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Vedolizumab specifically recognises the α4β7 integrin and selectively blocks gut lymphocyte trafficking: potentially, it offers gut-specific immunosuppression.To review the safety of vedolizumab and summarise post-marketing data to assess if any safety concerns that differ from registration trials have emerged.A systematic bibliographic search identified six registration trials and nine cohort studies.Integrated data from registration trials included 2830 vedolizumab-exposed patients (4811 person-years exposure [PYs]) and 513 placebo patients. This reported lower exposure-adjusted incidence rates of infection (63.5/100 PYs; 95% CI: 59.6-67.3) and serious adverse events (20.0/100 PYs; 95% CI: 18.5-21.5) compared to placebo (82.9/100 PYs; 95% CI: 68.3-97.5) and (28.3/100 PYs 95% CI: 20.6-35.9) respectively. Higher, but statistically insignificant rates of enteric infections occurred in vedolizumab-exposed patients (7.4/100 PYs; 95% CI: 6.6-8.3) compared to placebo (6.7 PYs; 95% CI: 3.2-10.1). Six post-marketing cohort studies (1049 patients, 403 PYs) demonstrated rates of infection of 8% (82/1049); enteric infection of 2% (21/1049) and adverse events of 16% (166/1049). Multivariate analysis in one cohort study suggested increased risk of surgical site infection with perioperative VDZ. Human experience in pregnancy is limited.Post-marketing data confirm the excellent safety of vedolizumab observed in registration trials. The signal of post-operative complications should be interpreted with caution, but warrants further study. Although comparative studies are needed, Vedolizumab may be a safe alternative in patients who best avoid systematic immunosuppression, including those pre-disposed to infection, malignancy or the elderly.

Original publication

DOI

10.1111/apt.14075

Type

Journal article

Journal

Alimentary pharmacology & therapeutics

Publication Date

07/2017

Volume

46

Pages

3 - 15

Addresses

Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, UK.

Keywords

Animals, Humans, JC Virus, Infection, Leukoencephalopathy, Progressive Multifocal, Neoplasms, Inflammatory Bowel Diseases, Gastrointestinal Agents, Vaccines, Infusions, Intravenous, Lactation, Pregnancy, Female, Antibodies, Monoclonal, Humanized