Nail, Scalp, and Palmoplantar PSO Data | COSENTYX® (secukinumab)

STUDY DESIGNS

TRANSFIGURE
TRANSFIGURE was a double-blind, randomized, placebo-controlled study examining the safety and efficacy of COSENTYX in patients with moderate to severe nail PsO. Patients were randomized to COSENTYX 300 mg (n=66), COSENTYX 150 mg (n=67), or placebo (n=65). All patients were adults with moderate to severe plaque PsO (PASI score ≥12 and BSA ≥10%), and significant nail involvement (fingernail NAPSI score of ≥16 and ≥4 fingernails involved), who were candidates for systemic therapy. At Week 16, patients initially receiving placebo were rerandomized 1:1 to COSENTYX 150 mg or COSENTYX 300 mg; initial dosing: once weekly for 5 weeks followed by once every 4 weeks. Primary end point was NAPSI assessment at Week 16. Secondary end points included NAPSI response over time up to Week 132.¹

Scalp Study
Scalp was a multicenter, double-blind, randomized, placebo-controlled study in adult patients with moderate to severe scalp psoriasis for at least 6 months prior to randomization with PSSI score >12 and IGA mod 2011 (scalp only) >3 and >30% scalp surface area affected. At baseline, patients were randomized to COSENTYX 300 mg (n=51) or placebo (n=51). During the initial treatment period (from baseline to Week 12), patients in both treatment groups received subcutaneous treatment weekly at baseline and Weeks 1, 2, 3, and 4, followed by treatment every 4 weeks. Primary end point was the proportion of patients who achieved PSSI 90 at Week 12. At Week 12, patients initially receiving placebo who did not achieve a PSSI 90 response were switched to COSENTYX 300 mg (n=46): doses at Weeks 12, 13, 14, 15, 16, and 20. Patients who achieved response while receiving placebo continued receiving placebo (n=l) through Week 20.²
BSA, body surface area; IGA, Investigator's Global Assessment modified 2011; NAPSI, Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; PsO, plaque psoriasis; PSSI, Psoriasis Scalp Severity Index.

References
1. Data on file. CAIN457 A2313 Clinical Study Report. Novartis Pharmaceuticals Corp; October 2017.
2. Bagel J, Duffin KC, Moore A, et al. The effect of secukinumab on moderate-to-severe scalp psoriasis: results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study. J Am Acad Dermatol. 2017;77(4):667-674.

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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Dedicated studies show clearance is possible even in troublesome areas of psoriasis

COSENTYX is effective in nail, scalp, and palmoplantar

Effective in nail^1,2*

Baseline

Week 16

Week 80

Effective in scalp^3,4†

Baseline

Week 12

Week 24

Effective in palmoplantar^5,6‡

Baseline

Week 16

Week 80

Please see TRANSFIGURE and Scalp study design details

Tap to see IMPORTANT SAFETY INFORMATION and INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

References

Dedicated studies show clearance is possible even in troublesome areas of psoriasis

COSENTYX is effective in nail, scalp, and palmoplantar

Effective in nail1,2*

Baseline

Week 16

Week 80

Effective in scalp3,4†

Baseline

Week 12

Week 24

Effective in palmoplantar5,6‡

Baseline

Week 16

Week 80

Please see TRANSFIGURE and Scalp study design details

References

Effective in nail^1,2*

Effective in scalp^3,4†

Effective in palmoplantar^5,6‡