How Will Evolving Future Therapies and Strategies Change How We Position the Use of Biologics in Moderate to Severely Active Inflammatory Bowel Disease

Abstract

Several biologic agents have been added to our armamentarium of treatment options for moderate to severely active IBD, and this number is expected to only increase in the near future. With our growing understanding of disease mechanisms and pharmacokinetics, we are now able to target several mechanisms of action to achieve key end points (steroid free remission, mucosal healing) associated with improved long-term disease related outcomes. In this context, concerns arise regarding the optimal positioning of currently available biologics and key biologics in development. In this review, we will discuss the currently available evidence for comparative effectiveness of biologic agents approved for use in moderate to severely active IBD, with a focus on practical considerations to be made when utilizing these agents in practice. We will further review novel biologic agents and small molecule inhibitors in development and discuss future opportunities through which providers may personalize treatment decisions to achieve optimal treatment outcomes.

The Real-World Effectiveness and Safety of Vedolizumab for Moderate–Severe Crohn’s Disease: Results From the US VICTORY Consortium

“…Although the rates of clinical remission with VDZ are similar to those seen with TNF-antagonists (6)(7)(8), and its mechanism of action may suggest an improved safety profi le, uncertainty remains regarding its real-world eff ectiveness and safety given the strict inclusion criteria employed in clinical trials ( 2,(9)(10)(11)(12). Th us, it remains unclear what the optimal positioning of this agent will be in routine clinical practice among currently approved biologics.…”

Development and Validation of a Scoring System to Predict Outcomes of Vedolizumab Treatment in Patients With Crohn’s Disease

“…6, 7 With the evolving landscape of biologic therapy in CD and increasing treatment choice, a validated prognostic tool for treatment outcomes with VDZ would be of considerable value. 8 We aimed to address this gap by deriving and validating a multivariable clinical prediction model within the GEMINI 2 clinical trial dataset. To improve the ease with which this prediction model can be used at the ‘bedside’, we transformed it into a prognostic clinical decision support tool (CDST) and validated this tool in a cohort of CD patients treated with VDZ in routine clinical practice.…”

Effects of Vedolizumab Therapy on Extraintestinal Manifestations in Inflammatory Bowel Disease

“…Inflammatory bowel disease (IBD), which comprises ulcerative colitis (UC) and Crohn’s disease (CD), is characterized by chronic intestinal inflammation that results in mucosal ulceration and tissue damage [ 1 ]. Although the etiology of IBD is not yet fully elucidated, multiple factors including genetic susceptibility, environmental influences, the intestinal microbiota, and defective host defense mechanisms contribute to the pathological process [ 2 ].…”