Almirall: Tildrakizumab is the first and only IL-23p19 inhibitor to demonstrate meaningful sleep improvement in people living with psoriasis

• The phase IV study TRIBUTE demonstrated that tildrakizumab is the first and only IL-23p19 inhibitor to improve sleep impairment in psoriasis patients after 24 weeks of treatment in conditions close to clinical practice^[i]
• Patients also reported significant improvement in burdensome symptoms of psoriasis such as itching, pain, and scaling with 7 out of 10 patients reporting no health-related impairment on quality of life^1,[ii]
• In line with previous Real World Evidence studies, TRIBUTE showed that tildrakizumab was highly effective with a favourable safety profile²
• Along with TRIBUTE, another eleven tildrakizumab posters were presented at the 31^st Congress of the European Association of Dermatology and Venereology

Barcelona, Spain, September 14, 2022 – Almirall S.A. (BME: ALM), a global biopharmaceutical company focused on skin health, announced at the 31^st 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[xi]. 

“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[xii] with similar results in both bio-experienced and bio-naïve patients[xiii].

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).[xiv]

About TRIBUTE

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

About Almirall

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.

[i] Costanzo et al Tildrakizumab improves symptoms of pruritus, pain, and scaling in patients with moderate-to-severe chronic plaque psoriasis in conditions close to real clinical practice. Presented at 31st European Academy of Dermatology and Venereology (EADV) Sept 7-10 ,2022, Online and Milan, Italy P1470

[ii] Costanzo et al. Tildrakizumab demonstrates high efficacy and a favourable safety profile in conditions close to realclinical practice in patients with moderate to severe chronic pl aque psoriasis. Presented at 31st European Academy of Dermatology and Venereology (EADV) Sept 7-10 ,2022, Online and Milan, Italy P1466

[iii] Costanzo et al. Tildrakizumab improves quality of life, treatment satisfaction and patient benefits in patients with moderate-to-severe chronic plaque psoriasis in conditions close to real clinical practice. Presented at 31st European Academy of Dermatology and Venereology (EADV) Sept 7-10 ,2022, Online and Milan, Italy P1471

^[iv] Global Psoriasis Atlas. Psoriasis statistics: Prevalence. Accessed March, 2021. https://www.globalpsoriasisatlas.org/en/statistics

[v] Pariser D et al. J Dermatolog Treat. 2016;27:19-26.

[vi] Meneguin S, et al. BMC Dermatol. 2020;20(22):1-6.

[vii] Armstrong A et al. Adv in therapy. 2022;39:2657-2667.

[viii] World Psoriasis Happiness Report 2018. psoriasishappiness.report (accessed July 2022).

[ix] Armstrong A et al. Adv in therapy. 2022;39:2657-2667.

[x] Armstrong AW et al. PLOS One. 2012;7(12): e52935

[xi] Van Eel et al. JEADV. 2022;36(1):403–12.

[xii] Tsianakas A et al. Real world effectiveness and safety of tildrakizumab in long term treatment of moderate to severe plaque psoriasis: results from the non interventional, prospective, mul ticenter study tilot at 52 weeks. Presented at 31st European Academy of Dermatology and Venereology (EADV) Sept 7-10 ,2022, Online and Milan, Italy P1501

[xiii] Tsianakas A. Tildrakizumab in bio-experienced and bio-naïve patients: significant and sustained effectiveness, high therapy satisfaction, and favourable safety profile in a real-life setting. Presented at 31st European Academy of Dermatology and Venereology (EADV) Sept 7-10 ,2022, Online and Milan, Italy P1493

[xiv] Thaci et al. Maintenance of the response to tildrakizumab regardless of baseline characteristics over 5 years: pooled analyses from reSURFACE 1 and reSURFACE 2 phase 3 trials in patients with moderate-to-severe psoriasis. Presented at 31st European Academy of Dermatology and Venereology (EADV) Sept 7-10 ,2022, Online and Milan, Italy P1464