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How does fatigue affect the daily lives of your patients with PsA?
  • The FACIT-F is a 13-item questionnaire that assesses self-reported fatigue and its impact on daily activities and function1*

In FUTURE 5, in biologic-naive patients

  • At 1 year, patients in the 300 mg arm and the 150 mg arm experienced a 40% and 61% mean change from baseline in FACIT-F (n=147), respectively2

In FUTURE 5, fatigue was measured by FACIT-F, a prespecified exploratory end point at 1 year. Results were analyzed using MMRM in a subgroup of biologic-naive patients. No clinical or statistical conclusions can be drawn.1,2

Items in the FACIT-F questionnaire are relevant to patients with PsA, and include1:
  • I feel tired

  • I need help doing my usual activities

  • I have to limit my social activities because I am tired

  • I feel weak all over

Hear what matters to patients
A patient experience
A patient’s experience:
“It gets fatiguing sometimes. But I don’t let it slow me down. I keep moving and pushing through.”

Meet Joni

Joni, an actual patient with PsA on COSENTYX, was compensated for her time. Individual results may vary.

At 1 year in the mixed population, the FACIT-F scores were 14.1 and 16.9 for groups receiving COSENTYX 300 mg (n=206) and COSENTYX 150 mg (n=202), respectively.1,2

At baseline in the mixed population, the FACIT-F scores were 21.6, 23.6, and 21.7 for groups receiving COSENTYX 300 mg (n=220), COSENTYX 150 mg (n=218), and placebo (n=328), respectively. At Week 16, the FACIT-F scores were 15.4, 17.1, and 18.8 for groups receiving COSENTYX 300 mg (n=214), COSENTYX 150 mg (n=210), and placebo (n=303), respectively.1

*On a scale of 0 ("not at all") to 4 ("very much").1

ALL-IN-ONE relief in AS

Results in the hallmarks of disease that matter to patientsg,h

Tap to see IMPORTANT SAFETY INFORMATION and INDICATIONS

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
COSENTYX 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 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 PsO, 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 in subjects treated with COSENTYX compared to placebo-treated subjects. A similar increase in risk of infection in subjects treated with COSENTYX was seen in placebo-controlled trials in subjects with PsA, AS and nr-axSpA. The incidence of some types of infections, including fungal infections, appeared to be dose-dependent in clinical trials. 

In the postmarketing setting, serious and some fatal infections have been reported in patients treated with 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

Inflammatory Bowel Disease (IBD) exacerbations, in some cases serious and/or leading to discontinuation of COSENTYX, occurred in COSENTYX treated subjects during clinical trials in PsO, PsA, AS, nr-axSpA, and HS. In adult subjects with HS, the incidence of IBD was higher in subjects who received COSENTYX 300 mg every 2 weeks (Ulcerative Colitis [UC] 1 case, EAIR 0.2/100 subject-years; Crohn’s Disease [CD] 1 case, EAIR 0.2/100 subject-years) compared to subjects who received COSENTYX 300 mg every 4 weeks (IBD 1 case, EAIR 0.2/100 subject-years). In addition, new onset IBD cases occurred in subjects treated with COSENTYX in clinical trials. In an exploratory trial in 59 subjects with active Crohn’s disease [COSENTYX is not approved for the treatment of Crohn’s disease], there were trends toward greater disease activity and increased adverse reactions in subjects treated with COSENTYX as compared to placebo-treated subjects. 

Exercise caution when prescribing COSENTYX to patients with IBD. Patients treated with COSENTYX should be monitored for signs and symptoms of IBD.

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® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis (PsO) 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® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis (PsO) 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.

COSENTYX is indicated for the treatment of adult patients with moderate to severe hidradenitis suppurativa (HS).

*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

FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; MMRM, mixed-effect model repeated measure; PsA, psoriatic arthritis.

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): Interim Data Analysis Report FACIT-Fatigue data through Week 52. Novartis Pharmaceuticals Corp; April 2019.

3. Data on file. CAIN457F2312 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2014.

4. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

5. Data on file. CAIN457A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2015.

6. Data on file. CAIN457F2312 Interim Study Report. Novartis Pharmaceuticals Corp; November 2015.

7. 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.

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.