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Introduction <p>Moderate-to-severe plaque psoriasis can be difficult to treat; not all patients respond to treatment. POETYK PSO-1 and PSO-2 were 52-week, phase 3, multinational, double-blinded trials in plaque psoriasis. We determined deucravacitinib efficacy in PSO-1/PSO-2 patients who did not respond to apremilast.</p> Methods <p>PSO-1/PSO-2 were conducted between July 2018 and November 2020; this analysis includes data from both trials. Adults with moderate-to-severe plaque psoriasis (baseline&#xa0;Psoriasis Area and Severity Index [PASI] ≥ 12, static Physician Global Assessment [sPGA] ≥ 3, body surface area involvement ≥ 10%) were included and randomized 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. Clinical endpoints included ≥ 75%/90% reduction from baseline PASI (PASI 75/90), sPGA score of 0 (clear) or 1 (almost clear) (sPGA 0/1) response rates, and mean percent change from baseline PASI and BSA involvement. Patient-reported outcomes included Dermatology Life Quality Index 0 (no effect) or 1 (little effect) (DLQI 0/1) and mean change from baseline Psoriasis Symptoms and Signs Diary (PSSD) symptom score.</p> Results <p>Of 168 (PSO-1) and 254 (PSO-2) patients randomized to apremilast, 54 (32.1% [PSO-1]) and 111 (43.7% [PSO-2]) did not achieve PASI 50 (PSO-1) and PASI 75 (PSO-2) at Week 24 and were switched to deucravacitinib. PASI 75 response rates improved from 0% at Week 24 to 46.3% (PSO-1) and 42.3% (PSO-2) at Week 52. From Weeks 24–52, PASI 90, sPGA 0/1, and DLQI 0/1 response rates increased; mean percent change from baseline PASI decreased by 60% (PSO-1) and 26% (PSO-2); mean change from baseline in PSSD symptom score decreased by ≈20% in both studies; mean percent change from baseline BSA involvement decreased by 65% (PSO-1) and 25% (PSO-2).</p> Conclusion <p>Deucravacitinib was efficacious in patients with moderate-to-severe plaque psoriasis who did not respond to apremilast.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT03624127, NCT03611751.</p>

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Deucravacitinib in Plaque Psoriasis After Inadequate Response to Apremilast: Phase 3 POETYK Analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月5日

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  • April W. Armstrong,
  • Richard B. Warren,
  • Howard Sofen,
  • Lynda Spelman,
  • Misti Linaberry,
  • Brandon Becker,
  • Ying-Ming Jou,
  • Carolin Daamen,
  • Alexa B. Kimball

摘要

Introduction

Moderate-to-severe plaque psoriasis can be difficult to treat; not all patients respond to treatment. POETYK PSO-1 and PSO-2 were 52-week, phase 3, multinational, double-blinded trials in plaque psoriasis. We determined deucravacitinib efficacy in PSO-1/PSO-2 patients who did not respond to apremilast.

Methods

PSO-1/PSO-2 were conducted between July 2018 and November 2020; this analysis includes data from both trials. Adults with moderate-to-severe plaque psoriasis (baseline Psoriasis Area and Severity Index [PASI] ≥ 12, static Physician Global Assessment [sPGA] ≥ 3, body surface area involvement ≥ 10%) were included and randomized 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast 30 mg twice daily. Clinical endpoints included ≥ 75%/90% reduction from baseline PASI (PASI 75/90), sPGA score of 0 (clear) or 1 (almost clear) (sPGA 0/1) response rates, and mean percent change from baseline PASI and BSA involvement. Patient-reported outcomes included Dermatology Life Quality Index 0 (no effect) or 1 (little effect) (DLQI 0/1) and mean change from baseline Psoriasis Symptoms and Signs Diary (PSSD) symptom score.

Results

Of 168 (PSO-1) and 254 (PSO-2) patients randomized to apremilast, 54 (32.1% [PSO-1]) and 111 (43.7% [PSO-2]) did not achieve PASI 50 (PSO-1) and PASI 75 (PSO-2) at Week 24 and were switched to deucravacitinib. PASI 75 response rates improved from 0% at Week 24 to 46.3% (PSO-1) and 42.3% (PSO-2) at Week 52. From Weeks 24–52, PASI 90, sPGA 0/1, and DLQI 0/1 response rates increased; mean percent change from baseline PASI decreased by 60% (PSO-1) and 26% (PSO-2); mean change from baseline in PSSD symptom score decreased by ≈20% in both studies; mean percent change from baseline BSA involvement decreased by 65% (PSO-1) and 25% (PSO-2).

Conclusion

Deucravacitinib was efficacious in patients with moderate-to-severe plaque psoriasis who did not respond to apremilast.

Trial Registration

ClinicalTrials.gov identifier, NCT03624127, NCT03611751.