Almirall announced new data from the real-world evidence clinical study called ?POSITIVE? demonstrating that Ilumetri® (tildrakizumab) effectively restores the level of wellbeing of patients with moderate-to-severe plaque psoriasis to those of the general population as early as Week 16 after initiating the treatment. In the study, this fundamental benefit was shown to be maintained for up to 1 year of treatment.

These interim results evaluating the impact of tildrakizumab on patient-reported outcomes and skin clearance in people with moderate-to-severe psoriasis were presented for the first time at the International Federation of Psoriasis Associations (IFPA) Conference 2024, held from June 27-29 in Stockholm, Sweden. The POSITIVE study showed that treatment with tildrakizumab led to notable improvements in skin clearance, particularly in sensitive areas (scalp, nail and palms/soles), as well as in high-burden symptoms (itch, pain, joint pain and fatigue). These physical symptoms have a significant impact on patients?

daily lives and wellbeing. The data from this study show that following 52 weeks of treatment, almost 6 out of 10 patients achieved a PASI =1 response, with no new safety signals observed, consistent with previous studies. The POSITIVE study is the first clinical study in dermatology to assess patients?

wellbeing as a primary endpoint using the WHO-5 approach. The 5-item World Health Organization Wellbeing Index is a widely used questionnaire that assesses health-related subjective psychological wellbeing in a variety of chronic diseases. The outcomes of the POSITIVE study highlight ?

from the patient perspective - the importance of understanding the psychosocial burden of psoriasis beyond the physical symptoms of the skin perspective, considering how high-burden symptoms affect patients' overall wellbeing. Psoriasis is a highly prevalent disease, affecting around 60 million people worldwide and 3% of the population in Europe, .Nearly 77% of patients believe that psoriasis negatively affects their normal daily activities (personal, social, and work life) and wellbeing. Almirall and IFPA have been actively collaborating for years to improve the wellbeing of people with psoriasis and to raise awareness of the impact of this disease on their lives.

Last year, Almirall supported IFPA's ?Access for All? campaign on World Psoriasis Day, aiming to ensure that people with psoriasis have affordable access to the right treatment at the right time. In addition, the company highlighted the impact of the disease on the wellbeing of individuals, their families, and friends through the launch of a disease awareness campaign featuring the series called Nina.

The POSITIVE study uses the 5 item World Health Organization Wellbeing Index, WHO-5, a widely used questionnaire that assesses health-related subjective psychological wellbeing in a variety of chronic diseases. Following the holistic approach, the POSITIVE study will also use innovative secondary endpoints, theFamilyPso questionnaire to evaluate the impact of the disease on the family environment, and on Physician wellbeing, using the Physician?s Satisfaction Score. This ongoing non-interventional, prospective, observational, real-world evidence study has enrolled 782 adults with moderate-to-severe psoriasis at multiple sites in Europe, including Austria, Belgium, France, Germany, Italy, Spain, Switzerland, The Netherlands, and the United Kingdom.

The study will follow these patients for 24 months in their treatment with tildrakizumab. Tildrakizumab is a humanized monoclonal antibody that targets the p19 subunit of interleukin-23 (IL-23) and inhibits the release of proinflammatory cytokines and chemokines with limited impact on the rest of the immune system. It is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.