In these preliminary results from the ongoing POSITIVE study, tildrakizumab was shown to have led to significant improvement for patients who have psoriasis.
A version of this article was originally published on HCPLive. This version has been lightly edited.
Tildrakizumab substantially improves the symptoms and quality of life of patients with moderate to severe plaque psoriasis, according to late-breaking data presented at the 25th World Congress of Dermatology.1
In these findings announced by global biopharmaceutical company Almirall, it was noted that skin symptoms and life quality showed improvement in individuals with psoriasis following 28 weeks of treatment in a real-world setting.
Almirall first entered into a licensing agreement with tildrakizumab manufacturer Sun Pharma in 2016 to develop and commercialize tildrakizumab for use in Europe.2
These preliminary results from the POSITIVE study also demonstrate that tildrakizumab has a safety profile consistent with several randomized phase 3 clinical trials, and patient well-being level at baseline was comparable with levels seen in other diseases such as breast cancer.3,4
"We are thrilled with the promising results of the POSITIVE study, as they underline the importance of incorporating well-being into clinical trials,” said Frida Dunger Johnsson, executive director of the International Federation of Psoriasis Associations, in a statement.1 “Having a holistic and patient-centered approach allows for more data on the impact of treatments on people living with psoriatic disease and therefore improves health and quality of life.”
The POSITIVE study is an ongoing clinical trial that focuses on patients' overall well-being as the primary outcome. This is accomplished by utilizing the 5-item World Health Organization Well-Being Index, a widely-accepted questionnaire that measures subjective psychological well-being related to health in various chronic illnesses.5
The trial is a real-world evidence, noninterventional, prospective study, observing around 780 adult patients with moderate to severe psoriasis across multiple European sites, including Austria, France, Belgium, Germany, Spain, Italy, Switzerland, The Netherlands, and the United Kingdom. It is taking a comprehensive approach by using secondary end points, such as the FamilyPso questionnaire, to assess the impact of the disease on the family environment, and the Physician's Satisfaction Score, to gauge physician well-being. A comprehensive and patient-centered approach to evaluations of well-being is seen as valuable and has not been developed in a rigorous prospective study prior to POSITIVE.
The study’s findings could have the potential to expand the current repertoire of psoriasis evaluation techniques, allowing dermatologists to be able to use novel tools to enhance patient-clinician relationships and promote better outcomes for patients.
The treatment itelf is a type of humanized monoclonal antibody designed to specifically target the p19 subunit of interleukin-23. In doing so, tildrakizumab effectively blocks the release of proinflammatory cytokines and chemokines, while minimizing its effects on the overall immune system.
The medication is recommended for adults who have moderate to severe plaque psoriasis who are also eligible for systemic treatment.
1. Almirall: Ilumetri (tildrakizumab) significantly improved the wellbeing of patients with moderate-to-severe plaque psoriasis. News release. Business Wire. July 7, 2023. Accessed July 7, 2023. https://www.businesswire.com/news/home/20230707896992/en/Almirall-Ilumetri%C2%AE-tildrakizumab-significantly-improved-the-wellbeing-of-patients-with-moderate-to-severe-plaque-psoriasis
2. Almirall and Sun Pharma enter into a license agreement for tildrakizumab in Europe for psoriasis. News release. PR Newswire. July 27, 2016. Accessed July 13, 2023. https://www.prnewswire.com/news-releases/almirall-and-sun-pharma-enter-into-a-license-agreement-for-tildrakizumab-in-europe-for-psoriasis-300304946.html
3. Thaci D, Piaserico S, Warren RB, et al. Five-year efficacy and safety of tildrakizumab in patients with moderate-to-severe psoriasis who respond at week 28: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2). Br J Dermatol. 2021;185(2):323-334. doi:10.1111/bjd.19866
4. Drerup KA, Seemann C, Gerdes S, Mrowietz U. Effective and safe treatment of psoriatic disease with the anti-IL-23p19 biologic tildrakizumab: results of a real-world prospective cohort study in nonselected patients. Dermatology. 2022;238(4):615-619. doi:10.1159/000519924
5. Who Five Well Being Index (WHO-5). Medscape. Accessed July 13, 2023. https://reference.medscape.com/calculator/535/who-five-well-being-index-who-5