The trial will monitor patients across Europe for 24 months as they are treated with tildrakizumab
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 ultimate aim is to capture the patients’ overall well-being in a real-world setting while being treated with tildrakizumab – a therapy indicated for moderate-to-severe plaque psoriasis.
Although the requirement for a holistic perspective has been considered vital – in addition to evaluating the severity of psoriasis – a person-centred approach has never been undertaken during a dermatology trial before.
In response, the POSITIVE study is using the five-part World Health Organization (WHO) Well-being Index, ‘WHO-5’ – a widely used questionnaire that assesses health-related subjective psychological well-being.
POSITIVE will also incorporate innovative secondary endpoints, such as evaluating the impact on the family environment.
This ongoing non-interventional, prospective real-world evidence research has now enrolled around 780 adults with moderate-to-severe psoriasis. The recruitment has taken in multiple sites across Europe, with locations in the UK, Austria, Belgium, France, Germany, Italy, Spain, Switzerland and The Netherlands. The trial will monitor patients for 24 months as they are treated with tildrakizumab.
Frida Dunger Johnsson, executive director at the IFPA, was optimistic about the comprehensive study: “It is crucial to consider the serious effects that a chronic disease such as psoriasis has on the physical, psychological, and social well-being of people living with psoriasis, their family members and partners.”
She added: “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.”
Professor Dr Matthias Augustin, principal investigator of the POSTIVE study, concluded: “We need to go beyond the clinical endpoints and the current use of the Dermatology Life Quality Index questionnaire, extending our understanding of how the patient is really feeling.
“We need to switch from just looking at the disease burden and setting up positive treatment goals that promote good health and well-being. Therefore, our true goal as dermatologists is to reach the maximum well-being of our patients.”
Psoriasis impacts an estimated 60 million people worldwide and the severity of psoriasis is considerable, involving both physical and psychological side effects. Nearly 77% of patients believe that psoriasis negatively affects their daily activities and wider well-being.
