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.

INTRODUCTION: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSION: 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.