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Plaque psoriasis symptom relief

Help patients live with less compromise caused by their disease

Patient-reported outcomes from the Psoriasis Symptom Diary© (PSD)1*

Among the subjects who chose to participate (39%) in assessments of patient-reported outcomes, improvements in signs and symptoms related to itching, pain, and scaling at Week 12 compared to placebo (ERASURE and FIXTURE studies) were observed using the PSD.2*

Reduction in psoriasis-related pain1

EQ-5D-3L Patient Reported Outcomes

Least squares means change from baseline at Week 12 in other domains of the PSD1*

Less itching

  • COSENTYX 300 mg (n=224): -5.1 (mean score at baseline=6.4)COSENTYX 150 mg (n=229): -4.9 (mean score at baseline=6.5)

  • Placebo (n=225): -0.4 (mean score at baseline=6.1)

Less scaling

  • COSENTYX 300 mg (n=224): -5.2 (mean score at baseline=6.4)COSENTYX 150 mg (n=229): -4.8 (mean score at baseline=6.5)

  • Placebo (n=225): -0.3 (mean score at baseline=6.2)

Patient-reported outcomes from the EQ-5D-3L

Improvement in mobility, self-care, and usual activities reported in an exploratory analysis3†

Psoriasis Symptom Diary Pain Score

*The current analysis used pooled data from two randomized, double-blind, placebo-controlled, multicenter phase 3 trials (ERASURE and FIXTURE). The PSD was developed to capture the daily signs and symptoms of PsO reported by the patient, based on 16 items evaluating PsO-related characteristics that patients found important. Each item was rated on a scale of 0-10, with 0 indicating no effect and higher scores indicating worse effects of psoriasis. Analyses of the three PSD items—itching, pain, and scaling—were conducted using the 12-week induction period for subjects with a baseline and Week 12 PSD assessment. The results reported here focus on three psoriasis-related signs and symptoms—itching, pain, and scaling.1
These results are from a pooled analysis of four phase 3 clinical trials (ERASURE, FIXTURE, FEATURE, and JUNCTURE), which included adult patients with moderate to severe PsO who were randomized to receive placebo or COSENTYX 300 mg and who reported problems with mobility, self-care, or usual activities at baseline. The objective of the study was to assess effect of COSENTYX treatment on mobility, self-care, and usual activities domains of the EQ-5D-3L questionnaire in patients with moderate to severe PsO who reported problems at baseline. The percentages of patients reporting problems in the EQ-5D-3L mobility, self-care, or usual activities domains were compared at Weeks 4, 8, and 12 between patients receiving placebo and those receiving COSENTYX 300 mg. Among the 282 patients receiving placebo and 309 receiving COSENTYX 300 mg, 172 and 180 reported any problems with mobility, 94 and 99 with self-care, and 214 and 254 with usual activities at baseline, respectively.3

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.

Definition
PsO, plaque psoriasis.

References
1. Strober B et al. Secukinumab improves patient-reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo-controlled clinical trials. Int J Dermatol. 2016;55(4):401-407.
2. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.

3. Data on file. ADAR US112: Summary of EQ-5D health states in patients reporting problems at baseline. Interim Report. Novartis Pharmaceuticals Corp; January 2019.