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Introduction <p>Plaque psoriasis (PsO) is an inflammatory skin disease that can impair quality of life. Tildrakizumab, an anti-IL-23 p19 monoclonal antibody, offers a treatment option for patients eligible for systemic therapy or phototherapy, but real-world results have not been comprehensively analyzed. This systematic review and meta-analysis evaluated real-world effectiveness, quality-of-life impact, and safety of tildrakizumab for treatment of moderate-to-severe plaque PsO, alone and relative to guselkumab and risankizumab.</p> Methods <p>MEDLINE® and Embase were searched on November 16, 2023, along with meeting abstracts (2021–2023) and bibliographies of previous reviews, for English-language real-world studies of tildrakizumab (singly or comparative) in adults with chronic moderate-to-severe plaque PsO. Outcomes included effectiveness (Psoriasis Area and Severity Index [PASI], Physician’s Global Assessment [PGA], body surface area percentage [%BSA] affected), Dermatology Life Quality Index (DLQI), and safety (adverse events [AEs], serious AEs [SAEs], treatment-related AEs [TRAEs], or withdrawals due to AEs [WDAEs]). Meta-analyses were performed at 12–16, 24–28, and 36–52&#xa0;weeks.</p> Results <p>Of 6982 records screened, 37 studies (45 publications) were analyzed. Tildrakizumab-treated patients experienced 78–87% improvement from baseline to 36–52&#xa0;weeks across mean absolute PASI (12.81 [95% confidence interval 11.69, 13.92] to 1.62 [1.03, 2.20]), %BSA (16.21% [13.72%, 18.70%] to 3.27% [1.26%, 5.28%]), PGA (3.18 [2.89, 3.47] to 0.70 [0.08, 1.33]), and DLQI (14.59 [12.32, 16.87] to 1.83 [0.84, 2.82]), with low rates of AEs, SAEs, TRAEs, and WDAEs. Benefits and safety of tildrakizumab were similar to guselkumab and risankizumab.</p> Conclusion <p>Tildrakizumab demonstrated effectiveness, with reduction from moderate-to-severe to mild disease and improved DLQI scores, without notable safety concerns, for up to 1&#xa0;year in this real-world meta-analysis. Although real-world data must be interpreted cautiously because of heterogeneity and potential bias, these findings align with randomized trial results, further supporting the use of tildrakizumab in clinical practice.</p>

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Real-World Benefit of Tildrakizumab for Moderate-to-Severe Plaque Psoriasis: Findings from a Systematic Literature Review and Meta-Analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年1月7日

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  • Scott Gottlieb,
  • Aaron S. Farberg,
  • Neal Bhatia,
  • Mir Sohail Fazeli,
  • Kimberly Hofer,
  • Otto Lam,
  • Victoria Barghout,
  • Jacob Mathew,
  • Thomas J. Ferro

摘要

Introduction

Plaque psoriasis (PsO) is an inflammatory skin disease that can impair quality of life. Tildrakizumab, an anti-IL-23 p19 monoclonal antibody, offers a treatment option for patients eligible for systemic therapy or phototherapy, but real-world results have not been comprehensively analyzed. This systematic review and meta-analysis evaluated real-world effectiveness, quality-of-life impact, and safety of tildrakizumab for treatment of moderate-to-severe plaque PsO, alone and relative to guselkumab and risankizumab.

Methods

MEDLINE® and Embase were searched on November 16, 2023, along with meeting abstracts (2021–2023) and bibliographies of previous reviews, for English-language real-world studies of tildrakizumab (singly or comparative) in adults with chronic moderate-to-severe plaque PsO. Outcomes included effectiveness (Psoriasis Area and Severity Index [PASI], Physician’s Global Assessment [PGA], body surface area percentage [%BSA] affected), Dermatology Life Quality Index (DLQI), and safety (adverse events [AEs], serious AEs [SAEs], treatment-related AEs [TRAEs], or withdrawals due to AEs [WDAEs]). Meta-analyses were performed at 12–16, 24–28, and 36–52 weeks.

Results

Of 6982 records screened, 37 studies (45 publications) were analyzed. Tildrakizumab-treated patients experienced 78–87% improvement from baseline to 36–52 weeks across mean absolute PASI (12.81 [95% confidence interval 11.69, 13.92] to 1.62 [1.03, 2.20]), %BSA (16.21% [13.72%, 18.70%] to 3.27% [1.26%, 5.28%]), PGA (3.18 [2.89, 3.47] to 0.70 [0.08, 1.33]), and DLQI (14.59 [12.32, 16.87] to 1.83 [0.84, 2.82]), with low rates of AEs, SAEs, TRAEs, and WDAEs. Benefits and safety of tildrakizumab were similar to guselkumab and risankizumab.

Conclusion

Tildrakizumab demonstrated effectiveness, with reduction from moderate-to-severe to mild disease and improved DLQI scores, without notable safety concerns, for up to 1 year in this real-world meta-analysis. Although real-world data must be interpreted cautiously because of heterogeneity and potential bias, these findings align with randomized trial results, further supporting the use of tildrakizumab in clinical practice.