Tildrakizumab Real-World Experience (T-REX) in Plaque Psoriasis: Meta-Analysis of Four Non-interventional Studies.

INTRODUCTION

Tildrakizumab, an anti-IL-23p19 antibody, is registered for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Its effectiveness in specific patient subgroups-e.g. those with high body weight, high disease burden, involvement of high-impact areas or older patients-is often underrepresented in randomised clinical trials and better captured in real-world settings. To address this gap, the present meta-analysis was undertaken to synthesise data from four observational studies conducted in Germany (TILOT, TiGER, TIL-SENIOR, TIL-TWO), each focusing on distinct psoriasis populations.

METHODS

This meta-analysis of four prospective multicentre non-interventional studies evaluated the effectiveness and safety of tildrakizumab in different patient populations with moderate-to-severe plaque psoriasis. Outcome parameters assessed at baseline, week 16 and 28 included absolute Psoriasis Area Severity Index (PASI) values, proportion of patients with PASI < 1, < 3, < 5, PASI 75, PASI 90 and PASI 100, body surface area (BSA), Physician's Global Assessment (PGA) 0/1 and Dermatology Life Quality Index (DLQI) 0/1. The meta-analysis was conducted using a random effects model.

RESULTS

The meta-analysis included 1504 patients. The course of the absolute PASI and BSA and the proportion of patients achieving PASI < 3, PASI 75, 90, 100, PGA 0/1 and DLQI 0/1 at week 28 was comparable across all four studies. Overall, mean PASI scores decreased from 16.5 (95% confidence intervals (CI) 15.8-17.3) at baseline to 2.8 (95% CI 2.5-3.0) at week 28. The proportion of patients with PGA 0/1 and DLQI 0/1 increased from 1.8% and 3.7% at baseline to 63.5% and 51.2% at week 28, respectively. No new safety signals were identified.

CONCLUSIONS

Tildrakizumab showed consistent effectiveness across different study populations. Substantial effectiveness was achieved over 28 weeks. Safety results were comparable across populations, without outliers in older patients or patients with higher disease burden. Graphical abstract available for this article.