title: The safety of vedolizumab for the treatment of ulcerative colitis.
abstract: Vedolizumab is a humanized monoclonal antibody to the α4β7-integrin that blocks lymphocyte trafficking to the gut and is approved for treatment of patients with moderate-to-severe ulcerative colitis (UC). The gut-selective mechanism of action has the potential to improve vedolizumab's safety profile compared to other approved biologic drugs. Areas covered: We review the mechanism of action, efficacy and safety of vedolizumab treatment for UC. The positioning of vedolizumab in management algorithms is also discussed. Expert opinion: The highly selective mechanism of action of vedolizumab restricts immunosuppressive effects to the gut. Vedolizumab is efficacious as induction and maintenance therapy in UC patients who are naïve or refractory to tumor necrosis factor antagonists. No clinically important safety signals have been identified. Infusion reactions are reported in <5% of cases. The rates of adverse events (AE), serious AEs, and serious infections were not different between patients treated with placebo and those who received vedolizumab in a pooled analysis of six randomized controlled trials. Rates of malignancy and mortality in vedolizumab-exposed patients are similar to those of the general UC patient population. Progressive multifocal leukoencephalopathy has not been observed. Vedolizumab is a safe and effective therapy for UC with a unique mechanism of action.
authors.affiliation: a Robarts Clinical Trials Inc. , University of Western Ontario , London , Canada.|b Department of Gastroenterology and Hepatology , University Medical Centre , Ljubljana , Slovenia.
authors.forename: Gregor
authors.initials: G
authors.lastname: Novak
authors.affiliation: a Robarts Clinical Trials Inc. , University of Western Ontario , London , Canada.|c Department of Gastroenterology , University of Ghent , Ghent , Belgium.
authors.forename: Pieter
authors.initials: P
authors.lastname: Hindryckx
authors.affiliation: a Robarts Clinical Trials Inc. , University of Western Ontario , London , Canada.|d Department of Medicine , University of Western Ontario , London , Canada.
authors.forename: Reena
authors.initials: R
authors.lastname: Khanna
authors.affiliation: a Robarts Clinical Trials Inc. , University of Western Ontario , London , Canada.|d Department of Medicine , University of Western Ontario , London , Canada.|e Department of Epidemiology and Biostatistics , University of Western Ontario , London , Canada.
authors.forename: Vipul
authors.initials: V
authors.lastname: Jairath
authors.affiliation: a Robarts Clinical Trials Inc. , University of Western Ontario , London , Canada.|d Department of Medicine , University of Western Ontario , London , Canada.|e Department of Epidemiology and Biostatistics , University of Western Ontario , London , Canada.
authors.forename: Brian G
authors.initials: BG
authors.lastname: Feagan
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000503:physiopathology; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D016023:Integrins / Q000037:antagonists & inhibitors; D008214:Lymphocytes / Q000378:metabolism; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D005765:Gastrointestinal Agents; D016023:Integrins; C071777:integrin alpha4beta7; C543529:vedolizumab
keywords: Inflammatory bowel disease; adverse events; anti-integrin; safety; ulcerative colitis; vedolizumab