Almirall, S.A., a global biopharmaceutical company dedicated to medical dermatology, announced new long-term results from the POSITIVE study, presented as a late-breaker at the 34th Congress of the European Academy of Dermatology and Venereology (EADV 2025) in Paris.
The POSITIVE study represents a landmark in dermatology research. It is the first real-world evidence (RWE) study in dermatology to adopt the World Health Organization Well-Being Index (WHO-5) as its primary endpoint. The decision to prioritize this well-being scale reflects a growing recognition that psoriasis is not only a chronic skin condition but also a disease with broad psychological, social, and physical consequences.
The acceptance of POSITIVE as a late-breaker abstract underscores the importance of its findings and highlights the innovative methodology used to assess treatment impact. For patients with moderate-to-severe psoriasis, the study shows how modern biologic therapies can not only improve visible symptoms but also significantly enhance emotional and psychological health, thereby addressing a broader definition of patient well-being.
The Burden of Psoriasis and the Need for Holistic Care
Psoriasis affects millions of people worldwide, often manifesting as red, scaly patches of skin that can be itchy, painful, and difficult to manage. Beyond the physical symptoms, the condition has a profound impact on mental health, social functioning, and quality of life. Studies consistently show that people living with psoriasis have higher rates of depression, anxiety, and social isolation compared to the general population.
Until recently, treatment success was primarily measured through clinical skin clearance scores, such as the Psoriasis Area and Severity Index (PASI). While important, these metrics do not fully capture the broader patient experience. The POSITIVE study breaks new ground by shifting the focus toward well-being and quality of life, aligning with the World Health Organization’s 2025 resolution that recognizes skin diseases as a global public health priority and calls for more integrated, patient-centered approaches.
POSITIVE: A First-of-Its-Kind Study
POSITIVE is a 24-month, multinational, observational phase IV study involving 785 adult patients with moderate-to-severe plaque psoriasis across nine European countries. All participants received tildrakizumab, an anti-IL-23p19 monoclonal antibody, as part of routine clinical practice.
By adopting the WHO-5 Well-Being Index as its primary endpoint, the study directly measured the psychological state of patients, offering a richer understanding of how effective treatment influences daily life. The trial also incorporated Dermatology Life Quality Index-Revised (DLQI-R) and FamilyPsO, which assess the impact of psoriasis not only on patients but also on their partners and families.
Key Two-Year Results
The findings of the POSITIVE study show that treatment with tildrakizumab leads to rapid, durable, and holistic improvements for people living with psoriasis:
- Psychological well-being (WHO-5): At baseline, patients scored an average of 53.7, significantly below the European population mean of 64.9, and comparable to levels seen in chronic conditions like diabetes or breast cancer. After 16 weeks, scores rose to 63.2, reaching parity with the general population. By the two-year mark, patients achieved an average score of 70.43, surpassing the European norm and reflecting a sustained improvement in mental well-being.
- Skin clearance (PASI): Clinical improvement was both rapid and durable. Baseline PASI scores of 12.9 dropped to 2.4 at week 16 and 1.3 at year 2. Notably, 79% of patients maintained PASI ≤2 after two years, demonstrating long-term disease control.
- Quality of life (DLQI-R): Mean DLQI-R scores improved dramatically, from 12.0 at baseline to 2.1 at year 2, highlighting the transformative impact on patients’ daily functioning and emotional health.
- Family and partner burden (FamilyPsO): Psoriasis not only affects patients but also places a burden on close relationships. POSITIVE revealed that partner burden decreased significantly, with scores falling from 1.1 at baseline to 0.6 at year 2 (P<0.001).
- Safety: Tildrakizumab was generally well tolerated throughout the two-year period, with a safety profile consistent with previous clinical studies.
Expert Perspectives
Prof. Ulrich Mrowietz, lead investigator of POSITIVE, emphasized the study’s innovative contribution:
“We are delighted that the two-year data from the POSITIVE study has been accepted as a late breaker at the 2025 EADV Congress – a recognition that reflects the innovative nature of this real-world evidence research. POSITIVE takes a truly holistic approach to managing psoriasis by incorporating patient-reported outcomes that were previously unexplored in dermatology, such as the WHO-5 score for psychological well-being and the impact on patients’ partners. This study provides valuable new insights for the dermatology community.”
Dr. Volker Koscielny, Almirall’s Chief Medical Officer, highlighted the broader implications:
“The POSITIVE study demonstrates that advanced therapies such as those targeting IL-23 can truly raise the bar when it comes to treatment success. By measuring psychological and physical well-being as primary outcomes, POSITIVE shows comprehensively – for the first time – that patients can ‘get their lives back.’ The inclusion of partner impact sets a new standard for patient-centered dermatological care.”
A New Standard in Dermatology Research
POSITIVE reflects the holistic, patient-centered care model increasingly called for in global dermatology. Its alignment with the WHO’s Global Action Plan demonstrates how real-world evidence can guide future policies, improve care standards, and ensure that dermatology addresses not only physical symptoms but also the emotional and social dimensions of chronic skin conditions.
By integrating the WHO-5 index into dermatology research, Almirall is pioneering a new standard for evaluating treatment success. The company also plans to extend this approach across multiple dermatological indications, including atopic dermatitis, reinforcing its role as a leader in patient-centric dermatology innovation.
Almirall at EADV 2025
Beyond POSITIVE, Almirall’s scientific presence at EADV 2025 reflects its ongoing commitment to advancing dermatology. The company is presenting 44 abstracts spanning atopic dermatitis, psoriasis, and actinic keratosis. In addition, it is hosting two expert-led symposia on psoriasis and atopic dermatitis, alongside an interactive booth for clinicians.
This robust presence demonstrates Almirall’s strategy to combine clinical trial data with real-world evidence, strengthening the link between innovation and everyday practice. By doing so, the company aims to deliver meaningful outcomes for patients, healthcare professionals, and the broader dermatology community.
Conclusion
The two-year results of the POSITIVE study mark a significant milestone in dermatology research. By demonstrating that tildrakizumab can restore well-being to levels surpassing the general population, while also providing long-term skin clearance and improved quality of life, the study sets a new standard for what treatment success looks like in psoriasis.
Most importantly, POSITIVE underscores a shift in dermatology toward holistic care, where psychological health, quality of life, and family impact are considered as crucial as clinical outcomes. With this approach, Almirall is helping reshape the future of dermatological treatment and offering new hope to people living with chronic skin diseases.
The POSITIVE Abstract Link can be found on the EADV website.
About Almirall
Almirall is a global biopharmaceutical company dedicated to medical dermatology. We closely collaborate with leading scientists, healthcare professionals, and patients to deliver our purpose: to transform the patients’ world by helping them realize their hopes and dreams for a healthy life. We are at the forefront of science to deliver ground-breaking, differentiated medical dermatology innovations that address patients´ needs.
Almirall, founded in 1944 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM, total revenue in 2024: €990 MM, over 2000 employees globally). Almirall products help to improve the lives of patients every day and are available in over 100 countries.
For more information, please visit https://www.almirall.com/
