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This interview highlights both key findings and the significance of the POSITIVE trial for clinicians and for individuals with psoriasis.
In an HCPLive interview, Ulrich Mrowietz, MD, professor of dermatology at the University Medical Center Schleswig-Holstein in Kiel, Germany, spoke about recently published findings resulting from Almirall’s POSITIVE study (NCT06488170), describing the rising importance of patient-reported outcomes in the psoriasis research landscape and within the broader movement toward patient-centered care.1,2
The POSITIVE study, also previously highlighted at the 34th Congress of the European Academy of Dermatology and Venereology 2025 in Paris, was noted by Mrowietz as having been designed as one of the first real-world psoriasis studies to implement the World Health Organization-Five Well-Being Index (WHO-5) as its primary end point rather than traditional physician-assessed disease measures.2
This analysis, according to Almirall, reflects their commitment to developing innovative solutions that address the broader burden of skin disease, rather than only its symptoms.
“POSITIVE…was planned as such to be the first [trial] in the real-world evidence-based space where the primary end point was not a somatic score, like in psoriasis with PASI or the Physician's Global Assessment, but a patient-reported outcome tool,” Mrowietz said.
Despite his acknowledgment of clinical metrics such as the Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index as important, Mrowietz described WHO-5 as capturing a broader concept of well-being among patients, given its encompassing of social, psychological, and personal health elements. Given the instrument’s established normative data from general populations across multiple countries, the POSITIVE team was able to directly compare the well-being of patients with psoriasis with that of the general European population.
Mrowietz described one of the study's most striking findings as the degree of improvement observed following treatment with tildrakizumab. Baseline WHO-5 scores were substantially lower than expected, reaching levels comparable to those reported in patients living with other serious chronic illnesses.
By the 16-week mark, however, average well-being scores had risen to levels comparable to those of those in the general European population and continued to see improvement throughout the 2-year study period. These gains paralleled sustained levels of skin clearance, with the majority of those evaluated showing low absolute PASI scores. Such scores were indicative of minimal disease activity.
Beyond patient well-being assessments, the POSITIVE study also examined the effects of psoriasis on family members using the FamilyPsO questionnaire. In his interview, Mrowietz stated that although partner burden improved over the course of the trial, concerns related to disease recurrence often persisted despite long-term disease control. What this essentially suggests, Mrowietz noted, is that the psychological impact of chronic inflammatory disease may extend beyond the patient and continue after clinical symptoms have been addressed.
Disclosures: Mrowietz has reported serving as an adviser and/or receiving speakers’ honoraria and/or received grants and/or participating in clinical trials of AbbVie, Aditxt, Almirall, Amgen, Aristea, Boehringer-Ingelheim, Bristol Myers Squibb, Celgene, Dr. Reddy’s, Eli Lilly, Foamix, Formycon, Immunic, Janssen, LEO Pharma, Medac, MetrioPharm, Novartis, Phi-Stone, Pierre Fabre, Sanofi-Aventis, and UCB Pharma.
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