Almirall has announced that their Phase 3 POSITIVE study showed that tildrakizumab (Ilumetri®) significantly improved the wellbeing of patients with moderate-to-severe plaque psoriasis.
The study sought to examine the real-world impact of tildrakizumab treatment of more severe cases of plaque psoriasis in adult patients, looking at the long-term benefits on both patient and physician satisfaction. It is the first clinical study in dermatology to utilize the 5-item World Health Organization (WHO) WHO-5 Wellbeing Index as a primary tool to assess patient wellbeing.
The study also measured secondary endpoints using the Physician’s Satisfaction Questionnaire, FamilyPso questionnaire to evaluate the impact of the disease on the family environment, as well as DLQI-R (skin-generic quality of life), TSQM-9 (treatment satisfaction), PBI-S-10 (treatment-related benefits), WPAI: PSO (work impairment), HRQoL (health-related quality of life), and absolute PASI score.
The study consisted of a retrospective data collection period followed by a 24-month prospective data collection period. This included follow-up visits at weeks 16 and 28, as well as at 12, 18, and 24 months post-treatment.
An initial evaluation of the data shows that tildrakizumab has led to significant improvements in patients’ wellbeing and quality of life as high rates of patient satisfaction were reported.
Additionally, no new safety signals were reported in the study and participants were able to achieve a similar wellbeing status as that of the general population (those without psoriasis) in as few as 16 weeks of treatment.
"We are thrilled with the promising results of the POSITIVE study, as they underline the importance of incorporating wellbeing into clinical trials. Having a holistic and patient-centered approach allows for more data on the impact of treatments on people living with psoriatic disease and therefore improves health and quality of life."
"At Almirall, we have long strived to improve patient quality of life by taking a holistic approach to skin diseases that captures the full impact of these conditions. The POSITIVE study marks a ground-breaking milestone in dermatology research and its preliminary findings reveal a notable enhancement in the wellbeing of individuals with psoriasis who were treated with tildrakizumab. These initial results reinforce our conviction that we are on the right track in fulfilling our commitment to offer healthcare professionals and patients innovative solutions that effectively address their unmet needs."
- https://www.businesswire.com/news/home/20230707896992/en/Almirall-Ilumetri%C2%AE-tildrakizumab-significantly-improved-the-wellbeing-of-patients-with-moderate-to-severe-plaque-psoriasis
- https://www.dermatologytimes.com/view/tildrakizumab-data-reveals-significant-wellbeing-improvement-in-patients-with-plaque-psoriasis
