- Almirall presented the interim Week 52 results of the
POSITIVE clinical study at the IFPA Conference 2024, showing the
benefits of the effective treatment with Ilumetri (tildrakizumab)
in patients with moderate to severe psoriasis achieving improvement
of physical symptoms and overall wellbeing.
- This first-of-its-kind study underscores the psychosocial
burden of psoriasis and its deep impact on people' wellbeing. It
also demonstrates how treatment with tildrakizumab can improve
high-burden symptoms and sensitive areas, enhance daily activities,
and benefit patients' lives beyond the disease.
- Psoriasis is a highly prevalent skin disease that affects
around 60 million people worldwide2. Nearly 77% of patients state
that psoriasis negatively impacts their normal daily activities
(personal, social, and work life)3 and overall
wellbeing4
Almirall, a global pharmaceutical company dedicated to medical
dermatology, announced today 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 worldwide2 and 3% of the population in
Europe,5.Nearly 77% of patients believe that psoriasis
negatively affects their normal daily activities (personal, social,
and work life)3 and wellbeing.4
“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,” stated Prof. Dr.
Ulrich Mrowietz, from the Psoriasis Center at the University
Medical Center Schleswig-Holstein, Campus Kiel.
“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,” stated Dr. Volker Koscielny, Chief
Medical Officer at Almirall.
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.
*PASI: Psoriasis Area and Severity Index.
About the POSITIVE Study
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, the
FamilyPso 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.
About Ilumetri (tildrakizumab)6
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.
About psoriasis
Psoriasis is a common, non-contagious, chronic skin disease,
with no clear cause or cure. The negative impact of psoriasis on
people’s lives can be immense as it affects the appearance of the
skin with red, scaly plaques. Psoriasis affects people of all ages,
and in all countries. The reported prevalence of psoriasis in
Europe varies from 0.6% to 6.5% with an average of approximately 3%
of the population,7 making psoriasis a serious global problem with
about 60 million individuals affected worldwide2. The flares of
psoriasis can be unpredictable and significant comorbidities are
common, including arthritis, cardiovascular diseases, metabolic
syndrome, inflammatory bowel disease and depression.
About Almirall
Almirall is a global pharmaceutical company dedicated to medical
dermatology. We closely collaborate with leading scientists,
healthcare professionals, and patients to deliver our purpose: to
transform the patients' world by helping them realize their hopes
and dreams for a healthy life. We are at the forefront of science
to deliver ground-breaking, differentiated medical dermatology
innovations that address patients´ needs.
Almirall, founded in 1944 and headquartered in Barcelona, is
publicly traded on the Spanish Stock Exchange (ticker: ALM, total
revenue in 2023: €898.8 MM, 1900 employees globally). Almirall
products help to improve the lives of patients every day and are
available in over 100 countries.
For more information, please visit
https://www.almirall.com/
Legal notice:
This document includes only summary information and is not
intended to be exhaustive. The facts, figures, and opinions
contained in this document, in addition to the historical ones, are
"forward-looking statements." These statements are based on the
information currently available and the best estimates and
assumptions that the Company considers reasonable. These statements
involve risks and uncertainties beyond the control of the Company.
Therefore, actual results may differ materially from those declared
by such forward-looking statements. The Company expressly waives
any obligation to revise or update any forward-looking statements,
goals, or estimates contained in this document to reflect any
changes in the assumptions, events, or circumstances on which such
forward-looking statements are based, unless required by the
applicable law.
1 Rachel Sommer, Patient-reported well-being using tildrakizumab
in a real-world setting: 52-week interim data of the phase IV
POSITIVE study 2 Parisi R, Iskandar IYK, Kontopantelis E, et al.
BMJ. 2020; 369 :m1590 doi:10.1136/bmj.m1590. 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.
5 Chandran V and Raychaudhuri SP. J. Autoimmune. 2010; 34:
J314-J21. 6 Ilumetri® (tildrakizumab) Summary of Product
Characteristics. Date of prep: October 2021 UK-IL-2100111.
7Chandran V and Raychaudhuri SP. Geoepidemiology and environmental
factors of psoriasis and psoriatic arthritis. J. Autoimmune. 2010
May; 34(3):J314-J21. doi: 10.1016/j.jaut.2009.12.001. Epub 2009 Dec
24. PMID: 20034760.
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