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Objective <p>This post-hoc analysis used the data from a previous randomized controlled trial (NCT04839016) and aimed to compare patient-reported outcomes (PROs) between patients who achieved complete (PASI 100; N = 178) and near-complete (PASI 90–99; N = 181) skin clearance during 12&#xa0;weeks of Vunakizumab treatment.</p> Methods <p>PROs included the Dermatology Life Quality Index (DLQI) score, DLQI 0/1 response rate, Itch Numerical Rating Scale (NRS) score, and Short Form-36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS).</p> Results <p>The proportion of patients who achieved a DLQI of 0/1 at week (W)8 (<i>P</i> &lt; 0.010), W12 (<i>P</i> &lt; 0.010), W20 (<i>P</i> &lt; 0.001), W28 (<i>P</i> &lt; 0.050), W36 (<i>P</i> &lt; 0.010), and W52 (<i>P</i> &lt; 0.050) was higher in the PASI 100 group compared to the PASI 90–99 group. The mean DLQI score at W4 (<i>P</i> &lt; 0.010), W8 (<i>P</i> &lt; 0.010), W12 (<i>P</i> &lt; 0.001), W20 (<i>P</i> &lt; 0.001), W28 (<i>P</i> &lt; 0.001), W36 (<i>P</i> &lt; 0.001), W44 (<i>P</i> &lt; 0.001), and W52 (<i>P</i> &lt; 0.001), as well as itch NRS score at W8 (<i>P</i> &lt; 0.001), W12 (<i>P</i> &lt; 0.010), W20 (<i>P</i> &lt; 0.001), W28 (<i>P</i> &lt; 0.010), W36 (<i>P</i> &lt; 0.001), W44 (<i>P</i> &lt; 0.010), and W52 (<i>P</i> &lt; 0.010) were lower in the PASI 100 group than in the PASI 90–99 group. The mean SF-36 MCS at W4 (<i>P</i> &lt; 0.050), W12 (<i>P</i> &lt; 0.001), W20 (<i>P</i> &lt; 0.010), W28 (<i>P</i> &lt; 0.001), W36 (<i>P</i> &lt; 0.050), W44 (<i>P</i> &lt; 0.010), and W52 (<i>P</i> &lt; 0.050), as well as SF-36 PCS at W8 (<i>P</i> &lt; 0.050) and W36 (<i>P</i> &lt; 0.050) were higher in the PASI 100 group than in the PASI 90–99 group.</p> Conclusion <p>Patients with complete skin clearance following Vunakizumab treatment showed improved quality of life, reduced pruritus, and enhanced mental health compared to those with near-complete skin clearance.</p>

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Comparison of patient-reported outcomes in patients achieving complete versus near-complete skin clearance following Vunakizumab treatment: a post-hoc analysis of a phase III trial

  • 期刊论文

  • 发表日期：

    2025年8月25日

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  • Shuang Wang,
  • Fuqiu Li

摘要

Objective

This post-hoc analysis used the data from a previous randomized controlled trial (NCT04839016) and aimed to compare patient-reported outcomes (PROs) between patients who achieved complete (PASI 100; N = 178) and near-complete (PASI 90–99; N = 181) skin clearance during 12 weeks of Vunakizumab treatment.

Methods

PROs included the Dermatology Life Quality Index (DLQI) score, DLQI 0/1 response rate, Itch Numerical Rating Scale (NRS) score, and Short Form-36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS).

Results

The proportion of patients who achieved a DLQI of 0/1 at week (W)8 (P < 0.010), W12 (P < 0.010), W20 (P < 0.001), W28 (P < 0.050), W36 (P < 0.010), and W52 (P < 0.050) was higher in the PASI 100 group compared to the PASI 90–99 group. The mean DLQI score at W4 (P < 0.010), W8 (P < 0.010), W12 (P < 0.001), W20 (P < 0.001), W28 (P < 0.001), W36 (P < 0.001), W44 (P < 0.001), and W52 (P < 0.001), as well as itch NRS score at W8 (P < 0.001), W12 (P < 0.010), W20 (P < 0.001), W28 (P < 0.010), W36 (P < 0.001), W44 (P < 0.010), and W52 (P < 0.010) were lower in the PASI 100 group than in the PASI 90–99 group. The mean SF-36 MCS at W4 (P < 0.050), W12 (P < 0.001), W20 (P < 0.010), W28 (P < 0.001), W36 (P < 0.050), W44 (P < 0.010), and W52 (P < 0.050), as well as SF-36 PCS at W8 (P < 0.050) and W36 (P < 0.050) were higher in the PASI 100 group than in the PASI 90–99 group.

Conclusion

Patients with complete skin clearance following Vunakizumab treatment showed improved quality of life, reduced pruritus, and enhanced mental health compared to those with near-complete skin clearance.