Volume 12 ; Issue 1 ; in Month : (2021) Article No : 112
P Vinod Kumar

Background: Vedolizumab is a fully humanized monoclonal IgG-1 antibody that selectively inhibits the interaction between α4β7 integrin and mucosal addressin cell adhesion molecule-1 (MAdCAM-1). It prevents lymphocyte translocation from the blood into the inflamed gut tissue, resulting in a reduction in local inflammation. Ulcerative colitis (UC) and Crohn’s disease (CD) are inflammatory conditions of the bowel affecting approximately 1.4 million people in the US. The efficacy of the drug was studied. Methods: The outcome measures for Phase 3 and randomized clinical trials in ulcerative colitis and Crohn’s disease, was as per GEMINI 1, 2, and 3 for its efficacy. Results: A total of 309 out of 499 reported vedolizumab AEs. In comparison with all other drugs, 3PRR signals were detected including joint-related symptoms like arthralgia, upper respiratory tract infections like nasopharyngitis and sinusitis, and upper respiratory tract symptoms like oropharyngeal pain. Among the vedolizumab-associated reports with serious outcomes, the drug was used for CD in 52.5% and UC in 27.4% compared with 86.1% and 13.9% for the anti-TNFs-associated reports. Although safety data from both these studies suggest VDZ is safe, larger studies with longer follow-up will be necessary to determine the potential risk for the development of PML. Conclusion: There is limited information on other potential confounders, such as co-morbidities, duration, and severity of disease, disease phenotype, surgical history, smoking, and concurrent IBD treatment. The benefit and risk profile of combining Vedolizumab with anti-TNF-α agents in the treatment of IBD will need to be examined. Vedolizumab is revolutionary in the community of inflammatory bowel disease, especially with the potential advantage for VDZ’s selectivity to the gastrointestinal immune system. Vedolizumab provides an alternate class to biologic therapy with an encouraging response and safety profile.

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