For moderate to severe plaque psoriasis

For moderate to severe
plaque psoriasis
A complete patient approach to long-lasting results

  • 5-year efficacy and safety in PsO1-4
  • Effective in nail, scalp, and palmoplantar psoriasis5-7
  • Inhibits progression of joint structural damage in PsA8-10
  • Strong recaptured efficacy data11
  • Comprehensive support and broad access12

Lauralee
Actual COSENTYX patient since 2015

Skin Results You Can SeeSkin 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.

In the 300-mg arm (n=245) of the ERASURE study at Week 121*:

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 skin1*
  • 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 521‡

Click here for study design and details.

*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<0.0001. Results similar in FEATURE and JUNCTURE.1,13

In ERASURE, 59% of patients achieved PASI 90 on 300 mg vs 1% for placebo at Week 12.1

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 52.1

5-Year Results Demonstrate that Skin Clearance Can Last5-Year Results Demonstrate that Skin Clearance Can Last

PASI 90 response rates were maintained from Year 1 to Year 52,4*
(as observed analysis)

PASI 90 Response Rates, Years 1-5 PASI 90 Response Rates, Years 1-5

SCULPTURE uncontrolled extension: Patients received COSENTYX 300 mg every 4 weeks. PASI 75 responders at Week 12 were eligible to enter the maintenance period (90% of patients in the 300-mg arm achieved PASI 75 at Week 12 [nonresponder imputation]). At Week 52, patients could continue in the extension regardless of PASI 75 response.2,3

  • All data presented are as observed-patients with missing data at a specific time point are not included in the analysis2,3
  • 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: PASI 90 at Year 1 (68.5%) and Year 5 (65.9%).4

Click here for study design details and results.

The first IL-17A antagonist with 5-year
PsO efficacy and safety data in a Phase III study1,4

Dedicated Studies Show Clearance is Possible even in Persistent Troublesome AreasDedicated Studies Show Clearance is Possible even in Persistent Troublesome Areas

Effective in nail psoriasis5*

Nail Psoriasis Clearance Nail Psoriasis Clearance

Effective in scalp psoriasis6†

Scalp Psoriasis Clearance Scalp Psoriasis Clearance

Effective in palmoplantar plaque psoriasis7‡

Palmoplantar Plaque Psoriasis in Hand & Foot Clearance Palmoplantar Plaque Psoriasis in Hand & Foot Clearance

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 NAPSI score at Week 16 (Primary Endpoint): COSENTYX 300 mg: -46.1%; placebo: -11.7% (repeated measure analysis; P<0.0001). At Week 80: COSENTYX 300 mg: -68.7% (LOCF).5

PSSI 90 response at Week 12 (Primary Endpoint): COSENTYX 300 mg: 52.9%; placebo: 2.0% (NRI; P<0.001).6

ppIGA 0/1 response at Week 16 (Primary Endpoint): COSENTYX 300 mg: 33.3%; placebo: 1.5% (NRI; P<0.0001). At Week 80: COSENTYX 300 mg: 46.4% (NRI).7

An Opportunity to Uncover PsA SymptomsAn Opportunity to Uncover PsA Symptoms

Did you know: 1/3 of patients with PsO have PsA?14,15

If your patients answer yes to 3 or more questions,
this could be indicative of psoriatic arthritis16*

  • 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.

Consider a PsO treatment proven effective in PsA

#1

#1 Prescribed Biologic Therapy for PsA Patients#1 Prescribed Biologic Therapy for PsA Patients

for PsA patients in rheumatology starting
or switching biologic agents in the US17†

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.

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)§

  • 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, 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 mTSS8#**

  • COSENTYX 300 mg (n=217): 0.08 (P<0.0011)
  • COSENTYX 150 mg (n=213): 0.17 (P=0.0117)
  • Placebo (n=296): 0.50

Click here for study design details and results. NRI: non-responder imputation.

§All patients received an initial once-weekly X5 weeks loading dose followed by doses every 4 weeks.1

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

#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.8

**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.8

After a Pause in Therapy, Efficacy can be RecapturedAfter a Pause in Therapy, Efficacy can be Recaptured

95% of patients regained their PASI 75 response after retreatment with Cosentyx 300mg11*

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

n=136 (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 9011*

Median time to relapse was 28 weeks11*

*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.11

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.11

Demonstrated PsO Safety ProfileDemonstrated PsO Safety Profile

PsO safety profile through Week 121

  • 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 trials1

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

Inflammatory bowel disease in patients with PsO1

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 PsO.1

*Phase III data showed an increased trend for some types of infection with increasing serum concentrations of COSENTYX, including Candida infections, herpes viral infections, staphylococcal skin infections, and infections requiring treatment.1

In a clinical study,

5 Years of Experience: A Consistent Safety Profile in PsO 5 Years of Experience: A Consistent Safety Profile in PsO

a consistent safety profile in PsO2,4

In a 300-mg fixed interval dose

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

aPatient years is calculated as a sum of individual subject durations in days divided by 365 for each interval; bDeath was due to MACE, which was not considered by the investigators to be related to study drug; patient had ≥2 pre-existing MACE risk factors; c1 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; 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.

AE: adverse event; IR: incidence rate per 100 subject-years; N: the number of patients exposed to the therapy with yearly (365 days) cut off; NMSC: nonmelanoma skin cancer; SAE: serious adverse event; TB: tuberculosis; URTI: upper respiratory tract infection.

Adverse events reported by investigators.

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 through Week 12 and through 5 years1,4 In PsA through Week 16 and through 3 years1,19

Getting Patients Started on COSENTYX just got EasierGetting Patients Started on COSENTYX just got Easier

Enhanced Specialty
Pharmacy Network (ESPN)

A single point of contact for the HCP,
from Rx receipt through dispense

Benefits:

  • Facilitates enrollment of eligible PA-denied patients into the Covered Until You're Covered Program without the requirement for an SRF
  • Informs you of the patient's status if the prescription is transferred to a payer-mandated specialty pharmacy
  • Uninsured or underinsured patients will be connected to the Novartis Patient Assistance Program to see if they are eligible for financial assistance

A complete list of the Enhanced Specialty Pharmacy Network is available through your Novartis representative. Enhanced Specialty Pharmacy Network providers can directly enroll eligible patients into the Covered Until You're Covered Program without the need for a Service Request Form. Eligible patients using other network specialty pharmacy providers require a completed Service Request Form sent to COSENTYX Connect to access the program.

150+ Specialty
Pharmacy Providers

Broad availability to get COSENTYX
that is convenient for you

Benefits:

  • Choose from our broad network of pharmacies
  • Flexibility in prescribing
  • Access to the Covered Until You're Covered Program via COSENTYX Connect

Patients can also be prescribed COSENTYX via a Service Request Form referred directly to COSENTYX Connect, if preferred.

Download SRF View sample of completed SRF

Covered Until You're Covered Program: Eligible patients must have commercial insurance, a valid prescription for COSENTYX, and a denial of insurance coverage based on a prior authorization request. Program requires the submission of an appeal of the coverage denial within the first 90 days of enrollment in order to remain eligible. Program provides initial 5 weekly doses (if prescribed) and monthly doses for free to patients for up to two years or until they receive insurance coverage approval, whichever occurs earlier. Program is not available to patients whose medications are reimbursed in whole or in part by Medicare, Medicaid, Tricare, or any other federal or state program. Patients may be asked to re-verify insurance coverage status during the course of the program. No purchase necessary. Program is not health insurance, nor is participation a guarantee of insurance coverage. Limitations may apply. Enrolled patients awaiting coverage for COSENTYX after two years may be eligible for a limited Program extension. Novartis Pharmaceuticals Corporation reserves the right to rescind, revoke, or amend this Program without notice. Program enrollment must occur by [12/31/18].

Broad coverage: available for more than

213 MILLION COVERED LIVES12

$0 CO-PAY

for commercially
insured patients*

*Limitations apply. For those commercially insured and 18 years or older. Up to a $16,000 annual cap. Patient will be responsible for any co-pay once limit is reached in a calendar year. This offer is not valid under Medicare, Medicaid, or any other federal or state program. Not valid for cash-paying patients. Novartis reserves the right to rescind, revoke, or amend this program without notice. Enrollment expires 12/31/18.

STUDY DESIGNS

The ERASURE study was a multicenter, randomized, double-blind, placebo-controlled trial of 738 patients.1

  • All patients were adults with moderate to severe plaque psoriasis who had a BSA ≥10%, PASI score ≥12, IGA mod 2011 score ≥3, and were candidates for systemic therapy or phototherapy1
  • All patients were followed for up to 52 weeks1
  • Coprimary end points were the proportion of subjects who achieved a reduction in PASI score of ≥75% (PASI 75) from baseline to Week 12 and treatment success (clear or almost clear) on the IGA mod 2011 at Week 121
  • Other evaluated outcomes included the proportion of subjects who achieved a reduction in PASI score of ≥90% (PASI 90) from baseline at Week 12, maintenance of efficacy (PASI 75 and IGA clear or almost clear) to Week 52 in patients who were responders at Week 12, and improvements in itching, pain, and scaling at Week 12 based on the Psoriasis Symptom Diary20
  • Initial dosing: once weekly for 5 weeks; maintenance: once every 4 weeks, Week 8 through 48.1
  • Placebo nonresponders (who did not achieve PASI 75 at Week 12) were rerandomized 1:1 to COSENTYX 150 mg or COSENTYX 300 mg.1

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

The FIXTURE study was a multicenter, randomized, double-blind, placebo-controlled trial of 1306 patients.1

  • All patients were adults with moderate to severe plaque psoriasis who had a BSA ≥10%, PASI score ≥12, IGA mod 2011 score ≥3, and were candidates for systemic therapy or phototherapy1
  • All patients were followed for up to 52 weeks1
  • Coprimary end points were the proportion of subjects who achieved a reduction in PASI score of ≥75% (PASI 75) from baseline to Week 12 and treatment success (clear or almost clear) on the IGA mod 2011 at Week 121
  • Other evaluated outcomes included the proportion of subjects who achieved a reduction in PASI score of ≥90% (PASI 90) from baseline at Week 12, maintenance of efficacy (PASI 75 and IGA clear or almost clear) to Week 52 in patients who were responders at Week 12, and improvements in itching, pain, and scaling at Week 12 based on the Psoriasis Symptom Diary.21
  • Initial dosing: once weekly for 5 weeks; maintenance: once every 4 weeks, Week 8 through 48.1
  • Placebo nonresponders (who did not achieve PASI 75 at Week 12) were rerandomized 1:1 to COSENTYX 150 mg or COSENTYX 300 mg.1

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

SCULPTURE 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.3

  • All patients had a BSA ≥10%, PASI score ≥12, IGA mod 2011 score ≥3, and were candidates for systemic therapy or phototherapy
  • The primary end point was noninferiority of the retreatment at SoR regimen vs the FI regimen for maintaining PASI 75 at Week 52
    Results - Weeks 12 and 52
  • At Week 12, 90% of patients in the 300-mg arm achieved PASI 75, and at Week 52, 78% and 60% of patients who continued COSENTYX 300 mg every 4 weeks maintained PASI 75 and PASI 90, respectively
  • At Week 12, PASI 75 was achieved by 84% of patients receiving COSENTYX 150 mg. At Week 52, PASI 75 was maintained 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
  • Initial dosing at baseline and Weeks 1, 2, 3, 4, and 8
  • 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.

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

The SCULPTURE extension study is a multicenter, double-blind and open-label (from Week 156 through Week 260) extension study.4

  • Patients who completed 52 weeks of the SCULPTURE 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)
  • Results shown are for COSENTYX 300 mg FI patients who were followed for up to 208 weeks
  • Primary and secondary end points were long-term safety and PASI 75/90 responses over time in PASI 75 responders at Week 12 from the core study, respectively
  • Patients could switch regimens based on investigator judgment

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

TRANSFIGURE was a double-blind, randomized, placebo-controlled study examining the safety and efficacy of COSENTYX in patients with moderate to severe nail psoriasis.5

  • All patients were adults with 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 therapy5
  • Primary end point: NAPSI assessment at Week 165
  • Secondary end points included NAPSI response up to Week 1325
  • Initial dosing: once weekly for 5 weeks; maintenance: once every 4 weeks, Weeks 8 through 128.5
  • 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.5

BSA=body surface area; NAPSI=Nail Psoriasis Severity Index; PASI=Psoriasis Area and Severity Index; PsO=plaque psoriasis; R=randomization.

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.6

  • 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:6
    • PSSI score ≥12 AND
    • Investigator's Global Assessment, 2011 modified version (IGA mod 2011; scalp only) score ≥3 AND
    • ≥30% of scalp surface area affected
  • Primary end point: PSSI 90 response rate at Week 126
  • All patients were candidates for systemic therapy6
  • Other end points included IGA mod 2011 0/1 (scalp only) at Week 126
  • Initial dosing: once weekly for 5 weeks; maintenance: once every 4 weeks, Weeks 8 through 20.6

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

GESTURE was a randomized, double-blind, placebo-controlled multicenter study in patients with moderate to severe palmoplantar plaque psoriasis.7

  • 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 skin7
  • Patients were required to be candidates for systemic therapy7
  • 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 167
  • Secondary end points included ppIGA and ppPASI responses to Week 167
  • 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).7
  • Placebo patients who were not ppIGA 0/1 responders by Week 76 were rerandomized to receive either COSENTYX 300 mg or COSENTYX 150 mg starting at Week 80.7

BSA=body surface area; IGA=Investigator's Global Assessment; NR=nonresponders; PASI=Psoriasis Area and Severity Index; ppIGA=Palmoplantar Investigator's Global Assessment; ppPASI=Palmoplantar Psoriasis Area Severity Index; PsO=plaque psoriasis; R=randomization.

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 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 to COSENTYX 150 mg or 300 mg every 4 weeks at Week 16 or Week 24 based on responder status.1,18

  • The primary end point was the percentage of patients with ACR20 response at Week 24. 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 through 3 years. Starting 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 up-dosed from 150-mg dose to 300-mg dose. At Week 156, 31 patients from the 150-mg dose had been up-dosed to 300 mg1,18,22,23
  • 75-mg dose included in study but not shown18
  • Study population was mixed: 2/3 of patients were anti-TNF-α naive and 1/3 were anti-TNF-α experienced1
  • 44% of patients treated with COSENTYX were treated with concomitant methotrexate at baseline18

ACR=American College of Rheumatology; BMI=body mass index; BSA=body surface area; DMARDs=disease-modifying antirheumatic drugs; HAQ-DI=Health Assessment Questionnaire- Disability Index; NSAIDs=nonsteroidal anti-inflammatory drugs; PsA=psoriatic arthritis; R=randomization; SJC=swollen joint count; TJC=tender joint count; TNF=tumor necrosis factor.

FUTURE 5 was a phase III, multicenter, randomized, double-blind, placebo-controlled trial that evaluated 996 adult patients with active PsA. Patients were randomized 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). Patients who received placebo were rerandomized to receive COSENTYX (either 150 mg or 300 mg every 4 weeks) based on responder status at Week 16 (nonresponders) or Week 24 (responders).8

  • The primary end point was the percentage of patients with ACR20 response at Week 168
  • Secondary end points included change in mTSS score at Week 24 from baseline, ACR50 response at Week 16, proportion of patients with dactylitis and enthesitis changes from baseline, and overall safety and tolerability8
  • Study population was mixed: more than 2/3 of patients were anti-TNF-α naive and less than 1/3 were anti-TNF-α experienced8

ACR=American College of Rheumatology; BSA=body surface area; BMI=body mass index; HAQ-DI=Health Assessment Questionnaire-Disability Index; mTSS=modified Total Sharp Score; PsA=psoriatic arthritis; R=randomization; SJC=swollen joint count; TJC=tender joint count; TNF=tumor necrosis factor

The ERASURE and FIXTURE extension study is a multicenter, double-blind, randomized, uncontrolled, withdrawal study of COSENTYX in patients completing 52 weeks in the ERASURE and FIXTURE studies.11

  • Patients treated with COSENTYX 300 mg or 150 mg during the maintenance period in either the ERASURE or FIXTURE core studies and 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)11
  • Placebo patients who experienced relapse (defined as loss of >50% of maximum PASI improvement compared to baseline of the core study) at any visit were retreated with 5 weekly doses of COSENTYX 300 mg (n=136) or 150 mg (n=123), followed by 1 dose every 4 weeks11
  • Retreatment results are for patients retreated with COSENTYX after relapsing on placebo in the extension (multiple imputation analysis)11
  • 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 or 1 response rates over time, proportion of patients who relapsed, and PASI 50/75/90 response rates over time in patients who were retreated with COSENTYX 300 mg or 150 mg after relapse on placebo11

IGA=Investigator's Global Assessment; PASI=Psoriasis Area and Severity Index; R=randomization.

References:
1. Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2018. 2. Data on file. 4-Year Interim Report: Study CAIN457A2304E1. Novartis Pharmaceuticals Corp; December 2016. 3. Data on file. CAIN457A2304 Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013. 4. Data on file. CAIN457A2304E1. Novartis Pharmaceuticals Corp; September 2017. 5. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015. 6. Data on file. CAIN457AUS01 Clinical Study Report. Novartis Pharmaceuticals Corp; February 2017. 7. Data on file. CAIN457A2312 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015. 8. Data on file. CAIN457F2342 Interim Analysis Clinical Study Report Week 24. Novartis Pharmaceuticals Corp; November 2017. 9. Mease P, McInnes I, Kirkham B, et al. Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis. N Engl J Med. 2015;373(14):1329-1339.
10. Mease P, McInnes I. Secukinumab: a new treatment option for psoriatic arthritis. Rheumatol Ther. 2016;3(1):5-29. 11. Data on file. Data Analysis Report: Study CAIN457A2302E1. Novartis Pharmaceuticals Corp. December 2, 2015. 12. Data on file. Novartis Formulary Access Tracker. Novartis Pharmaceuticals Corp; March 2018. 13. 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. 14. National Psoriasis Foundation. Psoriatic arthritis. http://www.psoriasis.org/psoriatic-arthritis. Accessed August 31, 2017. 15. Mease P, Gladman D, Papp K, 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 16. 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. 17. Data on file. IQVIA NBRx Data Dec 2017 and SHS PTD (Patient Transactional data) from Dec 2017. Novartis Pharmaceuticals Corp; Dec 2017. 18. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014. 19. Data on file. CAIN457F2312 Interim Summary Report. Novartis Pharmaceuticals Corp; Sept 2017. 20. Data on file. AIN457A2302 Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013. 21. Data on file. AIN457A2303 Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013. 22. Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015. 23. Data on file. CAIN457F2312 (FUTURE 2): 3-Year Interim Report. Novartis Pharmaceuticals Corp; September 2017.

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.

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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.