Patient-reported well-being using tildrakizumab in a real-world setting: 28-week interim data in patients with nail psoriasis from the phase IV POSITIVE study

Nail psoriasis is a difficult-to-treat manifestation of psoriatic disease affecting 40-60% of patients with plaque psoriasis and often causing significant impairments in health-related quality of life (HRQoL). Tildrakizumab is an interleukin-23p19 inhibitor indicated for moderate-to-severe plaque psoriasis. The objective of this subanalysis was to assess the effectiveness of tildrakizumab on the overall well-being and HRQoL in patients with nail psoriasis from the POSITIVE study. This is a 24-month, phase IV observational multinational study in adult patients with moderate-to-severe plaque psoriasis treated with tildrakizumab in routine care. The well-being was assessed through the 5-item WHO Well-being Index (WHO-5; range 0-100, 100=maximal well-being). The HRQoL instrument was Dermatology Life Quality Index-Relevant (DLQI-R). Nail assessments included change from baseline in Nail Psoriasis Severity Index (NAPSI) score. Here, we report 28-week (W) interim data of Austrian patients with nail psoriasis from the POSITIVE study using an observed cases approach. Twenty-five patients were included (72% male, mean [SD] age: 47.9 [14.4]). Mean (SD) WHO-5 score increased from 51.3 (18.6) at baseline to 70.9 (22.5) at W28. Mean (SD) Psoriasis Area and Severity Index (PASI) decreased from 11.1 (5.6) at baseline to 0.6 (0.6) at W28. At W28, 100%/75% of patients achieved PASI ≤3/≤1 responses. Mean (SD) DLQI-R score decreased from 13.4 (8.8) at baseline to 2.7 (3.4) at W28. Mean (SD) NAPSI decreased from 33.2 (32) at baseline to 15.3 (20.4) at W28. At the point of this analysis no adverse events were reported. For the first time, we demonstrated that tildrakizumab significantly improved patients’ well-being as well as skin symptoms, nail outcomes, and HRQoL without safety concerns in patients with nail psoriasis after 28 weeks.