Barcelon, a global biopharmaceutical company focused on skin health, announced at the 31st EADV (European Association of Dermatology and Venereology) Congress the results from TRIBUTE, an interventional phase IV clinical study, which resembled real-life clinical practice. In this study, Ilumetri®▼ (tildrakizumab) is the first IL-23p19 inhibitor to demonstrate improvement on sleep impairment in patients with moderate-to-severe chronic plaque psoriasis. At week 24, the MOS-Sleep (Medical Outcomes Study-Sleep) index II showed a statistically significant and clinically relevant benefit, with a score close to population norm.1
Moreover, after 24 weeks of treatment with tildrakizumab, 76,5% and 84,9% of patients reported mild itch and pain, respectively. Significant improvement in scaling was also demonstrated in the TRIBUTE study. These benefits on burdensome symptoms were accompanied by high levels of treatment satisfaction, and 70,4% of patients had no impairment on health-related quality of life.1,2,[iii]
TRIBUTE once again confirms the effectiveness of tildrakizumab with two thirds of patients achieving a psoriasis area and severity score of less than 1 after 24 weeks.1,2,3
Finally, tildrakizumab demonstrated a favourable safety profile similar to that seen in phase III trials.1,2,3
Approximately 60 million people live with psoriasis worldwide.[iv] This skin condition disrupts every aspect of patients’ daily lives: from sleep, clothing choices, and exercise, to work and social life[v],[vi],[vii],[viii], preventing them from the possibility of leading a normal daily life.[ix] Although 88% of the patients affirm that the condition affects their overall emotional wellbeing[x], the impact of psoriasis on physical, social, and psychological wellbeing is often underestimated].
“At Almirall, we go beyond studying and treating the physical symptoms of psoriasis. We strive to gain an individual understanding of the obstacles faced by a person living with psoriasis and the impact it has on their daily lives. Studies close to clinical practice, such as TRIBUTE, and other real-world evidence research presented at the EADV Congress, help us understand and measure how tildrakizumab delivers benefits to a wide range of patients” states Volker Koscielny, Chief Medical Officer of Almirall.
Almirall presented 12 tildrakizumab posters at the 31st EADV Congress. In addition to TRIBUTE, the company showcased long-term data from the large, non-interventional, prospective TILOT study. Tildrakizumab demonstrated significant and sustained efficacy, high treatment satisfaction and a favourable safety profile in a real-world setting with similar results in both bio-experienced and bio-naïve patients
Pooled analyses from the Phase 3 trials reSURFACE 1 and reSURFACE 2 over 5 years, also presented in the congress, indicate that tildrakizumab provides long-term disease control across a wide range of patient characteristics (e.g. previous biological therapy, type 2 diabetes and psychiatric disorders).
TRIBUTE (NCT04229836) is an international, multicentre, open-label, interventional phase IV clinical study in patients with moderate-to-severe chronic plaque psoriasis. A total of 177 patients were included in both the safety and efficacy analyses. The objective was to assess the efficacy, safety, and impact on HRQoL (using the DLQI and the new proposed score, DLQI-R*) in a phase IV study in close to similar conditions to clinical practice.
*HRQoL: Health Related Quality of Life; DLQI: Dermatology Life Quality Index; DLQI-R: Dermatology Life Quality Index-Relevant
Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient’s needs through science to improve their lives. Our Noble Purpose is at the core of our work: “Transform the patients’ world by helping them realize their hopes and dreams for a healthy life.” We invest in differentiated and ground-breaking medical dermatology products to bring our innovative solutions to patients in need.
The company, founded in 1943 and headquartered in Barcelona, is publicly traded on the Spanish Stock Exchange (ticker: ALM). Throughout its 79-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, with about 1,800 employees. Total revenues in 2021 were 836.5 million euros.