Vedolizumab use in patients with inflammatory bowel diseases undergoing surgery: clinical trials and post-marketing experience

Shen, Bo; Blake, Aimee; Lasch, Karen; Smyth, Michael; Bhayat, Fatima

doi:10.1093/gastro/goz034

Cited by 11 publications

(8 citation statements)

References 32 publications

(45 reference statements)

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“…Current pharmacological treatment for IBD mainly includes 5-aminosalicylate, corticosteroids, anti-TNF (tumor necrosis factor) drugs (infliximab (IFX), adalimumab (ADA)), antiintegrin preparation (vedolizumab (VDZ)) [49][50][51][52][53], all of which may reduce the occurrence of infectious complications to some extent. Since the pharmacokinetics of the medications in obese patients are not the same as that in the normal, the efficacy of these drugs may be altered in obese patients.…”

Section: Discussionmentioning

confidence: 99%

Systematic review and meta-analysis: association between obesity/overweight and surgical complications in IBD

Jiang

Chen

Lou

et al. 2022

Int J Colorectal Dis

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Purpose While the prevalence of obesity in inflammatory bowel disease (IBD) patients is rapidly increasing, it is unclear whether obesity affects surgical outcomes in this population. This meta-analysis aims to assess the impact of obesity/overweight on patients undergoing surgery for IBD. Methods Databases (PubMed, Web of Science, Cochrane Library, and Springer) were searched through September 2021. The meta-analysis included patients with surgically treated IBD to investigate the impact of obesity/overweight on this population. Primary outcomes included overall complications, infectious complications, noninfectious complications, and conversion to laparotomy. Results Fifteen studies totaling 12,622 IBD patients were enrolled. Compared with nonobese (including overweight) patients, obese IBD patients have increased the risk in terms of overall complications (OR = 1.45, p < 0.001), infectious complications (OR = 1.48, p = 0.003) (especially wound complications), as well as conversion to laparotomy (OR = 1.90, p < 0.001). Among the noninfectious complications, only the incidence of visceral injury (OR = 2.36, p = 0.05) had significantly increased. Compared with non-overweight patients, the risk of developing wound complications (OR = 1.65, p = 0.01) and sepsis (OR = 1.73, p = 0.007) were increased in overweight patients, but the rates of overall complications (OR = 1.04, p = 0.81), infectious complications (OR = 1.31, p = 0.07), and conversion to laparotomy (OR = 1.33, p = 0.08) associated with body mass index (BMI) were not significantly different. Conclusion Obesity is a risk factor for surgical complications in IBD patients, mainly reflected in infectious complications. Moreover, obese patients seem to have a more common chance of developing surgical complications than overweight patients.

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Section: Discussionmentioning

confidence: 99%

Systematic review and meta-analysis: association between obesity/overweight and surgical complications in IBD

Jiang

Chen

Lou

et al. 2022

Int J Colorectal Dis

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“…Furthermore, the frequency of postoperative complications in a postmarketing setting is low. 97 Lightner et al 98 A meta-analysis by Guo et al 100 indicated that, compared with a control group, the incidence of infection complications was reduced after preoperative treatment with VDZ (OR = 0.40, P = 0.04).…”

Section: Vdzmentioning

confidence: 99%

Perioperative optimization of Crohn's disease

Lin

Chen

et al. 2022

Annals of Gastroent Surgery

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Crohn's disease (CD) is a chronic inflammatory disease mainly affecting the gastrointestinal tract. With the increased availability of modalities in the last two decades, the treatment of CD has advanced remarkably. Although medical treatment is the mainstay of therapy, most patients require surgery during the course of their illness, especially those who experience complications. Nutritional optimization and ERAS implementation are crucial for patients with CD who require surgical intervention to reduce postoperative complications. The increased surgical risk was found to be associated with the use of corticosteroids, but the association of surgical risk with immunomodulators, biologic therapy, such as anti‐TNF mediations, anti‐integrin medications, and anti‐IL 12/23 was low in certainty. Decisions about preoperative medication must be made on an individual case‐dependent basis. Preoperative imaging studies can assist in the planning of appropriate surgical strategies and approaches. However, patients must be informed of any alterations to their treatment. In summary, the management of perioperative medications and surgery‐related decision‐making should be individualized and patient‐centered based on a multidisciplinary approach.

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“…Despite that, Danese et al (2019) found that people with moderate to severe CD who were treated with vedolizumab presented with endoscopic and histological healing at both 26 and 52 weeks. Furthermore, Shen et al (2019) analyzed data from the GEMINI 1, GEMINI 2, GEMINI Long Term Safety studies, and Vedolizumab Global Safety Database, reporting only a minor difference in the frequency of postoperative complications after intestinal surgery in people treated with vedolizumab compared to placebo. Together, this suggests that the beneficial anti-inflammatory effects of vedolizumab may override concerns about a lack of recruitment of non-classical monocytes, compromised wound healing, and downstream complications.…”

Section: Vedolizumab: Potential Mechanisms Of Actionmentioning

confidence: 99%

Vedolizumab: Potential Mechanisms of Action for Reducing Pathological Inflammation in Inflammatory Bowel Diseases

Luzentales-Simpson

Pang

Zhang

et al. 2021

Front. Cell Dev. Biol.

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Inflammatory bowel diseases (IBD), encompassing ulcerative colitis (UC), and Crohn’s disease (CD), are a group of disorders characterized by chronic, relapsing, and remitting, or progressive inflammation along the gastrointestinal tract. IBD is accompanied by massive infiltration of circulating leukocytes into the intestinal mucosa. Leukocytes such as neutrophils, monocytes, and T-cells are recruited to the affected site, exacerbating inflammation and causing tissue damage. Current treatments used to block inflammation in IBD include aminosalicylates, corticosteroids, immunosuppressants, and biologics. The first successful biologic, which revolutionized IBD treatment, targeted the pro-inflammatory cytokine, tumor necrosis factor alpha (TNFα). Infliximab, adalimumab, and other anti-TNF antibodies neutralize TNFα, preventing interactions with its receptors and reducing the inflammatory response. However, up to 40% of people with IBD become unresponsive to anti-TNFα therapy. Thus, more recent biologics have been designed to block leukocyte trafficking to the inflamed intestine by targeting integrins and adhesins. For example, natalizumab targets the α4 chain of integrin heterodimers, α4β1 and α4β7, on leukocytes. However, binding of α4β1 is associated with increased risk for developing progressive multifocal leukoencephalopathy, an often-fatal disease, and thus, it is not used to treat IBD. To target leukocyte infiltration without this life-threatening complication, vedolizumab was developed. Vedolizumab specifically targets the α4β7 integrin and was approved to treat IBD based on the presumption that it would block T-cell recruitment to the intestine. Though vedolizumab is an effective treatment for IBD, some studies suggest that it may not block T-cell recruitment to the intestine and its mechanism(s) of action remain unclear. Vedolizumab may reduce inflammation by blocking recruitment of T-cells, or pro-inflammatory monocytes and dendritic cells to the intestine, and/or vedolizumab may lead to changes in the programming of innate and acquired immune cells dampening down inflammation.

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Vedolizumab use in patients with inflammatory bowel diseases undergoing surgery: clinical trials and post-marketing experience

Cited by 11 publications

References 32 publications

Systematic review and meta-analysis: association between obesity/overweight and surgical complications in IBD

Systematic review and meta-analysis: association between obesity/overweight and surgical complications in IBD

Perioperative optimization of Crohn's disease

Vedolizumab: Potential Mechanisms of Action for Reducing Pathological Inflammation in Inflammatory Bowel Diseases

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