Company Introduces WHO-5 as Primary Endpoint in Clinical Trials
ISTANBUL – Almirall announced a transformative approach to dermatological research at the 21st Congress of the European Society for Dermatology and Psychiatry, emphasizing psychological well-being as a key treatment outcome across multiple skin conditions.
Innovative Assessment Methodology
The pharmaceutical company will implement the WHO-5 Well-being Index as a primary endpoint in clinical trials – the first such application in medical dermatology. This patient-reported outcome measure, developed by the World Health Organization in 1998, will help quantify treatment impacts beyond physical symptoms.
“We’re committed to advancing dermatology by focusing on patients’ real-life needs,” said Dr. Volker Koscielny, Almirall’s Chief Medical Officer. “Integrating psychological wellbeing can meaningfully enhance quality of life.”
Key Research Findings
Almirall presented data demonstrating the mind-skin connection across three conditions:
Moderate-to-Severe Psoriasis (POSITIVE Study)
- Most patients showed skin and psychological improvement after 16 weeks
- 10% experienced delayed psychological recovery despite skin clearance
- Some maintained psychological distress even with resolved symptoms
Scalp Psoriasis (PRO-SCALP Study)
- Significant negative impact on itch, sleep and emotional well-being
- 8 weeks of calcipotriene/betamethasone dipropionate cream improved outcomes
Moderate-to-Severe Atopic Dermatitis (ADvantage Study)
- Lebrikizumab plus topical corticosteroids improved WHO-5 scores by week 16
- Benefits sustained through week 52
- Final well-being levels matched general population norms
Expanding Therapeutic Pipeline
At the 2025 AAD Annual Meeting, Almirall presented additional research on:
- Tirbanibulin for actinic keratosis
- LAD191 (anti-IL-1RAP mAb) for hidradenitis suppurativa
The company positions this holistic approach as a paradigm shift, combining clinician assessments with patient-reported outcomes to develop more personalized care strategies.
Future Directions
Almirall’s initiative marks growing recognition of psychodermatology’s importance, with potential to reshape clinical trial design and treatment evaluation standards industry-wide.
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