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

lmprovements in mobility, self-care,
and usual activities3*

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Patient-Reported Outcomes

lmprovements 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

PsO=plaque psoriasis.

References: 1. Strober B, Sigurgeirsson B, Popp G, 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; June 2018. 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.

WARNINGS AND PRECAUTIONS

Infections

COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in subjects treated with

INDICATIONS

COSENTYX® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis
in adult patients who are candidates for systemic therapy or phototherapy.

COSENTYX is indicated for the treatment of adult patients with active psoriatic arthritis.

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

INDICATIONS AND IMPORTANT SAFETY INFORMATION

INDICATIONS

COSENTYX® (secukinumab) is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

COSENTYX is indicated for the treatment of adult patients with active psoriatic arthritis.

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

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients.

WARNINGS AND PRECAUTIONS

Infections

COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in subjects treated with COSENTYX compared to placebo-treated subjects. In placebo-controlled clinical trials in patients 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 patients with psoriatic arthritis and ankylosing spondylitis. The incidence of some types of infections appeared to be dose-dependent in clinical studies.

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, the patient should be closely monitored and COSENTYX should be discontinued until the infection resolves.

Pre-treatment Evaluation for Tuberculosis

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Do not administer 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. Patients receiving COSENTYX should be monitored 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 patients treated with COSENTYX during clinical trials in plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. In addition, new onset inflammatory bowel disease cases occurred in clinical trials with COSENTYX. In an exploratory study in 59 patients 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 patients treated with COSENTYX 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 cap of the COSENTYX Sensoready® pen and the COSENTYX prefilled syringe contains 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.

Vaccinations

Prior to initiating therapy with COSENTYX, consider completion of all age appropriate immunizations according to current immunization guidelines. Patients treated with COSENTYX should not receive live vaccines.

Non-live vaccinations received during a course of COSENTYX may not elicit an immune response sufficient to prevent disease.

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.