Evidence map›Paper›PMID 40605963›Full record

ArticlePsoriasis (Auckland, N.Z.)2025

Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive Study.

Ulrich Mrowietz, Rachel Sommer, Sascha Gerdes, Ziad Reguiai, Wolfgang Weger, Esteban Daudén, Julia-Tatjana Maul, Pierre-Dominique Ghislain, Philip M Laws, Luigi Naldi and 8 more

Registry-linked trialAbstract read
In one paragraph

Article in Psoriasis (Auckland, N.Z.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04823247 (A Multicenter, Prospective Observational RWE Study to Assess Patient-reported Wellbeing Using Tildrakizumab in a Live Setting - POSITIVE Study), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04823247 completednot on this map

A Multicenter, Prospective Observational RWE Study to Assess Patient-reported Wellbeing Using Tildrakizumab in a Live Setting - POSITIVE Study

Typeobservational_patient_registrySponsorAlmirall, S.A.Ran2021 to 2025Enrolled782ConditionsPlaque PsoriasisArmsTildrakizumab
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Ulrich MrowietzPsoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Rachel SommerInstitute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
Sascha GerdesPsoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.ORCID 0000-0002-6667-7757
Ziad ReguiaiDermatology Department, Polyclinic Courlancy-Bezannes, Reims, France.
Wolfgang WegerDepartment of Dermatology and Venereology, Medical University of Graz, Graz, Austria.
Esteban DaudénDermatology Department, La Princesa University Hospital - Instituto de Investigación Sanitaria La Princesa (IIS-IP), Madrid, Spain.
Julia-Tatjana MaulDepartment of Dermatology, University Hospital Zurich, Zurich, Switzerland.
Pierre-Dominique GhislainDepartment of Dermatology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.
Philip M LawsLeeds Centre for Dermatology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
Luigi NaldiDivision of Dermatology, San Bortolo Hospital, Vicenza, Italy.
Elke De JongDepartment of Dermatology, Radboud University Medical Center (Radboudumc), Nijmegen, the Netherlands.ORCID 0000-0003-3872-5704
Sicily MburuInternational Federation of Psoriasis Associations, Stockholm, Sweden.
Volker KoscielnyAlmirall S.A, Barcelona, Spain.
Eric MassanaAlmirall S.A, Barcelona, Spain.
Arnau DomenechAlmirall S.A, Barcelona, Spain.
Kristian Gaarn du JardinAlmirall S.A, Barcelona, Spain.
Ismail KasujeeAlmirall S.A, Barcelona, Spain.
Matthias AugustinInstitute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.ORCID 0000-0002-4026-8728

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

effectivenesspsoriasisreal-world evidenceRWEtildrakizumabwell-beingWHO-5 Well-being Index

Identifiers

PMID40605963
PMCPMC12219165

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.