Ilumetri (tildrakizumab) demonstrates high rates of skin clearance and sustained wellbeing restoration in adults with moderate-to-severe plaque psoriasis to general population levels for up to one year
Almirall, announced new data from the real-world evidence clinical study called “POSITIVE” demonstrating that Ilumetri (tildrakizumab) effectively restores the level of wellbeing of patients with moderate-to-severe plaque psoriasis to those of the general population as early as Week 16 after initiating the treatment
In the study, this fundamental benefit was shown to be maintained for up to 1 year of treatment.
The POSITIVE study showed that treatment with tildrakizumab led to improvements in skin clearance, particularly in sensitive areas (scalp, nail and palms/soles), as well as in high-burden symptoms (itch, pain, joint pain and fatigue). These physical symptoms have a significant impact on patients’ daily lives and wellbeing. The data from this study show that following 52 weeks of treatment, almost 6 out of 10 patients achieved a PASI less than 1 response, with no new safety signals observed, consistent with previous studies. The POSITIVE study is the first clinical study in dermatology to assess patients’ wellbeing as a primary endpoint using the WHO-5 approach. The 5-item World Health Organization Wellbeing Index is a widely used questionnaire that assesses health-related subjective psychological wellbeing in a variety of chronic diseases. The outcomes of the POSITIVE study highlight – from the patient perspective - the importance of understanding the psychosocial burden of psoriasis beyond the physical symptoms of the skin perspective, considering how high-burden symptoms affect patients' overall wellbeing.
Psoriasis is a highly prevalent disease, affecting around 60 million people world wide and 3% of the population in Europe. Nearly 77% of patients believe that psoriasis negatively affects their normal daily activities (personal, social, and work, life, and wellbeing).
“The impact of psoriasis on patients’ wellbeing cannot be overstated. It affects their overall health, psychological state, and social life. The interim results from the POSITIVE study are promising, they demonstrate that treatment with tildrakizumab restores patients’ well-being within 16 weeks and maintains it for at least one year. Additionally, significant improvements are observed in skin condition, high-burden symptoms, and sensitive areas. This underscores tildrakizumab’s potential to alleviate the profound burden of psoriasis on daily life” stated Prof. Dr. Ulrich Mrowietz, from the Psoriasis Center at the University Medical Center Schleswig-Holstein, Campus Kiel.
About the POSITIVE Study: The POSITIVE study uses the 5 item World Health Organization Wellbeing Index, WHO-5, a widely used questionnaire that assesses health-related subjective psychological wellbeing 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 wellbeing, using the Physician’s Satisfaction Score. This ongoing non-interventional, prospective, observational, real-world evidence study has enrolled 782 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.
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