A Paradigm Shift in Psoriasis Care: Almirall's POSITIVE Study and the Focus on Patient Well-Being

Dermatology, a field long dominated by the evaluation of objective clinical markers like skin clearance, is undergoing a significant paradigm shift toward a more holistic approach to patient care. This evolution emphasizes the importance of a patient's overall well-being and quality of life, moving beyond traditional measurements to encompass the full scope of a disease's impact on an individual. A recent study from Almirall, the POSITIVE study, exemplifies this new direction by using the WHO-5 Well-Being Index as a primary endpoint. The findings, presented at the 34th Congress of the European Academy of Dermatology and Venereology (EADV) 2025, highlight the sustained benefits of tildrakizumab in treating moderate to severe psoriasis, demonstrating not only skin clearance but also a marked improvement in psychological well-being.¹

Methods and Materials

The POSITIVE study was conceived 3 years prior by a group of leading European experts in psoriasis. The driving question behind the study was whether advanced biologic therapies could not only improve skin symptoms, but also truly "give patients their lives back." In an EADV interview with Dermatology Times, the CMO of Almirall, Volker Koscielny, MD, MBA, explained, "Current therapies are improving the quality of life, but can we give patients a normal life? That was a radical question that we wanted to ask." While previous studies focused on traditional measures like the Psoriasis Area and Severity Index (PASI), the POSITIVE study sought to be more ambitious.

To achieve this, the study was designed as the first real-world evidence (RWE) study in dermatology to use the WHO-5 Well-Being Index as a primary endpoint. This index is a self-report instrument that measures subjective psychological well-being, assessing a patient's positive mood, vitality, and general interest in life. Koscielny noted that this concept of holistic care had never been put as a primary endpoint in any previous dermatology study. By complementing traditional endpoints like PASI and the Physician's Global Assessment (PGA), as well as the Dermatology Life Quality Index (DLQI), the POSITIVE study aimed to provide a more comprehensive, holistic view of treatment success. The study's focus aligns with the World Health Organization's (WHO) health definition and recent resolution on skin diseases, underscoring the broader public health importance of these conditions.²

Core Discoveries and Impact

The long-term results of the POSITIVE study showed that treatment with tildrakizumab led to sustained improvements in multiple areas over a 2-year period. Patients with moderate to severe psoriasis experienced significant and sustained improvements in skin clearance and psychological well-being. The initial data from the study revealed that "the well being of patients with psoriasis is far below the general populations, in fact, comparable to patients suffering from breast cancer or diabetes,” Koscielny stated. The CMO added, "I think that gives you a good perspective on the suffering and the burden that patients with psoriasis carry.” Furthermore, the study also revealed an improved quality of life for the patients' partners, highlighting the systemic impact of the disease on both the individual and their social network. As Koscielny stated, "The impact of these diseases is not limited to the patient. It affects the whole ecosystem of the patient. And that's profound.”

This research marks a significant step forward in the management of psoriasis. During his interview, Koscielny emphasized that advanced therapies have traditionally focused on achieving clinical success from a physician's perspective, but the POSITIVE study provides evidence that these treatments can deliver on a patient-centric, holistic concept of care. The findings suggest that by focusing on well-being, clinicians can be more ambitious in their treatment goals and truly impact a patient's life beyond just skin symptoms.

Broader Dermatological Research and Future Outlook

Almirall's commitment to advancing patient-centered dermatology extends beyond the POSITIVE study. At the EADV 2025 congress, the company presented a total of 44 abstracts covering a range of key dermatological conditions. These included new research in atopic dermatitis, actinic keratosis, and hidradenitis suppurativa. Koscielny noted that the fear of relapse is a significant concern for all of these patient groups, which can deter a lot of people from treatment. He added that the goal is to give patients a "peace of mind" that their disease can be controlled, contributing to their overall well-being.

The collective body of work presented by Almirall at EADV 2025 underscores a growing trend in dermatology to move past a symptom-only approach. By validating patient-reported outcomes like the WHO-5 Well-Being Index as a primary measure, the POSITIVE study serves as a blueprint for future clinical trials and real-world research. This shift in focus is not just a scientific advancement but a fundamental change in philosophy, aiming to provide care that is not only effective but also truly restores a normal, high quality of life for patients with chronic dermatological conditions. The use of holistic measures marks a new era in which clinical success is truly defined by the patient's experience.

References

1. 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. Press release. Almirall. Published September 18, 2025. Accessed September 18, 2025. https://www.businesswire.com/news/home/20250917565524/en/Almirall-Presents-LongTerm-Results-from-First-RealWorld-Dermatology-Study-Using-WHO5-WellBeing-Index-as-Primary-Endpoint-in-the-treatment-of-Psoriasis-at-EADV-2025
2. Skin diseases as a global public health priority. News release. WHO. Published May 27, 2025. Accessed September 17, 2025. https://apps.who.int/gb/ebwha/pdf_files/WHA78/A78_R15-en.pdf