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Individual results may vary. Darren was compensated for his time. Child shown is not Darren's actual daughter.

 
Nearly 4 out of 5 patients present with more than 1 key clinical manifestation of PsA5
 

In the FUTURE 2 clinical trial, in a mixed population: 2/3 biologic-naive and 1/3 anti–TNF-α inadequate responders6

 
In FUTURE 5, in a mixed population: more than 2/3 biologic-naive and less than 1/3 anti–TNF-α inadequate responders, ACR20 responses at Week 16 (primary end point) were 63% for COSENTYX 300 mg (n=222; P<0.0001), 56% for COSENTYX 150 mg (n=220; P<0.0001), and 27% for placebo (n=332).8
 
ENTHESITIS8
Complete resolution (LEI=0) in patients with enthesitis at baseline (NRI):
  • 56% for COSENTYX 300 mg (n=140)
  • 55% for COSENTYX 150 mg (n=141)
  • 35% for placebo (n=192)
    •  
DACTYLITIS8
Complete resolution (LDI=0) in patients with dactylitis at baseline (NRI):
  • 66% for COSENTYX 300 mg (n=82)
  • 57% for COSENTYX 150 mg (n=80)
  • 32% for placebo (n=124)
    •  
SKIN8
Patients who achieved PASI 90 (NRI):
  • 54% for COSENTYX 300 mg (n=110)
  • 37% for COSENTYX 150 mg (n=125)
  • 9% for placebo (n=162)
    •  
NAIL8*
Reduction in nail disease (mNAPSI as observed) response rates were:
  • 51% for COSENTYX 300 mg (n=125)
  • 53% for COSENTYX 150 mg (n=128)
  • 11% for placebo (n=203)
*
Nail data in PsA were consistent with those in the dedicated nail PsO study, TRANSFIGURE. Improvement from baseline NAPSI at Week 16 (primary end point) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).9
At baseline, mNAPSI scores were 18.0 and 17.8 in the 300-mg and 150-mg arms, respectively. At Week 16, mNAPSI scores were 8.8 and 8.4 in the 300-mg and 150-mg arms, respectively.8
 
ACR=American College of Rheumatology; LDI=Leeds Dactylitis Index; LEI=Leeds Enthesitis Index; mNAPSI=modified Nail Psoriasis Severity Index; NAPSI=Nail Psoriasis Severity Index; NRI=nonresponder imputation; PASI=Psoriasis Area and Severity Index; PsA=psoriatic arthritis; PsO=plaque psoriasis; TNF=tumor necrosis factor.
 
Please see FUTURE 2, FUTURE 5, and TRANSFIGURE study design details.
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In FUTURE 5
 

Fast relief as early as Week 21

 
ACR20 responses at Week 2 in a mixed population (exploratory analysis)1
 
FUTURE 5: ACR20 response at Week 2 in the mixed population is an exploratory end point. No clinical or statistical conclusions can be drawn.
 
ACR50: Up to 47% response achieved at Week 24 in biologic-naive patients8
 
47 Percent of Patients Achieved ACR50 at Week 24
47 Percent of Patients Achieved ACR50 at Week 24
 
 
FUTURE 5 uncontrolled exploratory analysis: Nonresponder imputation in a subgroup of biologic-naive patients from Week 1 to Week 24. No clinical or statistical conclusions can be drawn.1,10
In FUTURE 2, long-term results in biologic-naive patients

Strong ACR responses at 5 years3*

 
300 mg at 5 years (n=49) (as observed analysis)3
ACR Responses at 5 Years for 300mg
ACR Responses at 5 Years for 300mg
 
No mandatory nonresponder discontinuation requirement in the study extension11*
 
 
ACR Responses at 5 Years for 150mg
ACR Responses at 5 Years for 150mg
 
 
 
*
FUTURE 2 uncontrolled exploratory analysis: As observed in a subgroup of biologic-naive patients from baseline through 5 years. Analysis is exploratory and has not been adjusted for multiple comparisons. No clinical or statistical conclusions can be drawn.3,12
 
As with other uncontrolled studies, this phase of the study has limitations (eg, no placebo comparisons, and patients responding better are more likely to stay in the study over time).
At baseline, n=67 and n=63 were biologic-naive in the 300-mg and 150-mg arms, respectively. ACR20/50/70 response rates were lower in the anti–TNF-α inadequate responder subgroup at 5 years, which comprised 1/3 of patients.3,6
COSENTYX 150-mg arm includes 26 patients who were up-titrated to 300 mg starting at Week 128, at the investigator's discretion.3
All data presented are as observed; patients with missing data at a specific time point are not included in the analysis.6
In the mixed population, 74% of patients in the 300-mg arm and the 150-mg arm achieved an ACR20 response at 5 years; 48% of patients in the 300-mg arm and 42% in the 150-mg arm achieved an ACR50 response; 28% of patients in the 300-mg arm and 29% in the 150-mg arm achieved an ACR70 response.3
 
Please see FUTURE 5 and FUTURE 2 study design details.
 
 
 
ACR Responses at 5 Years for 150mg
ACR Responses at 5 Years for 150mg
 
 
No radiographic progression is defined as a change from baseline in mTSS ≤0.0.13
 
  • In the COSENTYX 150-mg arm, 71% of patients had no radiographic progression at 2 years (n=137)13
    • 39% of biologic-naive patients were up-titrated to 300 mg starting at Week 52, at the investigator's discretion13
  • Baseline mTSS in the 300-mg and 150-mg treatment arms was 11.5 and 9.6, respectively13*
 
In FUTURE 5, mTSS was a prespecified exploratory end point at Year 2. Results were analyzed using a linear mixed-effects model in a subgroup of biologic-naive patients. No clinical or statistical conclusions can be drawn.1,13
 
Key secondary end point: In the mixed population, mean change from baseline at 24 weeks in mTSS was 0.03 for COSENTYX 300 mg (n=217), 0.14 for COSENTYX 150 mg (n=213), and 0.51 for placebo (n=296). Patients in the placebo group who were rescued at Week 16 had their value imputed using linear extrapolation. 77%, 71%, and 68% of patients had no radiographic progression at 6 months in the 300-mg, 150-mg, and placebo groups, respectively.1,7
 
mTSS measures radiographic progression in the hands and feet and is expressed as the sum of erosion score and joint space narrowing. Higher scores indicate more articular damage.8
 
*
As measured by mTSS in biologic-naive patients (analysis is based on patients with evaluable x-ray at baseline and Year 2).13
 
mTSS=modified Total Sharp Score.
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In FUTURE 5, in biologic-naive patients
 

Complete resolution of enthesitis at 2 years (as observed)13*

 
Complete Resolution of Enthesitis
Complete Resolution of Enthesitis
 
 
Complete resolution at Week 16 in mixed population using NRI analysis: 56% for COSENTYX 300 (n=140) mg and 55% for COSENTYX 150 mg (n=141) vs 35% for placebo (n=192).1
 
*
FUTURE 5 uncontrolled exploratory analysis: As observed in a subgroup of biologic-naive patients with LEI >0 at baseline. No clinical or statistical conclusions can be drawn.1,13
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In FUTURE 5, in biologic-naive patients
 

Complete resolution of dactylitis at 2 years (as observed)13

 
Complete Resolution of Dactylitis
Complete Resolution of Dactylitis
 
 
 
Complete resolution at Week 16 in mixed population using NRI analysis: 66% for COSENTYX 300 mg (n=82) and 57% for COSENTYX 150 mg (n=80) vs 32% for placebo (n=124).1
 
FUTURE 5 uncontrolled exploratory analysis: As observed in a subgroup of biologic-naive patients with LDI >0 at baseline. No clinical or statistical conclusions can be drawn.1,13
 
As with other uncontrolled studies, this phase of the study has limitations (eg, no placebo comparisons, and patients responding better are more likely to stay in the study over time).
At baseline, 93 patients and 97 patients had enthesitis, and 52 and 55 patients had dactylitis in the 150-mg and 300-mg arms, respectively (biologic-naive patients). At Week 16, complete resolution in enthesitis was achieved by 59% of biologic-naive patients on 300 mg (n=97), 54% on 150 mg (n=93), and 38% on placebo (n=131) (NRI), and complete resolution in dactylitis was achieved by 71% of biologic-naive patients on 300 mg (n=55), 58% on 150 mg (n=52), and 36% on placebo (n=92) (NRI).1
Patients with no enthesitis are defined as having an LEI score of 0 among patients with a score of 1 or more at baseline.1
§
Patients with no dactylitis are defined as having an LDI score of 0 among patients with a score of 1 or more at baseline.1
Please see FUTURE 5 study design details.
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In FUTURE 5, in biologic-naive patients
 

More than 1 out of 3 patients achieved PASI 100 (as observed)2

 
PASI 100 Scores at Week 16
PASI 100 Scores at Week 16
 
PASI 100 Scores at Week 16
 
 
 
 
 
 
 
 
In FUTURE 5, in a mixed population: more than 2/3 of patients were biologic-naive and less than 1/3 were anti–TNF-α inadequate responders8
 
PASI 100 Scores at 2 Years
PASI 100 Scores at 2 Years
 
PASI 100 Scores at 2 Years
 
 
 
 
 
PASI 100 is a post hoc analysis based on PASI 75/90 as exploratory end points in FUTURE 5. No clinical or statistical conclusions can be drawn.1
 
 
Real treatment success with COSENTYX*
 
Baseline and PASI 100 at 2 Years
 
*
Actual patient photos representative of the average response taken by investigators during PsO clinical trials. Individual results may vary.
In FUTURE 2, in patients with coexistent plaque psoriasis receiving COSENTYX (n=99), the skin lesions of psoriasis improved with treatment, relative to placebo, as measured by the PASI.7
 
 
71% PASI 90 Response at 2 Years
71% PASI 90 Response at 2 Years
 
 
In FUTURE 5, PASI 90 was a prespecified exploratory end point at 2 years. Results were as observed in a subgroup of biologic-naive patients with PsA and PsO. No clinical or statistical conclusions can be drawn.1,15
Please see FUTURE 5 and FUTURE 2 study design details.
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In FUTURE 5, in biologic-naive patients
 

Improvement in nail disease at 2 years (as observed)2

 
Nail Disease Improvement at 2 Years
Nail Disease Improvement at 2 Years
 
 
In FUTURE 5,* mNAPSI was a prespecified exploratory end point at 2 years. Results were as observed in a subgroup of biologic-naive patients with nail psoriasis at baseline. No clinical or statistical conclusions can be drawn.1,2
 
At baseline, 66% and 61% of biologic-naive patients had nail PsO in the COSENTYX 300-mg and 150-mg arms, respectively. Mean baseline and 2-year mNAPSI values are 19.2 and 3.1, and 19.7 and 2.2 for COSENTYX 300 mg and 150 mg, respectively.1,2
 
Images from a dedicated study of patients with moderate to severe nail psoriasis
Patient photos taken by investigators
 
Nail Disease Comparison of Baseline to Week 128
Nail Disease Comparison of Baseline to Week 128
Icon
 
It takes on average about 24 weeks to 1 year for the nail to grow out.16
 
Actual patient photos taken by investigators during a clinical trial are representative of average responses with COSENTYX. Individual results may vary.
 
 
*
Nail data in PsA were consistent with those in the dedicated PsO study, TRANSFIGURE. Improvement from baseline NAPSI at Week 16 (primary end point) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).9
Please see FUTURE 5, FUTURE 2, and TRANSFIGURE study design details.
First and only dedicated biologic study
First and only dedicated biologic study
 
 

Significant improvement in axial symptoms

 
 
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In the MAXIMISE study of axial symptoms in biologic-naive patients with PsA
 
At Week 12 (primary end point)4
  • 63% experienced relief on COSENTYX 300 mg vs 31% with placebo, as measured by ASAS20 responses (MI) (P<0.0001) (n=164)4
    • In the 150-mg arm (key secondary end point), 66% of biologic-naive patients achieved ASAS20 (MI) (n=157)4
 
 
Patients Experienced Axial Relief on Cosentyx
Patients Experienced Axial Relief on Cosentyx
 
 
The components of ASAS are relevant to your patients and include7:
 
Chart
Chart
 
 
In MAXIMISE, ASAS20 AND ASAS40 were prespecified exploratory end points at Week 52. Results were as observed. No clinical or statistical conclusions can be drawn.18
 
Data from the MAXIMISE trial whose study design, patient population, and dosing regimen are consistent with that of FUTURE 2. In the FUTURE 2 trial, 20% of patients had spondylitis with peripheral arthritis.
ASAS=Assessment of SpondyloArthritis international Society criteria; BASFI=Bath Ankylosing Spondylitis Functional Index; MI=multiple imputation.
 
Please see MAXIMISE study design details.

PsA Safety

 
An established and consistent safety profile
PsA safety profile through Week 16
 
PsA Safety Profile Through Week 16 and Selected Adverse Events in Pivotal PsA Program
PsA Safety Profile Through Week 16 and Selected Adverse Events in Pivotal PsA Program
 
There were cases of Crohn's disease and ulcerative colitis that included patients who experienced either exacerbations or the development of new disease. There were 3 cases of inflammatory bowel disease, of which 2 patients received secukinumab and 1 received placebo7
 
If a serious infection develops, discontinue COSENTYX until the infection resolves.7
If an anaphylactic reaction or other serious allergic reaction occurs, discontinue COSENTYX immediately and initiate appropriate therapy.7
In FUTURE 3, COSENTYX did not show any new or unexpected safety signals through Week 16.20
In MAXIMISE, COSENTYX did not show any new or unexpected safety signals through 1 year.18
 
 
Chart
Chart
 
*
AEs listed are those occurring in at least 2% of patients in pooled secukinumab dose group up to Week 16.6
Includes 75-mg, 150-mg, and 300-mg doses (pooled outcome).6
Pivotal PsA program was FUTURE 1 and FUTURE 2.19
§
Some patients were IV loaded (10 mg/kg) at Weeks 0, 2, and 4.19
||
Rate of injection site reactions means the percentage of patients affected by 1 or more injection site reaction(s) during the first 16 weeks of the pooled FUTURE 1 and 2 trials.21
AE=adverse event; IV=intravenous; N=number of patients in the analysis.
 
Please see FUTURE 1, FUTURE 2, FUTURE 3, and MAXIMISE study design details.

5-year safety profile

 
PsA safety profile through Year 5
 
Adverse Events of Special Interest
Adverse Events of Special Interest
 
 
Consistent results seen in FUTURE 5 (N=996)1,26
 
<1% of patients had immunogenicity over 5 years27
 
Callout
Callout
 
COSENTYX does not require routine lab monitoring during treatment7
 
COSENTYX has no boxed warning7
 
Please see Important Safety Information, including CONTRAINDICATIONS.
 
*
Rates are for the system organ class "infections and infestations," which includes multiple associated PTs.23
Rates are for Candida infections high-level term, which includes multiple associated PTs.23
Data are displayed to 2 decimals where N>1000 and to 1 decimal if N<1000.
§
Rates are for the Novartis MedDRA Query term which comprises [1] any myocardial infarction, any CVA, and [2] all other CV events that are fatal, out of a listing of 2200+ terms.23
||
The detection of antibody formation is highly dependent on the sensitivity and the 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.
CV=cardiovascular; CVA=cerebrovascular accident; EAIR=exposure-adjusted incidence rate; IBD=inflammatory bowel disease; IL=interleukin; MedDRA=Medical Dictionary for Regulatory Activities; PTs=preferred terms; PY=patient-years; TB=tuberculosis.
 
Please see FUTURE 1, FUTURE 2, FUTURE 3, and FUTURE 5 study design details.

Positive injection experience with easy-to-use Sensoready® pen20*†‡

 
Once-monthly maintenance dosing
 
The Sensoready pen is designed for comfortable use. According to a study completed in patients with active PsA:
 
Easy-to-use Sensoready pen for convenient self-administration*
 
 
 
Cosentyx Sensoready Pen
Cosentyx Sensoready Pen
 
 
*
The removable cap of the COSENTYX Sensoready pen and the prefilled syringe contains natural rubber latex and should not be handled by latex-sensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied.7
Feelings about injection (FL), self-confidence (CO), and satisfaction with self-injection (SA) were evaluated in 414 patients with active PsA in the FUTURE 3 study based on the Self-Injection Assessment Questionnaire. On a scale of 0 to 10, with higher score indicating more ease of use and greater satisfaction, the mean scores at baseline were: 8.2 FL, 6.5 CO, and 6.8 SA. At Week 2, the mean scores were: 8.8 FL, 7.8 CO, and 8.4 SA.20
The first self-injection should be performed under the supervision of a qualified healthcare professional. Patients should be trained in proper administration techniques prior to self-administration.7
§
Administer with or without a loading dose. With a loading dose, administer 150 mg at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. Without a loading dose is 150 mg every 4 weeks.7
 
Please see FUTURE 3 study design details.
For patients with PsA with coexistent moderate to severe plaque psoriasis7:

300 mg once a week for the first 5 weeks, monthly thereafter. For some patients, a dose of 150 mg may be acceptable7

 
Monthly Maintenance Dosing
Monthly Maintenance Dosing
 
 
For other patients with PsA7:
 
*
Monthly maintenance dose=1 dose every 4 weeks.7
The first self-injection should be performed under the supervision of a qualified healthcare professional. Patients should be trained in proper administration techniques prior to self-administration.7
Without a loading dose is 150 mg every 4 weeks.7
 
nr-axSpA dosing
 
AS dosing

COSENTYX is the first and only fully human monoclonal antibody to selectively target IL-17A7

 
IL-17A in PsA, AS, nr-axSpA, and PsO:
 
COSENTYX blocks IL-17A, irrespective of its sources7,30-35
Cosentyx Mechanism of Action and IL-17A
Cosentyx Mechanism of Action and IL-17A
 
COSENTYX:
  • Selectively binds to IL-17A, and inhibits its interaction with the IL-17 receptor7
  • Inhibits the subsequent release of proinflammatory cytokines and chemokines7
 
IL17A
COSENTYX:
 
  • Selectively binds to IL-17A, and inhibits its interaction with the IL-17 receptor7
  • Inhibits the subsequent release of proinflammatory cytokines and chemokines7
 
 
Clinical significance of the COSENTYX mechanism of action is unknown.
 
Images not drawn to scale.
The immune pathophysiology of PsA, AS, nr-axSpA, and PsO involves complex molecular mechanisms of action not shown in this graphic.
IL=interleukin; Th17=T helper 17.

Guaranteed access for eligible commercially insured patients

 
We've got you covered
 
 
Cosentyx Connect Program
 
is a free personal support program with a dedicated team of support specialists to provide your patients with savings options and adherence tools
 
 
 
If your patients have any questions, feel free to direct them to visit www.cosentyx.com or call 1-844-COSENTYX (1-844-267-3689).
 
 
*
COSENTYX is present on the formularies as either a first-, second-, third-, or fourth-line biologic.
Certain payers have carve-outs that restrict utilization of manufacturer support program.
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 reverify 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.
§
Limitations apply. Up to a $16,000 annual limit. Offer not valid under Medicare, Medicaid, or any other federal or state program. Novartis reserves the right to rescind, revoke, or amend this program without notice. Limitations may apply in MA and CA. For complete Terms & Conditions details, call 1-844-267-3689.
||
||
 
 
Resources to get your patients started

Study Designs

 
FUTURE 1 Study Design
FUTURE 1 was a multicenter, randomized, double-blind, placebo-controlled study that evaluated 606 patients with active PsA. Patients were treated with secukinumab 10 mg/kg IV treatment (or placebo) at Weeks 0, 2, and 4, followed by 75 mg or 150 mg subcutaneous COSENTYX treatment (or placebo) every 4 weeks. Patients receiving placebo were rerandomized to receive COSENTYX 75 mg or 150 mg every 4 weeks based on responder status at Week 16 or Week 24. Primary end point was the percentage of patients with ACR20 response at Week 24.7,39
 
FUTURE 2 Study Design
FUTURE 2 was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 397 adult patients with active PsA (≥3 swollen and ≥3 tender joints) despite use of NSAIDs, corticosteroids, or DMARDs. Patients had a diagnosis for ≥5 years and received COSENTYX 150 mg (n=100), 300 mg (n=100), or placebo (n=98) 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. The primary end point was the percentage of patients with ACR20 response at Week 24. 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 Week 92, every 12 weeks through Week 140, then at Weeks 156, 180, 208, 232, and 260. 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 the 150-mg dose to the 300-mg dose. At Week 260, 42 patients from the 150-mg dose had been up-dosed to 300 mg. 75-mg dose included in study but not shown (n=99). Study population was mixed: 2/3 of patients were biologic-naive and 1/3 were anti–TNF-α inadequate responders. 44% of patients treated with COSENTYX were treated with concomitant methotrexate at baseline.3,6,7,12
 
FUTURE 3 Study Design
FUTURE 3 was a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 3-year study that evaluated 414 adult patients with active PsA. Patients received COSENTYX 150 mg (n=138), 300 mg (n=139), or placebo (n=137) subcutaneously at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks thereafter. Patients were stratified at randomization based on previous anti-TNF therapy use as anti–TNF-naive or anti–TNF-IR; at least 60% of patients in each treatment arm were anti–TNF-naive. At Week 16, patients who received placebo were rerandomized to COSENTYX 150 mg or 300 mg every 4 weeks based on responder status at Week 16 (nonresponders) or Week 24 (responders). The primary end point was the percentage of patients with ACR20 response at Week 24. Autoinjector usability was also examined. Safety assessments included evaluation of AEs, SAEs, and immunogenicity.20
 
FUTURE 5 Study Design
FUTURE 5 was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that evaluated 996 adult patients with active PsA. Patients were randomized to receive 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). The primary end point was the percentage of patients with ACR20 response at Week 16. Secondary end points included change in mTSS score at Week 24 from baseline, ACR50 response and proportion of patients with dactylitis and enthesitis at Week 16, and overall safety and tolerability. ACR70 response at Week 24 was an exploratory end point. ACR20/50/70 responses at Week 104, proportion of patients with no structural progression at Week 104, and proportion of patients achieving MDA at Week 104 were also exploratory end points. Blinding was maintained until Week 52. Study population was mixed: more than 2/3 of patients were biologic-naive and less than 1/3 were anti–TNF-α inadequate responders (patients could have been exposed to up to 3 different TNF-α inhibitors).1,7,8
 
MAXIMISE Study Design
The MAXIMISE study was a randomized, double-blind, placebo-controlled, multicenter, 52-week study that evaluated 495 patients with active psoriatic arthritis and axial skeleton involvement (defined by BASDAI score ≥4, spinal pain VAS ≥40 [0 to 100 mm scale]) who have had inadequate response to at least 2 NSAIDs for at least 4 weeks. Patients were randomized to receive subcutaneous COSENTYX in a 1:1:1 ratio in COSENTYX 150 mg (n=165), COSENTYX 300 mg (n=165), and placebo (n=165) at Weeks 0, 1, 2, 3, and 4, then 4 weeks later at Week 8. The primary end point was the proportion of patients with ASAS20 response at Week 12. After Week 12, patients who were placed in the placebo group at baseline were rerandomized (1:1) to active treatment with COSENTYX 150 mg or COSENTYX 300 mg, administered every 4 weeks from Week 12 to Week 52 (last dose on Week 48), but remained blinded to dose. Patients taking NSAIDs, MTX, or systemic corticosteroids alongside study medication were required to remain on a stable dose until Week 52.4
 
TRANSFIGURE Study Design
TRANSFIGURE was a double-blind, randomized, placebo-controlled study examining the safety and efficacy of COSENTYX in patients with moderate to severe nail PsO. Patients were randomized to COSENTYX 300 mg (n=66), COSENTYX 150 mg (n=67), or placebo (n=65). All patients were adults with moderate to severe PsO (PASI score ≥12 and BSA ≥10%) and significant nail involvement (fingernail NAPSI score of ≥16 and ≥4 fingernails involved) who were candidates for systemic therapy. Primary end point: NAPSI assessment at Week 16. Secondary end points included NAPSI response over time up to Week 132.40
 
ACR=American College of Rheumatology; AE=adverse event; ASAS=Assessment of SpondyloArthritis international Society criteria; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index; BSA=body surface area; DMARDs=disease-modifying antirheumatic drugs; MDA=minimal disease activity; mTSS=modified Total Sharp Score; MTX=methotrexate; NSAIDs=nonsteroidal anti-inflammatory drugs; PsA=psoriatic arthritis; SAE=serious adverse event; TNF=tumor necrosis factor; TNF-IR=tumor necrosis factor inadequate responder; VAS=visual analog scale.
 
References: 1. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017. 2. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019. 3. Data on file. CAIN457F2312 (FUTURE 2): 5-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019. 4. Data on file. CAIN457F3302 (MAXIMISE) Data Analysis Report. Novartis Pharmaceuticals Corp; June 2016. 5. Data on file. Patterns of disease domain presentation of psoriatic arthritis patients: results from a Corrona Psoriatic Arthritis/Spondyloarthritis (PsA/SpA) Registry. Novartis Pharmaceuticals Corp; July 2019. 6. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014. 7. Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; May 2021. 8. Mease P, van der Heijde D, Landewé R, et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis. 2018;77(6):890-897. 9. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015. 10. Data on file. CAIN457F2342 (FUTURE 5): Week 52 Interim Report. Novartis Pharmaceuticals Corp; August 2018. 11. Data on file. CAIN457F2312 (FUTURE 2): 3-Year Interim Report. Novartis Pharmaceuticals Corp; September 2017. 12. Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015. 13. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019. 14. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report Radiographic and PASI 100 data. Novartis Pharmaceuticals Corp; May 2019. 15. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR components data. Novartis Pharmaceuticals Corp; January 2020. 16. National Psoriasis Foundation. Managing nail psoriasis. https://www.psoriasis.org/about-psoriasis/specific-locations/hands-feet-nails/managing-nail-psoriasis. Accessed January 8, 2020. 17. Data on file. CAIN457F3302 (MAXIMISE): 1-Year Interim Report. Novartis Pharmaceuticals Corp; February 2020. 18. Data on file. CAIN457F3302 (MAXIMISE): 1-Year Clinical Study Report. Novartis Pharmaceuticals Corp; August 2020. 19. Data on file. AIN457F Summary of Clinical Safety in Psoriatic Arthritis. Novartis Pharmaceuticals Corp; February 2015. 20. Nash P, Mease PJ, McInnes IB, et al; on behalf of the FUTURE 3 study group. Efficacy and safety of secukinumab administration by autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3). Arthritis Res Ther. 2018;20(1):47. 21. Data on file. AIN457F SCS Appendix 1 (Integrated Summary of Safety, data analyses). 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