Almirall Is First to Apply WHO-5 Well-Being Index in Dermatological Clinical Trial Endpoints

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Almirall will be implementing a new approach to dermatological research, according to their presentations and posters 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 31.¹ The recent data, which included mild-to-moderate scalp psoriasis, moderate-to-severe psoriasis, and moderate-to-severe atopic dermatitis (AD), focused on the psychological burden of each condition and how effective treatment can positively impact patient well-being.

The World Health Organization’s WHO-5 Well-being Index (WHO-5) was introduced in 1998, and this is the first time it will be used as a primary endpoint in medical dermatology clinical trials. With this initiative, Almirall will focus on integrating patient-reported outcomes into research, thus aiding care.

Real-world analyses from the POSITIVE Study showed that most patients with moderate-to-severe psoriasis experienced improvements in both skin symptoms and psychological well-being after being treated for 16 weeks. However, in about 10% of the patients, there was a delay in psychological improvement when compared to the improvement on the skin. Some patients still had persistent psychological distress even when skin clearance was reached.

Data from the PRO-SCALP study demonstrated the negative impact scalp psoriasis has on itch, sleep, and psychosocial symptoms like quality of life and emotional well-being. These improved after 8 weeks of treatment with calcipotriene and betamethasone dipropionate cream with PAD technology

ADvantage, the phase 3b, randomized, placebo-controlled study, also implemented the WHO-5 endpoint in patients with moderate-to-severe AD. After lebrikizumab and topical corticosteroid treatment, psychological well-being improved greatly from baseline to week 16. These results were sustained through week 52, and levels of AD patient well-being were comparable to the general population.

“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,” Volker Koscielny, MD, MBA, Almirall’s Chief Medical Officer, said in a press release.¹

At the 2025 American Academy of Dermatology (AAD) Annual Meeting, Almirall presented clinical data via 5 abstracts on other therapies, such as tirbanibulin for actinic keratosis and LAD191, a novel monoclonal antibody targeting IL-1RAP, for immune-modulated skin conditions such as hidradenitis suppurativa.² With this recent research, Almirall is spotlighting a “paradigm shift” in dermatology. Combining clinician-reported disease severity scores with patient-centered outcomes will better represent the impact of these conditions on patients, their families, and clinicians and help to create more personalized care strategies, according to the company.

References

1. Almirall leads a paradigm shift to holistic patient care in dermatology, applying the WHO-5 well-being index as primary endpoint in clinical trials. News Release. Almirall. Published June 4, 2025. Accessed June 9, 2025. https://www.almirall.com/newsroom/news/almirall-leads-a-paradigm-shift-to-holistic-patient-care-in-dermatology-applying-the-who-5-well-being-index-as-primary-endpoint-in-clinical-trials

2. AAD 2025: Almirall presents early-stage pipeline progress and real-world evidence on demonstrating AK treatment success and patient satisfaction with tirbanibulin. News Release. Business Wire. Published March 7, 2025. Accessed June 9, 2025. https://www.businesswire.com/news/home/20250307364570/en/AAD-2025-Almirall-presents-early-stage-pipeline-progress-and-real-world-evidence-on-demonstrating-AK-treatment-success-and-patient-satisfaction-with-Tirbanibulin