Almirall leads a paradigm shift to holistic patient care in dermatology, applying the WHO-5 well-being index as primary endpoint in clinical trials

Istanbul, Turkey. June 3 rd 2025 – Almirall, S.A. (ALM) , a global leader in medical dermatology, showcased its pioneering work in psychodermatology at the 21st Congress of the European Society for Dermatology and Psychiatry and the inaugural World Psychodermatology Congress held in Istanbul from May 28 to 31. Five oral presentations and three e-posters covering studies on the psychological burden of mild-to-moderate scalp psoriasis, and moderate-to-severe psoriasis as well as atopic dermatitis demonstrate the positive impact of treatments on patient wellbeing. Since its introduction in 1998, the World Health Organization’s WHO-5 Well-being Index (WHO-5) has been widely used to measure psychological wellbeing across various medical fields. However, Almirall is the first to use the WHO-5 Well-being Index as a primary endpoint in medical dermatology clinical trials , representing a significant advancement in assessing psychological wellbeing in patients with skin diseases. This innovative approach is a core part of Almirall’s focus on integrating patient-reported outcomes (PROs) to promote patient-centered care and research. Psoriatic disease profoundly impairs patients’ social, psychological, and physical quality of life, impacting on their overall wellbeing. [i] Among the oral presentations at the congress, Almirall shared two new analyses from the POSITIVE study , the first real-world study in dermatology to assess patients’ psychological well-being as a primary endpoint using the WHO-5 Well-being index. The data revealed that most patients with moderate-to-severe psoriasis experienced improvements in both skin symptoms and psychological wellbeing within 16 weeks treatment 2 . However, in about 10% of the patients, there was a delay in psychological improvement compared to the improvement on the skin —a phenomenon called “psycholag”—. These findings highlight the importance of evaluating psychological parameters alongside physical symptoms to achieve comprehensive disease management. Additionally, some patients suffered persistent psychological distress despite significant advances in their skin clearance, underscoring the need for integrated approaches beyond traditional skin-focused measures. [ii] Mild to moderate scalp psoriasis often has significant impact on patients’ health, including itching, sleep deprivation and psychosocial symptoms. [iii] , [iv] D ata from the PRO-SCALP study was presented highlighting the psychosocial burden experienced by patients with mild-to-moderate scalp psoriasis in real-life. The study also demonstrated that treatment with calcipotriene and betamethasone dipropionate cream with PAD technology significantly reduced symptoms such as itching and sleep disturbance, as well as improvements in patients’ emotional wellbeing and overall quality of life after eight weeks of therapy [v] . Atopic dermatitis (AD) can also have a substantial impact on psychological wellbeing [vi] . ADvantage is a Ph3b, randomized, placebo-controlled study, conducted in patients with moderate-to-severe atopic dermatitis considering wellbeing measured with the WHO-5 score as primary endpoint, that revealed a significant impairment of their psychological wellbeing at baseline. Results showed that treatment with lebrikizumab combined with topical corticosteroids, revealed significant improvements in psychological well-being as early as week 16 , which were sustained through week 52, reaching levels of wellbeing comparable to the general population. These data reflect a paradigm shift in dermatology, moving beyond clinician-reported disease severity scores towards patient-centered outcomes that capture the full impact of skin diseases on patients’ lives [vii] , [viii] . By integrating these innovative endpoints, clinicians can better understand the broader effects of skin conditions and their treatments , ultimately enabling more personalized and effective care strategies. [ix] , [x] “ At Almirall, we are committed to advancing dermatology by focusing on the real-life needs of patients and support the healthcare professionals caring for them. Our contributions to this congress demonstrate how integrating psychological wellbeing into dermatology can improve clinical outcomes and also meaningfully enhance patients’ quality of life ,” said Dr. Volker Koscielny, Almirall’s Chief Medical Officer. About Almirall Almirall is a global pharmaceutical 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/ Corporate Communications: Investor Relations [email protected] [email protected] Phone: +34 93 291 35 08 Phone: (+34) 93 291 30 87 Legal notice: This document includes only summary information and is not intended to be exhaustive. The facts, figures, and opinions contained in this document, in addition to the historical ones, are "forward-looking statements." These statements are based on the information currently available and the best estimates and assumptions that the Company considers reasonable. These statements involve risks and uncertainties beyond the control of the Company. Therefore, actual results may differ materially from those declared by such forward-looking statements. The Company expressly waives any obligation to revise or update any forward-looking statements, goals, or estimates contained in this document to reflect any changes in the assumptions, events, or circumstances on which such forward-looking statements are based, unless required by the applicable law. [i] Sommer R, Mrowietz U, Gaarn Du Jardin K, Kasujee I, Martini E, Daudén E, Fabbrocini G, Zink A, Griffiths CEM, Augustin M. Implementing well-being in the management of psoriasis: An expert recommendation. J Eur Acad Dermatol Venereol. 2024 Feb;38(2):302-310.

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