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

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. CLINICALTRIALSGOV ID: NCT04823247.