Safety profile in clinical trials up to 52 weeks1*

Adverse Reactions in AS Patients

*Adverse reactions listed are those ≥2% and at a higher proportion in the COSENTYX groups than in the placebo groups.2

75 mg or 150 mg administered as IV or subcutaneous dose (pooled outcome).2

No new or unexpected safety signals seen at Year 13

Low immunogenicity at Year 12

  • Less than 0.5% of patients developed antibodies that were classified as neutralizing at 52 weeks2
    • ­
    • Neutralizing antibodies were not associated with loss of efficacy2‡

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.2

  • Incidence of infections in the COSENTYX groups was 31% vs 18% for placebo2
  • The incidence of serious infections was 0.3% with any COSENTYX dose vs 0% with placebo at Week 161
  • Immune/administration reactions were comparable among patients treated with the COSENTYX 150-mg dose and placebo1
  • In the ankylosing spondylitis program, with 571 patients exposed to COSENTYX, there were 8 cases of inflammatory bowel disease2
    • During the entire treatment period there were 5 cases of Crohn’s disease (0.7 per 100 patient-years) and 3 cases of ulcerative colitis (0.4 per 100 patient-years). During the placebo-controlled 16-week period, there were 2 Crohn’s disease exacerbations and 1 new onset ulcerative colitis case that was a serious adverse event in patients treated with COSENTYX compared to none of the patients treated with placebo
    • During the remainder of the study when all patients received COSENTYX, 1 patient developed Crohn’s disease, 2 patients had Crohn’s exacerbations, 1 patient developed ulcerative colitis, and 1 patient had an ulcerative colitis exacerbation

  • Adverse reactions reported by >1% of patients taking COSENTYX (and higher than placebo) in clinical trials for moderate to severe plaque psoriasis were nasopharyngitis, diarrhea, upper respiratory tract infection, rhinitis, oral herpes, pharyngitis, urticaria, and rhinorrhea2
  • The safety profile observed in patients with ankylosing spondylitis is consistent with the safety profile in psoriasis2

References: 1. Data on file. AIN457H Summary of Clinical Safety in (Ankylosing Spondylitis). Novartis Pharmaceuticals Corp; February 2015. 2. Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2016. 3. Data on file. CAIN457F2310 Clinical Study Report. Novartis Pharmaceuticals Corp; November 2014.

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.