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In the MEASURE 2 trial, the primary end point of MEASURE 2 (ASAS20 at Week 16) was achieved by 61% of patients vs 28% for placebo in a mixed population (2/3 biologic-naive, 1/3 anti–TNF-α inadequate responder)1

AS safety

 
COSENTYX offers an established and consistent safety profile1,8,9
 
AS safety profile through Week 16 and Year 1: MEASURE 1 and 2 (pooled data, any dose)1,8*
 
Week 16 and Year 1 Safety Profile
Week 16 and Year 1 Safety Profile
 
 
*
75 mg or 150 mg administered as IV or subcutaneous dose (pooled outcome).8
EAIR=exposure-adjusted incidence rate; IV=intravenous.
 
Please see MEASURE 2 study design details.

AS safety profile through Year 510-13

 
Year 5 Safety Profile
Year 5 Safety Profile
 
 
<1% of patients had immunogenicity over 5 years14
 
COSENTYX does not require routine lab monitoring during treatment1
 
COSENTYX has no boxed warning
 
Please see Important Safety Information, including CONTRAINDICATIONS.
 
*
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.1
IBD=inflammatory bowel disease; MACE=major adverse cardiovascular event; PsO=plaque psoriasis; TB=tuberculosis.
 
Please see MEASURE 2 study design details.

Positive injection experience with easy-to-use Sensoready® pen15*†‡

 
Once-monthly maintenance dosing
1.5% of patients with AS exposed to COSENTYX reported injection site reactions during the first 16 weeks of the pooled MEASURE 1 and MEASURE 2 trials.16
 
The Sensoready pen is designed for comfortable use. According to a study completed in active PsA patients15:
 
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 contain 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.1
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.15
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.1
§
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, administer 150 mg every 4 weeks.1
PsA=psoriatic arthritis.

COSENTYX is the first and only fully human monoclonal antibody to selectively target IL-17A1

 
IL-17A in AS, PsA, and PsO:
 
COSENTYX blocks IL-17A, irrespective of its sources1,19-23
Cosentyx Mechanism of Action and IL-17A
Cosentyx Mechanism of Action and IL-17A
MOA Callout
 
COSENTYX:
  • Selectively binds to IL-17A, and inhibits its interaction with the IL-17 receptor1
  • Inhibits the subsequent release of proinflammatory cytokines and chemokines1
 
IL17A
COSENTYX:
 
  • Selectively binds to IL-17A, and inhibits its interaction with the IL-17 receptor1
  • Inhibits the subsequent release of proinflammatory cytokines and chemokines1
 
 
Clinical significance of the COSENTYX mechanism of action is unknown.
 
Images not drawn to scale.
The immune pathophysiology of PsO, PsA, and AS involves complex molecular mechanisms of action not shown in this graphic.
IL=interleukin; Th17=T helper 17.

Guaranteed access for commercially insured patients

 
We've got you covered
 
Cosentyx Connect - Personal Support Program
 
Cosentyx Connect is a free personal support program with a dedicated team of support specialists to provide your patients with financial support and adherence tools
 
*
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. Program enrollment must occur by 12/31/20.
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

 
Literature and handouts for your practice
 
Service Request Form (SRF)
(English)
 
Appeals Kit: Moderate to Severe Plaque Psoriasis Indication
 
Please save this PDF to your desktop for access to editable versions of the letter templates
 
 

Appeals Kit: Moderate to Severe Plaque Psoriasis + Psoriatic Arthritis Indications (Combined)
 
Please save this PDF to your desktop for access to editable versions of the letter templates
 
 
Appeals Kit: Psoriatic Arthritis Indication
 
 

Appeals Kit: Ankylosing Spondylitis Indication
 
Appeals Kit: Non-radiographic Axial Spondyloarthritis Indication
 
Please save this PDF to your desktop for access to editable versions of the letter templates
 
 

Enhanced Specialty Pharmacy Network Flashcard
 
Specialty Pharmacy Providers List
 
 

ICD-10 Code List
 

Study Design

 
MEASURE 2 (AS 1) Study Design1,3*
MEASURE 2 was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 219 adult patients with active AS who received COSENTYX 75 mg, 150 mg, or placebo subcutaneous treatment at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks. At Week 16, patients who received placebo were rerandomized to either COSENTYX 75 mg or 150 mg every 4 weeks. The primary end point was the percentage of patients who achieved ASAS20 response at Week 16.1,3
 
*
75-mg dose included in study but not shown.3
After 16 weeks, patients knew they were taking active medication, but were blinded to the dose. After 1 year, patients continued to receive the same active dose as open-label treatment and were assessed every 8 weeks through 2 years, then every 12 weeks through 5 years.2,3
 
References: 1. Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2020. 2. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; May 2019. 3. Data on file. CAIN457F2310 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2014. 4. Poddubnyy DA, Rudwaleit M, Listing J, Braun J, Sieper J. Comparison of a high sensitivity and standard C reactive protein measurement in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis. Ann Rheum Dis. 2010;69(7):1338-1341. 5. Data on file. Conversion data tables for ankylosing spondylitis. Novartis Pharmaceuticals Corp; April 2019. 6. Smolen JS, Schöls M, Braun J, et al. Treating axial spondyloarthritis and peripheral spondyloarthritis, especially psoriatic arthritis, to target: 2017 update of recommendations by an international task force. Ann Rheum Dis. 2018;77(1):3-17. 7. Ward MM. Health-related quality of life in ankylosing spondylitis: a survey of 175 patients. Arthritis Care Res. 1999;12(4):247-255. 8. Data on file. AIN457H Summary of Clinical Safety in (Ankylosing Spondylitis). Novartis Pharmaceuticals Corp; February 2015. 9. Data on file. Data Analysis Report: Study AIN457/secukinumab. Novartis Pharmaceuticals Corp; May 8, 2018. 10. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020. 11. Data on file. Selected EAIRs MEASURE 2 Year 2. Novartis Pharmaceuticals Corp; January 2020. 12. Data on file. Selected EAIRs MEASURE 2 Year 3. Novartis Pharmaceuticals Corp; January 2020. 13. Data on file. Selected EAIRs MEASURE 2 Year 4. Novartis Pharmaceuticals Corp; January 2020. 14. Reich K, Blauvelt A, Armstrong A, et al. Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibits low immunogenicity in psoriasis patients treated up to 5 years. J Eur Acad Dermatol Venereol. 2019;33(9):1733-1741. 15. 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. 16. Data on file. AIN457H Summary of Clinical Safety Appendix 1. Novartis Pharmaceuticals Corp; February 2015. 17. Paul C, Lacour J-P, Tedremets L, et al; for the JUNCTURE Study Group. Efficacy, safety, and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2015;29(6):1082-1090. 18. Miossec P, Kolls JK. Targeting IL-17 and TH17 cells in chronic inflammation. Nat Rev Drug Discov. 2012;11(10):763-776. 19. Miossec P, Korn T, Kuchroo VK. Interleukin-17 and type 17 helper T cells. N Engl J Med. 2009;361(9):888-898. 20. Girolomoni G, Mrowietz U, Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167(4):717-724. 21. Cua DJ, Tato CM. Innate IL-17-producing cells: the sentinels of the immune system. Nat Rev Immunol. 2010;10(7):479-490. 22. Kehl AS, Corr M, Weisman MH. Enthesitis: new insights into pathogenesis, diagnostic modalities, and treatment. Arthritis Rheumatol. 2016;68(2):312-322. 23. Smith JA, Colbert RA. Review: the interleukin-23/interleukin-17 axis in spondyloarthritis pathogenesis: Th17 and beyond. Arthritis Rheumatol. 2014;66(2):231-241. 24. Lynde CW, Poulin Y, Vender R, Bourcier M, Khalil S. Interleukin 17A: toward a new understanding of psoriasis pathogenesis. J Am Acad Dermatol. 2014;71(1):141-150. 25. Zeichner JA, Armstrong A. The role of IL-17 in the pathogenesis and treatment of psoriasis. J Clin Aesthet Dermatol. 2016;9(6)(suppl 1):S3-S6. 26. Keijsers RR, Joosten I, van Erp PE, Koenen HJ, van de Kerkhof PC. Cellular sources of IL-17 in psoriasis: a paradigm shift? Exp Dermatol. 2014;23(11):799-803. 27. Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; December 18, 2019.
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