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Introduction <p>Deucravacitinib, an oral, selective, allosteric tyrosine kinase&#xa0;2 inhibitor, is approved in multiple countries for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. The safety and efficacy of deucravacitinib in psoriasis has been demonstrated through 3&#xa0;years in the phase&#xa0;3 POETYK PSO-1, PSO-2, and long-term extension (LTE) trials enrolling adults with moderate to severe plaque psoriasis.</p> Methods <p>To review the effect of deucravacitinib treatment on adverse events of interest (AEIs) over 3&#xa0;years in POETYK PSO-1, PSO-2, and LTE, cumulative exposure-adjusted incidence rates (EAIRs) of AEIs were recorded through 3&#xa0;years.</p> Results <p>AEIs and 3-year EAIRs of select infections included serious infections (2.5/100 person-years [PY]), COVID-19 (1.6/100&#xa0;PY), and herpes zoster (0.6/100&#xa0;PY). Excluding COVID-19, the serious infections EAIR was 0.9/100&#xa0;PY. Major adverse cardiovascular event (MACE) and venous thromboembolism EAIRs were 0.3/100&#xa0;PY and 0.1/100&#xa0;PY, respectively. The EAIRs for malignancies were 0.9/100&#xa0;PY overall and 0.5/100&#xa0;PY, excluding nonmelanoma skin cancer (NMSC). Cutaneous events included acne (EAIR, 1.3/100&#xa0;PY) and folliculitis (EAIR, 1.1/100&#xa0;PY). Three-year cumulative EAIRs generally remained stable or decreased relative to 1-year rates. EAIRs of non-COVID-19 serious infections, malignancies excluding NMSC, and MACE through 3&#xa0;years were consistent with rates for other antipsoriatic agents from clinical trials, disease registries, and real-world claims data.</p> Conclusion <p>In adults with plaque psoriasis treated with deucravacitinib, the cumulative incidence of AEIs remained comparable or decreased over 3&#xa0;years of follow-up and aligned with comparison data for other antipsoriatic therapies.</p>

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Deucravacitinib: Adverse Events of Interest Across Phase 3 Plaque Psoriasis Trials

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年2月7日

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  • Joseph F. Merola,
  • Laura K. Ferris,
  • Jeffrey M. Sobell,
  • Howard Sofen,
  • John Osborne,
  • John Vaile,
  • Ying-Ming Jou,
  • Carolin Daamen,
  • Julie Scotto,
  • Thomas Scharnitz,
  • Mark Lebwohl

摘要

Introduction

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in multiple countries for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy. The safety and efficacy of deucravacitinib in psoriasis has been demonstrated through 3 years in the phase 3 POETYK PSO-1, PSO-2, and long-term extension (LTE) trials enrolling adults with moderate to severe plaque psoriasis.

Methods

To review the effect of deucravacitinib treatment on adverse events of interest (AEIs) over 3 years in POETYK PSO-1, PSO-2, and LTE, cumulative exposure-adjusted incidence rates (EAIRs) of AEIs were recorded through 3 years.

Results

AEIs and 3-year EAIRs of select infections included serious infections (2.5/100 person-years [PY]), COVID-19 (1.6/100 PY), and herpes zoster (0.6/100 PY). Excluding COVID-19, the serious infections EAIR was 0.9/100 PY. Major adverse cardiovascular event (MACE) and venous thromboembolism EAIRs were 0.3/100 PY and 0.1/100 PY, respectively. The EAIRs for malignancies were 0.9/100 PY overall and 0.5/100 PY, excluding nonmelanoma skin cancer (NMSC). Cutaneous events included acne (EAIR, 1.3/100 PY) and folliculitis (EAIR, 1.1/100 PY). Three-year cumulative EAIRs generally remained stable or decreased relative to 1-year rates. EAIRs of non-COVID-19 serious infections, malignancies excluding NMSC, and MACE through 3 years were consistent with rates for other antipsoriatic agents from clinical trials, disease registries, and real-world claims data.

Conclusion

In adults with plaque psoriasis treated with deucravacitinib, the cumulative incidence of AEIs remained comparable or decreased over 3 years of follow-up and aligned with comparison data for other antipsoriatic therapies.