Adverse Events & Safety | COSENTYX® (secukinumab)

For your adult patients with PsO at risk of developing PsA

Trust in the well-studied clinical profile

~90 completed studies and >74,000 patients¹

NO Boxed WARNING²
NO warning for suicidal ideation and behavior²
NO routine lab monitoring, including liver enzymes, during treatment²
- Evaluate patients for TB prior to initiating treatment
NO trend toward increased AE incidence rates of IBD, Candida infections, MACE, or malignancy through Year 5³
<1% of patients had immunogenicity over 5 years⁴

Adult PsO safety profile at Week 12²

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.²

In adults with PsO at Week 12 and at 5 years^2,3

In adults with PsA at Week 16 and at 5 years^2,5,6

The safety profile observed in adults with PsA treated with COSENTYX is consistent with the safety profile observed in PsO.²

A robust safety profile²

No new cases of CD and 3 cases of exacerbation (in which 1 patient received COSENTYX); 2 new cases of ulcerative colitis and 2 cases of exacerbation; no cases of IBD in patients with placebo
29% of patients experienced infections (n=1382) vs 19% with placebo (n=694)
0.1% of patients reported serious infections (n=1382) vs 0.3% with placebo (n=694)
If a serious infection develops, discontinue COSENTYX until the infection resolves

A well-studied safety profile³

Safety data up to Year 1 based on a post hoc analysis of the SCULPTURE core study in patients treated with 300 mg who achieved PASI 75 at Week 12, who were rerandomized to 300 mg FI arm, and reconsented at Week 52 to enter the SCULPTURE extension study. Year 2 to Year 5 safety data are presented in this same patient subpopulation; thus, not all patients who started with 300 mg in the SCULPTURE core study were included.

^†Patient exposure is calculated as a sum of individual subject durations in days divided by 365 for each interval. A patient with multiple occurrences of the same AE in a 1-year interval was counted only once, while a patient with multiple occurrences of the same AE in different-year intervals was counted for each year.
^‡Includes neutropenia adverse events reported by investigators in the SCULPTURE study; does not include lab reports of neutropenia.³
^§Of the 2 cases of ulcerative colitis in Year 2, 1 case was an exacerbation of previously existing UC.
^¶1 case of cholangiocarcinoma, 1 case of invasive ductal breast carcinoma.
^#1 case of breast cancer.

Low immunogenicity

Neutralizing antibodies developed in less than 0.5% of patients at 1 year and were not associated with loss of efficacy^2**

^**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 inflammatory bowel disease in PsO patients treated with COSENTYX up to 52 weeks²

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.²

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Dosing

Please see ERASURE (pivotal trial), FIXTURE, FEATURE, JUNCTURE, and SCULPTURE extension study design details

STUDY DESIGNS

ERASURE and FIXTURE
ERASURE and FIXTURE were multicenter, randomized, double-blind, placebo-controlled trials. ERASURE evaluated 738 adult patients who received subcutaneous COSENTYX 150 mg (n=245), COSENTYX 300 mg (n=245), or placebo (n=248). FIXTURE evaluated 1306 adult patients who received COSENTYX 150 mg (n=327), COSENTYX 300 mg (n=327), placebo (n=326), or a biologic active control: etanercept (n=323). All patients were adults with moderate to severe plaque psoriasis who had BSA ≥10%, PASI score ≥12, and IGA mod 2011 score ≥3 and were candidates for systemic therapy or phototherapy. Patients received treatment at Weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter. Patients randomized to receive placebo who were nonresponders at Week 12 and did not achieve PASI 75 were then rerandomized to receive COSENTYX 300 mg or 150 mg. Coprimary end points were PASI 75 and IGA 0 or 1 (clear or almost clear).^1-3

FEATURE
FEATURE was a multicenter, randomized, double-blind, placebo-controlled trial in 177 adults with PsO. It assessed the safety, tolerability, and usability of COSENTYX self-administration via prefilled syringe for 12 weeks. Patients received subcutaneous treatment at Weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter. Coprimary end points were PASI 75 and IGA 0 or 1 (clear or almost clear) at Week 12.¹

JUNCTURE
JUNCTURE was a multicenter, randomized, double-blind, placebo-controlled parallel-group trial in 182 adults with moderate to severe PsO. Patients were stratified by weight (<90 kg or ≥90 kg) and randomized to receive COSENTYX 300 mg, COSENTYX 150 mg, or placebo (at Weeks 0, 1, 2, 3, and 4, and every 4 weeks thereafter). Coprimary end points were PASI 75 and IGA 0/1 at Week 12. Secondary end points included observer rating of usability of the autoinjector and patient rating of acceptability using SIAQ.⁴

SCULPTURE Extension
SCULPTURE Extension was a multicenter, double-blind, and open-label (from Week 156 through Week 260) extension study. Patients who completed 52 weeks of the SCULPTURE Core study were eligible to continue the same COSENTYX dose and regimen in the extension to Week 156. At Week 156, the study was unblinded and, based on investigator judgment, patients could switch dosing regimens (from SoR to FI regimen and from COSENTYX 150 mg to 300 mg). Primary objective was to assess long-term safety and tolerability of COSENTYX in patients who completed treatment in the core studies. Other objectives included efficacy over time with respect to PASI 50/75/90.⁵

BSA, body surface area; FI, fixed interval; IGA, Investigator’s Global Assessment modified 2011; PASI, Psoriasis Area and Severity Index; PsO, plaque psoriasis; SIAQ, Self-Injection Assessment Questionnaire; SoR, start of relapse.

References
1. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
2. Data on file. AIN457 A2302 Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013.
3. Data on file. AIN457 A2303 Clinical Study Report. Novartis Pharmaceuticals Corp; September 2013.
4. Paul C, Lacour J-P, Tedremets L, et al; for the JUNCTURE study group. Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol. 2015;29(6):1082-1090.
5. Data on file. 4-Year Interim Report: Study CAIN457 A2304E1. Novartis Pharmaceuticals Corp; December 2016.

Tap to see IMPORTANT SAFETY INFORMATION and INDICATIONS

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
COSENTYX^® (secukinumab) is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis and angioedema have been reported during treatment with COSENTYX...

CONTRAINDICATIONS

COSENTYX^® (secukinumab) is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis and angioedema 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. In placebo-controlled clinical trials in subjects with moderate to severe PsO, 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 in subjects treated with COSENTYX compared to placebo-treated subjects. A similar increase in risk of infection in subjects treated with COSENTYX was seen in placebo-controlled trials in subjects with PsA, AS and nr-axSpA. The incidence of some types of infections, including fungal infections, appeared to be dose-dependent in clinical trials.

In the postmarketing setting, serious bacterial, viral, and fungal opportunistic infections, and some fatal infections have been reported in patients receiving IL-17 inhibitors including COSENTYX. Cases of Hepatitis B virus reactivation have been reported.

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.

If signs of Hepatitis B virus reactivation occur, consult a hepatitis specialist. COSENTYX is not recommended for use in patients with active viral hepatitis.

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

Inflammatory Bowel Disease (IBD) exacerbations, in some cases serious and/or leading to discontinuation of COSENTYX, occurred in COSENTYX treated subjects during clinical trials in PsO, PsA, AS, nr-axSpA, and HS. In adult subjects with HS, the incidence of IBD was higher in subjects who received COSENTYX 300 mg every 2 weeks (Ulcerative Colitis [UC] 1 case, EAIR 0.2/100 subject-years; Crohn’s Disease [CD] 1 case, EAIR 0.2/100 subject-years) compared to subjects who received COSENTYX 300 mg every 4 weeks (IBD 1 case, EAIR 0.2/100 subject-years). In addition, new onset IBD cases occurred in subjects treated with COSENTYX in clinical trials. In an exploratory trial in 59 subjects with active Crohn’s disease [COSENTYX is not approved for the treatment of Crohn’s disease], there were trends toward greater disease activity and increased adverse reactions in subjects treated with COSENTYX as compared to placebo-treated subjects.

Exercise caution when prescribing COSENTYX to patients with IBD. Patients treated with COSENTYX should be monitored for signs and symptoms of IBD.

Eczematous Eruptions

In postmarketing reports, cases of severe eczematous eruptions, including atopic dermatitis-like eruptions, dyshidrotic eczema, and erythroderma, were reported in patients receiving COSENTYX; some cases resulted in hospitalization. The onset of eczematous eruptions was variable, ranging from days to months after the first dose of COSENTYX.

Treatment may need to be discontinued to resolve the eczematous eruption. Some patients were successfully treated for eczematous eruptions while continuing COSENTYX.

Hypersensitivity Reactions

Serious hypersensitivity reactions including anaphylaxis, angioedema, and urticaria have been reported in COSENTYX treated subjects in clinical trials and in the post-marketing setting. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of COSENTYX and initiate appropriate therapy.

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.

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Trust in the well-studied clinical profile

~90 completed studies and >74,000 patients1

Adult PsO safety profile at Week 122

In adults with PsO at Week 12 and at 5 years2,3

In adults with PsA at Week 16 and at 5 years2,5,6

A robust safety profile2

A well-studied safety profile3