PRISMA—Efficacy and Safety of Vedolizumab for Inflammatory Bowel Diseases

Wang, Mancai; Zhang, Ling Yi; Han, Wei; Shao, Yuan; Chen, Mo; Ni, Rui; Wang, Gen Nian; Wei, Feng; Zhang, Ya Wu; Xu, Xiao Dong; Zhang, You Cheng

doi:10.1097/md.0000000000000326

Cited by 60 publications

(19 citation statements)

References 36 publications

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“…[ 12 ] – which we excluded from the meta-analysis – was included in the meta-analysis by Wang et al . with the same two RCTs that were included by us [ 24 ]. The main reasons why we excluded the Feagan et al .…”

Section: Discussionmentioning

confidence: 99%

Effectiveness and safety of vedolizumab for treatment of Crohn’s disease: a systematic review and meta-analysis

Moćko

Kawalec

Smela-Lipińska

et al. 2016

aoms

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IntroductionThe aim of this systematic review (SR) and meta-analysis was to assess the efficacy and safety of vedolizumab in the treatment of Crohn's disease (CD).Material and methodsA systematic literature search was conducted in Medline/PubMed, Embase and Cochrane Library until 25 January, 2015. Included studies were critically appraised according to the PRISMA protocol. Assessment in specified subgroups of CD patients and meta-analysis with Revman software were performed.ResultsTwo randomized controlled trial (RCTs) were included in a meta-analysis for the induction phase of therapy: GEMINI II and GEMINI III. The clinical response was significantly higher for patients who received vedolizumab compared to placebo in the general population (risk benefit (RB) = 1.48; p = 0.0006) and in both analyzed subgroups: patients with previous failure of anti-TNFs treatment (RB = 1.51; p = 0.006) and patients naive to earlier anti-TNFs (RB = 1.41; p = 0.001). The clinical remission in the general population and subpopulation of TNF-antagonist naive patients was significantly higher for patients who received vedolizumab compared to placebo (RB = 1.77; p = 0.003; RB = 2.29; p = 0.0004; respectively). Meta-analysis for adverse events, serious adverse events (SAEs) and serious infections, revealed that vedolizumab was as safe as placebo in the induction phase of therapy.ConclusionsThe clinical response was significantly higher for patients who received vedolizumab in the general population and in both analyzed subgroups of patients. The clinical remission in the general population and subpopulation of TNF-antagonist naive patients was significantly higher for vedolizumab, but no significant differences were revealed in the subgroup of patients with previous TNF antagonist failure.

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Section: Discussionmentioning

confidence: 99%

Effectiveness and safety of vedolizumab for treatment of Crohn’s disease: a systematic review and meta-analysis

Moćko

Kawalec

Smela-Lipińska

et al. 2016

aoms

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“…Vedolizumab (Entyvio ® ) is a humanized antibody IgG inhibitor of integrin α4β7, originally developed by Millenium pharmaceuticals (Cambridge, MA, USA) as MLN002, and launched in May 2014 after successful PH3 trials in patients with TNF-resistant Crohn’s disease and UC [ 181 , 182 ]. Further late-stage clinical trials are in progress, including for steroid-refractory acute intestinal graft vs. host disease, in fistulizing Crohn’s disease and in chronic pouchitis.…”

Section: Integrins Targeted In Clinical Trialsmentioning

confidence: 99%

“…This blocks the homing of cytokine-activated T- cells to the high-endothelial venules of Peyer’s patches in gut [ 183 ]. No induction of PML has been reported for vedolizumab [ 182 ], which unlike natalizumab does not block T-cell patrolling in brain. This enhances the risk-benefit profile for vedolizumab, and may extend its future utility in inflammatory gut diseases.…”

Section: Integrins Targeted In Clinical Trialsmentioning

confidence: 99%

Integrins as Therapeutic Targets: Successes and Cancers

Raab-Westphal

Marshall

2017

Cancers

182

179

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Integrins are transmembrane receptors that are central to the biology of many human pathologies. Classically mediating cell-extracellular matrix and cell-cell interaction, and with an emerging role as local activators of TGFβ, they influence cancer, fibrosis, thrombosis and inflammation. Their ligand binding and some regulatory sites are extracellular and sensitive to pharmacological intervention, as proven by the clinical success of seven drugs targeting them. The six drugs on the market in 2016 generated revenues of some US$3.5 billion, mainly from inhibitors of α4-series integrins. In this review we examine the current developments in integrin therapeutics, especially in cancer, and comment on the health economic implications of these developments.

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“…The only criterion for such treatment selection is that patients afford to wait 10 weeks for the onset of the pharmacological effect. 67 , 70 …”

Section: Pathogenic Factorsmentioning

confidence: 99%

Recent insights into the molecular pathogenesis of Crohn's disease: a review of emerging therapeutic targets

Manuc¹,

Manuc²,

Diculescu³

2016

CEG

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Chronic inflammatory bowel diseases (IBDs) are a subject of great interest in gastroenterology, due to a pathological mechanism that is difficult to explain and an optimal therapeutic approach still undiscovered. Crohn’s disease (CD) is one of the main entities in IBD, characterized by clinical polymorphism and great variability in the treatment response. Modern theories on the pathogenesis of CD have proven that gut microbiome and environmental factors lead to an abnormal immune response in a genetically predisposed patient. Genome-wide association studies in patients with CD worldwide revealed several genetic mutations that increase the risk of IBD and that predispose to a more severe course of disease. Gut microbiota is considered a compulsory and an essential part in the pathogenesis of CD. Intestinal dysmicrobism with excessive amounts of different bacterial strains can be found in all patients with IBD. The discovery of Escherichia coli entero-invasive on resection pieces in patients with CD now increases the likelihood of antimicrobial or vaccine-type treatments. Recent studies targeting intestinal immunology and its molecular activation pathways provide new possibilities for therapeutics. In addition to antitumor necrosis factor molecules, which were a breakthrough in IBD, improving mucosal healing and resection-free survival rate, other classes of therapeutic agents come to focus. Leukocyte adhesion inhibitors block the leukocyte homing mechanism and prevent cellular immune response. In addition to anti-integrin antibodies, chemokine receptor antagonists and SMAD7 antisense oligonucleotides have shown encouraging results in clinical trials. Micro-RNAs have demonstrated their role as disease biomarkers but it could also become useful for the treatment of IBD. Moreover, cellular therapy is another therapeutic approach under development, aimed for severe refractory CD. Other experimental treatments include intravenous immunoglobulins, exclusive enteral nutrition, and granulocyte colony-stimulating factors.

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PRISMA—Efficacy and Safety of Vedolizumab for Inflammatory Bowel Diseases

Abstract: Supplemental Digital Content is available in the text

Cited by 60 publications

References 36 publications

Effectiveness and safety of vedolizumab for treatment of Crohn’s disease: a systematic review and meta-analysis

Effectiveness and safety of vedolizumab for treatment of Crohn’s disease: a systematic review and meta-analysis

Integrins as Therapeutic Targets: Successes and Cancers

Recent insights into the molecular pathogenesis of Crohn's disease: a review of emerging therapeutic targets

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PRISMA—Efficacy and Safety of Vedolizumab for Inflammatory Bowel Diseases

Abstract: Supplemental Digital Content is available in the text

Cited by 60 publications

References 36 publications

Effectiveness and safety of vedolizumab for treatment of Crohn’s disease: a systematic review and meta-analysis

Effectiveness and safety of vedolizumab for treatment of Crohn’s disease: a systematic review and meta-analysis

Integrins as Therapeutic Targets: Successes and Cancers

Recent insights into the molecular pathogenesis of Crohn&#39;s disease: a review of emerging therapeutic targets

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Product

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Recent insights into the molecular pathogenesis of Crohn's disease: a review of emerging therapeutic targets