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
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.
Long-term inflammation reduction
- hsCRP correlates better than routine CRP with clinical parameters in patients with AS4
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.
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
ASDAS-CRP=Ankylosing Spondylitis Disease Activity Score–C-reactive protein; BASDAI=Bath Ankylosing Spondylitis Disease Activity Index.
Reductions in disease activity that continued through 5 years2*
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
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
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
FACIT=Functional Assessment of Chronic Illness Therapy.
Improvements in daily living (ASQoL)
- 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
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
Spinal pain and morning stiffness relief
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
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.
AS safety
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
EAIR=exposure-adjusted incidence rate; IV=intravenous.
AS safety profile through Year 510-13
- 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
- Neutralizing antibodies developed in 0.6% of patients with PsO and were not associated with loss of efficacy14*
- Evaluate patients for TB infection prior to initiating treatment
Please see Important Safety Information, including CONTRAINDICATIONS.
IBD=inflammatory bowel disease; MACE=major adverse cardiovascular event; PsO=plaque psoriasis; TB=tuberculosis.
Positive injection experience with easy-to-use Sensoready® pen15*†‡
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
- >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
PsA=psoriatic arthritis.
Once-monthly maintenance dosing1*
If a patient continues to have active ankylosing spondylitis, consider a dosage of 300 mg.
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
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COSENTYX is the first and only fully human monoclonal antibody to selectively target IL-17A1
- 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 AS1,18
- 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
- Selectively binds to IL-17A, and inhibits its interaction with the IL-17 receptor1
- Inhibits the subsequent release of proinflammatory cytokines and chemokines1
- 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
- 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
Resources
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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
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.