Almirall has announced the publication in the British Medical Journal of its POSITIVE study protocol, which represents the first clinical study in dermatology assessing patients’ well-being as a primary endpoint.
The ongoing study is aiming to capture patients’ overall well-being in a real-world setting when being treated with tildrakizumab, a recombinant human monoclonal antibody indicated for moderate-to-severe plaque psoriasis.
Psoriasis affects an estimated 60 million people worldwide, with almost 77% of patients reporting that the condition negatively affects their normal daily activities and well-being. Almirall also reports that psoriasis can significantly affect the general well-being of patients’ families, as well as physician satisfaction.
It is hoped that the results could potentially be added to the available psoriasis evaluation methods and provide dermatologists with new tools to improve their own and their patients’ well-being.
Almirall’s POSITIVE study uses the five-item World Health Organization (WHO) Well-being Index, a widely used questionnaire that assesses health-related psychological well-being in a variety of chronic diseases, but that had never been used in dermatology.
Following the holistic approach, the study will use secondary endpoints, such as evaluating the impact on the family environment and on physician well-being.
Professor Dr Matthias Augustin, director, Institute of Health Care Research in Dermatology and Nursing University of Hamburg and principal investigator of the POSITIVE study, said: “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.”
Around 780 adults with moderate-to-severe psoriasis are enrolled in the study, which will follow 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 this year, the company said.
Frida Dunger Johnsson, executive director of the International Federation of Psoriasis Associations, said: “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.
“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.”