Plaque psoriasis symptom relief

Help patients live with less compromise caused by their disease

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

Psoriasis Symptom Diary Pain Score

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)

*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

Patient-Reported Outcomes

Improvements in mobility, self-care,
and usual activities3†

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Patient-Reported Outcomes

Improvements in mobility, self-care,
and usual activities3†

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Click here to see study designs.

*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 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. Analyses were for hypothesis generation and no adjustments were made for multiple comparisons. 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

Click here to see study designs.

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

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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.

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.

INDICATIONS

COSENTYX® (secukinumab) 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.

INDICATIONS

COSENTYX® (secukinumab) 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.

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.

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

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.

Please see full Prescribing Information, including Medication Guide.