WCD News: Tildrakizumab Improves Wellbeing of PsO Patients

The wellbeing of patients with moderate to severe plaque psoriasis at baseline is comparable to the level of wellbeing found in people with breast cancer.

Ilumetri (tildrakizumab) significantly improved the wellbeing of patients with moderate-to-severe plaque psoriasis, according to research reported by Almirall, S.A. (ALM) at poster at the 25th World Congress of Dermatology in Singapore.

Patients taking tildrakizumab achieved a wellbeing status similar to the general population after 16 weeks, which was maintained up to week 28.

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. Tildrakizumab, sold under the brand names Ilumya and Ilumetri.

The preliminary analysis also showed that tildrakizumab significantly improved skin symptoms and patients’ health-related quality of life (HRQoL), with high rates of treatment satisfaction in patients with moderate-to-severe plaque psoriasis after 28 weeks in a real-world setting, with no new safety signals and a reassuring safety profile consistent with randomized clinical trials (RCT). The results also demonstrated for the first time that the wellbeing level at baseline of patients with moderate-to-severe plaque psoriasis was comparable to the wellbeing level found in other diseases3 such as breast cancer.

Tildrakizumab also significantly improved skin symptoms and quality of life in patients with moderate to severe plaque psoriasis after 28 weeks in a real-world setting and with a safety profile consistent with randomized phase III clinical trials.

The POSITIVE study is the first clinical study in dermatology to assess patients’ wellbeing as a primary endpoint using the WHO-5. The 5item World Health Organization Wellbeing Index is a widely used questionnaire that assesses health-related subjective psychological wellbeing in a variety of chronic diseases. In addition to evaluating the severity of psoriasis5, there is a need for a holistic, person-centered approach to the assessment of wellbeing that has never before been measured in a robust prospective study. The results of this study could potentially be added to the available psoriasis evaluation methods and provide dermatologists with new tools to improve their patients’ wellbeing by enhancing patient-clinician relationships.

This ongoing non-interventional, prospective, observational, real-world evidence study has enrolled approximately 780 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.

"We are thrilled with the promising results of the POSITIVE study, as they underline the importance of incorporating wellbeing into clinical trials. 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", says Frida Dunger Johnsson, IFPA Executive Director, in a news release. 

"At Almirall, we have long strived to improve patient quality of life by taking a holistic approach to skin diseases that captures the full impact of these conditions. 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. These initial results reinforce our conviction that we are on the right track in fulfilling our commitment to offer healthcare professionals and patients innovative solutions that effectively address their unmet needs”, adds Volker Koscielny, Chief Medical Officer at Almirall.