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)
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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)
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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.
Definitions and references
Definitions
BSA=body surface area; HD=high dose; IGA mod 2011=Investigator’s Global Assessment modified 2011; IRT=Interactive Response Technology; LD=low dose; PASI=Psoriasis Area and Severity Index; pNRI=pure nonresponder imputation; PsO=plaque psoriasis; Q1=every 1.
References
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