For Children with Moderate to Severe Plaque Psoriasis
Provide skin clearance with COSENTYX1
For Children with Moderate to Severe Plaque Psoriasis
Provide skin clearance with COSENTYX1
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
Results by baseline weight strata for the approved dose
Dosing of COSENTYX1:Patients <50 kg received 75mg; patients ≥50 kg received 150mg; Administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4, followed by dosing every 4 weeks.
BSA=Body Surface Area; IGA=Investigator's Global Assessment modified 2011; PASI=Psoriasis Area and Severity Index; PBO=placebo.
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
Results by baseline weight strata for the approved dose
Dosing of COSENTYX1:Patients <50 kg received 75mg; patients ≥50 kg received 150mg; Administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4, followed by dosing every 4 weeks.
BSA=Body Surface Area; IGA=Investigator's Global Assessment modified 2011; PASI=Psoriasis Area and Severity Index; PBO=placebo.
In Trial PsO6, patients were randomized into two COSENTYX arms:
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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, bases 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) asssessment. 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).16
Patients were randomized into two COSENTYX arms in the same manner as Trial PsO6.
Co-primary 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%.16
BSA=body surface area; LD=loading dose; PASI=Psoriasis Area and Severity Index; PBO=placebo;
pNRI= pure nonresponder imputation; PsO=plaque psoriasis; RR=response rate.
Click here to see study designs.
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, bases 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) asssessment. This value represents the population not affected by the dosing error.
BSA=body surface area; LD=loading dose; PASI=Psoriasis Area and Severity Index; PBO=placebo; pNRI= pure nonresponder imputation; PsO=plaque psoriasis; RR=response rate.
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).16
Patients were randomized into two COSENTYX arms in the same manner as Trial PsO6.
Co-primary 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%.16
BSA=body surface area; LD=loading dose; PASI=Psoriasis Area and Severity Index; PBO=placebo; pNRI= pure nonresponder imputation; PsO=plaque psoriasis; RR=response rate.
Click here to see study designs.
*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.11
†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.
Safety Considerations
If an anaphylactic reaction or other serious allergic reaction occurs,
discontinue COSENTYX immediately and initiate appropriate therapy.1
-
No boxed warning:
Please see Important Safety Information,
including Contraindications1 -
No malignant or unspecified tumors at Week 5217
-
No routine lab monitoring required during treatment:
Prior to initiating treatment with COSENTYX, evaluate
for tuberculosis1 -
No new safety signals observed over time up to Week 5216,17
Infection and neutropenia in pediatric PsO trials.
One pediatric case of MRSA-TSS was reported during PBO-controlled period of Trial PsO6.
In the pediatric safety pool of Trials PsO6 and PsO7, (N=198;287 patient years), 22 (11%) reported ≥CTCAE Grade 2 neutropenia (≥1,000 to <1500 cells/mm3).* During the 12-week PBO-controlled period of Trial PsO6, ≥CTCAE Grade 2 neutropenia was reported in 3 (4%) subjects treated with COSENTYX (n=80) compared with no subjects treated with placebo (n=41). No serious infections were associated with cases of neutropenia.
* Includes all subjects who took at least one dose of COSENTYX during the treatment periods. 57% of subjects followed for ≥1 year, 30% of subjects followed for ≥2 years.
CTCAE=Common Terminology Criteria for Adverse Events, MRSA-TSS=methicillin-resistant Staphylococcus aureus Toxic Shock Syndrome; PBO=placebo; PsO=plaque psoriasis.
Safety Considerations
If an anaphylactic reaction or other serious allergic reaction occurs,discontinue COSENTYX immediately and initiate appropriate therapy.1
-
No boxed warning:
Please see Important Safety Information,
including Contraindications1 -
No malignant or unspecified tumors at Week 5217
-
No routine lab monitoring required during treatment:
Prior to initiating treatment with COSENTYX, evaluate
for tuberculosis1 -
No new safety signals observed over time
up to Week 5216,17
Infection and neutropenia in pediatric PsO trials.
One pediatric case of MRSA-TSS was reported during PBO-controlled period of Trial PsO6.
In the pediatric safety pool of Trials PsO6 and PsO7, (N=198;287 patient years), 22 (11%) reported ≥CTCAE Grade 2 neutropenia (≥1,000 to <1500 cells/mm3).* During the 12-week PBO-controlled period of Trial PsO6, ≥CTCAE Grade 2 neutropenia was reported in 3 (4%) subjects treated with COSENTYX (n=80) compared with no subjects treated with placebo (n=41). No serious infections were associated with cases of neutropenia.
* Includes all subjects who took at least one dose of COSENTYX during the treatment periods. 57% of subjects followed for ≥1 year, 30% of subjects followed for ≥2 years.
CTCAE=Common Terminology Criteria for Adverse Events, MRSA-TSS=methicillin-resistant Staphylococcus aureus Toxic Shock Syndrome; PBO=placebo; PsO=plaque psoriasis.
Simple weight-based dosing for pediatric patients
The recommended pediatric dosage of COSENTYX is based on body weight at time of dosing.
Available in prefilled, one-time-use administration options, No drawing or reconstitution required 1
Simple weight-based dosing for pediatric patients
The recommended pediatric dosage of COSENTYX is based on body weight at time of dosing.
Available in prefilled, one-time-use administration options, No drawing or reconstitution required 1
References: 1. COSENTYX [prescribing information] East Hanover, NJ: Novartis Pharmaceuticals Corp; May 2021. 2. Data on file. IQVIA National Prescription Audit TRxs as reported in SMART US Edition. Novartis Pharmaceuticals Corp; January 6, 2021 3. Data on file. AIN457A2102 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2008. 4. Bissonnette R et al. Secukinumab demonstrates high sustained efficacy and a varourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acd Dermatol Veneraol. 2018; 32(9):1507-1514. 5. Data on file. CAIN457A2304E1 Clinical Study Report. Novartis Pharmaceuticals Corp; February 2018. 6. Data on file. CAIN457F2312 (FUTURE 2) 5-Year Interim Report_May 2019. 7. Date on file. IQVIA un-projected patient counts. Internal communication, Roopal Jain, roopal.jain@novartis.com, January 6, 2021. 8. Kane D et al. A prospective, clinical and radiological study of early psoriatic arthritis; an early synovitis clinic experience. Rheumatology. 2003;42:1460-1468. 9. Brembilla NC et al. The Il-17 family of cytokines in psoriasis: IL-17A and beyond. Front Immunol.2018;9:1682. doi:10.3389/fimmu.2018.01682. 10. Nestile FO et al. Psoriasis. N Engl J Med. 2099;361(5):496-509. 11. Bronckers IMGJ et al. Psoriasis in children and adolescents: diagnosis, management and comorbidities. Paediatr Drugs. 2015;17(5):373-384. 12. Karimi K et al. Pediatric psoriasis: a rebiew. J Dermatolog Clin Res. 2018;6(3):1123. 13. Menter A et al. Joint American Academy of Dermatology- National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis i pediatric patients. J Am Acad Dermatol. 2020;82(1): 161-201. 14. Eichenfield LF et al. Pediatric psoriasis: Evolving perspectives. Pediatr Dermatol. 2018;35:17-181. 15. Data on file. CAIN457A2310 Clinical Study Report. Week 24 Analysis. Novartis Pharmaceuticals Corp; July 2018. 16. Data on file. CAIN457A2311 Clinical Study Report.Week 24 Analysis. Novartis *harmaceuticals Corp; September 2019. 17. Data on file. CAIN457A2310 Clinical Study Report. Week 52 Analysis. Novartis Pharmaceuticals Corp; September 2019.
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