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Here with you to help patients get through their day

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

61% Up to

improvement in fatigue at 1 year²

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’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 patients^g,h

AS efficacy

Consistent safety profile overall across ALL indications^m

Explore our safety data

Help patients get started quickly and successfully

See our resources

9/21 135551

Please see FUTURE 2 (pivotal trial), and FUTURE 5 primary end points and study design details

COSENTYX clinical trial end points

FUTURE 2

FUTURE 2 studied a mixed population of patients with PsA: 2/3 biologic-naive and 1/3 anti–TNF-α inadequate responders³

ACR20 responses at Week 16 (NRI) in the mixed population were 57% (P <0.0001), 60% (P <0.0001), and 18%, respectively, for COSENTYX 300 mg (n=100), 150 mg (n=100), and placebo (n=98)^3,4

The primary end point of ACR20 responses at Week 24 (NRI) was achieved by 54% of patients on COSENTYX 300 mg (n=100) (P <0.0001), 51% on COSENTYX 150 mg (n=100) (P <0.0001), and 15% on placebo (n=98)^3,4

Skin lesions improved in patients with coexistent PsO who received COSENTYX (n=99) compared with placebo (n=43), as measured by the PASI^3,4

Improvements in enthesitis and dactylitis scores were observed in the COSENTYX group compared with placebo at Week 24⁴

FUTURE 5

FUTURE 5 studied a mixed population of patients with PsA: more than 2/3 biologic-naive and 1/3 anti–TNF-α inadequate responders¹

JOINT¹

ACR20 response rates (NRI) (primary end point) were:

63% for COSENTYX 300 mg (n=222) (P <0.0001)

56% for COSENTYX 150 mg (n=220) (P <0.0001)

27% for placebo (n=332)

ENTHESITIS¹

Complete resolution (LEI=0) in patients with enthesitis at baseline (NRI):

56% for COSENTYX 300 mg (n=140)

55% for COSENTYX 150 mg (n=141)

35% for placebo (n=192)

DACTYLITIS¹

Complete resolution (LDI=0) in patients with dactylitis at baseline (NRI):

66% for COSENTYX 300 mg (n=82)

57% for COSENTYX 150 mg (n=80)

32% for placebo (n=124)

SKIN¹

Patients who achieved PASI 90 (NRI):

54% for COSENTYX 300 mg (n=110)

37% for COSENTYX 150 mg (n=125)

9% for placebo (n=162)

NAIL¹*

Reduction in nail disease (mNAPSI as observed) response rates were^†:

51% for COSENTYX 300 mg (n=125)

53% for COSENTYX 150 mg (n=128)

11% for placebo (n=203)

*Nail data in PsA were consistent with those in the dedicated nail PsO study, TRANSFIGURE. Improvement from baseline NAPSI at Week 16 (primary end point) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P <0.0001).⁵

^†At baseline, mNAPSI scores were 18.0 and 17.8 in the 300-mg and 150-mg arms, respectively. At Week 16, mNAPSI scores were 8.8 and 8.4 in the 300-mg and 150-mg arms, respectively.¹

Study designs

FUTURE 2 study design

FUTURE 2 was a multicenter, randomized, double-blind, placebo-controlled trial that evaluated 397 adult patients with active PsA (≥3 swollen and ≥3 tender joints) despite use of NSAIDs, corticosteroids, or DMARDs. Patients had a diagnosis for ≥5 years and received subcutaneous COSENTYX 75 mg (n=99), 150 mg (n=100), 300 mg (n=100), or placebo (n=98) at Weeks 0, 1, 2, 3, and 4, followed by the same dose every 4 weeks thereafter. Patients who received placebo were rerandomized to COSENTYX 150 mg or 300 mg every 4 weeks at Week 16 or Week 24 based on responder status. Primary end point was the percentage of patients with ACR20 response at Week 24. Study population was mixed: 2/3 of patients were biologic-naive and 1/3 were anti–TNF-α inadequate responders.^3,4,6

FUTURE 5 study design

FUTURE 5 was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial that evaluated 996 adult patients with active PsA. Patients were randomized to receive subcutaneous COSENTYX 150 mg without load (n=222), 150 mg with load (n=220), 300 mg with load (n=222), or placebo (n=332). Patients who received placebo were rerandomized to receive COSENTYX 150 mg or 300 mg every 4 weeks, based on responder status at Week 16 (nonresponders) or Week 24 (responders). Primary end point was the percentage of patients with ACR20 response at Week 16. Secondary end points included change in mTSS at Week 24 from baseline. Study population was mixed: more than 2/3 of patients were biologic-naive and less than 1/3 were anti–TNF-α inadequate responders (individual patients could have been exposed to up to 3 TNF-α inhibitors).^1,7

ACR=American College of Rheumatology; LDI=Leeds Dactylitis Index; LEI=Leeds Enthesitis Index; mNAPSI=modified Nail Psoriasis Severity Index; mTSS=modified Total Sharp Score; NAPSI=Nail Psoriasis Severity Index; NRI=nonresponder imputation; PASI=Psoriasis Area and Severity Index; PsA=psoriatic arthritis; PsO=plaque psoriasis; TNF=tumor necrosis factor.

Definitions and references

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]. East Hanover, NJ: Novartis Pharmaceuticals Corp; December 2021.

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]. East Hanover, NJ: Novartis Pharmaceuticals Corp; December 2021.

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.

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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 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.
Click or scroll down to see full Indications and Important Safety Information

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.

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.
Click or scroll down to see full Indications and Important Safety Information
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.

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.

7/21 132185

Click or scroll down to see full Indications and Important Safety Information

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.
Click or scroll down to see full Indications and Important Safety Information

Click or scroll down to see full Indications and Important Safety Information

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.

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.

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 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.

Please see full Prescribing Information, including Medication Guide.

7/21 132185

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7/21 124824

Here with you to help patients get through their day

How does fatigue affect the daily lives of your patients with PsA?

improvement in fatigue at 1 year2

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

Hear what matters to patients

A patient’s experience:

“It gets fatiguing sometimes. But I don’t let it slow me down. I keep moving and pushing through.”

ALL-IN-ONE relief in AS

Consistent safety profile overall across ALL indicationsm

Help patients get started quickly and successfully

Please see FUTURE 2 (pivotal trial), and FUTURE 5 primary end points and study design details

COSENTYX clinical trial end points

Study designs

Definitions and references

Definitions

References

INDICATIONS

IMPORTANT SAFETY INFORMATIONCONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Infections

Pre-treatment Evaluation for Tuberculosis

Inflammatory Bowel Disease

Hypersensitivity Reactions

Immunizations

MOST COMMON ADVERSE REACTIONS