Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive Study
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 Ismai...
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Dove Medical Press
2025-06-01
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| Series: | Psoriasis: Targets and Therapy |
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| author | Mrowietz U Sommer R Gerdes S Reguiai Z Weger W Daudén E Maul JT Ghislain PD Laws PM Naldi L De Jong E Mburu S Koscielny V Massana E Domenech A Gaarn du Jardin K Kasujee I Augustin M |
| author_facet | Mrowietz U Sommer R Gerdes S Reguiai Z Weger W Daudén E Maul JT Ghislain PD Laws PM Naldi L De Jong E Mburu S Koscielny V Massana E Domenech A Gaarn du Jardin K Kasujee I Augustin M |
| author_sort | Mrowietz U |
| collection | DOAJ |
| description | 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 |
| format | Article |
| id | doaj-art-58b735036d1c4c9cb16ad2b94f84ce28 |
| institution | OA Journals |
| issn | 2230-326X |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Psoriasis: Targets and Therapy |
| spelling | doaj-art-58b735036d1c4c9cb16ad2b94f84ce282025-08-20T02:37:58ZengDove Medical PressPsoriasis: Targets and Therapy2230-326X2025-06-01Volume 15Issue 1243259104330Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive StudyMrowietz U0Sommer R1Gerdes S2Reguiai Z3Weger WDaudén E4Maul JT5Ghislain PD6Laws PMNaldi LDe Jong E7Mburu S8Koscielny V9Massana E10Domenech A11Gaarn du Jardin K12Kasujee I13Augustin M14Psoriasis-ZentrumInstitute for Health Services Research in Dermatology and Nung (IVDP)Center for Inflammatory Skin Diseases, Department of DermatologyDermatologyDepartment of DermatologyDepartment of DermatologyDepartment of DermatologyDepartment of DermatologyScienceGlobal Medical AffairsGlobal Medical AffairsReal-World Evidence and Outcomes ResearchMedical AffairsGlobal Medical AffairsInstitute for Health Services Research in Dermatology and Nung (IVDP)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 Indexhttps://www.dovepress.com/patient-reported-well-being-in-value-based-routine-care-using-tildraki-peer-reviewed-fulltext-article-PTTeffectivenesspsoriasisreal-world evidence (RWE)tildrakizumabwell-beingWHO-5 Well-being Index. |
| spellingShingle | Mrowietz U Sommer R Gerdes S Reguiai Z Weger W Daudén E Maul JT Ghislain PD Laws PM Naldi L De Jong E Mburu S Koscielny V Massana E Domenech A Gaarn du Jardin K Kasujee I Augustin M Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive Study Psoriasis: Targets and Therapy effectiveness psoriasis real-world evidence (RWE) tildrakizumab well-being WHO-5 Well-being Index. |
| title | Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive Study |
| title_full | Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive Study |
| title_fullStr | Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive Study |
| title_full_unstemmed | Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive Study |
| title_short | Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive Study |
| title_sort | patient reported well being in value based routine care using tildrakizumab 52 week interim data of the phase iv positive study |
| topic | effectiveness psoriasis real-world evidence (RWE) tildrakizumab well-being WHO-5 Well-being Index. |
| url | https://www.dovepress.com/patient-reported-well-being-in-value-based-routine-care-using-tildraki-peer-reviewed-fulltext-article-PTT |
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