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

Almirall presented novel approaches to integrated patient care at the 21st Congress of the European Society for Dermatology and Psychiatry and the inaugural World Psychodermatology Congress with five oral presentations and three e-posters on the psychological burden of skin diseases

Data presented focused on a range of dermatological conditions (mild-to-moderate scalp psoriasis, moderate-to-severe psoriasis, and moderate-to-severe atopic dermatitis) and demonstrated how its product portfolio including calcipotriene and betamethasone dipropionate cream, tildrakizumab and lebrikizumab can contribute to improvements in patients’ well-being beyond the resolution of physical symptoms

This approach to integrating patient-reported outcomes (PROs) advances patient-centered care and research at the heart of Almirall´s purpose

Almirall, 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.¹ 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 treatment². 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.²

Mild to moderate scalp psoriasis often has significant impact on patients’ health, including itching, sleep deprivation and psychosocial symptoms.^3,4 Data 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 therapy⁵.

Atopic dermatitis (AD) can also have a substantial impact on psychological wellbeing⁶. 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^7,8. 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.^9,10

“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.

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¹ 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.

² Rachel Sommer, Ulrich Mrowietz, Sascha Gerdes, Ziad Reguiai, Wolfgang Weger, Esteban Daudén, Julia-Tatjana Maul, Pierre-Dominique Ghislain, Philip Laws, Luigi Naldi, Elke de Jong, Sicily Mburu, Volker Koscielny, Eric Massana, Arnau Domenech, Kristian Gaarn du Jardin, Ismail Kasujee, Matthias Augustin. When PASI is not enough: psychological impairments despite improvements in skin

³ WHO Global report on psoriasis. https://apps.who.int/iris/ha.

⁴ Møller AH, et al. Patient Relat Outcome Meas. 2015;6:167-77.

⁵ Anthony Bewley, Andreas Pinter, Jose Luis López Estebaranz, Jordi Galván, Siva Narayanan, Arnau Domenech, Volker Koscielny, Ismail Kasujee. Impact of calcipotriene and betamethasone dipropionate cream with PAD technology (CAL/BPD PAD cream) on patient symptoms, functioning, emotions, level of itching, sleep quality, and psychosocial burden among patients with mild-to-moderate scalp psoriasis in routine clinical practices in Europe. The PRO-SCALP study

⁶ Jacek C Szepietowski, Marjolein de Bruin-Weller, Athanasios Tsianakas, Abdallah Khemis, Richard B Warren, Pedro Herranz, Silvia M Ferrucci, H Chih-Ho Hong, Victor Sapena, Arnau Domenech, Stephan Weidinger. Impact of lebrikizumab in combination with topical corticosteroids in the psychological wellbeing of patients with moderate-to-severe atopic dermatitis: a randomized phase 3 clinical study (ADvantage)

⁷ Vyas J, et al. Br J Dermatol. 2024;191(Supplement_1):i36.

⁸ Gordon KB, et al. Br J Dermatol. 2014;170(3):705-715.

⁹ Ewelina Wajs, Ismail Kasujee, Volker Koscielny, Arnau Domenech. Beyond Skin Deep: A Decade of Patient Voices Through Novel Patient-Reported Outcomes in Dermatology

¹⁰ Arnau Domenech, Ismail Kasujee, Volker Koscielny, Anthony Bewley. Patient-Centered Outcomes in Dermatology: A Paradigm Shift in Measuring Disease Impact.