What question did this study set out to answer?

The study aims to evaluate the long-term effects of tildrakizumab on well-being and health-related quality of life in patients with psoriatic disease.

May 14, 2026Psoriasis Targets and Therapy0 citationsOpen Access

Patient-Reported Well-Being in Value-Based Routine Care in Psoriatic Disease Using Tildrakizumab: 2-Year Data of the Phase IV POSITIVE Study

UMU MrowietzUniversity Hospital Schleswig-Holstein RSRachel SommerUniversität Hamburg ZRZiad ReguiaiL’Institut du Cancer Courlancy Reims

Key Points

The study aims to evaluate the long-term effects of tildrakizumab on well-being and health-related quality of life in patients with psoriatic disease.
24-month, prospective observational multinational study enrolling 785 adults with moderate-to-severe plaque psoriasis.
Assessments included WHO-5, PASI, and DLQI-R for measuring well-being and disease severity.
WHO-5 score improved from 53.7 at baseline to 70.4 at W104 (95% CI: 68.1, 72.7).
PASI decreased from 12.9 at baseline to 1.3 at W104 (95% CI: 1.1, 1.5) with 87.9% of patients maintaining PASI ≤ 3.
DLQI-R score improved from 12.0 at baseline to 2.1 at W104 (95% CI: 1.7, 2.5), with 11.1% experiencing related adverse events.

Abstract

Purpose: Psoriasis extends beyond skin manifestations and significantly impacts patients’ psychological health, social interactions, and daily functioning. The main objective was to assess the 2-year effect of tildrakizumab, an interleukin-23p19 inhibitor, on the skin, the psychological well-being and the health-related quality of life (HRQoL) of people with psoriatic disease in real-world. Patients and Methods: The POSITIVE study is a 24-month, prospective observational multinational study enrolling adults with moderate-to-severe plaque psoriasis treated with tildrakizumab according to clinical practice. Outcome measurements included the 5-item WHO Well-being Index (WHO-5), Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index-Relevant (DLQI-R). Results: 785 patients were included. The mean (95% CI) WHO-5 score increased from 53.7 (52.2, 55.3) at baseline to 63.2 (61.5, 64.8) at W16 and continued improving over time: 65.9 (64.0, 67.9) at W52 and 70.4 (68.1, 72.7) at W104. The mean (95% CI) PASI decreased from 12.9 (12.3, 13.5) at baseline to 2.4 (2.2, 2.7) at W16 and was maintained until W104 1.3 (1.1, 1.5). At W104, 87.9/79.0/65.1% of patients maintained PASI ≤ 3/≤ 2/≤ 1. Drug survival due to lack of effectiveness or adverse events (AE) was 87.8% and 96.3% after 2 years. The mean (95% CI) DLQI-R score decreased from 12.0 (11.4, 12.6) at baseline to 3.1 (2.6, 3.6) W52 and 2.1 (1.7, 2.5) at W104. At the final analysis, 11.1% of patients had ≥ 1 related AE. Conclusion: Treatment with tildrakizumab delivered sustained and holistic long-term health for moderate to severe psoriasis over 2 years by consistently improving patients’ psychological well-being, life and clinical outcomes with a favourable safety profile. ClinicalTrials.gov ID: NCT04823247 Keywords: psoriasis, real-world evidence, tildrakizumab, well-being, effectiveness, long-term control, safety, WHO-5

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