New 52-Week Data Highlights Benefits of Tildrakizumab for Psoriasis

Ulrich Mrowietz

Credit: International Psoriasis Council

Tildrakizumab (Ilumetri) substantially improved the wellbeing of adult individuals with moderate-to-severe plaque psoriasis, according to recent findings, restoring levels comparable to those of the general population as early as 16 weeks following treatment initiation.¹

These new findings, released by pharmaceutical firm Almirall, resulted from the POSITIVE real-world evidence clinical study, which also indicated that the aforementioned improvements were sustained for up to a year. The interim results covering both patient-reported outcomes and clearance of skin were first presented at the International Federation of Psoriasis Associations (IFPA) Conference 2024 in Stockholm, Sweden.

“The impact of psoriasis on patients’ wellbeing cannot be overstated. It affects their overall health, psychological state, and social life,” Ulrich Mrowietz, MD, of the Psoriasis Center at the University Medical Center Schleswig-Holstein, said in a statement. “...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.”

Some of the major improvements observed in study participants’ skin were in sensitive regions such as nails, scalp, and palms/soles. The investigators also noted that higher-burden symptoms such as pain, itch, pain in joints, and fatigue, saw improvements.

The announcement by Almirall acknowledged the widespread nature of psoriasis as a chronic disease, impacting about 60 million people globally and significantly affecting patients’ wellbeing. The condition affects patients of all ages. Prior research into the drug’s efficacy among psoriasis patients has been highlighted by HCPLive.²

The drug assessed in POSITIVE, known as tildrakizumab, is a humanized monoclonal antibody which is designed to target the p19 subunit of interleukin-23 (IL-23). The drug inhibits proinflammatory cytokine release as well as chemokines, and was formulated to limit impact on the rest of patients’ immune systems.¹

POSITIVE is a non-interventional, observational, prospective, real-world study which involved the recruitment of 782 adult participants with moderate-to-severe cases of psoriasis. These patients were identified at multiple sites throughout Europe—Austria, France, Belgium, Italy, Spain, Germany, Switzerland, The Netherlands, and the UK—and the trial’s investigators followed the participants for 24 months.

The research team utilizes the 5 item World Health Organization Wellbeing Index (WHO-5), a questionnaire which is widely applied and used to evaluate health-related subjective psychological wellbeing among patients facing a variety of chronic conditions. The study is also set to implement the FamilyPso questionnaire to assess the disease’s impact on the family environments as well as the Physician’s Satisfaction Score.

Thus far in the study, around 60% of subjects were able to achieve a Psoriasis Area and Severity Index (PASI) ≤1 response, and the investigators noted zero new safety concerns. These conclusions align with prior research.

A significant element of their research is that POSITIVE is the first trial in dermatology to implement patients' wellbeing as a main endpoint utilizing the WHO-5 approach. The team emphasized the value of understanding psoriasis’s psychosocial burden beyond just the physical manifestations, given the high burden of symptoms and their effect on patients' overall quality of life.

“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 chief medical officer at Almirall, Volker Koscielny, said in a statement. “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. ^{Almirall’s Ilumetri® (tildrakizumab) Restores and Maintains Wellbeing of Patients With Moderate-to-severe Plaque Psoriasis to the Levels of the General Population for up to 1 Year. Almirall. June 28, 2024. https://www.businesswire.com/news/home/20240628033294/en/Almirall%E2%80%99s-Ilumetri%C2%AE-tildrakizumab-Restores-and-Maintains-Wellbeing-of-Patients-With-Moderate-to-severe-Plaque-Psoriasis-to-the-Levels-of-the-General-Population-for-up-to-1-Year1. Date accessed: June 28, 2024.}
2. ^{Smith T. Tildrakizumab Improved Quality of Life, Skin Symptoms in Plaque Psoriasis Patients. HCPLive. July 7, 2023. https://www.hcplive.com/view/tildrakizumab-improved-quality-life-skin-symptoms-plaque-psoriasis-patients. Date accessed: June 28, 2024.}