INFLAMMATORY BOWEL DISEASE: Edited by Miguel RegueiroSafety considerations with biologics and new inflammatory bowel disease therapiesQueiroz, Natália S.F.a; Regueiro, MiguelbAuthor Information aDepartment of Gastroenterology, University of Sao Paulo School of Medicine, Sao Paulo, Brazil bDepartment of Gastroenterology, Hepatology & Nutrition, The Pier C and Renee A. Borra Family Endowed Chair in Gastroenterology and Hepatology, Cleveland, OH Correspondence to Natália S.F. Queiroz, Department of Gastroenterology, University of Sao Paulo School of Medicine, Dr Eneas Carvalho Aguiar 255, São Paulo 05403-000, Brazil. Tel: +55 11 2661 65 87; e-mail: [email protected] Current Opinion in Gastroenterology: July 2020 - Volume 36 - Issue 4 - p 257-264 doi: 10.1097/MOG.0000000000000607 Buy Metrics Abstract Purpose of review The safety profile of therapies is an important issue that should always be shared with patients when choosing their treatment. The introduction of biologics over the past 2 decades represented a breakthrough in the management of inflammatory bowel diseases (IBDs). With better understanding of the pathophysiology of the disease, emerging therapies targeting different mechanisms of action have been developed including targeted monoclonal antibodies and small molecules. However, increasing concerns about the safety and side effects of these drugs have been challenging clinicians in clinical practice. Recent findings Comparative safety data between different therapies are lacking in the literature. Most safety recommendations are based on adverse events reported in clinical trials and register-based cohorts. An extensive literature review addressing the risk of infections, malignancies, immunogenicity, and metabolic disorders was performed for biologics and new IBD therapies based on reported adverse events in pivotal trials, long-term extension trials and real-world studies. Summary In this article, we summarize the most recent data on safety of biologics and new IBD therapies and propose hierarchical positioning of drugs regarding safety based on expert opinion recommendations. Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.