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In JUNIPERA in biologic-naive patients with ERA

Longer time to flare in Treatment Period 21,9

Time to flare in ERA vs placebo (exploratory end point) did not reach statistical significance. Supplementary analyses provided confirmatory evidence of the treatment effect in ERA.1

In JUNIPERA, the primary end point was time to flare in Treatment Period 2 of the study in the combined JPsA and ERA patient population.9

Time to flare

Disease flare was defined as a ≥30% worsening in ≥3 of the 6 JIA ACR response criteria, and ≥30% improvement in ≤1 of the 6 JIA ACR response criteria and ≥2 active joints.1

JIA ACR response criteria consist of 6 core components9
JIA ACR response criteria consist of 6 core components

*During Treatment Period 2, a total of 6 patients with ERA in the COSENTYX® (secukinumab) arm experienced a flare event compared with 10 patients in the placebo arm.1
†Measured on a 100-mm VAS.9
‡Any joint with swelling or, in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity.9

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Important Safety Information

CONTRAINDICATIONS
COSENTYX® (secukinumab) is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis have been reported during treatment with COSENTYX...

CONTRAINDICATIONS

COSENTYX® (secukinumab) is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis have been reported during treatment with COSENTYX.

WARNINGS AND PRECAUTIONS

Infections

COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in COSENTYX treated subjects compared to placebo-treated subjects. In placebo-controlled clinical trials in subjects 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 subjects with psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. The incidence of some types of infections appeared to be dose-dependent in clinical studies. In the postmarketing setting, serious and some fatal infections have been reported in patients receiving COSENTYX.

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, monitor the patient closely and discontinue COSENTYX until the infection resolves.

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Avoid administration of 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. Monitor patients 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 COSENTYX treated subjects during clinical trials in plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. In addition, new onset inflammatory bowel disease cases occurred in clinical trials with COSENTYX. In an exploratory trial in 59 subjects 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.

Eczematous Eruptions

In postmarketing reports, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma, were reported in patients receiving COSENTYX; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of COSENTYX. 

Treatment may need to be discontinued to resolve the eczematous eruption. Some patients were successfully treated for eczematous eruptions while continuing COSENTYX. 

Hypersensitivity Reactions

Anaphylaxis and cases of urticaria occurred in COSENTYX treated subjects 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 caps of the COSENTYX Sensoready® pen and the COSENTYX 1 mL and 0.5 mL prefilled syringes contain 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.

Immunizations

Prior to initiating therapy with COSENTYX, consider completion of all age appropriate immunizations according to current immunization guidelines. COSENTYX may alter a patient’s immune response to live vaccines. Avoid use of live vaccines in patients treated with COSENTYX.

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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Indications

COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.

COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older...

COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.

COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older.

COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis (AS).

COSENTYX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr‑axSpA) with objective signs of inflammation.

COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older.

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*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 and Conditions details, call 1-844-267-3689.

Definitions

ACR, American College of Rheumatology; CHAQ, Childhood Health Assessment Questionnaire; CI, confidence interval; CRP, C-reactive protein; ERA, enthesitis-related arthritis; HR, hazard ratio; JIA, juvenile idiopathic arthritis; JPsA, juvenile psoriatic arthritis; VAS, visual analog scale.

References

1. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

2. Humira. Prescribing Information. AbbVie Inc; 2021.

3. Orencia. Prescribing Information. Bristol-Myers Squibb Co; 2021.

4. Actemra. Prescribing Information. Genentech Inc; 2022.

5. Ilaris. Prescribing Information. Novartis Pharmaceuticals Corp; 2020.

6. Simponi Aria. Prescribing Information. Janssen Biotech Inc; 2021.

7. Xeljanz. Prescribing Information. Pfizer Inc; 2022.

8. Taltz. Prescribing Information. Eli Lilly & Co; 2021.

9. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.

a. Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2021;80(5):582-590.

b. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report. Novartis Pharmaceuticals Corp; May 2019.

c. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report PASI 90 and ACR Components data. Novartis Pharmaceuticals Corp; January 2020.

d. Data on file. CAIN457F2342 (FUTURE 5): 2-Year Interim Report mNAPSI and PASI 100 data. Novartis Pharmaceuticals Corp; October 2019.

e. Data on file. CAIN457H2315 Data Analysis Report. Novartis Pharmaceuticals Corp; April 2020.

f. Data on file. CAIN457H2315 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2019.

g. Data on file. CAIN457F2310 Data Analysis Report. Novartis Pharmaceuticals Corp; June 2019.

h. Data on file. CAIN457F2310 (MEASURE 2): Nocturnal Back Pain. Novartis Pharmaceuticals Corp; February 2021.

i. Data on file. CAIN457F2342 (FUTURE 5): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.

j. 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.

k. Data on file. CAIN457F2342 Clinical Study Report Interim Analysis-Week 24. Novartis Pharmaceuticals Corp; November 2017.

l. Data on file. CAIN457F2342 (FUTURE 5): 2-Year HAQ-DI biologic-naive data. Novartis Pharmaceuticals Corp; February 2021.

m. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

n. Data on file. Selected EAIRs MEASURE 2 Year 5. Novartis Pharmaceuticals Corp; January 2020.

o. 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.

p. Data on file. LTD Cosentyx Prescriber and Patient Counts. Novartis Pharmaceuticals Corp; July 2021.

q. Boonen A, Sieper J, van der Heijde D, et al. The burden of non-radiographic axial spondyloarthritis. Semin Arthritis Rheum. 2015;44(5):556-562.

r. Data on file. CAIN457F2304 Clinical Study Report. Novartis Pharmaceuticals Corp; June 2020.

s. Data on file. CAIN457F2304 Data Analysis Report. Novartis Pharmaceuticals Corp; January 2022.

t. Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab demonstrates high efficacy and a favourable safety profile in paediatric patients with severe chronic plaque psoriasis: 52-week results from a Phase 3 double-blind randomized, controlled trial. J Eur Acad Dermatol Venereol. 2021;35(4):938-947.