in NAPSI2‡

improvement in NAPSI3

First IL-antagonist with a dedicated trial in nail psoriasis4

Early, strong, and sustained visible results in hard-to-treat scalp psoriasis5,6

Scalp psoriasis results seen as early as Week 35§

Baseline||

Week 12

Week 24

achieved PSSI 90

achieved PSSI 90

First IL-antagonist with a dedicated trial in scalp psoriasis7

Please see TRANSFIGURE and Scalp primary end points and study design details

Fast and long-lasting skin clearance in adult patients with PsO

Faster onset vs IL-12/23 targeting agent in CLARITY8

achieved PASI 75

5-year skin clearance in SCULPTURE Extension9

achieved PASI 90

COSENTYX is the firstIL-17A antagonist with5-year PsO efficacy and safety data in a phase 3 study.10,11

Please see CLARITY and SCULPTURE Extension primary end points and study design details

Definitions and references

Complete clearance is achievable¹

Early, strong, and sustained clearance in nail psoriasis^2,3

Nail psoriasis results seen as early as Week 2^2*

Baseline^†

improvement in NAPSI^2‡

improvement in NAPSI³

First IL-antagonist with a dedicated trial in nail psoriasis⁴

Early, strong, and sustained visible results in hard-to-treat scalp psoriasis^5,6

Scalp psoriasis results seen as early as Week 3^5§

Baseline^||

First IL-antagonist with a dedicated trial in scalp psoriasis⁷

Faster onset vs IL-12/23 targeting agent in CLARITY⁸

5-year skin clearance in SCULPTURE Extension⁹

COSENTYX is the first
IL-17A antagonist with
5-year PsO efficacy and safety data in a phase 3 study.^10,11