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      Update on the role of upadacitinib in the treatment of adults with moderately to severely active ulcerative colitis

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          Abstract

          With further knowledge of the pathogenesis of inflammatory bowel disease, small oral molecules have become available, including the Janus kinase (JAK) inhibitors. Upadacitinib (UPA) is a selective JAK1 inhibitor and has become the newest drug in this class, with recent approval for the management of moderate-to-severe ulcerative colitis. The large phase III program (including the U-ACHIEVE and U-ACCOMPLISH parallel induction trials and the U-ACHIEVE Maintenance trial) demonstrated superiority over placebo, for all primary and secondary endpoints including key clinical, endoscopic, and histological outcomes utilizing 45 mg orally (po) once daily (OD) during induction and either 30 mg or 15 mg po OD in maintenance. From a safety perspective, UPA has proven to be a safe and well-tolerated medication across immune-mediated diseases with manageable adverse risks such as an increase in herpes zoster. Proper discussion and patient profiling are essential when positioning UPA, considering efficacy and potential risks associated with this highly effective medication.

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          Ulcerative colitis

          Ryan Ungaro, Saurabh Mehandru, Patrick Allen … (2017)
          Ulcerative colitis is a chronic inflammatory disease affecting the colon, and its incidence is rising worldwide. The pathogenesis is multifactorial, involving genetic predisposition, epithelial barrier defects, dysregulated immune responses, and environmental factors. Patients with ulcerative colitis have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. Ulcerative colitis usually presents with bloody diarrhoea and is diagnosed by colonoscopy and histological findings. The aim of management is to induce and then maintain remission, defined as resolution of symptoms and endoscopic healing. Treatments for ulcerative colitis include 5-aminosalicylic acid drugs, steroids, and immunosuppressants. Some patients can require colectomy for medically refractory disease or to treat colonic neoplasia. The therapeutic armamentarium for ulcerative colitis is expanding, and the number of drugs with new targets will rapidly increase in coming years.
          Article 0 comments Cited 1154 times – based on 0 reviews     Review now
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            Infliximab for induction and maintenance therapy for ulcerative colitis.

            Paul Rutgeerts, William J Sandborn, Brian Feagan … (2005)
            Infliximab, a chimeric monoclonal antibody directed against tumor necrosis factor alpha, is an established treatment for Crohn's disease but not ulcerative colitis. Two randomized, double-blind, placebo-controlled studies--the Active Ulcerative Colitis Trials 1 and 2 (ACT 1 and ACT 2, respectively)--evaluated the efficacy of infliximab for induction and maintenance therapy in adults with ulcerative colitis. In each study, 364 patients with moderate-to-severe active ulcerative colitis despite treatment with concurrent medications received placebo or infliximab (5 mg or 10 mg per kilogram of body weight) intravenously at weeks 0, 2, and 6 and then every eight weeks through week 46 (in ACT 1) or week 22 (in ACT 2). Patients were followed for 54 weeks in ACT 1 and 30 weeks in ACT 2. In ACT 1, 69 percent of patients who received 5 mg of infliximab and 61 percent of those who received 10 mg had a clinical response at week 8, as compared with 37 percent of those who received placebo (P<0.001 for both comparisons with placebo). A response was defined as a decrease in the Mayo score of at least 3 points and at least 30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute rectal-bleeding subscore of 0 or 1. In ACT 2, 64 percent of patients who received 5 mg of infliximab and 69 percent of those who received 10 mg had a clinical response at week 8, as compared with 29 percent of those who received placebo (P<0.001 for both comparisons with placebo). In both studies, patients who received infliximab were more likely to have a clinical response at week 30 (P< or =0.002 for all comparisons). In ACT 1, more patients who received 5 mg or 10 mg of infliximab had a clinical response at week 54 (45 percent and 44 percent, respectively) than did those who received placebo (20 percent, P<0.001 for both comparisons). Patients with moderate-to-severe active ulcerative colitis treated with infliximab at weeks 0, 2, and 6 and every eight weeks thereafter were more likely to have a clinical response at weeks 8, 30, and 54 than were those receiving placebo. (ClinicalTrials.gov numbers, NCT00036439 and NCT00096655.) Copyright 2005 Massachusetts Medical Society.
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              The global burden of IBD: from 2015 to 2025.

              Gilaad Kaplan (2015)
              Over 1 million residents in the USA and 2.5 million in Europe are estimated to have IBD, with substantial costs for health care. These estimates do not factor in the 'real' price of IBD, which can impede career aspirations, instil social stigma and impair quality of life in patients. The majority of patients are diagnosed early in life and the incidence continues to rise; therefore, the effect of IBD on health-care systems will rise exponentially. Moreover, IBD has emerged in newly industrialized countries in Asia, South America and Middle East and has evolved into a global disease with rising prevalence in every continent. Understanding the worldwide epidemiological patterns of IBD will prepare us to manage the burden of IBD over time. The goal of this article is to establish the current epidemiology of IBD in the Western world, contrast it with the increase in IBD in newly industrialized countries and forecast the global effects of IBD in 2025.
              Article 0 comments Cited 690 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Kenneth Ernest-Suarez: Role: ConceptualizationRole: Data curationRole: Writing - original draftRole: Writing - review & editing
                Remo Panaccione:
                ORCID: https://orcid.org/0000-0002-5247-940X
                Role: ConceptualizationRole: Data curationRole: InvestigationRole: Writing - original draftRole: Writing - review & editing
                Journal
                Journal ID (nlm-ta): Therap Adv Gastroenterol
                Journal ID (iso-abbrev): Therap Adv Gastroenterol
                Journal ID (publisher-id): TAG
                Journal ID (hwp): sptag
                Title: Therapeutic Advances in Gastroenterology
                Publisher: SAGE Publications (Sage UK: London, England )
                ISSN (Print): 1756-283X
                ISSN (Electronic): 1756-2848
                Publication date (Electronic): 11 March 2023
                Publication date Collection: 2023
                Volume: 16
                Electronic Location Identifier: 17562848231158235
                Affiliations
                [1-17562848231158235]Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Calgary, AB, Canada
                [2-17562848231158235]Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, Department of Medicine, University of Calgary, Rm 6D32, Cal Wenzel Precision Health Building, 3280 Hospital Dr NW, Calgary, AB T2N 4Z6, Canada
                Author notes
                Author information
                https://orcid.org/0000-0002-5247-940X
                Article
                Publisher ID: 10.1177_17562848231158235
                DOI: 10.1177/17562848231158235
                PMC ID: 10009038
                PubMed ID: 36923487
                SO-VID: 1b9a01db-dfb6-4ed6-aefd-f21477ad0830
                Copyright © © The Author(s), 2023
                License:

                This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License ( https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page ( https://us.sagepub.com/en-us/nam/open-access-at-sage).

                History
                Date received : 1 November 2022
                Date accepted : 1 February 2023
                Categories
                Subject: Review
                Custom metadata
                cover-date January-December 2023
                typesetter ts1

                Keywords: inflammatory bowel disease,jak inhibitor,ulcerative colitis,upadacitinib,small oral molecules
                Data availability:
                Keywords: inflammatory bowel disease, jak inhibitor, ulcerative colitis, upadacitinib, small oral molecules

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