Global biopharmaceutical company Almirall has announced the launch of the POSITIVE study, marking the first dermatological research to assess patient wellbeing as a primary endpoint. The groundbreaking study aims to capture patients' overall wellbeing in a real-world setting while being treated with tildrakizumab for moderate-to-severe plaque psoriasis.
Revolutionary Approach to Psoriasis Assessment
The POSITIVE study protocol, published in the British Medical Journal, employs the 5-item World Health Organization Wellbeing Index (WHO-5), a widely used questionnaire that assesses health-related subjective psychological wellbeing across various chronic diseases. This represents the first time the WHO-5 has been utilized in dermatology research, signaling a shift toward more holistic patient care approaches.
"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," said Professor Dr. Matthias Augustin, director of the Institute of Health Care Research in Dermatology and Nursing University of Hamburg and principal investigator of the POSITIVE study. "We need to switch from just looking at the disease burden and setting up positive treatment goals that promote good health and wellbeing."
Comprehensive Study Design and Scope
This ongoing non-interventional, prospective, observational, real-world evidence study has enrolled approximately 780 adults with moderate-to-severe psoriasis across multiple European sites, including Austria, Belgium, France, Germany, Italy, Spain, Switzerland, The Netherlands, and the United Kingdom. Patients will be followed for 24 months during their treatment with tildrakizumab, with the first 28-week data pull scheduled for presentation at scientific meetings at the end of 2023.
The study incorporates innovative secondary endpoints beyond traditional measures, including evaluation of impact on the family environment using the FamilyPso questionnaire and assessment of physician wellbeing through the Physician's Satisfaction Score.
Addressing Unmet Needs in Psoriasis Care
The study addresses a significant gap in psoriasis research, as almost 77% of patients believe that psoriasis negatively affects their normal daily activities including personal, social, and work life, and up to 25% of patients have reported being depressed. Despite these substantial impacts on patient wellbeing, a robust prospective study had never previously measured the overall wellbeing of psoriasis patients.
Psoriasis impacts an estimated 60 million people worldwide, with considerable severity involving both physical and psychological side effects. The disease's burden extends beyond the patient to affect family members and partners, highlighting the need for comprehensive assessment approaches.
Treatment Focus: Tildrakizumab
Tildrakizumab, the treatment being evaluated in the study, is a humanized monoclonal antibody that targets the p19 subunit of interleukin-23 (IL-23) and inhibits the release of proinflammatory cytokines and chemokines with limited impact on the rest of the immune system. The drug is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.
Recent research from California, Michigan, and New Jersey has demonstrated that tildrakizumab treatment significantly improved work productivity in psoriasis patients, supporting the broader wellbeing benefits being investigated in the POSITIVE study.
Industry and Patient Advocacy Support
Frida Dunger Johnsson, executive director at the International Federation of Psoriasis Associations (IFPA), expressed optimism about the comprehensive study approach: "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 that the study "will significantly promote patient involvement and awareness, as recommended in the WHO Report on Psoriasis, while simultaneously strengthening patient-clinician relationship."
Future Implications for Dermatology Practice
Professor Augustin emphasized the pioneering nature of the research, stating, "We are really pioneers opening a large terrain of new options in research with the POSITIVE study." The results could potentially be added to available psoriasis evaluation methods and provide dermatologists with new tools to improve both their own and their patients' wellbeing while enhancing patient-clinician relationships.
The study represents a paradigm shift in dermatology research, moving from traditional disease-focused assessments to comprehensive wellbeing evaluations that could reshape how chronic skin conditions are managed and monitored in clinical practice.
