EADV News: Almirall’s Ilumetri Improves Well-being of Pso Patients and Their Families


The IL-23 blocker significantly improved patients' well-being after 16 weeks, which was maintained at week 28 and also had a positive impact on the well-being of patient's relatives after 28 weeks.

Ilumetri (tildrakizumab) significantly improves the well-being of psoriasis patients and their relatives, according to new data presented at the European Association of Dermatology and Venereology Congress 2023.

Interim data from the POSITIVE study showed that tildrakizumab significantly improved patients' well-being after 16 weeks, which was maintained at week 28 and also had a positive impact on the well-being of patient's relatives after 28 weeks.

Additionally, tildrakizumab improves patients' health-related quality of life (HRQoL), with high rates of treatment satisfaction in patients with moderate-to-severe plaque psoriasis after 28 weeks in a real-world setting, the study showed. There were no new safety signals seen in the POSITIVE study.

"The POSITIVE study represents an important step forward in our understanding of psoriasis by assessing the effect on the wellbeing of patients, their families, and healthcare professionals", says study author Dr. Ulrich Mrowietz, Founder of the Psoriasis Center at the University Medical Center Schleswig-Holstein in Kiel, Germany, in a news release.

The POSITIVE study uses the five-item World Health Organization Wellbeing Index (WHO-5) to assess health-related subjective psychological well-being in a variety of chronic diseases. Following the holistic approach, the POSITIVE study will also use innovative secondary endpoints, the FamilyPso questionnaire to evaluate the impact of the disease on the family environment, and on Physician well-being, using the Physician's Satisfaction Score. The ongoing non-interventional, prospective, observational, real-world evidence study has enrolled approximately 780 adults with moderate-to-severe psoriasis at multiple sites in Europe, including Austria, Belgium, France, Germany, Italy, Spain, Switzerland, The Netherlands, and the United Kingdom. The study will follow these patients for 24 months in their treatment with tildrakizumab.


New data from the TRIBUTE study showed that tildrakizumab improved other patient-reported outcomes (PROs) such as sleep quality, which is highly correlated with the itch, pain, quality of life, and work productivity, and not with Psoriasis Area and Severity Index (PASI).

The study also showed that tildrakizumab demonstrated similar efficacy and safety regardless of the baseline characteristics of the patients. These new data highlight the importance of evaluating other endpoints beyond skin symptoms to ensure a holistic approach to psoriasis management.

TRIBUTE is an international, multicentre, open-label, interventional Phase IV clinical study in patients with moderate-to-severe chronic plaque psoriasis. A total of 177 patients were included in both the safety and efficacy analyses. The objective was to assess the efficacy, safety, and impact on HRQoL (using the DLQI and the new proposed score, DLQI-R*) in a Phase IV study in close to similar conditions to clinical practice.

The TILOT study

Almirall also reported results from the TILOT study at EADV which demonstrated sustained efficacy and safety of tildrakizumab over two years in patients with moderate-to-severe plaque psoriasis in routine clinical practice including sensitive areas and improvements of itch. This was reflected in significant improvements in all measured parameters, including treatment satisfaction and quality of life.

TILOT is a prospective, non-interventional, multicenter study from Germany to assess the effectiveness and safety profile of tildrakizumab in the long-term treatment of moderate-to-severe plaque psoriasis in routine practice. The observational period of this study will be approximately 3 years, including a large population (around 900 patients), providing the longest and largest real-world data on the treatment.

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