Barcelona, Spain – April 12,2023– Almirall, S.A. (ALM), a global biopharmaceutical company specializing in skin health, has made a significant breakthrough in dermatological research by becoming the first to incorporate the WHO-5 Well-Being Index as a primary endpoint in a clinical trial. The company announced the publication of the POSITIVE study protocol in the *British Medical Journal (BMJ)*, marking a milestone in patient-centered dermatology.
The POSITIVE study aims to evaluate the overall well-being of patients with moderate-to-severe plaque psoriasis in a real-world setting, focusing on their treatment with tildrakizumab, an anti-IL-23p19 biologic. Psoriasis, a chronic skin condition affecting approximately 60 million people worldwide, imposes a substantial physical and psychological burden on patients. Nearly 77% of patients report that psoriasis negatively impacts their daily activities, including personal, social, and work life. This study seeks to address the holistic needs of patients by measuring their well-being using the WHO-5 Well-Being Index, a widely recognized questionnaire for assessing health-related psychological well-being in chronic diseases.
This innovative approach is part of Almirall’s commitment to a holistic, people-centric healthcare model. The study will also explore secondary endpoints, such as the impact on the family environment using the FamilyPso questionnaire and on physician well-being using the Physician’s Satisfaction Score. The POSITIVE study is a non-interventional, prospective, observational trial involving approximately 780 adults across multiple sites in Europe. The initial 28-week data will be presented at scientific meetings by the end of 2023.
Prof. Dr. Matthias Augustin, Director of the Institute of Health Care Research in Dermatology and Nursing at the University of Hamburg and principal investigator of the study, emphasized the importance of this approach: “We need to go beyond clinical endpoints and extend our understanding of how patients truly feel. Our goal is to achieve maximum well-being for our patients, and the POSITIVE study is pioneering new research avenues in this direction”.
Frida Dunger Johnsson, Executive Director of the International Federation of Psoriasis Associations (IFPA), highlighted the significance of this study:”It is crucial to consider the serious effects of psoriasis on the physical, psychological, and social well-being of patients and their families. This study will promote patient involvement and awareness, strengthening patient-clinician relationships”.
Volker Koscielny, Almirall’s Chief Medical Officer, reiterated the company’s dedication:”Our Noble Purpose guides us to make a physical and emotional impact on patients’ lives. The POSITIVE study reinforces our commitment to assessing the impact of skin diseases on well-being and demonstrates our dedication to people-centered healthcare”.
This groundbreaking initiative by Almirall sets a new standard in dermatological research, emphasizing the importance of patient well-being and holistic care in managing skin conditions.
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