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Study Designs
The efficacy and safety of SOTYKTU were studied in 2 pivotal Phase 3 trials1-3
*Apremilast was titrated from 10 mg QD to 30 mg BID over the first 5 days of dosing as per its label.2,3
†Upon relapse (≥50% loss of Week 24 PASI percentage improvement from baseline), patients were to be switched to SOTYKTU 6 mg QD; due to a programming error, however, these patients continued on placebo until Week 52.3,5
BID=twice daily; BSA=body surface area; PASI=psoriasis area and severity index; PASI 50=50% reduction from baseline in PASI; PASI 75=75% reduction from baseline in PASI; QD=once daily; sPGA 0/1=static Physician’s Global Assessment, patients achieving clear (0) or almost clear (1) skin.
STUDY DESIGNS1
POETYK PSO-1 (N=664) and POETYK PSO-2 (N=1020) were two, 52-week, multicenter, randomized, double-blind, placebo- and active (apremilast 30 mg twice daily)-controlled, Phase 3 studies to evaluate the safety and efficacy of SOTYKTU (6 mg once daily) in adult patients with moderate-to-severe plaque psoriasis.
Both studies assessed the responses at Week 16 compared to placebo for the 2 co-primary endpoints1:
Other comparisons between SOTYKTU and placebo that were secondary endpoints at Week 161:
Comparisons between SOTYKTU and apremilast were made for the following secondary endpoints at these time points1:
Key eligibility criteria1
Demographics
Select baseline demographics for POETYK PSO-1 and POETYK PSO-2 pooled5,6
SD=standard deviation.
Baseline characteristics
Select baseline characteristics for POETYK PSO-1 and POETYK PSO-2 (pooled)5
BSA=body surface area; IL=interleukin; sPGA=static Physicians Global Assessment; PASI=Psoriasis Area and Severity Index; TNF=tumor necrosis factor.