Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive Study
Bibliographic record
Abstract
Ulrich Mrowietz,1 Rachel Sommer,2 Sascha Gerdes,1 Ziad Reguiai,3 Wolfgang Weger,4 Esteban Daudén,5 Julia-Tatjana Maul,6,7 Pierre-Dominique Ghislain,8 Philip M Laws,9 Luigi Naldi,10 Elke De Jong,11 Sicily Mburu,12 Volker Koscielny,13 Eric Massana,13 Arnau Domenech,13 Kristian Gaarn du Jardin,13 Ismail Kasujee,13 Matthias Augustin2 1Psoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany; 2Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany; 3Dermatology Department, Polyclinic Courlancy-Bezannes, Reims, France; 4Department of Dermatology and Venereology, Medical University of Graz, Graz, Austria; 5Dermatology Department, La Princesa University Hospital - Instituto de Investigación Sanitaria La Princesa (IIS-IP), Madrid, Spain; 6Department of Dermatology, University Hospital Zurich, Zurich, Switzerland; 7Faculty of Medicine, University of Zurich, Zurich, Switzerland; 8Department of Dermatology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium; 9Leeds Centre for Dermatology, Leeds Teaching Hospitals NHS Trust, Leeds, UK; 10Division of Dermatology, San Bortolo Hospital, Vicenza, Italy; 11Department of Dermatology, Radboud University Medical Center (Radboudumc), Nijmegen, the Netherlands; 12International Federation of Psoriasis Associations, Stockholm, Sweden; 13Almirall S.A, Barcelona, SpainCorrespondence: Ulrich Mrowietz, Psoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Arnold-Heller-Str 3/Haus C, Kiel, 24105, Germany, Email umrowietz@dermatology.uni-kiel.dePurpose: 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. Keywords: effectiveness, psoriasis, real-world evidence, RWE, tildrakizumab, well-being, WHO-5 Well-being Index
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.006 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".