Real-world effectiveness and safety of tildrakizumab in long-term treatment of plaque psoriasis: Results from the non-interventional, prospective, multicentre study TILOT.

ABSTRACT

BACKGROUND: Plaque psoriasis is a chronic inflammatory disorder affecting the skin and impacting quality of life. Tildrakizumab (TIL) is an IL-23 inhibitor licensed for moderate-to-severe plaque psoriasis. Regulatory approval of medicinal products is based on safety and efficacy data from randomized controlled trials (RCTs) which impose stringent selection criteria. Long-term non-interventional studies (NIS) are needed to establish effectiveness and safety in daily practice bridging the gap between RCTs and the real-world setting. OBJECTIVES: This analysis of the NIS TILOT seeks to evaluate effectiveness and safety of TIL in patients with moderate-to-severe plaque psoriasis in a real-world setting. Secondary objectives include the assessment of the Dermatology Life Quality Index (DLQI), treatment satisfaction and course of scalp and nail disease using Physician Global Assessment (PGA). METHODS: Interim analysis at 52 weeks (W) of the ongoing non-interventional, prospective, long-term multicentre study TILOT. RESULTS: The effectiveness analysis included 412 patients. The mean [standard deviation, SD] Psoriasis Area and Severity Index (PASI) score was 16.0 [9.1] at baseline improving by 82.4% (95% confidence interval [CI], 78.9-86.0) to 2.1 [2.9] at W52. The proportion of patients achieving PASI scores of <3 and <5 increased over time peaking at 74.6% (95% CI, 69.3-79.4) and 88.4% (95% CI, 84.3-91.8) at W52. Scalp-PGA and nail-PGA improved by 79.8% (95% CI, 75.6-84.0) and 72.7% (95% CI, 63.9-81.6), respectively. DLQI of 0/1 was achieved by 48.2% (95% CI, 42.3-54.2). Nine out of 10 physicians and patients expressed a high level of treatment satisfaction. No new safety signals were observed. CONCLUSIONS: This prospective cohort study demonstrates a high degree of effectiveness and a reassuring safety profile of TIL in a real-world setting over 52 weeks. Patients with scalp and nail involvement or pruritus showed marked improvements.