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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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A first-line oral option for moderate-to-severe plaque psoriasis1

*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. See additional study design details.1

Co-primary endpoints: percentage of patients achieving PASI 75 at Week 16 vs placebo and percentage of patients achieving sPGA 0/1 vs placebo at Week 16. The results were achieved for PASI 75 (POETYK PSO-1: 58% vs 13%; POETYK PSO-2: 53% vs 9%) and sPGA 0/1 (POETYK PSO-1: 54% vs 7%; POETYK PSO-2: 50% vs 9%). Statistical significance was achieved for secondary endpoint PASI 75 vs apremilast at Week 16 (POETYK PSO-1: 58% vs 35%; POETYK PSO-2: 53% vs 40%).1

PASI=psoriasis area and severity index; PASI 75=75% reduction from baseline in PASI; sPGA 0/1=statistic Physician’s Global Assessment, patients achieving clear (0) or almost clear (1) skin.

SOTYKTU tablet is not actual size. Shown for illustrative purposes only.

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1787-US-2200576 09/22

1787-US-2200110 09/22