Patients receiving tildrakizumab for the treatment of moderate-to-severe psoriasis could experience improvements to their psychological wellbeing and quality of life in addition to skin health benefits, a two-year study has found.
Outcomes from the POSITIVE study, the first real-world evidence study in dermatology to use the World Health Organization-Five Well-being Index (WHO-5), was exclusively presented at the 34th Congress of the European Academy of Dermatology and Venereology 2025.
The WHO-5 is a self-reported questionnaire that asks five questions to measure mental wellbeing. It was used over a two-year period to provide long-term results on the impact of tildrakizumab on skin and psychological patient health.
The multinational, phase 4 observational study enrolled 785 adult patients with moderate-to-severe plaque psoriasis across nine European countries. All participants received tildrakizumab via routine clinical practice over the 24-month study period.
Wellbeing improvements with tildrakizumab
The researchers found treatment with the interleukin-23 (IL-23) agonist tildrakizumab led to rapid and sustained improvement of psychological wellbeing. Baseline WHO-5 wellbeing scores of study participants averaged 53.7 – much below the European population median score of 64.9. The baseline score was also comparable in levels to those seen in people with diabetes or breast cancer, for example.
After 16 weeks of treatment, participant median scores improved to 63.2. At 24 months, wellbeing scores had further improved to 70.43, surpassing the general population mean average.
Participants also experienced skin clearance improvements based on Psoriasis Area and Severity Index (PASI) scores. At baseline, median PASI scores were 12.9. At week 16 this had decreased to 2.4 and by year two the average PASI score reached 1.3. Added to this, 79% of patients maintained a PASI lower than 2 after two years.
The Dermatology Life Quality Index-Revised (DLQI-R) scores also improved from 12.0 at baseline to 2.1 at year two of using tildrakizumab.
Scores used to assess the impact of psoriasis on partners and family members of participants was also assessed and that too showed improvements over time. FamilyPso is a 15-item questionnaire designed to help physicians understand the wider impact of an individual’s psoriasis. From 1.1 at baseline, this score improved to 0.6 at year two (P<0.001).
Treatment with tildrakizumab was generally well tolerated, the researchers found, with a safety and tolerability profile in line with previous clinical studies.
Therapies targeting IL-23 ‘raise the bar’
‘POSITIVE takes a truly holistic approach to managing psoriasis by incorporating patient-reported outcomes that were previously unexplored in dermatology, such as the WHO-5 score for measuring psychological wellbeing, and the impact of the disease on patient’s partners,’ explained lead investigator Professor Ulrich Mrowietz, founder of the Psoriasis Center in the Department of Dermatology at University Hospital Schleswig-Holstein in Kiel, Germany. ‘This study provides valuable new insights for the dermatology community.’
The study was led by global biopharmaceutical company Almirall, with chief medical officer Dr Volker Koscielny saying that the results demonstrate that advanced therapies those targeting IL-23, such as tildrakizumab, ‘can truly raise the bar when it comes to treatment success’.
‘Measuring psychological and physical wellbeing as primary outcomes, POSITIVE demonstrates comprehensively for the first time that patients can “get their lives back” as a range of relevant health impacts improve with treatment,’ he added. ‘The study also proposes a model that looks at disease impact in a more holistic way, including the impact on people close to the patients.’
