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For over a decade, the biologics armamentarium for treating patients with inflammatory bowel diseases (IBD) was confined to anti-tumor necrosis factor (anti-TNF)-alpha monoclonal antibodies. The lack of therapeutic alternatives made it imperative to develop strategies to restore and maintain the response to these therapies. With the understanding that the actual drug exposure rather than the administered dose is related to the response, therapeutic drug monitoring (TDM) of anti-TNFs became an accepted practice.1

With a broad range of biologics in the late-stage drug development pipeline, the therapeutic options for treating patients with IBDs are expected to expand drastically in the next few years, making TNF just one of many therapeutic targets in clinical practice. The opportunity to choose between biologics with different mechanisms of action offers in the first place the potential for improved patient care, but it might also open the door for ‘trial-and-error medicine’.

Vedolizumab is a humanized monoclonal antibody that specifically binds to the α4β7-integrin on lymphocytes and thereby blocks its interaction with the mucosal addressin cell-adhesion molecule (MAdCAM)-1 on intestinal endothelial cells. Gastroenterologists now have the choice of preventing lymphocyte trafficking into the gut as well as that of blocking the anti-inflammatory cytokine TNF. The efficacy of vedolizumab in ulcerative colitis (UC) and Crohn’s disease (CD) has been evaluated in three pivotal Phase 3 studies (GEMINI 1, GEMINI 2 and GEMINI 3). These studies have shown that there is room for therapeutic improvement, as the clinical response rates at Week 6 were only 47% in UC and 31% in CD, compared with a 26% placebo response in both UC and CD.2–4

Issue Section:
Editorial
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