Pediatric PsO Treatment Information | COSENTYX® (secukinumab)

For children with moderate to severe plaque psoriasis

Provide skin clearance with COSENTYX^®(secukinumab)¹

Pivotal Trial PsO6 in pediatric patients with severe PsO

Randomized, double-blind, PBO- and active-controlled trial to demonstrate efficacy and assess safety and tolerability of COSENTYX vs PBO and etanercept (in a single-blinded arm) in subjects from 6 to <18 years of age with severe chronic PsO (defined by PASI score ≥20, an IGA modified 2011 score of 4, and involving ≥10% of the BSA) who were candidates for systemic therapy. Nonresponder imputation (NRI) is used to handle missing values.¹

Dosing of COSENTYX¹: Patients <50 kg received 75 mg; patients ≥50 kg received 150 mg; administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4, followed by dosing every 4 weeks.

In exploratory analyses of Trial PsO6

Results observed for COSENTYX low-dose arm^†

In Trial PsO6, patients were randomized into two COSENTYX arms:

Low-dose arm: 75 mg for body weight (BW) <50 kg or 150 mg for
≥50 kg.
High-dose arm: 75 mg for BW <25 kg, 150 mg for BW ≥25 kg and
<50 kg (2 times the recommended dose), or 300 mg for BW ≥50 kg (2 times the recommended dose).

^†COSENTYX low-dose arm: <50 kg=75 mg, ≥150 mg. Data presented here do not account for 3 subjects from the COSENTYX high-dose arm weighing <25 kg who received COSENTYX 75 mg, based on the recommended dosing for pediatric patients <50 kg.
^‡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. This value represents the population not affected by the dosing error.

Trial PsO7 in pediatric patients with moderate to severe PsO

Randomized, open-label trial to assess the efficacy, long-term safety and tolerability of COSENTYX compared to historical PBO in subjects from 6 to <18 years of age with moderate to severe chronic PsO (defined by a PASI score ≥12, IGA mod 2011 score of ≥3, and BSA involvement of ≥10% at randomization).⁴
Patients were randomized into two COSENTYX arms in the same manner as Trial PsO6.

Coprimary end point: low-dose arm (75 mg or 150 mg) at Week 12 (n=42): 93% of patients achieved PASI 75 and 79% achieved IGA 0/1; the estimated probability of a positive treatment effect for COSENTYX vs historical placebo was 100%.⁴

*PBO-PASI 75 nonresponders at Week 12 were switched to either the COSENTYX low-dose or COSENTYX high-dose treatment group in the maintenance period according to the pre-assignment at their baseline randomization visit. PBO subjects who were PASI 75 responders at Week 12 had to terminate the study.⁶
^†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 patients groups have been deemed to be too low for any differences to be considered as clinically relevant.
^‡Data presented here do not account for 3 subjects from the COSENTYX high-dose arm weighing <25 kg who received COSENTYX 75 mg, based on the recommended dosing for pediatric patients <50 kg.
LD, loading dose; PASI, Psoriasis Area and Severity Index; PBO, placebo; pNRI, pure nonresponder imputation; q1w, once per week.

See efficacy data in adult patients

Please see PsO6 and PsO7 study design details

STUDY DESIGNS

PsO6^1,2
Trial PsO6 is a 52-Week (total 236 weeks) randomized multicenter, double-blind, placebo- and active-controlled phase 3 study in pediatric patients with severe chronic plaque PsO.¹

Patients were aged 6 to <18 years¹
Severe psoriasis was defined as: PASI score of ≥20, and; IGA score of 4, and; total BSA affected of ≥10%, and; patient being regarded by the investigator to be a candidate for systemic therapy¹
Coprimary end points were the proportion of patients who achieved a reduction in PASI score of ≥75% (PASI 75) from baseline to Week 12 and the proportion of patients who achieved an IGA mod 2011 score of 0 "clear" or 1 "almost clear" with at least a 2 point improvement from baseline to Week 12^1,2
The key secondary end point was the proportion of patients who achieved PASI 90 from baseline to Week 12. Other outcomes evaluated included PASI 100 reponse rates from baseline to Week 12 and through Week 52¹

PsO7³
Trial PsO7 is a 208-week randomized, open label, multicenter study in pediatric patients with moderate to severe chronic plaque PsO.³

Patients were aged 6 to <18 years³
Moderate to severe psoriasis was defined as: PASI score of ≥12 or greater, and; IGA score of ≥3, and; total BSA affected of 10% or greater, and; patient being regarded by the investigator to be a candidate for systemic therapy³
Coprimary end points were the proportion of patients who achieved a reduction in PASI score of ≥75% (PASI 75) from baseline to Week 12 and the proportion of patients who achieved an IGA mod 2011 score of 0 "clear" or 1 "almost clear" with at least a 2 point improvement from baseline to Week 12³
The key secondary end point was achievement of PASI 90 reponse rate at Week 12. Other evaluated outcomes included PASI 100 reponse rates over time through Week 24³

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

References
1. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
2. Bissonnette R et al. Secukinumab demonstrates high sustained efficacy and a variable 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. CAIN457A2304E1 Clinical Study Report. Novartis Pharmaceuticals Corp; February 2018.

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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Provide skin clearance with COSENTYX® (secukinumab)1