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      Therapeutics and Clinical Risk Management (submit here)

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      Tildrakizumab: An Evidence-Based Review of Its Use in the Treatment of Moderate-to-Severe Chronic Plaque Psoriasis


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          Psoriasis is a common immune-mediated chronic inflammatory disease, and observations have pointed toward the IL-23/Th17 cell axis as having a key role in the pathogenesis of psoriasis. This new immunological understanding of the pathogenesis has been translated into targeted and highly effective biologic therapies. Tildrakizumab is a humanized IgG1/k monoclonal antibody targeting the p19 unit of IL-23 and has been registered for the treatment of patients with moderate-to-severe chronic plaque psoriasis in adults since 2018. This review provides an overview of the efficacy and safety of tildrakizumab, focusing on the results from clinical trials. In both Phase II and III trials, tildrakizumab 100 and 200 mg was significantly more efficacious than both placebo and etanercept at week 12. The effect of tildrakizumab continued to increase until week 28. Long-term follow-up showed high levels of efficacy for up to 3 years. Despite no difference between 100 and 200 mg in Phase III studies, subgroup analyses showed better efficacy when treated with 200 mg in patients with bodyweight ≥90 kg. The overall drug safety was good, and besides discrete higher incidence of nasopharyngitis, the conducted clinical trials show that tildrakizumab was very well tolerated without any safety concerns. Compared to other IL-23p19 inhibitors, tildrakizumab seemed to have slightly lower efficacy. However, to determine its position in the treatment algorithm of psoriasis, head-to-head trials with other IL-17, IL-12/23, and IL-23 inhibitors and long-term real-world data are required.

          Most cited references36

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          New England Journal of Medicine, 361(5), 496-509
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            Tildrakizumab versus placebo or etanercept for chronic plaque psoriasis (reSURFACE 1 and reSURFACE 2): results from two randomised controlled, phase 3 trials.

            Tildrakizumab is a high-affinity, humanised, IgG1 κ antibody targeting interleukin 23 p19 that represents an evolving treatment strategy in chronic plaque psoriasis. Previous research suggested clinical improvement with inhibition of interleukin 23 p19. We did two phase 3 trials to investigate whether tildrakizumab is superior to placebo and etanercept in the treatment of chronic plaque psoriasis.
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              Psoriasis causes as much disability as other major medical diseases.

              Little is known about how the health-related quality of life (HRQL) associated with psoriasis compares with that of other patient populations. We describe HRQL associated with psoriasis and compare it with HRQL of patients with other major chronic health conditions. A second aim is to identify which specific aspects of psoriasis contribute most to HRQL. A total of 317 patients completed a non-disease-specific measure of HRQL. Responses were compared with those of patients with 10 other chronic health conditions. HRQL was regressed on ratings of 18 aspects of psoriasis. Patients with psoriasis reported reduction in physical functioning and mental functioning comparable to that seen in cancer, arthritis, hypertension, heart disease, diabetes, and depression. Six aspects of psoriasis predicted physical functioning, and 5 different disease aspects predicted mental functioning. The impact of psoriasis on HRQL is similar to that of other major medical diseases. Different aspects of psoriasis are related to the different dimensions of HRQL supporting the need for multidimensional treatment models.

                Author and article information

                Ther Clin Risk Manag
                Therapeutics and Clinical Risk Management
                24 September 2020
                : 16
                : 903-916
                [1 ]Department of Dermatology and Allergy, Herlev and Gentofte Hospital , Copenhagen, Denmark
                [2 ]Faculty of Health and Medical Sciences, University of Copenhagen , Copenhagen, Denmark
                Author notes
                Correspondence: Claus Zachariae Department of Dermatology and Allergy, University of Copenhagen, Herlev and Gentofte Hospital , Gentofte Hospitalsvej 15, Hellerup2900, DenmarkTel +4538673203Fax +4538677615 Email claus.zachariae@regionh.dk
                Author information
                © 2020 Näslund-Koch et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                : 08 July 2020
                : 26 August 2020
                Page count
                Figures: 2, Tables: 6, References: 52, Pages: 14

                tildrakizumab, il-23p19, biologics, psoriasis, safety, efficacy


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