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

Fast relief with lasting response rates²

MEASURE 2: ASAS20 response in a subgroup from baseline to Week 16 was part of an exploratory end point. No clinical or statistical conclusions can be drawn.³

At Week 4, 53% of patients achieved ASAS20 at 150 mg (P=0.0006) vs 24% of patients in the placebo group, in a mixed population³
All patients received an initial loading dose of once-weekly dosing for 5 weeks¹
In a mixed population, 88% (63/72) of patients in the COSENTYX arm and 87% (64/74) in the placebo arm were taking NSAIDs through Week 16³

84 Percent of Patients Remained All 5 Years

MEASURE 2 uncontrolled exploratory analysis: As observed in a subgroup from baseline through Year 5. No clinical or statistical conclusions can be drawn.^2,3

After Week 16, patients knew they were taking the active treatment (75 mg or 150 mg). 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 then every 12 weeks through 5 years.^2,3

As with other uncontrolled extension studies, this phase of the study has limitations (eg, no placebo comparisons).^2,3

All data presented are as observed; patients with missing data at a specific time point are not included in the analysis.^2,3

In a mixed population, ASAS20/40 responses at 5 years were 67% and 50%, respectively, in the COSENTYX 150-mg arm²

ASAS=Assessment of SpondyloArthritis international Society criteria; NSAIDs=nonsteroidal anti-inflammatory drugs; TNF=tumor necrosis factor.

Please see MEASURE 2 study design details.

Long-term inflammation reduction

hsCRP correlates better than routine CRP with clinical parameters in patients with AS⁴

Week 16 vs. 5 Year Inflammation Reduction

Assessment was performed to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.³

^†

MEASURE 2 uncontrolled exploratory analysis: As observed from baseline through Year 5. No clinical or statistical conclusions can be drawn.^2,3

Mean baseline hsCRP mg/L levels: 25.8 (150-mg group), 15.7 (placebo group). At Week 16, mean baseline hsCRP levels were 27.0 and 16.3 (COSENTYX 150-mg group and placebo group, respectively). At Week 16, mean change from baseline: -17.2, 1.1, respectively.²

At Year 5, mean baseline hsCRP level was 20.2 (COSENTYX 150 mg). At Year 5, mean change from baseline was -14.3 (150 mg).²

Study population was mixed: 2/3 of patients were biologic-naive and 1/3 of patients were anti–TNF-α inadequate responders¹

CRP=C-reactive protein; hsCRP=high-sensitivity C-reactive protein.

Please see MEASURE 2 study design details.

ASDAS-CRP results at Year 5

The ASDAS-CRP measures back pain, peripheral pain and swelling, and duration of morning stiffness (BASDAI*), along with patient global assessment and CRP⁶

MEASURE 2 uncontrolled exploratory analysis: As observed from baseline through Year 5. No clinical or statistical conclusions can be drawn.^2,3

At Week 16, ~3 out of 10 patients achieved low/inactive disease. At Year 1, ~1 out of 2 patients achieved low/inactive disease²
At Week 16, ~1 out of 10 patients achieved inactive disease. At Year 1, ~1 out of 4 patients achieved inactive disease²

BASDAI questions 2, 3, and 6.⁶

ASDAS-CRP=Ankylosing Spondylitis Disease Activity Score–C-reactive protein; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index.

Please see MEASURE 2 study design details.

Reductions in disease activity that continued through 5 years²*

BASDAI assesses the 5 major symptoms of AS³:

Total Spinal Pain Symptom, Morning Stiffness Symptom. Fatigue Symptom, Joint Pain/Swelling Symptom, Enthesitis Symptom, BASDAI Scores at Week 16 Through Year 5

MEASURE 2 uncontrolled exploratory analysis: As observed from baseline through Year 5. No clinical or statistical conclusions can be drawn.^2,3

In biologic-naive patients, mean baseline score at Week 16 and Year 5: 6.6.²

Patients with missing data at a specific time point are not included in the analysis. As with other uncontrolled exploratory analyses, this analysis has limitations (eg, no placebo comparisons).²

In a mixed population, BASDAI scores improved at Week 16 by -2.3 (6.6 to 4.3) for COSENTYX 150 mg (n=67) vs -1.0 (6.9 to 5.9) for placebo (n=64). At Year 5, BASDAI scores improved by -2.7 (6.5 to 3.8) in the COSENTYX 150-mg group (n=54)²
- The analysis of BASDAI for the mixed population at Week 16 was a secondary end point³

As measured by BASDAI.³

Mean change of BASDAI. BASDAI consists of a 0 through 10 scale (0 being no problem and 10 being the worst problem, captured as a continuous visual analog scale), used to answer 6 questions pertaining to the 5 major symptoms of AS described above.³

Please see MEASURE 2 study design details.

Results in patients with fatigue

MEASURE 2 uncontrolled exploratory analysis: As observed from baseline through Year 5. No clinical or statistical conclusions can be drawn.^2,3

The impact of COSENTYX on fatigue was studied using FACIT-Fatigue³
- FACIT-Fatigue is a validated 13-item questionnaire that assesses the impact of fatigue on patients with AS³
The analysis of FACIT-Fatigue was an exploratory end point, and no statistical conclusions can be drawn³

At Week 16, mean baseline FACIT scores in biologic-naive patients were 22.3 and 23.3 (COSENTYX 150 mg and placebo, respectively). Mean change was 10.7 and 5.4, respectively. At Year 5, the mean baseline FACIT score was 22.6; mean change was 10.6.²

FACIT=Functional Assessment of Chronic Illness Therapy.

Please see MEASURE 2 study design details.

Improvements in daily living (ASQoL)

The Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) includes patient statements such as³:

It takes a long time to get going in the morning
I struggle doing jobs around the house
I am not able to participate in activities with my friends or family
My condition limits the places I can go

>2x improvement in ASQoL with COSENTYX vs placebo at Week 16; results seen at Year 1²

Baseline ASQoL scores were 12.7 for COSENTYX 150 mg, and 11.8 for placebo. Max score=18.0.²

Mean ASQoL score change at Year 1 was -6.0 (49%) for COSENTYX 150 mg.²

MEASURE 2 uncontrolled exploratory analysis: No clinical or statistical conclusions can be drawn.^2,3

Please see MEASURE 2 study design details.

Spinal pain and morning stiffness relief

Relief from stiffness and back pain are 2 key patient goals^2,5*

MEASURE 2 uncontrolled exploratory analysis: As observed from baseline through Year 5. No clinical or statistical conclusions can be drawn.^2,3

Mean baseline score of BASFI at Week 16: 6.4 (150-mg group), 6.3 (placebo group). Mean change at Week 16: -2.9 (46% improvement), -1.2 (19% improvement), respectively. Mean baseline score at Year 5: 6.4 (150-mg group). Mean change at Year 5: -2.9 (45% improvement).^2,5

Mean baseline score of patient global assessment of disease activity at Week 16: 67.0 (150-mg group), 69.0 (placebo group). Mean change at Week 16: -33.8 (50% improvement), -15.6 (23% improvement), respectively. Mean baseline score at Year 5: 67.1 (150-mg group). Mean change at Year 5: -35.5 (53% improvement).^2,5

According to a survey of 175 patients with AS.⁷

^†

Inflammation was evaluated using mean severity and duration of morning stiffness, represented by the average of the last 2 questions on the 6-question BASDAI as measured by VAS: How would you describe the overall level of morning stiffness you have had from the time you wake up? How long does your morning stiffness last from the time you wake up?³

ASAS components include: physical function (BASFI), Patient Global Assessment, total spinal pain, and morning stiffness.¹

The independent analysis of each ASAS component was a prespecified exploratory end point. Analysis has not been adjusted for multiple comparisons. No conclusions of statistical significance can be shown here or in any of the exploratory end points.³

BASFI=Bath Ankylosing Spondylitis Functional Index; VAS=visual analog scale.

Please see MEASURE 2 study design details.

AS safety

COSENTYX offers an established and consistent safety profile^1,8,9

AS safety profile through Week 16 and Year 1: MEASURE 1 and 2 (pooled data, any dose)^1,8*

If a serious infection develops, discontinue COSENTYX until the infection resolves¹
If an anaphylactic reaction or other serious allergic reaction occurs, discontinue COSENTYX immediately and initiate appropriate therapy¹

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 5^10-13

Adverse reactions reported by >1% of patients in clinical trials for moderate to severe PsO were nasopharyngitis, diarrhea, upper respiratory tract infection, rhinitis, oral herpes, pharyngitis, urticaria, and rhinorrhea¹
The safety profile observed in patients with AS is consistent with PsO¹

<1% of patients had immunogenicity over 5 years¹⁴

Neutralizing antibodies developed in 0.6% of patients with PsO and were not associated with loss of efficacy¹⁴*

COSENTYX does not require routine lab monitoring during treatment¹

Evaluate patients for TB infection prior to initiating treatment

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§

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:

>90% of patients reported no pain during or after the injection¹⁵
Nearly 9 out of 10 patients reported being satisfied or very satisfied with self-injection using the Sensoready pen¹⁵

Easy-to-use Sensoready pen for convenient self-administration^‡

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.

Once-monthly maintenance dosing¹*

For patients with AS: 150 mg once a week for the first 5 weeks, monthly thereafter¹

If a patient continues to have active ankylosing spondylitis, consider a dosage of 300 mg.

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

If a patient continues to have active ankylosing spondylitis, consider a dosage of 300 mg.

Monthly maintenance dose=1 dose every 4 weeks.¹

The first self-injection should be performed under the supervision of a qualified healthcare professional. Patients should be trained in proper injection technique prior to self-administration.¹

Psoriatic arthritis dosing

›

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

IL-17A in AS, PsA, and PsO:

IL-17A is a naturally occurring cytokine and an important mediator in the inflammatory process, which can cause joint damage in PsA and inflammation in both PsA and AS^1,18
Elevated levels of IL-17A are found in psoriatic plaques¹
Increased numbers of IL-17A–producing lymphocytes and innate immune cells, and increased levels of IL-17A have been found in the blood of patients with psoriatic arthritis and ankylosing spondylitis¹

COSENTYX blocks IL-17A, irrespective of its sources^1,19-23

COSENTYX:

Selectively binds to IL-17A, and inhibits its interaction with the IL-17 receptor¹
Inhibits the subsequent release of proinflammatory cytokines and chemokines¹

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

73% of commercially insured biologic patients with AS or PsA are covered first line, with 88% covered first or second line²⁷
If coverage is denied, free COSENTYX with Covered Until You're Covered for eligible* patients^†
$0 co-pay for 100% of your eligible* commercial patients^‡

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 Design^1,3*^†

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.

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

Fast relief with lasting response rates2

Long-term inflammation reduction

ASDAS-CRP results at Year 5

Reductions in disease activity that continued through 5 years2*

Results in patients with fatigue

Improvements in daily living (ASQoL)

Spinal pain and morning stiffness relief

AS safety

AS safety profile through Year 510-13

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

Once-monthly maintenance dosing1*

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

Guaranteed access for commercially insured patients

Resources

Study Design

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

Fast relief with lasting response rates²

Reductions in disease activity that continued through 5 years²*

AS safety profile through Year 5^10-13

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

Once-monthly maintenance dosing¹*

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