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      Real world practice indirect comparison between guselkumab and risankizumab: Results from an Italian retrospective study

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          Abstract

          IL‐23‐inhibitors, such as guselkumab and risankizumab, represent the newest class of biologics approved for psoriasis. Phase III trials have shown their efficacy and safety. However, real life data are still scant. to indirectly compare the effectiveness, safety and tolerability of guselkumab and risankizumab in real world practice. An Italian single‐center retrospective cohort study enrolling moderate‐to‐severe psoriasis patients from September 1, 2018 and December 31, 2020 was performed to indirectly compare guselkumab and risankizumab efficacy and safety. Sixty eight patients were included (36 received guselkumab and 32 risankizumab). The groups were comparable for all analyzed characteristics, except for mean psoriasis duration ( p < 0.01) which was higher for guselkumab. In guselkumab group, mean PASI reduced from 16.1 ± 6.4 (baseline) 2.1 ± 0.9 (week‐28) ( p < 0.001) up to 0.9 ± 0.8 (week‐44) ( p < 0.001). In risankizumab group mean PASI decreased from 13.5 ± 4.9 (baseline) 1.9 ± 0.8 ( p < 0.001), (week‐28) ( p < 0.001) up to 0.9 ± 0.4 (week‐40) ( p < 0.001). No significant difference in mean PASI and BSA were observed between the treatments. No cases of serious AEs, injection site reaction, candida, malignancy, cardiovascular events were reported in both groups. Guselkumab and risankizumab showed favorable efficacy and safety profile, being comparable in terms of PASI90 and PASI100 responses as well as in AEs frequency and discontinuation rates.

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          Most cited references32

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          Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials

          Risankizumab is a humanised IgG1 monoclonal antibody that binds to the p19 subunit of interleukin-23, inhibiting this key cytokine and its role in psoriatic inflammation. We aimed to assess the efficacy and safety of risankizumab compared with placebo or ustekinumab in patients with moderate-to-severe chronic plaque psoriasis.
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            Discovery of the IL-23/IL-17 Signaling Pathway and the Treatment of Psoriasis.

            Psoriasis vulgaris is a common, heterogeneous, chronic inflammatory skin disease characterized by thickened, red, scaly plaques and systemic inflammation. Psoriasis is also associated with multiple comorbid conditions, such as joint destruction, cardiovascular disease, stroke, hypertension, metabolic syndrome, and chronic kidney disease. The discovery of IL-17-producing T cells in a mouse model of autoimmunity transformed our understanding of inflammation driven by T lymphocytes and associations with human inflammatory diseases, such as psoriasis. Under the regulation of IL-23, T cells that produce high levels of IL-17 create a self-amplifying, feed-forward inflammatory response in keratinocytes that drives the development of thickened skin lesions infiltrated with a mixture of inflammatory cell populations. Recently, the Food and Drug Administration approved multiple highly effective psoriasis therapies that disrupt IL-17 (secukinumab, ixekizumab, and brodalumab) and IL-23 (guselkumab and tildrakizumab) signaling in the skin, thus leading to a major paradigm shift in the way that psoriatic disease is managed.
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              Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial.

              Guselkumab, an interleukin-23 blocker, was superior to adalimumab in treating moderate to severe psoriasis in a phase II trial.
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                Author and article information

                Contributors
                angeloruggiero1993@libero.it
                Journal
                Dermatol Ther
                Dermatol Ther
                10.1111/(ISSN)1529-8019
                DTH
                Dermatologic Therapy
                John Wiley & Sons, Inc. (Hoboken, USA )
                1396-0296
                1529-8019
                30 November 2021
                January 2022
                : 35
                : 1 ( doiID: 10.1111/dth.v35.1 )
                : e15214
                Affiliations
                [ 1 ] Section of Dermatology, Department of Clinical Medicine and Surgery University of Naples Federico II Naples Italy
                Author notes
                [*] [* ] Correspondence

                Angelo Ruggiero, Section of Dermatology, Department of Clinical Medicine and Surgery, University of Naples Federico II, Via Pansini 5, 80131 Napoli, Italy.

                Email: angeloruggiero1993@ 123456libero.it

                Author information
                https://orcid.org/0000-0002-4658-7391
                https://orcid.org/0000-0002-0064-1874
                https://orcid.org/0000-0003-3046-5493
                https://orcid.org/0000-0003-1803-2046
                Article
                DTH15214
                10.1111/dth.15214
                9285826
                34800070
                a9bf2cdd-111f-472e-ac87-e0f811aeabb1
                © 2021 The Authors. Dermatologic Therapy published by Wiley Periodicals LLC.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 05 August 2021
                : 12 January 2021
                : 16 November 2021
                Page count
                Figures: 1, Tables: 1, Pages: 6, Words: 4561
                Categories
                Original Article
                Original Articles
                Custom metadata
                2.0
                January 2022
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.1.7 mode:remove_FC converted:15.07.2022

                anti‐il‐23,biologics,guselkumab,indirect comparison,psoriasis,real world,risankizumab

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