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  • US Full Prescribing Information |
  • Medication Guide |
  • Indication

    Indication

    SOTYKTU is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

    Limitations of Use: SOTYKTU is not recommended for use in combination with other potent immunosuppressants.

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Study Designs

The efficacy and safety of SOTYKTU were studied in 2 pivotal Phase 3 trials1-3

POETYK PSO-12 and POETYK PSO-22  Clinical Trials
POETYK PSO-12 and POETYK PSO-22  Clinical Trials

*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:

  • The proportion of patients who achieved at least a 75% improvement in PASI scores from baseline (PASI 75)
  • The proportion of patients who achieved an sPGA score of 0 (clear) or 1 (almost clear)

Other comparisons between SOTYKTU and placebo that were secondary endpoints at Week 161:

  • The proportion of patients who achieved PASI 90, PASI 100, sPGA 0, scalp severity PGA (ss-PGA) score of 0 (clear) or 1 (almost clear), and Psoriasis Symptoms and Signs Diary (PSSD) Symptom Score of 0 (symptom-free)

Comparisons between SOTYKTU and apremilast were made for the following secondary endpoints at these time points1:

  • Week 16 and 24 (POETYK PSO-1 and POETYK PSO-2): the proportion of patients who achieved PASI 75, PASI 90, and sPGA 0/1
  • Week 16 (POETYK PSO-1 and POETYK PSO-2): the proportion of patients who achieved sPGA 0 and ss-PGA 0/1 (scalp)

Key eligibility criteria1

  • Adults with moderate-to-severe plaque psoriasis who were eligible for systemic therapy or phototherapy
  • PASI ≥12, sPGA ≥3, BSA involvement ≥10%

Demographics

Select baseline demographics for POETYK PSO-1 and POETYK PSO-2 pooled5,6

Select baseline demographics for POETYK PSO-1  and POETYK PSO-23
Select baseline demographics for POETYK PSO-1  and POETYK PSO-23

SD=standard deviation.

Baseline characteristics

Select baseline characteristics for POETYK PSO-1 and POETYK PSO-2 (pooled)5

Select baseline characteristics for POETYK PSO-1  and POETYK PSO-23
Select baseline characteristics for POETYK PSO-1  and POETYK PSO-23

BSA=body surface area; IL=interleukin; sPGA=static Physicians Global Assessment; PASI=Psoriasis Area and Severity Index; TNF=tumor necrosis factor.

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1787-US-2200720 12/22

1787-US-2200110 09/22