During the 31st EADV (European Association of Dermatology and Venereology) Congress, Almirall S.A shared  the results from TRIBUTE, an interventional phase IV clinical study that 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.

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.

The TRIBUTE study confirms the effectiveness of tildrakizumab with two thirds of patients achieving a psoriasis area and severity score of less than 1 after 24 weeks. And tildrakizumab demonstrated a favorable safety profile similar to that seen in Phase 3 trials.

Approximately 60 million people live with psoriasis worldwide.This skin condition disrupts every aspect of patients’ daily lives: from sleep, clothing choices, and exercise, to work and social life, preventing them from the possibility of leading a normal daily life. Although 88% of the patients affirm that the condition affects their overall emotional wellbeing, 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” says Volker Koscielny, Chief Medical Officer of Almirall, in a news release.

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).