Introduction
The management of inflammatory bowel disease (IBD) has been transformed by the introduction of biologic, antitumor necrosis factor alpha (anti-TNFα) therapies. However, a significant proportion of patients do not respond to these drugs, lose their response over time, or are intolerant to these treatments. Vedolizumab, a fully humanised monoclonal IgG-1 antibody, selectively inhibits the interaction between α4β7 integrin and mucosal addressin cell adhesion molecule-1 (MAdCAM-1), preventing lymphocyte translocation from the blood into the inflamed gut tissue, thereby reducing local inflammation.
Efficacy of Vedolizumab from RCTs
Vedolizumab's efficacy for inducing and maintaining remission in patients with IBD was demonstrated in the pivotal phase III GEMINI studies. These trials showed that vedolizumab was effective for the treatment of adult patients with moderate-to-severe active ulcerative colitis (UC) and Crohn’s disease (CD) who had an inadequate response to either standard therapies or TNFα antagonists.
Long-term Efficacy of Vedolizumab in IBD from Clinical Trials
An interim analysis of the GEMINI LTS study, an ongoing, open-label, extension trial, showed that vedolizumab maintained clinical remission in a significant proportion of patients with UC and CD over an extended period, confirming its long-term efficacy.
Effectiveness of Vedolizumab in Patients with IBD from Real-World Studies
Real-world studies have confirmed the effectiveness of vedolizumab in clinical practice, with several prospective and retrospective studies reporting positive outcomes in patients with moderate-to-severe UC and CD. These studies have also highlighted the importance of early response as a predictor of long-term remission.
Safety of Vedolizumab from Randomized Controlled Trials and Real-World Studies
Safety data from both randomized controlled trials and real-world studies have shown that vedolizumab has a favorable safety profile, with minimal immunogenicity and a low risk of serious infections. The gut-selectivity of vedolizumab is believed to contribute to its safety profile, avoiding systemic immunosuppression.
Conclusion
Vedolizumab represents a significant advancement in the treatment of IBD, offering a new therapeutic option for patients who have failed TNF-α antagonists. Its efficacy and safety profile, supported by both clinical trials and real-world evidence, make it a valuable addition to the treatment algorithms for IBD, particularly for patients in whom systemic immunosuppression is undesirable.
