Adverse Events & Safety | COSENTYX® (secukinumab)

COSENTYX has a robust and well-studied safety profile

Adult 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

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 is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis have been reported during treatment with COSENTYX...

CONTRAINDICATIONS

COSENTYX is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis 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 and some fatal infections have been reported in patients treated with COSENTYX.

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.

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

Anaphylaxis and cases of urticaria occurred in COSENTYX treated subjects 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 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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Over time and across adult PsO and PsA

COSENTYX has a robust and well-studied safety profile

Adult PsO safety profile at Week 12¹

In adults with PsO at Week 12 and at 5 years^1,2

In adults with PsA at Week 16 and at 5 years^1,3

A robust safety profile¹

A well-studied safety profile¹

Low immunogenicity

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

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

Tap to see IMPORTANT SAFETY INFORMATION and INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

Definitions and references

Over time and across adult PsO and PsA

COSENTYX has a robust and well-studied safety profile

Adult PsO safety profile at Week 121

In adults with PsO at Week 12 and at 5 years1,2

In adults with PsA at Week 16 and at 5 years1,3

A robust safety profile1

A well-studied safety profile1

Low immunogenicity

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

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

Tap to see IMPORTANT SAFETY INFORMATION and INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

Definitions and references

Adult PsO safety profile at Week 12¹

In adults with PsO at Week 12 and at 5 years^1,2

In adults with PsA at Week 16 and at 5 years^1,3

A robust safety profile¹

A well-studied safety profile¹

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