Tildrakizumab substantially improves the symptoms and quality of life of those with moderate-to-severe plaque psoriasis, according to recent late-breaking data from 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.

These preliminary results from the POSITIVE study demonstrated that tildrakizumab was found to have a safety profile that was consistent with several randomized phase 3 clinical trials, and patient wellbeing level at baseline was notably comparable to levels seen in other diseases such as breast cancer.^2,3

"We are thrilled with the promising results of the POSITIVE study, as they underline the importance of incorporating wellbeing into clinical trials,” IFPA Executive Director Frida Dunger Johnsson said in a statement. “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 which focuses on patients' overall wellbeing as the primary outcome. This is accomplished by utilizing the WHO-5, known to be a widely-accepted questionnaire that measures subjective psychological wellbeing related to health in various chronic illnesses.

The trial itself is a real-world evidence, non-interventional and 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 UK.

The WHO-5 questionnaire used in the POSITIVE study measures subjective psychological wellbeing related to health in various chronic illnesses.

The study takes a comprehensive approach by using secondary endpoints 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 wellbeing.

A comprehensive and patient-centered approach to evaluations of wellbeing 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 POSITIVE study marks a ground-breaking milestone in dermatology research and its preliminary findings reveal a notable enhancement in the wellbeing of individuals with psoriasis who were treated with tildrakizumab,” Volker Koscielny, Chief Medical Officer at Almirall, said in a statement.

The treatment itelf is a type of humanized monoclonal antibody designed to specifically target the p19 subunit of interleukin-23 (IL-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 adult individuals with diagnosed moderate-to-severe plaque psoriasis who are also eligible for systemic treatment.

References

1. ^{Business Wire. Almirall: Ilumetri® (tildrakizumab) significantly improved the wellbeing of patients with moderate-to-severe plaque psoriasis. Business Wire. Published July 7, 2023. Accessed July 7, 2023. Available from: 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. ^{Thaci D, Piaserico S, Warren RB, Gupta AK, Cantrell W, Draelos Z, Foley P, Igarashi A, Langley RG, Asahina A, Young M, Falqués M, Pau-Charles I, Mendelsohn AM, Rozzo SJ, Reich K. 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 Aug;185(2):323-334. doi: 10.1111/bjd.19866. Epub 2021 May 4. PMID: 33544883.}
3. ^{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. Epub 2021 Nov 12. PMID: 34775387; PMCID: PMC9393809.}