Study first to evaluate well-being as primary endpoint in patients with psoriasis

Key takeaways:

• Almirall calls its POSITIVE study the first dermatological clinical trial to assess patients’ well-being as a primary endpoint.
• The study uses the WHO-5 Well-being Index comprised of five items.

Almirall announced the publication of the first dermatological clinical study protocol to assess patient well-being as a primary endpoint in the treatment of moderate to severe plaque psoriasis, according to a company press release.

Almirall’s ongoing non-interventional, prospective, observational, real-world evidence POSITIVE study evaluates the overall well-being of patients who are being treated with tildrakizumab, an anti-interleukin-23p19 biologic indicated for moderate to severe plaque psoriasis.

The publication of this study protocol marks the first real-world, prospective trial to take a holistic and person-centered approach when treating a large number of patients with psoriasis, according to the press release.

“The publication of the POSITIVE study reinforces Almirall's dedication to assessing the impact of skin diseases on well-being and demonstrates our commitment to the World Health Organization’s claim for people-centered health care and patient engagement,” Volker Koscielny, Almirall’s chief medical officer, said in the release.

The POSITIVE study uses the WHO-5 Well-being Index, a questionnaire comprised of 5 items that assesses the psychological well-being of patients undergoing treatment. While it has been used in many other specialties, this is the first time the WHO-5 is being used in a dermatology setting, according to the press release.

For 24 months, the study will follow 780 adults across Europe taking tildrakizumab for moderate to severe psoriasis. Additionally, researchers will be tracking key secondary endpoints including the impact on the family environment and the physician’s well-being.

“With the publication of the design of this study, we are taking a step further towards understanding the needs of our patients,” Koscielny said.

According to the release, the first 28-week data pull will be presented at scientific meetings at the end of 2023.