This is the first clinical study in dermatology to assess patients’ wellbeing as a primary endpoint. 

Almirall, S.A. (ALM) will use patients’ wellbeing as a primary endpoint in the POSITIVE study protocol. 

This is the first clinical study in dermatology to assess patients’ wellbeing as a primary endpoint. 

The objective is to capture patients’ overall wellbeing in a real-world setting when in treatment with tildrakizumab, an anti-IL-23p19 biologic indicated for moderate-to-severe plaque psoriasis. 

Despite the need for a holistic, people-centric approach in the wellbeing assessment in addition to evaluating the severity of psoriasis, overall patient wellbeing and the holistic, person-centred approach to healthcare had never been measured in a robust prospective psoriasis study until now. 

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, but that had never been used in dermatology.  Following the holistic approach, the POSITIVE study will also use innovative secondary endpoints, such as evaluating the impact on the family environment, with the FamilyPso questionnaire 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. The first 28-week data pull will be presented in scientific meetings at the end of 2023.

“We need to go beyond the clinical endpoints and the current use of the DLQI (Dermatology Life Quality Index) questionnaire, extending our   understanding of how the patient is really feeling,” says Prof. Dr. Matthias Augustin, Director, Institute of Health Care Research in Dermatology and Nursing University of Hamburg and principal investigator of the POSTIVE study. “We need to switch from just looking at the disease burden and setting up positive treatment goals that promote good health and wellbeing. Therefore, our true goal as dermatologists is to reach the maximum wellbeing of our patients. We are really pioneers opening a large terrain of new options in research with the POSITIVE study.”

“It is crucial to consider the serious effects that a chronic disease such as psoriasis has on the physical, psychological, and social wellbeing of people living with psoriasis, their family members and partners. We are pleased that, for the first time, a study will significantly promote patient involvement and awareness, as recommended in the WHO Report on Psoriasis, while simultaneously strengthening patient-clinician relationship,” adds Frida Dunger Johnsson, Executive Director of the IFPA.

“Our Noble Purpose guides us every day to make a physical and emotional impact on patients' lives. The publication of the POSITIVE study reinforces Almirall's dedication to assessing the impact of skin diseases on wellbeing and demonstrates our commitment to the WHO’s claim for people-centred healthcare and patient engagement." Says Volker Koscielny, Almirall’s Chief Medical Officer “With the publication of the design of this study, we are taking a step further towards understanding the needs of our patients and will help us to continue working to provide them with real solutions that improve their health and wellbeing and that of their families.”