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Psychological Well-Being of Patients with Moderate-to-Severe Plaque Psoriasis Treated with Tildrakizumab: 28-Week Interim Results from a Multicenter Observational Study in Italy Using the DASS-21 Questionnaire, the BLUE Study

Year: 2026

Type: article

Abstract: Psoriasis is a chronic inflammatory skin disease associated with significant physical and psychological burden. Tildrakizumab, an interleukin-23 p19 inhibitor, has demonstrated efficacy in treating moderate-to-severe plaque psoriasis both in clinical trials and real-world setting. However, limited data are available on the impact of the effective treatment of psoriasis on the psychological health of patients. The aim of this study was to assess changes in psychological well-being, as well as clinical and quality-of-life outcomes, in patients with moderate-to-severe plaque psoriasis treated with tildrakizumab in routine clinical practice in Italy. This was an interim analysis (IA) of a 52-week multicenter, prospective, observational study. Adults with moderate-to-severe plaque psoriasis initiating tildrakizumab were enrolled. Endpoints focused on well-being and psychological health and included changes, from baseline to week 28, in Depression, Anxiety, and Stress Scale-21 (DASS-21) scores, Dermatology Life Quality Index (DLQI), European Social Survey (ESS) items, and World Health Organization-Five Well-Being Index (WHO-5). Effectiveness was also monitored via Psoriasis Area and Severity Index (PASI), and safety via treatment-emergent adverse event reporting. A total of 115 patients were included (mean age 52.5 years, 60.8% male), 102 receiving ≥ 1 dose of tildrakizumab and completing DASS-21 evaluations at baseline and week 28. At week 28, improvements were observed in DASS-21 subscales [depression (− 2.6, 95% CI − 2.0 to − 1.0), anxiety (− 2.3, 95% CI − 2.0 to − 1.0), and stress (− 3.4, 95% CI − 4.0 to − 2.0)], accompanied by marked PASI reduction (− 13.7, 95% CI − 12.8 to − 10.1). DLQI, ESS, and WHO-5 scores also improved. Adverse events were generally mild or moderate, with no unexpected safety signals. In this real-world IA, tildrakizumab was observed to improve the psychological well-being of patients, reflected by a reduction in all items of the DASS-21 scale and, in parallel, confirmed its effectiveness in managing physical symptoms of psoriasis, establishing its role in the holistic management of psoriasis. Psoriasis is a lifelong inflammatory skin disease that affects both physical and emotional well-being. Tildrakizumab is a newer biological treatment that targets inflammation causing the disease. Little is known on whether treating the skin improves mental health. This study looked at how tildrakizumab works in everyday clinical practice among adults in Italy who have moderate-to-severe plaque psoriasis and how effective treatment of the skin can also impact on the mental health of patients. A total of 115 adults were enrolled and treated with tildrakizumab for up to 28 weeks. Dermatologists and patients evaluated changes in skin symptoms, quality of life, and psychological health. Several standardized tools were used, including the Psoriasis Area and Severity Index to measure disease severity, and questionnaires to assess depression, anxiety, stress, and psychological well-being. After 28 weeks of treatment, most patients experienced clear improvements. Skin symptoms and affected areas were greatly reduced, and many participants reported feeling less depressed, anxious, and stressed. Their overall sense of psychological well-being and quality of life also improved. The treatment was generally well tolerated, with most side effects being mild or moderate and no unexpected safety signals reported. Overall, this real-world study supports the use of tildrakizumab as an effective and safe treatment for psoriasis. In addition to reducing physical symptoms, it appears to help patients feel better emotionally, highlighting its value in improving both the skin and the overall quality of life of people living with psoriasis.

Source: Dermatology and Therapy

DOI: 10.1007/s13555-026-01676-3