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Statement Rationale and Definition

For over a decade, biologic therapy in moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD) has targeted tumor necrosis factor-α (TNF).1,2 The first TNF monoclonal antibody (anti-TNF) to become available was the chimeric molecule, infliximab (IFX), followed by the human anti-TNF molecules, adalimumab (ADA), golimumab, and certolizumab pegol (CTZ).3 Worldwide, IFX and ADA are approved for the treatment of UC and CD; CTZ is approved only for treatment of CD, and golimumab is approved only for UC.2,4,5 A considerable number of UC cases failing conventional therapies with 5-aminosalicyclic acid, corticosteroids, and thiopurine antimetabolites may also fail anti-TNF treatment.6 Furthermore, since 30% to 50% of patients with moderately to severely active UC fail to respond to anti-TNF induction therapy, there is a substantial need for a target other than TNF, and an alternative biologic therapy that may be used as a first-line treatment in moderately to severely active UC has the potential to address this gap in treatment options.7 Vedolizumab, which targets the α4β7 integrin, is the first non-anti-TNF biologic therapy approved for patients with UC.3,8 The α4β7 integrin is expressed on immune cells that bind to gut endothelial cells via mucosal vascular addressin cell adhesion molecule 1 (MAdCAM-1).8 This statement explores vedolizumab as a viable option for first-line biologic therapy in moderately to severely active UC for induction and maintenance of remission.