Safety considerations with biologics and new inflammatory bowel disease therapies.

Abstract

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. 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. 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.