Positive Study shows significant improvement of wellbeing

Almirall – a company focused on skin health – has announced the release of its POSITIVE study protocol. The clinical trial represents the first dermatological research which assesses patient well-being as a primary endpoint.

The POSITIVE study is the first research in skin care to focus on patients' overall well-being as the most important measure. To do this, they used a questionnaire called the WHO-5, which asks patients about their mental and emotional health in relation to their chronic skin condition. This study goes beyond just looking at the severity of psoriasis. It aims to understand how psoriasis affects a person's whole life and their well-being. The results of this study could lead to new ways for dermatologists to assess and improve their patients' well-being, by taking a more personal and holistic approach to their care.

Psoriasis affects around 60 million people worldwide. It not only causes physical discomfort but also takes a toll on people's mental and emotional well-being. Many patients report that psoriasis interferes with their everyday activities, including personal, social, and work life. It also affects the well-being of their families and can even impact physicians' satisfaction.

The POSITIVE study has produced encouraging results that highlight the importance of considering well-being in clinical trials. By taking a comprehensive and patient-centered approach, we gain valuable insights into how treatments can improve the lives of people living with psoriasis. This study represents a significant milestone in dermatology research and the initial findings show a noticeable improvement in the well-being of individuals with psoriasis on treatment . These early results reinforce our commitment at Almirall to provide healthcare professionals and patients with innovative solutions that effectively address their needs and enhance their quality of life.

"We are thrilled with the promising results of the POSITIVE study, as they underline the importance of incorporating wellbeing into clinical trials. Having a holistic and patient-centered approach allows for more data on the impact of treatments on people living with psoriatic disease and therefore improves health and quality of life", said Frida Dunger Johnsson, IFPA Executive Director.

About the POSITIVE Study

The POSITIVE study uses the 5item 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 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.