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

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Almirall will be implementing a new approach to dermatological research, according to presentations and posters at the 21st Congress of the European Society for Dermatology and Psychiatry and the inaugural World Psychodermatology Congress held in Istanbul, Turkey, in May 2025.¹ The recent data on 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 end point 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 (NCT04823247) 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 approximately 10% of the patients, there was a delay in psychological improvement when compared with 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 such as quality of life and emotional well-being. These improved after 8 weeks of treatment with calcipotriene and betamethasone dipropionate cream with PAD technology

ADvantage (NCT05149313), a phase 3b, randomized, placebo-controlled study, also implemented the WHO-5 end point 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 well-being in patients with AD 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 health care professionals caring for them. Our contributions to this congress demonstrate how integrating psychological well-being 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 news release.¹

At the 2025 American Academy of Dermatology Annual Meeting in March, 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 noted that it 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. 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. 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