Systematic review: the safety of vedolizumab for the treatment of inflammatory bowel disease

Bye, William A.; Jairath, Vipul; Travis, Simon

doi:10.1111/apt.14075

Cited by 103 publications

(92 citation statements)

References 59 publications

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“…Previous studies have shown that disease remission prior to conception and throughout pregnancy is crucial for favourable pregnancy outcomes . In order to achieve disease remission, patients with IBD are frequently treated with biological therapies such as vedolizumab (VDZ), a monoclonal antibody directed against the α4β7 integrin—mucosal vascular addressin cell adhesion molecule 1 (MAdCAM‐1) interaction in the gut . By blocking this interaction, VDZ inhibits the trafficking of gut‐homing lymphocytes .…”

Section: Introductionmentioning

confidence: 99%

Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti‐TNF or conventional therapy: results of the European CONCEIVE study

Moens¹,

Woude²,

Julsgaard³

et al. 2019

Aliment Pharmacol Ther

102

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Summary Background Women with inflammatory bowel diseases (IBD) often receive biologicals during pregnancy to maintain disease remission. Data on outcome of vedolizumab‐exposed pregnancies (VDZE) are sparse. Aims To assess pregnancy and child outcomes of VDZE pregnancies and to compare these results to anti‐TNF exposed (TNFE) or both immunomodulatory and biologic unexposed (CON IBD) pregnancies. Methods A retrospective multicentre case‐control observational study was performed. Results VDZE group included 79 pregnancies in 73 IBD women. The TNFE and CON IBD group included 186 pregnancies (162 live births) in 164 IBD women and 184 pregnancies (163 live births) in 155 IBD women, respectively. At conception, cases more often had active disease ([VDZE: 36% vs TNFE: 17%, P = .002] and [VDZE: 36% vs CON IBD: 24%, P = .063]). No significant difference in miscarriage rates were found between groups (VDZE and TNFE: 16% vs 13%, P = .567; VDZE and CON IBD: 16% vs 10%, P = .216). In live‐born infants, median gestational age and birthweight were similar between groups. Median Apgar score at birth was numerically equal. Prematurity was similar in the VDZE group compared to the control groups, even when correcting for disease activity during pregnancy. The frequency of congenital anomalies was comparable between groups as were the percentages of breastfed babies. During the first year of life, no malignancies were reported and infants' infection risk did not significantly differ between groups. Conclusion No new safety signal was detected in VDZE pregnancies although larger, prospective studies are required for confirmation.

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Section: Introductionmentioning

confidence: 99%

Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti‐TNF or conventional therapy: results of the European CONCEIVE study

Moens¹,

Woude²,

Julsgaard³

et al. 2019

Aliment Pharmacol Ther

102

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“…Nasopharyngitis was the most common AE reported. This is, however, not higher as compared with placebo, 13.5/100 PY (95% CI, 12.3–14.7) versus 14.1/100 PY (95% CI, 8.8–19.3), respectively . All other infections were comparable between both cohorts.…”

Section: Vedolizumabmentioning

confidence: 76%

“…This is, however, not higher as compared with placebo, 13.5/100 PY (95% CI, 12.3-14.7) versus 14.1/100 PY (95% CI, 8.8-19.3), respectively. 24 All other infections were comparable between both cohorts. When assessed using the Cox proportional hazards model, independent risk factors of serious infection for UC included prior anti-TNF therapy and narcotics use.…”

Section: Primary Sclerosing Cholangitis Due To the Expression Ofmentioning

confidence: 80%

“…A recent systematic review of vedolizumab-exposed patients from six registration trials (2830 patients) and six postmarketing cohort studies (1049 patients) demonstrated no increase in adverse events (AE) or serious adverse events (SAE) in the vedolizumab-exposed group. 24 Follow up ranged from 10 weeks to 46 months for the registration trials and 14 to 53 weeks for the cohort studies. Risk of SAE for the vedolizumab-exposed group was 20.0/100 patient years (95% CI, 18.5-21.5) versus 28.3/100 patient years (95% CI, 20.6-35.9) for the placebo group.…”

Section: Primary Sclerosing Cholangitis Due To the Expression Ofmentioning

confidence: 99%

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A review of vedolizumab and ustekinumab for the treatment of inflammatory bowel diseases

et al. 2018

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Recent advancement in the understanding of the pathophysiology of inflammatory bowel disease has seen an expansion in therapeutic options. Vedolizumab, a selective α4β7 inhibitor, and ustekinumab, an IL 12/23 p40 inhibitor, have provided the much‐awaited out‐of‐class alternatives for patients who have failed or who are intolerant to anti‐Tumor Necrosis Factor (TNF) therapy. However, questions remain as to how we may best use these novel therapeutic agents. We evaluate the evidence available from randomized controlled trials and postmarketing cohort studies and discuss their safety, efficacy, and limitations, in relation to anti‐TNF therapy, in optimizing the treatment outcomes.

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“…[213][214][215][216][217][218] Progressive multifocal leukoencephalopathy has not been reported with vedolizumab and JC virus does not need to be checked before starting treatment. 219 Whenever a new agent shows efficacy and safety, the question arises whether to use it as the primary biologic treatment, to reserve it for rescue when anti-TNF therapy is ineffective, or to introduce it for maintenance of remission induced by another drug that is too toxic to use long term (for example, steroids, ciclosporin).…”

Section: Anti-attractantsmentioning

confidence: 99%

Update on anti-tumor necrosis factor agents and other new drugs for inflammatory bowel disease

Cohen

Sachar

2017

BMJ

115

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The treatment of inflammatory bowel disease (IBD)-ulcerative colitis (UC) and Crohn's disease (CD)-has evolved beyond surgery with the introduction of biologic agents, primarily antibodies against mediators of inflammation and cell attraction. Anti-tumor necrosis factor (TNF) agents have been the first line treatment for moderate to severe ulcerative colitis and Crohn's disease for more than 15 years. During that time much has been learnt about how best to use these agents. This review will assess the evidence on how to optimize the use of anti-TNF agents; when and how to start treatment; how to monitor treatment and when to de-escalate it; and the potential adverse effects of these drugs. New and emerging treatments such as anti-attractants, anti-interleukins, and Janus kinase (JAK) inhibitors will also be discussed.

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Systematic review: the safety of vedolizumab for the treatment of inflammatory bowel disease

Cited by 103 publications

References 59 publications

Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti‐TNF or conventional therapy: results of the European CONCEIVE study

Pregnancy outcomes in inflammatory bowel disease patients treated with vedolizumab, anti‐TNF or conventional therapy: results of the European CONCEIVE study

A review of vedolizumab and ustekinumab for the treatment of inflammatory bowel diseases

Update on anti-tumor necrosis factor agents and other new drugs for inflammatory bowel disease

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