Significant skin clearance achieved at Week 12 in moderate to severe plaque psoriasis patients1,3*†‡

82% of Patients Achieved PASI 75 Graph
Of patients on COSENTYX 300 mg who achieved PASI 75 at Week 12:

7 out of 10 patients achieved PASI 901‡

PASI 75 and IGA score of 0 or 1 were coprimary end points at Week 121

  • IGA results: Clear or almost clear skin (IGA score of 0 or 1) was achieved by 65% of patients receiving COSENTYX 300 mg vs 2% with placebo (P<0.001)1
  • The percentages of patients achieving PASI 75 and an IGA score of 0 or 1 with the 150-mg dose were 71% and 51% vs 4% and 2% with placebo, respectively (P<0.001)1

In a study of patients with PsA, improvements in skin lesions (PASI scores) were also seen in patients with coexistent plaque psoriasis1

Trial Designs in Plaque Psoriasis: The ERASURE and FIXTURE studies were multicenter, randomized, double-blind, placebo-controlled trials. ERASURE evaluated 738 adult patients who received COSENTYX 300 mg (n=245), COSENTYX 150 mg (n=245), or placebo (n=248). FIXTURE evaluated 1306 adult patients who received COSENTYX 300 mg (n=327), COSENTYX 150 mg (n=327), placebo (n=326), or a biologic active control (n=323). All patients were adults with moderate to severe plaque psoriasis who had a BSA ≥10%, PASI score ≥12, and IGA modified 2011 score ≥3, and were candidates for systemic therapy or phototherapy. Patients received treatment once a week for 5 weeks and once a month thereafter. Patients randomized to receive placebo who were nonresponders at Week 12 were then crossed over to receive COSENTYX 300 mg or 150 mg. All patients were followed for up to 52 weeks. Coprimary end points were PASI 75 and IGA 0 or 1 (clear or almost clear) response at Week 12, evaluated using nonresponder imputation analysis (NRI).1-3

*Results from the ERASURE study. In the COSENTYX 300-mg treatment arm of FIXTURE, PASI 75 was achieved by 76% of patients and IGA 0 or 1 was achieved by 62% of patients at Week 12 compared to 5% and 3% of patients in the placebo arm, respectively (P<0.001 for 300 mg vs placebo for both comparisons).1

In the COSENTYX 150-mg treatment arm, at Week 12, PASI 75 was achieved by 67% of patients in FIXTURE and IGA 0 or 1 was achieved by 51% of patients in FIXTURE compared to 5% and 3% of patients in the placebo arm, respectively (P<0.001 for 150 mg vs placebo for both comparisons).1

At Week 12 in the COSENTYX 300-mg treatment arm, PASI 90 was achieved by 59% of patients (n=145) in ERASURE and 54% of patients (n=175) in FIXTURE. In the COSENTYX 150-mg treatment arm, PASI 90 was achieved by 39% of patients (n=95) in ERASURE and 42% of patients (n=137) in FIXTURE. In the placebo arm, PASI 90 was achieved by 1% of patients (n=3) in ERASURE and 2% of patients (n=5) in FIXTURE.1

Similar results were seen in the FEATURE and JUNCTURE studies.1

BSA=body surface area; IGA=Investigator’s Global Assessment; PASI=Psoriasis Area and Severity Index; PsA=psoriatic arthritis.

References: 1. Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2016. 2. Data on file. AIN457A2302 Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013. 3. Data on file. AIN457A2303 Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013.

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.