Efficacy and Safety of Vedolizumab in Management of Moderate to Severe Ulcerative Colitis: A Systematic Review

Bhandari, Renu; Ogeyingbo, Opemipo D; Kareem, Roaa; Gyawali, Mallika; Venkatesan, Nanditha; Ahmed, Rowan; Botleroo, Rinky A; Elshaikh, Abeer O

doi:10.7759/cureus.17729

Cited by 6 publications

(6 citation statements)

References 27 publications

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“…The safety profile of ustekinumab may be comparable to other treatments for UC; for example, SAEs were identified in 9.0% to 17% of patients treated with vedolizumab, 28 in 14% of those treated with adalimumab, 28 and in 4.0% of those treated with tofacitinib. 29 In our systematic review, SAEs were identified in 3.4% to 8.5% of patients treated with ustekinumab.…”

Section: Discussionmentioning

confidence: 95%

“…The occurrence of serious infections was lower among patients treated with ustekinumab (3.5%) than among those treated with vedolizumab (19%). 28 In addition, like with vedolizumab, 28 most studies reporting on the advent of malignancy reported an incidence of less than 1% among patients treated with ustekinumab. Finally, treatment discontinuation due to AEs was identified in 1.1% to 8.1% of patients treated with ustekinumab, in 0% of those treated with vedolizumab, 30 and in 5% of those treated with adalimumab.…”

Section: Discussionmentioning

confidence: 99%

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Efficacy, Effectiveness, and Safety of Ustekinumab for the Treatment of Ulcerative Colitis: A Systematic Review

Gisbert

Parody-Rúa

Chaparro

2023

Inflammatory Bowel Diseases

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Objective This study aimed to evaluate ustekinumab efficacy, effectiveness, and safety as a treatment for ulcerative colitis in adult patients. Methods A systematic review of the efficacy, effectiveness, and safety of ustekinumab in ulcerative colitis was carried out. The search was conducted via PubMed, Embase, and the Cochrane library. Two reviewers independently assessed the quality of studies and extracted study data. Results Of the 892 studies identified, 17 were included: 1 randomized controlled trial (RCT), 3 long-term extensions, and 13 observational studies. In the randomized clinical trial evaluating efficacy at week 8, clinical remission was achieved in 16% of patients, whereas clinical response was achieved in 51% and 62% of patients who received intravenous ustekinumab at a dose of 130 mg and 6 mg/kg, respectively. At 3 years’ follow-up, symptomatic remission was achieved in 68% of patients. On the other hand, the effectiveness of ustekinumab was evaluated in 13 observational studies. In these studies, clinical remission at induction was achieved in 24% to 61% of cases, whereas clinical response at induction was achieved in 47% to 77% of cases. Moreover, clinical remission was achieved in 33% to 79% of cases at 52 weeks of follow-up. The adverse events ranged from 2.6% to 77% of all the studies that reported safety data. Adverse events leading to discontinuation ranged from 2.6% to 8.1%, and serious adverse events were uncommon and ranged from 3.7% to 6.0%. Conclusions Ustekinumab has demonstrated efficacy (in RCTs), effectiveness (in real clinical practice), and safety for the treatment of ulcerative colitis.

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Section: Discussionmentioning

confidence: 95%

Section: Discussionmentioning

confidence: 99%

Efficacy, Effectiveness, and Safety of Ustekinumab for the Treatment of Ulcerative Colitis: A Systematic Review

Gisbert

Parody-Rúa

Chaparro

2023

Inflammatory Bowel Diseases

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“…The goal of CD therapy is to achieve deep remission, that is, to induce and maintain symptomatic and endoscopic remission and mucosal healing. Common anti-inflammatory medications used in CD management include amino-salicylates, immunomodulators, corticosteroids, and biologics ( 1 , 63 , 64 ). Amino-salicylates are less used in CD due to their lack of efficacy in inducing/maintaining remission and preventing postoperative recurrence.…”

Section: Conventional Therapies In CD and Their Modulating Effects On...mentioning

confidence: 99%

Manipulation of Gut Microbiota as a Key Target for Crohn's Disease

2022

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Crohn's disease (CD) is an inflammatory bowel disease (IBD) sub-type characterized by transmural chronic inflammation of the gastrointestinal tract. Research indicates a complex CD etiology involving genetic predisposition and immune dysregulation in response to environmental triggers. The chronic mucosal inflammation has been associated with a dysregulated state, or dysbiosis, of the gut microbiome (bacteria), mycobiome (fungi), virome (bacteriophages and viruses), and archeaome (archaea) further affecting the interkingdom syntrophic relationships and host metabolism. Microbiota dysbiosis in CD is largely described by an increase in facultative anaerobic pathobionts at the expense of strict anaerobic Firmicutes, such as Faecalibacterium prausnitzii. In the mycobiome, reduced fungal diversity and fungal-bacteria interactions, along with a significantly increased abundance of Candida spp. and a decrease in Saccharomyces cerevisiae are well documented. Virome analysis also indicates a significant decrease in phage diversity, but an overall increase in phages infecting bacterial groups associated with intestinal inflammation. Finally, an increase in methanogenic archaea such as Methanosphaera stadtmanae exhibits high immunogenic potential and is associated with CD etiology. Common anti-inflammatory medications used in CD management (amino-salicylates, immunomodulators, and biologics) could also directly or indirectly affect the gut microbiome in CD. Other medications often used concomitantly in IBD, such as antibiotics, antidepressants, oral contraceptives, opioids, and proton pump inhibitors, have shown to alter the gut microbiota and account for increased susceptibility to disease onset or worsening of disease progression. In contrast, some environmental modifications through alternative therapies including fecal microbiota transplant (FMT), diet and dietary supplements with prebiotics, probiotics, and synbiotics have shown potential protective effects by reversing microbiota dysbiosis or by directly promoting beneficial microbes, together with minimal long-term adverse effects. In this review, we discuss the different approaches to modulating the global consortium of bacteria, fungi, viruses, and archaea in patients with CD through therapies that include antibiotics, probiotics, prebiotics, synbiotics, personalized diets, and FMT. We hope to provide evidence to encourage clinicians and researchers to incorporate these therapies into CD treatment options, along with making them aware of the limitations of these therapies, and indicate where more research is needed.

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“…56 Vedolizumab is associated with fewer adverse effects, with no increased risk of serious infections or malignancy seen in integrated analyses of placebo-controlled trials. 57 Vedolizumab may be associated with an increased risk of GI infections, which is hypothesized to be due to its relative gut specificity. 58…”

Section: Safety Considerationsmentioning

confidence: 99%

Accelerating the Evolution of Immune-Related Enterocolitis Management

Faleck

Dougan

Tello

et al. 2023

JCO

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Efficacy and Safety of Vedolizumab in Management of Moderate to Severe Ulcerative Colitis: A Systematic Review

Abstract: Bhandari et al. This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 4.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Cited by 6 publications

References 27 publications

Efficacy, Effectiveness, and Safety of Ustekinumab for the Treatment of Ulcerative Colitis: A Systematic Review

Efficacy, Effectiveness, and Safety of Ustekinumab for the Treatment of Ulcerative Colitis: A Systematic Review

Manipulation of Gut Microbiota as a Key Target for Crohn's Disease

Accelerating the Evolution of Immune-Related Enterocolitis Management

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