Almirall Presents Long‑Term Results from First Real‑World Dermatology Study Using WHO‑5 Well‑Being Index as Primary Endpoint in the treatment of Psoriasis at EADV 2025

Results of the POSITIVE study assessing the treatment with tildrakizumab showed sustained improvements in skin clearance, psychological well-being, and improved partner quality of life in adults with moderate-to-severe psoriasis over two years.POSITIVE is the first real-world evidence (RWE) study in dermatology to use the WHO-5 Well-Being Index as a primary endpoint, complementing traditional measures of skin disease (PASI, PGA), quality of life (DLQI), with the assessment of psychological well-being, marking a paradigm shift towards holistic management of psoriasis.The POSITIVE study highlights Almirall’s leadership in advancing patient-centred dermatology aligned with the WHO’s health definition and recent resolution on skin diseases.Almirall’s extensive scientific contributions to EADV 2025 include 44 abstracts across key dermatological conditions including atopic dermatitis, psoriasis, actinic keratosis, and hidradenitis suppurativa, and two expert-led symposia.

Almirall, S.A. (ALM) a global biopharmaceutical company focused on medical dermatology today 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 2025 (EADV) in Paris.

POSITIVE is the first RWE study in dermatology to use the World Health Organization Well-Being Index (WHO-5) as a primary endpoint. The selection of the abstract as a late breaker at the EADV congress highlights the importance of the findings of the POSITIVE study and its unique approach to evaluating the long-term holistic impact of an advanced treatment in patients with moderate-to-severe psoriasis, a condition that profoundly impairs social, psychological, and physical quality of life, impacting overall well-being¹.

Two‑Year Real‑World Results from POSITIVE

The 24-month, multinational, phase IV observational study enrolled 785 adult patients with moderate-to-severe plaque psoriasis across nine European countries, all receiving tildrakizumab in routine clinical practice. The results of the POSITIVE study show tildrakizumab's long-term effectiveness on both skin outcomes and patient-reported outcomes and demonstrates tildrakizumab's significant value in the long-term holistic management of psoriasis.

Key findings include:

• Rapid and sustained improvement of psychological well-being (assessed by WHO-5): Baseline well-being scores of subjects with moderate to severe psoriasis averaged 53.7, significantly below the European population mean scores of 64.9 and comparable to levels seen in people with diseases like diabetes or breast cancer. After 16 weeks of treatment, scores improved to 63.2, restoring well‑being to the same range as the European average. By two years, the well-being scores of subjects rose further to 70.43, surpassing the general population mean.
• Rapid and sustained skin clearance (PASI): Psoriasis Area and Severity Index (PASI) scores improved from 12.9 at baseline to 2.4 at week 16 and 1.3 at year 2, with 79% of patients maintaining PASI ≤2 after two years.
• Improved quality of life (DLQI-R): Dermatology Life Quality Index‑Revised scores improved from 12.0 at baseline to 2.1 at year 2.
• Reduced partner burden (FamilyPsO): Scores significantly improved throughout the study period from 1.1 at baseline to 0.6 at year 2 (P<0.001), demonstrating that the impact of effective therapy also benefits partners.

Treatment with tildrakizumab was generally well tolerated over the two-year study period, with a safety and tolerability profile in line with previous clinical studies.

Prof. Ulrich Mrowietz, lead investigator of POSITIVE, said: “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 (RWE) research. POSITIVE takes a truly holistic approach to managing psoriasis by incorporating PROs that were previously unexplored in dermatology, such as the WHO-5 score for measuring psychological well-being and the impact of the disease on patient's partners. This study provides valuable new insights for the dermatology community.”

POSITIVE’s focus on psychological well-being, quality of life, and the impact on patients’ partners reflects the integrated, patient‑centered approach called for in the WHO’s 2025 resolution² on skin diseases as a global public health priority. Adopted at the Seventy‑eighth World Health Assembly, the resolution calls for the development of a Global Action Plan to strengthen and integrate dermatology care worldwide – an ambition that POSITIVE supports through its holistic, patient-centric approach to psoriasis management.

Dr. Volker Koscielny, Almirall’s Chief Medical Officer, said:“The POSITIVE study demonstrates that advanced therapies such as those targeting IL -23 can truly raise the bar when it comes to treatment success. Measuring psychological and physical wellbeing as primary outcomes, the POSITIVE study demonstrates comprehensively - for the first time - that patients can “get their lives back” as a range of relevant health aspects improve with treatment. The study also proposes a model that looks at disease impact in a more holistic way, including the impact on people close to the patients. This means we at Almirall are – through our close collaboration with visionary dermatologists - setting a new standard for patient‑centred dermatological care and push the boundaries of optimized treatment outcomes.”

By incorporating the WHO‑5 into real‑world research across multiple dermatological indications including psoriasis and atopic dermatitis (AD), Almirall is advancing its commitment to the next generation of holistic, patient‑centred dermatology innovation as well as reinforcing its leadership in patient‑centred care.

Almirall - advancing skin science at EADV 2025

The company’s presence at EADV 2025 also includes 44 scientific abstracts across atopic dermatitis, psoriasis, and actinic keratosis, alongside two expert‑led symposia on psoriasis and atopic dermatitis, and an interactive booth. This presence reflects Almirall’s commitment to advancing science, sharing RWE and clinical data with the dermatology community, and helping to improve outcomes in everyday clinical practice.

The POSITIVE study will be presented as a late‑breaking abstract at EADV 2025 on Thursday 18 September, 17:15 – 17:30 (Room Paris‑Nord), by Prof. Ulrich Mrowietz. The 15‑minute slot will include a 12‑minute presentation followed by 3 minutes of Q&A.

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/

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¹ WHO Global report on psoriasis
²Skin diseases as a global public health priority (WHO).

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