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Introduction <p>Chronic plaque psoriasis significantly impairs physical, psychological, and social well-being. Patient-reported outcome measures (PROMs) are increasingly recognized as essential endpoints. Tildrakizumab, an interleukin (IL)-23p19 inhibitor, has demonstrated high efficacy and safety in clinical trials, but real-world data on its impact on PROMs remain limited. We aimed to evaluate the effect of tildrakizumab on psoriasis severity, symptoms, and health-related quality of life, including sleep disorders, and to assess correlations between severity of the disease (measured using the Psoriasis Area and Severity Index [PASI]) improvement and PROMs in a real-world cohort.</p> Methods <p>Consecutive adults with moderate-to-severe plaque psoriasis initiating tildrakizumab were enrolled and prospectively followed for 52&#xa0;weeks. Assessments at baseline, week 16, and week 52 included the PASI; Dermatology Life Quality Index (DLQI); Skindex-16; Visual Analog Scale (VAS) for pruritus, scaling, and pain; the Medical Outcomes Study Sleep Scale (MOS-Sleep); and Work Productivity and Activity Impairment (WPAI) questionnaire.</p> Results <p>Thirty-three patients were enrolled in the study. Tildrakizumab induced rapid skin clearance and symptoms relief, with marked reductions in PASI and most PROMs by week 16. Pain and MOS-Sleep improved significantly only at Week 52. PASI correlated with PROMs at Week 16 (Spearman correlation), especially DLQI (<i>r</i> = 0.69, <i>p</i> &lt; 0.001) and pruritus (<i>r</i> = 0.70, <i>p</i> &lt; 0.001). At Week 52, correlations weakened for most PROMs, except Skindex-16 (<i>r</i> = 0.62, <i>p</i>&#xa0;&lt;&#xa0;0.01), pruritus (<i>r</i> = 0.54, <i>p</i> = 0.02), and scaling (<i>r</i> = 0.55, <i>p</i> = 0.02). Repeated-measures correlation analysis demonstrated significant within-subject associations between PASI improvement and most patient-reported outcomes (DLQI, scaling, pain, pruritus, and Skindex-16), while no significant associations were observed for WPAI and MOS-Sleep.</p> Conclusions <p>Tildrakizumab improves both objective disease severity and quality of life at week 16. PASI strongly correlates with PROM improvements early in treatment, but correlations diminish over time, suggesting possible adaptation once skin clearance is sustained. PROMs should be integrated into long-term management to capture patient-centered benefits beyond skin clearance.</p>

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Tildrakizumab Improves Disease Severity and Patient-Reported Outcomes in Moderate-to-Severe Chronic Plaque Psoriasis: A Prospective Real-World Study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月24日

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  • Paola Facheris,
  • Francesco Piscazzi,
  • Giovanni Fiorillo,
  • Mario Valenti,
  • Antonio Costanzo,
  • Riccardo G. Borroni

摘要

Introduction

Chronic plaque psoriasis significantly impairs physical, psychological, and social well-being. Patient-reported outcome measures (PROMs) are increasingly recognized as essential endpoints. Tildrakizumab, an interleukin (IL)-23p19 inhibitor, has demonstrated high efficacy and safety in clinical trials, but real-world data on its impact on PROMs remain limited. We aimed to evaluate the effect of tildrakizumab on psoriasis severity, symptoms, and health-related quality of life, including sleep disorders, and to assess correlations between severity of the disease (measured using the Psoriasis Area and Severity Index [PASI]) improvement and PROMs in a real-world cohort.

Methods

Consecutive adults with moderate-to-severe plaque psoriasis initiating tildrakizumab were enrolled and prospectively followed for 52 weeks. Assessments at baseline, week 16, and week 52 included the PASI; Dermatology Life Quality Index (DLQI); Skindex-16; Visual Analog Scale (VAS) for pruritus, scaling, and pain; the Medical Outcomes Study Sleep Scale (MOS-Sleep); and Work Productivity and Activity Impairment (WPAI) questionnaire.

Results

Thirty-three patients were enrolled in the study. Tildrakizumab induced rapid skin clearance and symptoms relief, with marked reductions in PASI and most PROMs by week 16. Pain and MOS-Sleep improved significantly only at Week 52. PASI correlated with PROMs at Week 16 (Spearman correlation), especially DLQI (r = 0.69, p < 0.001) and pruritus (r = 0.70, p < 0.001). At Week 52, correlations weakened for most PROMs, except Skindex-16 (r = 0.62, p < 0.01), pruritus (r = 0.54, p = 0.02), and scaling (r = 0.55, p = 0.02). Repeated-measures correlation analysis demonstrated significant within-subject associations between PASI improvement and most patient-reported outcomes (DLQI, scaling, pain, pruritus, and Skindex-16), while no significant associations were observed for WPAI and MOS-Sleep.

Conclusions

Tildrakizumab improves both objective disease severity and quality of life at week 16. PASI strongly correlates with PROM improvements early in treatment, but correlations diminish over time, suggesting possible adaptation once skin clearance is sustained. PROMs should be integrated into long-term management to capture patient-centered benefits beyond skin clearance.