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Positive news for patients with moderate-to-severe plaque psoriasis

New data from an Almirall clinical study has given positive news for patients with moderate-to-severe plaque psoriasis.

The study, called POSITIVE, demonstrated 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 16 weeks after initiating the treatment. In the study, this fundamental benefit was shown to be maintained for up to one-year of treatment.
The interim results evaluated the impact of tildrakizumab on patient-reported outcomes and skin clearance in people with moderate-to-severe psoriasis, and were presented for the first time at the International Federation of Psoriasis Associations (IFPA) Conference 2024.

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 Psoriasis Area and Severity Index (PASI) ≤1 response, with no new safety signals observed, consistent with previous studies.

This is the first study in dermatology to assess patients’ wellbeing as a primary endpoint using the ‘WHO-5 approach’. The 5-item World Health Organisation 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 worldwide1 and 3% of the population in Europe2. Nearly 77% of patients believe that psoriasis negatively affects their normal daily activities (personal, social, and work life)3 and wellbeing4.

Prof. Dr. Ulrich Mrowietz, from the Psoriasis Center at the University Medical Center Schleswig-Holstein, Campus Kiel said: “The impact of psoriasis on patients’ wellbeing cannot be overstated. It affects their overall health, psychological state, and social life. The interim results from the POSITIVE study are promising, they demonstrate that treatment with tildrakizumab restores patients’ well-being within 16 weeks and maintains it for at least one year. Additionally, significant improvements are observed in skin condition, high-burden symptoms, and sensitive areas. This underscores tildrakizumab’s potential to alleviate the profound burden of psoriasis on daily life.”

Dr. Volker Koscielny, Chief Medical Officer at Almirall said: “These findings represent a significant milestone in our ongoing efforts to address the needs of patients and dermatologists to treat chronic dermatological conditions and help improve the patients’ health and wellbeing. The POSITIVE study demonstrates not only the efficacy of Ilumetri® in clearing skin but also its impact on enhancing patients’ overall wellbeing, which ultimately can contribute to the successful treatment enabling patients to get their lives back.”

References:

1 Parisi R, Iskandar IYK, Kontopantelis E, et al. BMJ. 2020; 369 :m1590 doi:10.1136/bmj.m1590.

2 Chandran V and Raychaudhuri SP. J. Autoimmune. 2010; 34: J314-J21.

3 Villacorta R, Teeple A, Lee S, et al. Br J Dermatol. 2020;183:548–58. doi:10.1111/bjd.18798.

4 Dubertret L, Mrowietz U, Ranki A, et al. Br J Dermatol. 2006;155:729–36. doi:10.1111/j.1365-2133.2006.07405

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Joanna Harvey
Joanna Harvey
Marketing and Communication Executive | Uniphar Commercial

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