Psoriasis​

Medical content

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Tildrakizumab

Tildrakizumab is a humanized monoclonal antibody that targets the p19 subunit of interleukin-23 (IL-23), which is indicated for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.1

Psoriasis Mechanism of Disease

POSITIVE Study

HQ-TIL-2100017

HQ-TIL-2200039

Relevant publications

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)

Thaci, D. 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) [published online ahead of print, 2021 Feb 5]. Br J Dermatol. 2021;10.1111/bjd.19866. doi:10.1111/bjd.19866

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Five-year safety of tildrakizumab in patients with moderate-to-severe psoriasis from two phase 3 trials (reSURFACE 1 and reSURFACE 2): number needed to harm for occurrence of adverse events of special interest

Egeberg, A. et al. Five-year safety of tildrakizumab in patients with moderate-to-severe psoriasis from two phase 3 trials (reSURFACE 1 and reSURFACE 2): number needed to harm for occurrence of adverse events of special interest. The Journal of dermatological treatment, 34(1), 2220447. https://doi.org/10.1080/09546634.2023.2220447

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Real-life effectiveness of tildrakizumab in chronic plaque psoriasis: A 52-week multicentre retrospective study—IL PSO (Italian landscape psoriasis)

Narcisi, A. et al. Real-life effectiveness of tildrakizumab in chronic plaque psoriasis: A 52-week multicentre retrospective study-IL PSO (Italian landscape psoriasis). Journal of the European Academy of Dermatology and Venereology : JEADV, 37(1), 93–103. https://doi.org/10.1111/jdv.18594

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Tildrakizumab improves high burden skin symptoms, impaired sleep and quality of life of moderate-to-severe plaque psoriasis patients in conditions close to clinical practice

Costanzo, A. et al. Tildrakizumab improves high burden skin symptoms, impaired sleep and quality of life of moderate-to-severe plaque psoriasis patients in conditions close to clinical practice. Journal of the European Academy of Dermatology and Venereology : JEADV, 10.1111/jdv.19229. Advance online publication. https://doi.org/10.1111/jdv.19229

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Patient-reported well-being in value- based care using tildrakizumab in a real-world setting: protocol of a multinational, phase IV, 1-cohort prospective observational study (the POSITIVE study)

Augustin, M. et al. Patient-reported well-being in value-based care using tildrakizumab in a real-world setting: protocol of a multinational, phase IV, 1-cohort prospective observational study (the POSITIVE study). BMJ Open. 2023 Feb 15;13(2):e060536.

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A New Landmark for Wellbeing in Psoriasis:

The POSITIVE Study.

Augustin M, Mrowietz U. A New Landmark for Wellbeing in Psoriasis: The POSITIVE Study. EMJ Dermatol. 2023;11[1]:71-78. DOI/10.33590/emjdermatol/10308846. https://doi.org/10.33590/emjdermatol/10308846

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Ongoing studies

An open-label, randomized study, to assess the efficacy and safety of Tildrakizumab in patients with moderate-to-severe chronic plaque psoriasis who are non-responders to dimethyl fumarate therapy.

Completed

  • Study started Sep 2019
  • Recruitment closed on Feb 2021

An open label clinical study to investigate the efficacy and safety of Tildrakizumab 100 mg in patients with moderate-to-severe chronic plaque psoriasis and its impact on their quality of life.

Completed

  • Study started Dec 2019
  • Recruitment closed on Mar 2021

Observational study to assess the effectiveness, safety profile and real-life prescribing and utilization patterns of Tildrakizumab in patients with moderate to severe plaque psoriasis in routine clinical practice.

Ongoing

  • Study started Dec 2019
  • Recruitment closed on Feb 2022

Optimizing value-based health care in psoriasis: Patient benefits and wellbeing from real-world treatment with Tildrakizumab.

Ongoing

  • Study started Nov 2021
  • Recruitment closed on Dec 2022
TILOT

Prospective, non-interventional, multicenter study to assess the safety and effectiveness of Tildrakizumab (Ilumetri®) in long-term treatment of moderate to severe plaque psoriasis in routine practice.

Completed

  • Study started Jan 2019
  • Recruitment closed on Oct 2021
TIGER

Patient satisfaction and quality of life in patients with moderate to severe plaque psoriasis and involvement of sensitive areas treated with TIldrakizumab in routine practice in GERmany (TI-GER).

Ongoing

  • Study started April 2022
  • Recruitment closed on Sept 2023
TIL-TWO

Tildrakizumab 200 mg for moderate to severe plaque psoriasis in routine practice in patients with elevated bodyweight or high disease burden (TIL-TWO).

Ongoing

  • Study started Jan 2023
TIL-SENIOR

Patient needs and patient benefit in elderly patients requiring biologic therapy (tildrakizumab) for treatment of moderate to severe plaque psoriasis in routine practice.

Ongoing

  • Study started Jan 2023
SW-ATCH

A non-interventional, prospective cohort, multicentre, real-world evidence study to assess the effects of switching from a biologic treatment to tildrakizumab using patient-reported outcomes in adult participants with moderate to severe plaque psoriasis in Austria and Switzerland.

Ongoing

  • Study started Jan 2023
ZODIPSO

Efficacy of Tildrakizumab in difficult to treat areas during psoriasis.

Ongoing

  • Study started Jun 2023
  • Recruitment closed June 2024
Phase 3b Nail Psoriasis – SUNPHARMA

Efficacy and Safety of Tildrakizumab in the treatment of Nail Psoriasis.

Ongoing

  • Study started May 2021
  • Study planned end Feb 2025
Phase 3b Scalp Psoriasis – SUNPHARMA

Efficacy and Safety of Tildrakizumab in the Treatment of Scalp Psoriasis.

Completed

  • Study started May 2021
Phase 3 RWE Quality of Life – SUNPHARMA

A Real World Study Evaluating the Long-Term Quality of life of Tildrakizumab in Adult Patients with Psoriasis.

Ongoing

  • Study started Jul 2019
  • Study planned end Dec 2027

References: 1. ILUMETRI® Summary of Product Characteristics. Acces at: https://www.ema.europa.eu/en/medicines/human/EPAR/ilumetri

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Medical Information

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)

Five-year safety of tildrakizumab in patients with moderate-to-severe psoriasis from two phase 3 trials (reSURFACE 1 and reSURFACE 2): number needed to harm for occurrence of adverse events of special interest

Real-life effectiveness of tildrakizumab in chronic plaque psoriasis: A 52-week multicentre retrospective study—IL PSO (Italian landscape psoriasis)

Tildrakizumab improves high burden skin symptoms, impaired sleep and quality of life of moderate-to-severe plaque psoriasis patients in conditions close to clinical practice

Patient-reported well-being in value- based care using tildrakizumab in a real-world setting: protocol of a multinational, phase IV, 1-cohort prospective observational study (the POSITIVE study)

A New Landmark for Wellbeing in Psoriasis:
The POSITIVE Study.

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Prof. Dirschka

Germany

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Thomas Dirschka graduated in medicine at the University of Bochum, Germany in 1993 and has since specialised in dermatology. After a period of research at the Medical College of Virginia in the USA, Professor Dirschka returned to Germany and did further research work before entering private dermatological practice.

His areas of special interest include prevention and treatment of skin cancer, inflammatory skin diseases, allergy,dermatopathology, and aesthetic dermatology.

He is actively involved in clinical study programmes and clinical trials to determine the efficacy and safety of novel treatments for dermatological conditions. In 2000 Professor Dirschka founded CentroDerm®, a company for research and development in the field of dermatology. In this context he runs a skin physiology laboratory for investigation of skin barrier function, skin sensitivity and effects of topical applications on the skin.

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Italy

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Maria Concetta Fargnoli is Full Professor of Dermatology and Chair of the Department of Dermatology at the University of L’Aquila, Italy. She received her medical degree in 1992 at the University of Rome “Tor Vergata”, completed her residency in Dermatology and Venereology at the University of L’Aquila in 1998 and started her academic career in 1999. She is the Director of the Laboratory of Molecular Biology in Dermato-Oncology, Director of the Interdepartmental Centre of Molecular Diagnostics and Advanced Therapies, Faculty of the PhD Program in Experimental Medicine at the University of L’Aquila and Coordinator of the Skin Cancer Tumor Board.

Her clinical and experimental research interests include epidemiology and molecular genetics of melanoma and non-melanoma skin cancers, non-invasive diagnostic techniques in dermatology, new therapeutic interventions for inflammatory and neoplastic skin diseases. She is actively involved in conducting clinical trials primarily focusing on non-melanoma skin cancers, psoriasis, atopic dermatitis and prurigo nodularis.

She has published 265 peer-reviewed scientific papers, contributed to many book chapters and lectured at national and international meetings. Prof. Fargnoli acts as reviewer of international journals on dermatology, oncology and genetics.

Prof. Fargnoli is currently VicePresident of the Italian Society of Dermatology (SIDeMaST) and has been board member, secretary, coordinator of the Group of Experimental Research and Bioengeneering in Dermatology and coordinator of the Scientific Committee of SIDeMaST.

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Spain

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Dr. Aram Boada (Barcelona, 1979) is a specialist in Dermatology and Venereology (2008) and PhD degree from the Universitat Autònoma de Barcelona (2020). He works as Section Chief and Melanoma Unit Coordinator of the Dermatology Department of Hospital Universitari Germans Trias i Pujol in Badalona (Barcelona, Spain). His main fields of research are Dermato-Oncology (melanoma, field cancerization and cutaneous toxicities of oncologic treatments) with more than 100 publications and conference communications.