PS57 Evaluating psychosocial outcomes in Italian patients with moderate-to-severe plaque psoriasis receiving tildrakizumab: results from the interim phase IV BLUE study

Abstract

Psoriasis is a chronic inflammatory skin disease that negatively impacts the quality of life and mental health of patients. However, the most commonly used tools in psoriasis, Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI), do not fully capture the impact of psoriasis. The BLUE study (funded by Almirall) evaluates the overall wellbeing of patients with moderate-to-severe psoriasis treated with tildrakizumab, in real-world clinical practice. Across 28 Italian centres, 331 adults with moderate-to-severe psoriasis initiated tildrakizumab. Assessments were performed at baseline, week 28 (interim results) and week 52. The primary endpoint was emotional distress measured by the Depression, Anxiety and Stress Scale – 21 Items (DASS-21). Secondary endpoints included psychological wellbeing (WHO-5). Other endpoints evaluated included symptoms (itch numerical rating scale and Functional Assessment of Chronic Illness Therapy – Fatigue), PASI and DLQI. The interim analysis included 115 patients for safety and 102 for efficacy. The mean age was 52.5 years (SD 15.7) and 40.9% of patients were female. By week 28 the mean (SD) DASS-21 scores had decreased from 5.0 (4.5) to 2.5 (3.0) for depression, from 4.2 (3.8) to 1.8 (2.2) for anxiety, and from 7.9 (4.8) to 4.5 (3.3) for stress. Mean (SD) WHO-5 scores increased (improved) from 50.9 (23.9) to 66.0 (18.4). Mean (SD) DLQI improved from 10.1 (7.1) to 1.2 (1.9), with 95.7% of patients moving to small or no impact. The mean (SD) PASI decreased from 15.6 (10.2) to 1.8 (2.6), with 77.5% of patients achieving a PASI score ≤ 3 and 52.9% PASI ≤ 1. Regarding symptoms, the mean (SD) fatigue and itch levels improved from 37.2 (11.0) to 43.6 (5.8) and from 5.9 (3.0) to 1.6 (2), respectively. Tildrakizumab was generally well tolerated; 13% of patients reported ­treatment-emergent adverse effects, with no unexpected safety signals. Tildrakizumab demonstrated meaningful improvements across emotional distress, psychological wellbeing, quality of life and skin disease by week 28, with a safety profile consistent with previous evidence. These findings support its use within a holistic approach to psoriasis.