Over time and across indications

COSENTYX has demonstrated a consistent safety profile

Over time and across indications

COSENTYX has demonstrated a consistent safety profile

PsO safety profile at Week 121

  • Infections were reported in 28.7% of patients on COSENTYX (n=1382) vs 18.9% on placebo (n=694)*
  • Serious infections occurred in 0.14% of patients treated with COSENTYX (n=1382) vs 0.3% of those receiving placebo (n=694)

*Phase III data showed an increasing trend for some types of infection with increasing serum concentration of COSENTYX, including Candida infections, herpes viral infections, staphylococcal skin infections, and infections requiring treatment.1


  • In PsO at Week 12 and at 5 years1,2
  • In PsA at Week 16 and at 3 years1,3

The safety profile observed in patients with PsA treated with COSENTYX is consistent with the safety profile observed in PsO.1

Adverse reactions reported
by >1% of patients with plaque
psoriasis through Week 12
in pivotal trials1

callout-diagonalArrow

In a clinical study

5 YEARS of experience: a consistent safety profile in PsO2,4

callout-diagonalArrow

Low immunogenicity

  • Neutralizing antibodies developed in less than 0.5% of patients at 1 year and were not associated with loss of efficacy1†

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.1

Low immunogenicity

  • Neutralizing antibodies developed in less than 0.5% of patients at 1 year and were not associated with loss of efficacy1†

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.1

Incidence of inflammatory bowel disease in PsO patients treated with COSENTYX up to 52 weeks1

Of the 3430 patients treated with COSENTYX, 3 experienced Crohn's disease exacerbation, 0 experienced new onset of Crohn's disease, 2 experienced Ulcerative colitis exacerbation, and 2 experienced new onset of Ulcerative colitis. There were no cases of inflammatory bowel disease in placebo patients (n=793). One case of exacerbation of Crohn's disease was reported from long-term, noncontrolled portions of ongoing clinical trials in PsO.1

Click here to see study designs.

PsA=psoriatic arthritis; PsO=plaque psoriasis.

References: 1. Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; June 2018. 2. Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32(9):1507-1514. 3. Data on file. CAIN457F2312 3-Year Interim Report. Novartis Pharmaceuticals Corp; September 2017. 4. Data on file. CAIN457A2304E1 Clinical Study Report. Novartis Pharmaceuticals Corp; February 2018.

See more
Close

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.