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Introduction <p>Tildrakizumab, an anti-interleukin (IL)-23p19 monoclonal antibody, is approved for the treatment of moderate-to-severe plaque psoriasis. Although pivotal clinical trials have shown its sustained efficacy and safety, real-world evidence (RWE) is crucial to assess its performance in routine clinical practice. The aim of this study is to evaluate the real-world effectiveness and safety of tildrakizumab in adult patients with moderate-to-severe plaque psoriasis in the Basque Country, northern Spain.</p> Methods <p>We conducted a multicenter, retrospective observational study, including 212 adult patients treated with tildrakizumab across five tertiary hospitals between November 2020 and April 2024. Clinical outcomes, including Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), and Physician Global Assessment (PGA) scores were collected at baseline and weeks 28, 52, 76, and 100–112. Safety data and reasons for treatment discontinuation were also recorded.</p> Results <p>Among the 212 patients (median age 52.7 years, 56.56% male), most had long-standing psoriasis (median duration: 20.9 years) and multiple comorbidities. Over 80% had previously received biologic therapy. At week 52, 68.8% of patients with follow-up achieved PASI ≤ 3, and 72.7% reached a PGA of 0/1. Median PASI decreased from 11.21 at baseline to 2.51 at week 52. No serious treatment-related adverse events were reported. Discontinuation occurred in 41 patients (19.3%), mainly owing to primary or secondary failure and patient decision.</p> Conclusions <p>Tildrakizumab demonstrated high effectiveness and a favorable safety profile in this large, real-world multicenter cohort. These findings support its role as a reliable therapeutic option for patients with moderate-to-severe plaque psoriasis in clinical practice.</p>

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Real-World Effectiveness and Safety of Tildrakizumab in Moderate-to-Severe Psoriasis: A Multicenter Experience in the Basque Country

  • 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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  • Rosa Izu-Belloso,
  • Isabel Gainza-Apraiz,
  • Mikel Meruelo-Ruano,
  • Irene Arevalo-Ortega,
  • Belen Navajas-Pinedo,
  • Ana Orbea-Sopeña,
  • Manuel Pascual-Ares,
  • Ana Martínez-Buil,
  • Gadea Braceras-Rincón,
  • Itziar Arrue-Michelena,
  • Ricardo González-Perez,
  • Begoña Ramos-Bareño,
  • Ana Martinez de Salinas- Quintana

摘要

Introduction

Tildrakizumab, an anti-interleukin (IL)-23p19 monoclonal antibody, is approved for the treatment of moderate-to-severe plaque psoriasis. Although pivotal clinical trials have shown its sustained efficacy and safety, real-world evidence (RWE) is crucial to assess its performance in routine clinical practice. The aim of this study is to evaluate the real-world effectiveness and safety of tildrakizumab in adult patients with moderate-to-severe plaque psoriasis in the Basque Country, northern Spain.

Methods

We conducted a multicenter, retrospective observational study, including 212 adult patients treated with tildrakizumab across five tertiary hospitals between November 2020 and April 2024. Clinical outcomes, including Psoriasis Area and Severity Index (PASI), Body Surface Area (BSA), and Physician Global Assessment (PGA) scores were collected at baseline and weeks 28, 52, 76, and 100–112. Safety data and reasons for treatment discontinuation were also recorded.

Results

Among the 212 patients (median age 52.7 years, 56.56% male), most had long-standing psoriasis (median duration: 20.9 years) and multiple comorbidities. Over 80% had previously received biologic therapy. At week 52, 68.8% of patients with follow-up achieved PASI ≤ 3, and 72.7% reached a PGA of 0/1. Median PASI decreased from 11.21 at baseline to 2.51 at week 52. No serious treatment-related adverse events were reported. Discontinuation occurred in 41 patients (19.3%), mainly owing to primary or secondary failure and patient decision.

Conclusions

Tildrakizumab demonstrated high effectiveness and a favorable safety profile in this large, real-world multicenter cohort. These findings support its role as a reliable therapeutic option for patients with moderate-to-severe plaque psoriasis in clinical practice.