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      Clinical Evaluation of Risankizumab in the Treatment of Adults with Moderately to Severely Active Crohn’s Disease: Patient Selection and Reported Outcomes

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          Abstract

          This article will review risankizumab, a monoclonal antibody targeting interleukin 23 (IL-23) for the treatment of moderate-to-severe Crohn’s disease. The article will detail the mechanism of action and dosing strategies. Efficacy in induction and maintenances will be reviewed from available clinical trials as well as an evaluation of safety of the medication for use in Crohn’s disease and other immune mediated diseases. Finally, a discussion of when to use this medication for treatment in Crohn’s disease as well as how to monitor patients after medication initiation will be discussed.

          Most cited references40

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          British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults

          Ulcerative colitis and Crohn’s disease are the principal forms of inflammatory bowel disease. Both represent chronic inflammation of the gastrointestinal tract, which displays heterogeneity in inflammatory and symptomatic burden between patients and within individuals over time. Optimal management relies on understanding and tailoring evidence-based interventions by clinicians in partnership with patients. This guideline for management of inflammatory bowel disease in adults over 16 years of age was developed by Stakeholders representing UK physicians (British Society of Gastroenterology), surgeons (Association of Coloproctology of Great Britain and Ireland), specialist nurses (Royal College of Nursing), paediatricians (British Society of Paediatric Gastroenterology, Hepatology and Nutrition), dietitians (British Dietetic Association), radiologists (British Society of Gastrointestinal and Abdominal Radiology), general practitioners (Primary Care Society for Gastroenterology) and patients (Crohn’s and Colitis UK). A systematic review of 88 247 publications and a Delphi consensus process involving 81 multidisciplinary clinicians and patients was undertaken to develop 168 evidence- and expert opinion-based recommendations for pharmacological, non-pharmacological and surgical interventions, as well as optimal service delivery in the management of both ulcerative colitis and Crohn’s disease. Comprehensive up-to-date guidance is provided regarding indications for, initiation and monitoring of immunosuppressive therapies, nutrition interventions, pre-, peri- and postoperative management, as well as structure and function of the multidisciplinary team and integration between primary and secondary care. Twenty research priorities to inform future clinical management are presented, alongside objective measurement of priority importance, determined by 2379 electronic survey responses from individuals living with ulcerative colitis and Crohn’s disease, including patients, their families and friends.
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            STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD

            The Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) has proposed treatment targets in 2015 for adult patients with inflammatory bowel disease (IBD). We aimed to update the original STRIDE statements for incorporating treatment targets in both adult and pediatric IBD.
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              Interleukin-23 rather than interleukin-12 is the critical cytokine for autoimmune inflammation of the brain.

              Interleukin-12 (IL-12) is a heterodimeric molecule composed of p35 and p40 subunits. Analyses in vitro have defined IL-12 as an important factor for the differentiation of naive T cells into T-helper type 1 CD4+ lymphocytes secreting interferon-gamma (refs 1, 2). Similarly, numerous studies have concluded that IL-12 is essential for T-cell-dependent immune and inflammatory responses in vivo, primarily through the use of IL-12 p40 gene-targeted mice and neutralizing antibodies against p40. The cytokine IL-23, which comprises the p40 subunit of IL-12 but a different p19 subunit, is produced predominantly by macrophages and dendritic cells, and shows activity on memory T cells. Evidence from studies of IL-23 receptor expression and IL-23 overexpression in transgenic mice suggest, however, that IL-23 may also affect macrophage function directly. Here we show, by using gene-targeted mice lacking only IL-23 and cytokine replacement studies, that the perceived central role for IL-12 in autoimmune inflammation, specifically in the brain, has been misinterpreted and that IL-23, and not IL-12, is the critical factor in this response. In addition, we show that IL-23, unlike IL-12, acts more broadly as an end-stage effector cytokine through direct actions on macrophages.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Des Devel Ther
                dddt
                Drug Design, Development and Therapy
                Dove
                1177-8881
                31 January 2023
                2023
                : 17
                : 273-282
                Affiliations
                [1 ]Vanderbilt University Medical Center , Nashville, TN, USA
                [2 ]University of Maryland School of Medicine , Baltimore, MD, USA
                Author notes
                Correspondence: Sara Horst, Vanderbilt University Medical Center, Inflammatory Bowel Disease Clinic , 719 Thompson Lane, Suite, 20500, Nashville, TN, 37204, USA, Tel +1 615-343-4758, Email sara.n.horst@vumc.org
                Article
                379446
                10.2147/DDDT.S379446
                9899013
                1d38526d-2684-4cc7-8084-5d80b5ab4070
                © 2023 Horst and Cross.

                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).

                History
                : 29 November 2022
                : 17 January 2023
                Page count
                Figures: 2, Tables: 2, References: 42, Pages: 10
                Categories
                Review

                Pharmacology & Pharmaceutical medicine
                crohn’s disease,risankizumab,biological therapy,interleukin-23 subunit p19,remission induction

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