Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive Study.
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All Authors
Mrowietz, U.
Sommer, R.
Gerdes, S.
Reguiai, Z.
Weger, W.
Dauden, E.
Maul, JT.
Ghislain, PD.
Laws, PM.
Naldi, L.
LTHT Author
Laws, Philip
LTHT Department
Dermatology
Non Medic
Publication Date
2025
Item Type
Journal Article
Language
Subject
Subject Headings
Abstract
Purpose: Psoriasis profoundly impairs patients' social, emotional, and physical condition, impacting on their overall well-being. Tildrakizumab is an interleukin-23p19 inhibitor labelled for the treatment of moderate-to-severe plaque psoriasis. The main objective of this study was to assess the effect of tildrakizumab on the overall well-being of people with psoriasis. Effectiveness, quality of life (QoL), symptomatology, treatment satisfaction, and the impact of psoriasis on the patients' partners were also evaluated.
Patients and Methods: POSITIVE is a 24-month observational study in adults with moderate-to-severe psoriasis treated with tildrakizumab in a real-world setting (ClinicalTrials.gov ID: NCT04823247). Outcome measurements included the 5-item WHO Well-being Index (WHO-5), Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index-Relevant (DLQI-R), Treatment Satisfaction Questionnaire for Medication (TSQM-9), and FamilyPso. We report 52-week (W52) interim data (N = 400; observed cases).
Results: Mean +/- 95% CI WHO-5 score increased from 53.8 +/- 2.2 at baseline to 66.0 +/- 2.3/65.7 +/- 2.7 at W28/W52 (p < 0.0001, both). Mean +/- 95% CI PASI decreased from 13.1 +/- 0.8 at baseline to 1.7 +/- 0.3/1.5 +/- 0.3 at W28/W52 (p < 0.0001, both). At W28 and W52, 85.8%/54.8% and 88.4%/56.8% of patients achieved PASI <= 3/<= 1. Mean +/- 95% CI DLQI-R score decreased from 12.6 +/- 0.8 at baseline to 3.3 +/- 0.6/3.1 +/- 0.6 at W28/W52 (p < 0.0001, both). At W52, mean +/- 95% CI TSQM-9 domain scores were 77.4 +/- 3.2 for effectiveness, 81.5 +/- 2.6 convenience, and 81.1 +/- 2.6 global satisfaction. Mean +/- 95% CI total FamilyPso decreased from 1.3 +/- 0.1 at baseline to 0.7 +/- 0.2 at W52 (p < 0.0001). At the point of this analysis, 24.0% of patients had >=1 adverse event (AE). Only one patient discontinued due to a treatment-related AE.
Conclusion: Tildrakizumab successfully contributes to value-based long-term health care for moderate-to-severe psoriasis by increasing patient wellbeing, QoL and clinical outcomes while showing very good safety and tolerability.
Journal
Psoriasis : Targets And Therapy