For moderate to severe plaque psoriasis

For moderate to severe
plaque psoriasis
Complete Cosentyx approachComplete Cosentyx approach

  • 5-year efficacy and safety in PsO1,2
  • Effective in nail, scalp, and palmoplantar psoriasis3-8
  • Inhibits progression of joint structural damage in PsA9
  • Strong recaptured efficacy data10
  • Comprehensive support and broad access11

LauraLee
Actual COSENTYX patient since 2015

Psoriasis care is evolving:
See what your peers have to say

Skin results you can see

PASI 75 & 90 Skin Results PASI 75 & 90 Skin Results

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

In the 300 mg arm (n=245) of the ERASURE study at Week 129*:

82% of Patients Achieved PASI 75 of patients achieved PASI 75,
and of those, 70% achieved PASI 90

  • The majority of patients achieved clear or almost clear skin9*
  • Over 80% of patients on COSENTYX 300 mg in the ERASURE and FIXTURE studies who achieved PASI 75 at Week 12 sustained their response at Week 529‡

Click here for study design and details.

PASI=Psoriasis Area Severity Index.

*In ERASURE, % of patients achieving an end point on 150 mg (n=245) vs placebo (n=248) at Week 12: PASI 75 (71 vs 4), IGA 0 or 1 (51 vs 2), and PASI 90 (39 vs 1). In FIXTURE, results on 300 mg (n=327) vs placebo (n=326) at Week 12: PASI 75 (76 vs 5), IGA 0 or 1 (62 vs 3), and PASI 90 (54 vs 2). In FIXTURE, results on 150 mg (n=327) vs placebo at Week 12: PASI 75 (67 vs 5), IGA 0 or 1 (51 vs 3), and PASI 90 (42 vs 2).
At Week 12 in ERASURE, 65% of patients on COSENTYX 300 mg achieved IGA mod 2011 0 or 1 vs 2% of patients on placebo.
All comparisons, P<0.001. Results similar in FEATURE and JUNCTURE.9,12

In ERASURE, 59% of patients achieved PASI 90 on 300 mg vs 1% for placebo at Week 12.9

In the COSENTYX 300-mg treatment arm, 81% and 84% of patients in ERASURE and FIXTURE, respectively, who achieved PASI 75 at Week 12 sustained their response at Week 52. In the COSENTYX 150-mg treatment arm, 72% and 82% of patients in ERASURE and FIXTURE, respectively, who achieved PASI 75 at Week 12 sustained their response at Week 52.9

5-year results
demonstrate that skin clearance can last1

PASI 90 response rates were maintained from Year 1 to Year 51*
(as observed analysis)

PASI 90 Response Rates, Years 1-5 PASI 90 Response Rates, Years 1-5
The first IL-17A antagonist with 5-year PsO efficacy and safety data in a Phase III study2

IL-17A=interleukin-17A.

SCULPTURE core uncontrolled extension studies: In COSENTYX 300 mg FI group of the core study, patients received COSENTYX 300 mg every 4 weeks. PASI 75 responders at Week 12 were eligible to enter the maintenance period. 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 5.1

  • All 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 only.1
  • 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.

*Response rates at Year 1: PASI 75 (89%) and PASI 90 (69%).1

Click here for study design details and results of the SCULPTURE Core study.

Dedicated studies show
clearance is possible even in persistent troublesome areas

Effective in nail psoriasis3,4*

Nail Psoriasis Clearance Nail Psoriasis Clearance

Effective in scalp psoriasis5,6†

Scalp Psoriasis Clearance Scalp Psoriasis Clearance

Effective in palmoplantar plaque psoriasis7,8‡

Palmoplantar Plaque Psoriasis Palmoplantar Plaque Psoriasis

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

Click here to see study designs.

*Mean percent change from baseline in nail psoriasis severity index (NAPSI) score at Week 16 (primary end point): COSENTYX 300 mg: -46.1%; placebo: -11.7% (repeated measure analysis; P<0.0001). At Week 80: COSENTYX 300 mg: -68.7% (last observation carried forward [LOCF]).3,4

Psoriasis scalp severity index (PSSI) 90 response at Week 12 (primary end point): COSENTYX 300 mg: 52.9%; placebo: 2.0% (nonresponder imputation [NRI]; P<0.0001). Patients with missing assessment were considered nonresponders. PSSI 90 at Week 24 was 58.8% with COSENTYX 300 mg.4,5

Palmoplantar Investigator's Global Assessment (ppIGA) 0/1 response at Week 16 (primary end point): COSENTYX 300 mg: 33.3%; placebo: 1.5% (nonresponder imputation [NRI]; P<0.0001)7. At Week 80: COSENTYX 300 mg: 46.4% (NRI).7,8

An opportunity
to uncover PsA symptoms

Did you know: Up to 1/3 of patients with PsO may have PsA?13,14

If your patients answer yes to 3 or more questions,
this could be indicative of psoriatic arthritis15*

  • Have you ever had a swollen joint (or joints)?
  • Has a doctor ever told you that you have arthritis?
  • Do your fingernails or toenails have holes or pits?
  • Have you had pain in your heel?
  • Have you had a finger or toe that was completely
    swollen and painful for no apparent reason?

*Psoriasis Epidemiology Screening Tool (PEST) questionnaire.
PsA=psoriatic arthritis

Consider a PsO treatment proven effective in PsA and prescribe COSENTYX for appropriate patients

#1 Prescribed Biologic Therapy for PsA Patients in Rheumatology Starting/Switching Biologics in US#1 Prescribed Biologic Therapy for PsA Patients in Rheumatology Starting/Switching Biologics in US

Prescribed Biologic Therapy for PsA Patients in Rheumatology Starting/Switching Biologics in USPrescribed Biologic Therapy for PsA Patients in Rheumatology Starting/Switching Biologics in US

for PsA patients in rheumatology starting
or switching biologic agents in the US16†

NBRx Share for PsO/PsA/AS in rheumatology offices allocated using SHS PTD Factors where RA (rheumatoid arthritis) is carved out for TNFs. NBRx is New to Brand measure showing the volume of NPA Prescriptions associated with first-time use of a product. It reports prescriptions for patients who are starting therapy with a product for the first time within the previous 12 months.

Clinical trial results in patients with active PsA

In the pivotal trial FUTURE 2:

Majority of Patients Achieved ACR20 Response at Week 24Majority of Patients Achieved ACR20 Response at Week 24

(P<0.0001 for both Rx groups vs placebo)17

  • COSENTYX 300 mg (n=100): 54%
  • COSENTYX 150 mg (n=100): 51%
  • Placebo (n=98): 15%

Also shown in FUTURE 2:

Observed ACR Scores at 3 YearsObserved ACR Scores at 3 Years

Uncontrolled exploratory analysis as observed from baseline to 3 years, from the open-label phase of the study

  • COSENTYX 300 mg (n=81) ACR20: 75% ACR50: 54% ACR70: 31%
  • COSENTYX 150 mg (n=73)IIACR20: 70%ACR50: 38% ACR70: 25%

In the FUTURE 5 clinical trial, COSENTYX has been

Shown to Inhibit Progression of Joint Structural DamageShown to Inhibit Progression of Joint Structural Damage

COSENTYX reduced radiographic disease progression at Week 24 as measured by change in mTSS from baseline

  • COSENTYX 300 mg (n=217): 0.03
  • COSENTYX 150 mg# (n=213): 0.14
  • Placebo (n=296): 0.51

77% of patients treated with COSENTYX 300 mg had no structural disease progression over 24 weeks77% of patients treated with COSENTYX 300 mg had no structural disease progression over 24 weeks

  • 71% with COSENTYX 150 mg#
  • 68% with placebo

Please see the FUTURE 2 and FUTURE 5 study design details. ACR=American College of Rheumatology; NRI=nonresponder imputation; mTSS=modified Total Sharp Score.

§Except where noted, patients received an initial once-weekly X5 weeks loading dose followed by doses every 4 weeks.9

||COSENTYX 150 mg arm includes 31 patients who were up-titrated to 300 mg starting at Week 128, at the investigator's discretion.18

Results from a linear mixed effects model that excluded data after escape for placebo subjects who received escape therapy at Week 16. The model assumes approximately linear progression over time and estimates a difference in rates (slopes) of progression over 24 weeks to compare treatment arms.9

#Represents COSENTYX 150 mg with loading dose (LD).
Modified Total Sharp Score (mTSS) measures radiographic progression in the hands and feet and is expressed as the sum of two components: erosion scores and joint space narrowing.9
In FUTURE 5, separate radiographs of each hand/wrist and each foot were taken at baseline, Week 16, and Week 24. Bone erosion, joint space narrowing, and total radiographic scores were determined using a PsA-modified van der Heijde-Sharp scoring method that included the second through fifth distal interphalangeal joints of each hand.9,19
At baseline, mTSS was 12.9, 13.6, and 15 for 300 mg, 150 mg, and placebo, respectively.19

**No structural disease progression defined as a change from baseline mTSS less than or equal to 0.0.9

After a pause in therapy,
efficacy can be recaptured

95% of patients regained their PASI 75 response after retreatment with COSENTYX 300mg10*

95% of Patients Regained PASI 75 response after Retreatment with 300mg 95% of Patients Regained PASI 75 response after Retreatment with 300mg

12 weeks after relapse and initiation of retreatment in treatment withdrawal group in ERASURE and FIXTURE Extension study*

Click here to see study design details.

  • Of the PASI 75 responders, 70% achieved PASI 9010*

Median time to relapse was 28 weeks10*

*In placebo patients who relapsed and were retreated with COSENTYX 300 mg. Retreatment results are for patients retreated with COSENTYX after relapsing on placebo in the extension study (multiple imputation analysis). Relapse defined as loss of >50% of maximum PASI improvement compared to baseline of the core study.10

At Week 12, after relapse and retreatment, PASI 75 and PASI 90 were achieved by 82% and 50% of patients, respectively, in the COSENTYX 150-mg arm (n=123). Median time to relapse was 20 weeks for patients on placebo who were retreated with COSENTYX 150 mg.10

Demonstrated PsO
safety profile

PsO safety profile through Week 129

  • Infections were reported in 28.7% of patients on COSENTYX (n=1382) vs 18.9% on placebo (n=694)*
  • Serious infections occurred in 0.14% of patients treated with COSENTYX (n=1382) vs 0.3% of those receiving placebo (n=694)

Adverse reactions reported by >1% of patients with plaque psoriasis through Week 12 in pivotal trials9

Adverse Reactions of PsO Patients Treated with COSENTYX, Chart Adverse Reactions of PsO Patients Treated with COSENTYX, Chart

Inflammatory bowel disease in patients with PsO9

Inflammatory Bowel Disease in PsO Patients Treated with COSENTYX, Chart Inflammatory Bowel Disease in PsO Patients Treated with COSENTYX, Chart
  • There were no cases of inflammatory bowel disease in placebo patients (n=793). One case of exacerbation of Crohn's disease was reported from long-term noncontrolled portions of ongoing clinical trials in plaque PsO9

*Phase III data showed an increased trend for some types of infection with increasing serum concentration of COSENTYX, including Candida infections, herpes viral infections, staphylococcal skin infections, and infections requiring treatment.9

In a clinical study,

5 YEARS of experience: a consistent safety profile in PsO1,2†

COSENTYX Safety Profile through 5 Years, Chart COSENTYX Safety Profile through 5 Years, Chart

aPatient exposure is calculated as a sum of individual subject durations in days divided by 365 for each interval1; bDeath was due to MACE, which was not considered by the investigators to be related to study drug; patient had ≥2 preexisting MACE risk factors1; cOf the two cases of ulcerative colitis in Year 2, 1 case was an exacerbation of previously existing ulcerative colitis; d1 case of cholangiocarcinoma, 1 case of invasive ductal breast carcinoma; e1 case of breast cancer.1
A subject with multiple occurrences of the same AE in a one-year interval was counted only once, while a subject with multiple occurrences of the same AE in different year intervals was counted for each year.1

AE=adverse event; IR= incidence rate per 100 subject-years; MACE=major adverse cardiac event; NMSC= nonmelanoma skin cancer; SAE=serious adverse event; TB=tuberculosis; URTI=upper respiratory tract infection.

Safety data up to year 1 based on a post-hoc analysis of the SCULPTURE Core study in only those patients treated with 300 mg who achieved PASI 75 at Week 12, rerandomized to 300-mg FI arm, and reconsented at Week 52 to enter the Extension study. Year-1 to year-5 safety data are presented in this same patient subpopulation, thus not all patients who started with 300 mg in the Core study are included.

Includes neutropenia adverse events reported by investigators in the SCULPTURE study; does not include lab reports of neutropenia.

Consistent safety over time and across indications

In PsO at Week 12 and at 5 years1,2,9 In PsA at Week 16 and at 3 years9,18

Low immunogenicity

  • Neutralizing antibodies developed in less than 0.5% of patients at 1 year and were not associated with loss of efficacy

§The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.9

References: 1. 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):1507-1514.2. Data on file. CAIN457A2304E1 Clinical Study Report. Novartis Pharmaceuticals Corp; February 2018. 3. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015. 4. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp;September 2017. 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 Full Clinical Study Report. Novartis Pharmaceuticals Corp; March 2017. 7. Gottlieb AB, Sullivan J, van Doorn M, et al. Secukinumab shows significant efficacy in palmoplantar psoriasis: results from GESTURE, a randomized controlled trial. J Am Acad Dermatol. 2017;76(1):70-80. 8. Data on file. CAIN457A2312 Clinical Study Report. Novartis Pharmaceuticals Corp; July 2017. 9. Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2018. 10. Data on file. CAIN457A2302E1 Data Analysis Report. Novartis Pharmaceuticals Corp; November 2015. 11. Data on file. Novartis Formulary Access Tracker. Novartis Pharmaceuticals Corp; August 2018. 12. 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. 13. Alinaghi F, Calov M, Kristensen LE, et al. Prevalence of psoriatic arthritis in patients with psoriasis: A systematic review and meta-analysis of observational and clinical studies [published online ahead of print June 10, 2018]. J Am Acad Dermatol. pii: S0190-9622(18)32149-2. doi: 10.1016/j.jaad.2018.06.027. 14. Mease PJ, Gladman DD, Papp KA, et al. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol.2013;69(5):729-735. 15. Ibrahim GH, Buch MH, Lawson C, Waxman R, Helliwell PS. Evaluation of an existing screening tool for psoriatic arthritis in people with psoriasis and the development of a new instrument: the Psoriasis Epidemiology Screening Tool (PEST) questionnaire. Clin Exp Rheumatol. 2009;27(3):469-474. 16. Data on file. IQVIA NBRx Data February 2018 and SHS PTD (Patient Transactional data) from February 2018. Novartis Pharmaceuticals Corp; February 2018. 17. McInnes IB, Mease PJ, Kirkham B, et al. for the FUTURE 2 Study Group. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo controlled, phase 3 trial. Lancet. 2015;386(9999):1137-1146. 18. Data on file. CAIN457F2312 3-Year Interim Report. Novartis Pharmaceuticals Corp; September 2017. 19. Mease P, van der Hijde 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.

STUDY DESIGNS

ERASURE and FIXTURE

The ERASURE and FIXTURE studies were multicenter, randomized, double-blind, placebo-controlled trials. ERASURE evaluated adult patients who received COSENTYX 300 mg (n=245), COSENTYX 150 mg (n=245), or placebo (n=248). FIXTURE evaluated adult patients who received COSENTYX 300 mg (n=327), COSENTYX 150 mg (n=327), placebo (n=326), or a biologic active control (n=326). All patients were adults with moderate to severe plaque psoriasis who had a BSA ≥10%, PASI score ≥12, and IGA mod 2011 score ≥3, and were candidates for systemic therapy or phototherapy. Patients received COSENTYX dosing at Weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter. Patients randomized to receive placebo who were nonresponders at Week 12 (did not achieve PASI 75) were then rerandomized 1:1 to receive COSENTYX 300 mg or 150 mg (once weekly for 5 weeks, followed by once every 4 weeks thereafter). Patients were followed for up to 52 weeks. Coprimary end points were PASI 75 and IGA mod 2011 0 or 1 (clear or almost clear) response at Week 12, evaluated using NRI analysis.1-3

BSA=body surface area; IGA=Investigator's Global Assessment; PASI=Psoriasis Area and Severity Index.

ERASURE and FIXTURE Extension4

The ERASURE and FIXTURE Extension study was a multicenter, double-blind, randomized, withdrawal trial of COSENTYX in patients completing 52 weeks in either the ERASURE or FIXTURE core studies4

  • Patients who were treated with COSENTYX 300 mg or 150 mg during the maintenance period in either the ERASURE or FIXTURE core studies and who exhibited PASI 75 at Week 52 were eligible to be rerandomized 2:1 to continue the same COSENTYX dose or receive placebo (withdrawal from active treatment)4
  • Placebo patients who experienced relapse (defined as loss of >50% of maximum PASI improvement compared with baseline of the core study) at any visit were re-treated with 5 weekly doses of COSENTYX 300 mg or 150 mg, followed by 1 dose every 4 weeks4
  • Retreatment results are for patients re-treated with COSENTYX after relapsing on placebo in the ERASURE and FIXTURE Extension study4
  • Primary end point was loss of PASI 75 response from baseline (Week 52) up to Week 68. Other end points included PASI 50/75/90 and IGA mod 2011 0/1 response rates over time in patients who were PASI 75 responders at Week 52, and PASI 50/75/90 response rates over time in patients who were PASI 75 responders at Week 52 and re-treated with COSENTYX 300 mg or 150 mg after relapse on placebo4

Core studies ERASURE and FIXTURE

  • PASI 75 responders COSENTYX 300 mg (randomized withdrawal and/or retreatment period, Weeks 52, 104, 156)
    • - COSENTYX 300 mg (n=363)
    • - Placebo-COSENTYX 300 mg (re-treated with COSENTYX 300 mg upon relapse) (n=181)
  • PASI 75 responders COSENTYX 150 mg (randomized withdrawal and/or retreatment period, Weeks 52, 104, 156)
    • - COSENTYX 150 mg (n=301)
    • - Placebo-COSENTYX 150 mg (re-treated with COSENTYX 150 mg upon relapse) (n=150)

SCULPTURE

The SCULPTURE Core study 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 diagnosis of chronic plaque type psoriasis for at least 6 months prior to randomization, moderate to severe PsO defined as a BSA ≥10%, PASI score ≥12, and IGA mod 2011 score ≥3, and were candidates for systemic therapy or phototherapy. Patients were randomized to subcutaneous COSENTYX 300 mg (n=484) or 150 mg (n=482) initial dosing at Weeks 1, 2, 3, 4, and 8. At Week 12, patients achieving PASI 75 response were rerandomized to either the retreatment at SoR regimen where patients received COSENTYX at Week 12 and then every 4 weeks from the start of relapse (≥20% loss of maximum PASI score improvement vs baseline and a loss of PASI 75 response) until they achieved PASI 75 again (n=217, 300 mg; n=206, 150 mg) or the FI regimen (n=217, 300 mg; n=203, 150 mg) every 4 weeks. Patients in the FI groups received the same dose they received during the induction period: COSENTYX 150-mg patients continued to receive 150 mg COSENTYX every 4 weeks, and COSENTYX 300-mg patients continued to receive 300 mg COSENTYX every 4 weeks from Week 12 up to and including Week 48. The primary end point was noninferiority of the retreatment at SoR regimen vs the FI regimen for maintaining PASI 75 at Week 52 in PASI 75 responders at Week 12.
Results at Week 12 and 52: 90% of patients in the COSENTYX 300-mg arm achieved PASI 75 response at Week 12. At Week 52, 78% of patients who continued COSENTYX 300 mg every 4 weeks achieved PASI 75 and 60% of patients achieved PASI 90. At Week 12, PASI 75 was achieved by 84% of patients receiving COSENTYX 150 mg. At Week 52, PASI 75 was achieved in 68%, 62%, and 52% of patients in the COSENTYX 300 mg retreatment at SoR, COSENTYX 150 mg FI, and COSENTYX 150 mg retreatment at SoR regimens, respectively. The primary end point was not met.5

BSA=body surface area; FI=fixed interval; IGA=Investigator's Global Assessment; PASI=Psoriasis Area and Severity Index; SoR=start of relapse.

SCULPTURE Extension

The SCULPTURE Extension study was a multicenter, uncontrolled, double-blind, and open-label (from Week 156 through Week 260) study (N=642). 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 (n=168, COSENTYX 300 mg FI; n=152, COSENTYX 150 mg FI; n=172, COSENTYX 300 mg SoR; n=150, COSENTYX 150 mg SoR). 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). Results shown are for COSENTYX 300-mg FI patients who were followed for up to 260 weeks. Primary objective was to assess long-term safety and tolerability of COSENTYX in patients who completed treatment in the core study. Other objectives included efficacy over time with respect to PASI 75/90.6

FI=fixed interval; PASI=Psoriasis Area and Severity Index; SoR=start of relapse

TRANSFIGURE7

TRANSFIGURE was a double-blind, randomized, placebo-controlled study examining the safety and efficacy of COSENTYX in patients with moderate to severe nail psoriasis. All patients were adults with chronic moderate to severe plaque psoriasis (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.

Patients were randomized to one of three arms: COSENTYX 300 mg (n=66), COSENTYX 150 mg (n=67), or placebo (n=65).7

Initial dosing was once weekly for 5 weeks and maintenance dosing was once every 4 weeks, from Week 8 through Week 128. At Week 16, patients initially receiving placebo were rerandomized 1:1 to COSENTYX 150 mg or COSENTYX 300 mg, with an initial dose of once weekly for 5 weeks followed by once every 4 weeks.7

Primary end point was NAPSI assessment at Week 16; other end points included NAPSI response over time up to Week 132.7

BSA=body surface area; NAPSI=Nail Psoriasis Severity Index; PASI=Psoriasis Area and Severity Index.

Scalp Study1,8

The Scalp study was a multicenter, double-blind, randomized, placebo-controlled study examining the safety and efficacy of COSENTYX in patients with moderate to severe scalp psoriasis. All patients were adults with chronic scalp psoriasis with or without plaque psoriasis elsewhere on the body for at least 6 months prior to randomization, and had moderate to severe scalp psoriasis defined as: PSSI score ≥12 AND Investigator's Global Assessment modified 2011 (IGA mod 2011; scalp only) score ≥3 AND ≥30% scalp surface area affected. All patients were candidates for systemic therapy.1,8

Patients were randomized to either COSENTYX 300 mg (n=51) or placebo (n=51).1,8

Initial dosing was once weekly for 5 weeks and maintenance dosing was once every 4 weeks, from Week 8 through Week 20. At Week 12, patients initially receiving placebo who did not achieve a PSSI 90 response were switched to COSENTYX 300 mg: 4 weekly doses at Weeks 12, 13, 14, and 15 and every 4 weeks thereafter at Weeks 16 and 20. Patients who achieved response while receiving placebo continued receiving placebo through Week 20. 1,8

Primary end point was PSSI 90 response rate at Week 12. Other end points included IGA mod 2011 0/1 (scalp only) at Week 12.1,8

IGA=Investigator's Global Assessment; PSSI=Psoriasis Scalp Severity Index.

GESTURE9

GESTURE was a randomized, double-blind, placebo-controlled multicenter study in patients with moderate to severe palmoplantar plaque psoriasis. All patients were adults with plaque type psoriasis, including moderate to severe psoriasis for at least 6 months, with significant involvement of palms and soles as defined by a ppIGA score of ≥3 and at least 1 extra palmoplantar plaque on the skin. Patients were required to be candidates for systemic therapy.9

Patients were randomized to one of three arms: COSENTYX 300 mg (n=69), COSENTYX 150 mg (n=68), or placebo (n=68).9

Initial dosing once weekly for 5 weeks, maintenance dosing: once every 4 weeks.

Patients in the placebo arm who were not ppIGA responders (did not achieve a ppIGA 0/1 and at least a 2-point reduction from baseline) were randomized to receive either COSENTYX 300 mg or 150 mg starting at Week 16 visit (5 weekly doses, followed by every 4 weeks thereafter). Placebo patients who were not ppIGA 0/1 responders by Week 76 were rerandomized to receive either COSENTYX 300 mg or 150 mg starting at Week 80.9

The primary end point was the proportion of patients achieving ppIGA 0/1 response and a reduction of at least 2 points from baseline on the ppIGA scale at Week 16. Secondary end points included ppIGA and ppPASI responses over time to Week 16 compared to placebo, and over time up to Week 132.9

ppIGA=palmoplantar Investigator's Global Assessment; ppPASI=palmoplantar Psoriasis Area Severity Index.

FUTURE 21,10-13

FUTURE 2 is an ongoing, phase 3, multicenter, randomized, double-blind, placebo-controlled trial that is evaluating 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 were randomized in a 1:1:1 ratio to receive COSENTYX 150 mg, 300 mg, or placebo subcutaneously at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks. Patients who received placebo were rerandomized (1:1) to COSENTYX 150 mg or 300 mg every 4 weeks, at Week 16 or Week 24, based on responder status.1,10

  • The primary end point was the percentage of patients with ACR20 response at Week 2410
  • After Week 24, patients knew they were taking the active treatment but remained blind to the dose until after 1 year. After 1 year, patients were unblinded and continued to receive the same active dose as open-label treatment and were assessed every 8 weeks through 2 years and every 12 weeks from 2 years to 4 years10
  • Starting at Week 128, patients whose signs and symptoms were not fully controlled and might improve further with an increase in dose as judged by the investigator, were updosed from 150-mg dose to 300-mg dose. At Week 208, 45 patients from the 150-mg dose arm had been updosed to 300 mg11,12
  • 75-mg arm was included in this study, but not shown and is not an approved dose1
  • Study population was mixed: two-thirds of patients were anti-TNFα-naÏve and one-third were anti-TNFα experienced (patients could have been exposed to up to 3 different TNFα inhibitors)10
  • 44% of patients treated with COSENTYX were treated with concomitant MTX at baseline10

ACR=American College of Rheumatology; DMARDs=disease-modifying antirheumatic drugs; NSAIDs=nonsteroidal anti-inflammatory drugs; PsA=psoriatic arthritis; TNF=tumor necrosis factor.

FUTURE 51,14-16

FUTURE 5 is an ongoing, phase 3, multicenter, randomized, double-blind, placebo-controlled trial that is evaluating 996 adult patients with active PsA. Patients were randomized in a 2:2:2:3 ratio to receive COSENTYX 150 mg without load (n=222), 150 mg with load (n=220), 300 mg with load (n=222), or placebo (n=332) subcutaneously at Weeks 0, 1, 2, and 3, followed by the same dose every 4 weeks. Patients who received placebo were rerandomized (1:1) to receive COSENTYX (either 150 mg or 300 mg every 4 weeks) based on responder status at Week 16 (nonresponders) or Week 24 (responders).14

  • The primary end point was the percentage of patients with ACR20 response at Week 16 14
  • After Week 24, patients knew they were taking the active treatment but remained blind to the dose until after 1 year
  • Secondary end points included change in mTSS score at Week 24 from baseline, ACR50 response, proportion of patients with dactylitis and enthesitis, and overall safety and tolerability14
  • Study population was mixed: more than two-thirds of patients were anti-TNFα-naÏve and less than one-third were anti-TNFα experienced (patients could have been exposed to up to 3 different TNFα inhibitors)14

ACR=American College of Rheumatology; mTSS=modified Total Sharp Score; PsA=psoriatic arthritis; TNF=tumor necrosis factor.

References: 1. Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2018. 2. Data on file. AIN457A2302 Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013. 3. Data on file. AIN457A2303 Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013. 4. Data on file. CAIN457A2302E1 Clinical Study Report. Novartis Pharmaceuticals Corp; May 2018. 5. Data on file. CAIN457A2304 Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013. 6. Data on file. Clinical Study Report. CAIN457A2304E1. Novartis Pharmaceuticals Corp; February 2018. 7. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals; November 2015. 8. Data on file. CAIN457AUS01 Clinical Study Report. Novartis Pharmaceuticals Corp; February 2017. 9. Data on file. CAIN457A2312 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015. 10. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014. 11. Data on file. CAIN457F2312 (FUTURE 2): 3-Year Interim Study Report. Novartis Pharmaceuticals Corp; September 2017. 12. Data on file. CAIN457F2312 (FUTURE 2): 4-Year Interim Report. Novartis Pharmaceuticals Corp; 2018. 13. McInnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015;386:1137-46. 14. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis at Week 24. Novartis Pharmaceuticals Corp; November 2017. 15. 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. 16. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis - Week 52. Novartis Pharmaceuticals Corp; 2018.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

CONTRAINDICATIONS

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients.


WARNINGS AND PRECAUTIONS

Infections

COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in subjects treated with COSENTYX compared to placebo-treated subjects.

INDICATIONS

COSENTYX® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

COSENTYX is indicated for the treatment of adult patients with active psoriatic arthritis.

COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis.


IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients.


WARNINGS AND PRECAUTIONS

Infections

COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in subjects treated with COSENTYX compared to placebo-treated subjects. In placebo-controlled clinical trials in patients with moderate to severe plaque psoriasis, 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 with COSENTYX compared with placebo. A similar increase in risk of infection was seen in placebo- controlled trials in patients with psoriatic arthritis and ankylosing spondylitis. The incidence of some types of infections appeared to be dose-dependent in clinical studies. 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, the patient should be closely monitored and COSENTYX should be discontinued until the infection resolves.


Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Do not administer 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. Patients receiving COSENTYX should be monitored closely for signs and symptoms of active TB during and after treatment.


Inflammatory Bowel Disease

Caution should be used when prescribing COSENTYX to patients with inflammatory bowel disease. Exacerbations, in some cases serious, occurred in patients treated with COSENTYX during clinical trials in plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. In addition, new onset inflammatory bowel disease cases occurred in clinical trials with COSENTYX. In an exploratory study in 59 patients with active Crohn's disease, there were trends toward greater disease activity and increased adverse events in the secukinumab group as compared to the placebo group. Patients who are treated with COSENTYX should be monitored for signs and symptoms of inflammatory bowel disease.


Hypersensitivity Reactions

Anaphylaxis and cases of urticaria occurred in patients treated with COSENTYX in clinical trials. If an anaphylactic or other serious allergic reaction occurs, administration of COSENTYX should be discontinued immediately and appropriate therapy initiated.

The removable cap of the COSENTYX Sensoready® pen and the COSENTYX prefilled syringe contains 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.


Vaccinations

Prior to initiating therapy with COSENTYX, consider completion of all age appropriate immunizations according to current immunization guidelines. Patients treated with COSENTYX should not receive live vaccines.

Non-live vaccinations received during a course of COSENTYX may not elicit an immune response sufficient to prevent disease.


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.

+ -

IMPORTANT SAFETY INFORMATION AND INDICATIONS

CONTRAINDICATIONS

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients.

INDICATIONS

COSENTYX® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

COSENTYX is indicated for the treatment of adult patients with active psoriatic arthritis.

COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis.


IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients.


WARNINGS AND PRECAUTIONS

Infections

COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in subjects treated with COSENTYX compared to placebo-treated subjects. In placebo-controlled clinical trials in patients with moderate to severe plaque psoriasis, 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 with COSENTYX compared with placebo. A similar increase in risk of infection was seen in placebo- controlled trials in patients with psoriatic arthritis and ankylosing spondylitis. The incidence of some types of infections appeared to be dose-dependent in clinical studies. 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, the patient should be closely monitored and COSENTYX should be discontinued until the infection resolves.


Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Do not administer 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. Patients receiving COSENTYX should be monitored closely for signs and symptoms of active TB during and after treatment.


Inflammatory Bowel Disease

Caution should be used when prescribing COSENTYX to patients with inflammatory bowel disease. Exacerbations, in some cases serious, occurred in patients treated with COSENTYX during clinical trials in plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. In addition, new onset inflammatory bowel disease cases occurred in clinical trials with COSENTYX. In an exploratory study in 59 patients with active Crohn's disease, there were trends toward greater disease activity and increased adverse events in the secukinumab group as compared to the placebo group. Patients who are treated with COSENTYX should be monitored for signs and symptoms of inflammatory bowel disease.


Hypersensitivity Reactions

Anaphylaxis and cases of urticaria occurred in patients treated with COSENTYX in clinical trials. If an anaphylactic or other serious allergic reaction occurs, administration of COSENTYX should be discontinued immediately and appropriate therapy initiated.

The removable cap of the COSENTYX Sensoready® pen and the COSENTYX prefilled syringe contains 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.


Vaccinations

Prior to initiating therapy with COSENTYX, consider completion of all age appropriate immunizations according to current immunization guidelines. Patients treated with COSENTYX should not receive live vaccines.

Non-live vaccinations received during a course of COSENTYX may not elicit an immune response sufficient to prevent disease.


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.