Skin Clearance | COSENTYX® (secukinumab)

Here with you to help kids be comfortable in their own skin

Please see primary and key secondary end point results and study design details for PsO6 (A2310) study

In the pivotal PsO6 (A2310) study of pediatric patients with severe PsO

Skin clearance results in children⁹

*In this study, an IRT error led to additional dosing and higher dosing of some patients (LD: n=16; HD: n=20) at Weeks 13, 14, and 15, after the primary end point (Week 12) assessment. The number of patients in the affected and not-affected patient groups was deemed to be too low for any differences to be considered clinically relevant.⁹

^†Data presented here do not account for 3 patients from the COSENTYX HD arm weighing <25 kg who received COSENTYX 75 mg, based on the recommended dosing for pediatric patients <50 kg.⁹

The PsO6 (Study A2310) study was a randomized, double-blind, placebo- and active-controlled trial to demonstrate efficacy and assess the safety and tolerability of COSENTYX vs placebo and etanercept (in a single-blinded arm) in patients from 6 to <18 years of age with severe chronic PsO (defined by a PASI score of ≥20 and an IGA modified 2011 score of 4, and involving ≥10% of the BSA) who were candidates for systemic therapy. pNRI was used to handle missing values.^1,9

Please see the coprimary and key secondary end point results and study design details for the pivotal PsO6 (A2310) study (pediatric PsO)

Pivotal PsO6 (Study A2310) study in pediatric patients ≥6 years of age with severe PsO¹

Results by baseline weight strata for the approved doses:

PASI 75 and IGA mod 2011 0 or 1 at Week 12 (coprimary end points)

PASI 75

—70% for COSENTYX 75 mg and 150mg (N=43)
—15% for placebo (N=41)

—55% for COSENTYX 75 mg (N=22; <50 kg)
—10% for placebo (N=20)

—86% for COSENTYX 150 mg (N=21; ≥50 kg)
—19% for placebo (N=21)

IGA mod 2011 0 or 1

—56% for COSENTYX 75 mg and 150 mg (N=43)
—5% for placebo (N=41)

—32% for COSENTYX 75 mg (N=22; <50 kg)
—5% for placebo (N=20)

—81% for COSENTYX 150 mg (N=21; ≥50 kg)
—5% for placebo (N=21)

PASI 90 at Week 12 (key secondary end point)

—60% for COSENTYX 75 mg and 150 mg (N=43)
—2% for placebo (N=41)

—41% for COSENTYX 75 mg (N=22; <50 kg)
—5% for placebo (N=20)

—81% for COSENTYX 150 mg (N=21; ≥50 kg)
—0% for placebo (N=21)

PsO6 (Study A2310) (pediatric PsO) study design

PsO6 (Study A2310) was a global, multicenter, randomized, double-blind, placebo- and active-controlled study in 162 pediatric patients from 6 to <18 years of age with severe chronic PsO (as defined by a PASI score ≥20, an IGA modified 2011 score of 4, and involving ≥10% of the BSA) who were candidates for systemic therapy. Patients received subcutaneous COSENTYX 75 mg if weighing <25 kg, COSENTYX 75 mg or 150 mg if weighing 25 to <50 kg, COSENTYX 150 mg or 300 mg if weighing ≥50 kg, or placebo. Treatment was administered at Weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter up to Week 52, followed by an extension period up to Week 236. Patients in the etanercept arm received a weekly subcutaneous dose of 0.8 mg/kg (up to a maximum of 50 mg). At Week 12, PASI 75 nonresponders on placebo were placed on COSENTYX based on their weight (as described above) while PASI 75 responders entered the follow-up period. The coprimary end points were PASI 75 and IGA mod 2011 0 or 1 response at Week 12. The key secondary end point was PASI 90 at Week 12.^1,9

BSA,body surface area; IGA mod 2011,Investigator’s Global Assessment modified 2011; PASI,Psoriasis Area and Severity Index; PsO,plaque psoriasis.

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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Here with you to help kids be comfortable in their own skin

Skin clearance results in children9

See time to flare in ERAm

Convenient once-a-month maintenance dosing (every 4 weeks)m

Support to help offices help patients

Please see the coprimary and key secondary end point results and study design details for the pivotal PsO6 (A2310) study (pediatric PsO)

Definitions and references

Skin clearance results in children⁹

See time to flare in ERA^m

Convenient
once-a-month
maintenance dosing
(every 4 weeks)^m