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

Shim, Hang Hock; Chan, Pak Wo; Chuah, Sai Wei; Schwender, Brian; Kong, San Choon; Ling, Khoon Lin

doi:10.1002/jgh3.12065

Cited by 33 publications

(23 citation statements)

References 90 publications

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“…The GEMINI study reported clinical remission rates of 39% and 42% at 12 months for CD and UC, respectively [15,16] and the recent VARSITY study in UC patients reported clinical remission rates of 31.3% for vedolizumab patients at 12 months [42]. Real-world studies have reported clinical remission rates varying between 21% and 76%, measured at various time-points up to 54 weeks, for both CD and UC [43].…”

Section: Discussionmentioning

confidence: 99%

Experiences of using vedolizumab in the treatment of inflammatory bowel disease in the East Midlands UK – a retrospective observational study

White

Din

Ingram

et al. 2020

Scandinavian Journal of Gastroenterology

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Purpose: Clinical trials have demonstrated efficacy of vedolizumab in ulcerative colitis (UC) and Crohn's disease (CD). Further real-world data is needed to inform clinical practice. The primary outcome was to assess corticosteroid-free and clinical remission after vedolizumab initiation. Secondary outcomes included effect on disease activity scores, biochemical markers, concomitant drug use, endoscopic remission, surgical intervention, hospital admissions and adverse events. Materials and methods: A multi-centre retrospective observational study was conducted with patients initiated on vedolizumab across seven UK hospitals 1/11/14-30/11/16. Clinical disease activity was assessed using the partial Mayo Scores (pMS) and Harvey Bradshaw Index (HBI). Clinical remission was defined as HBI 4 or pMS <2 with a combined stool frequency and rectal bleeding sub score of 1. Clinical response was defined as 2-point decrease from baseline in pMS and 3-point decrease from baseline in HBI. Results: One hundred ninety-two patients were included in the final analysis. 45% of UC and 10% of CD patients were anti-TNF naive. Over the observation period corticosteroid-free remission rates for UC and CD were 46% and 45%, while clinical remission rates were 52% and 44%, respectively. Time to corticosteroid free remission for UC and CD was 17.6 [IQR: 8.7-29.6] and 14.1 [QR: 6.0-21.7] weeks, respectively. Time to clinical response for UC was 9.4 [IQR: 5.7-15.4] and CD was 9.5 [IQR: 6.1-18.2] weeks. There was a substantial decrease in the concomitant use of immunomodulators and a similar decrease in concomitant corticosteroid use over the study period. Conclusions: Results in this predominately anti-TNF experienced population mirror other published real-world data, demonstrating good clinical effectiveness and a comparable safety profile.

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Section: Discussionmentioning

confidence: 99%

Experiences of using vedolizumab in the treatment of inflammatory bowel disease in the East Midlands UK – a retrospective observational study

White

Din

Ingram

et al. 2020

Scandinavian Journal of Gastroenterology

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“…Vedolizumab, an α4β7 antibody, 15,16 and ustekinumab, a human IgG antibody targeting the p40 subunit of IL‐12 and IL‐23, 17 were introduced for the treatment of IBD offering an alternative treatment option with a different mechanism of action than, for example, anti‐TNF therapy 18 . Both vedolizumab and ustekinumab have displayed a favourable safety profile in the registration trials and observational cohorts 15‐17,19,20 .…”

Section: Introductionmentioning

confidence: 99%

Comorbidity, not patient age, is associated with impaired safety outcomes in vedolizumab‐ and ustekinumab‐treated patients with inflammatory bowel disease—a prospective multicentre cohort study

Asscher

Biemans

Pierik

et al. 2020

Aliment Pharmacol Ther

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Summary Background Few data are available on the effects of age and comorbidity on treatment outcomes of vedolizumab and ustekinumab in inflammatory bowel disease (IBD). Aims To evaluate the association between age and comorbidity with safety and effectiveness outcomes of vedolizumab and ustekinumab in IBD. Methods IBD patients initiating vedolizumab or ustekinumab in regular care were enrolled prospectively. Comorbidity prevalence was assessed using the Charlson Comorbidity Index (CCI). Association between age and CCI, both continuously assessed, with safety outcomes (any infection, hospitalisation, adverse events) during treatment, and effectiveness outcomes (clinical response and remission, corticosteroid‐free remission, clinical remission combined with biochemical remission) after 52 weeks of treatment were evaluated. Multivariable logistic regression was used to adjust for confounders. Results We included 203 vedolizumab‐ and 207 ustekinumab‐treated IBD patients, mean age 42.2 (SD 16.0) and 41.6 (SD 14.4). Median treatment duration 54.0 (IQR 19.9‐104.0) and 48.4 (IQR 24.4‐55.1) weeks, median follow‐up time 104.0 (IQR 103.1‐104.0) and 52.0 weeks (IQR 49.3‐100.4). On vedolizumab, CCI associated independently with any infection (OR 1.387, 95% CI 1.022‐1.883, P = 0.036) and hospitalisation (OR 1.586, 95% CI 1.127‐2.231, P = 0.008). On ustekinumab, CCI associated independently with hospitalisation (OR 1.621, 95% CI 1.034‐2.541, P = 0.035). CCI was not associated with effectiveness, and age was not associated with any outcomes. Conclusions Comorbidity ‐ but not age ‐ is associated with an increased risk of hospitalisations on either treatment, and with any infection on vedolizumab. This underlines the importance of comorbidity assessment and safety monitoring of IBD patients.

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“…First, a quicker onset of action is desirable in patients with severe and prolonged symptoms. In comparison, vedolizumab's peak effect is seen at weeks 10–14 15 . This was certainly a factor in one of our patients whose resection of a metastatic lesion was delayed by his prolonged enterocolitis.…”

Section: Discussionmentioning

confidence: 83%

“…In comparison, vedolizumab's peak effect is seen at weeks 10-14. 15 This was certainly a factor in one of our patients whose resection of a metastatic lesion was delayed by his prolonged enterocolitis. In the largest study to date, a median of three vedolizumab infusions were required to achieve a satisfactory response for those who had failed infliximab.…”

Section: Discussionmentioning

confidence: 92%

Calcineurin inhibitors in steroid and anti‐TNF‐alpha refractory immune checkpoint inhibitor colitis

et al. 2021

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Background and Aim: Immune checkpoint inhibitor (ICI) colitis is an increasingly common problem encountered as the use of checkpoint inhibitors (CPIs) grows in the management of cancers. Corticosteroids and tumour necrosis factor (TNF)-alpha inhibitors are widely recommended in the management of ICI colitis; however, the experience is limited when patients are refractory. Different authors have reported success with vedolizumab, mycophenolate, and cyclosporine. This case series describes our experience with calcineurin inhibitors in the management of corticosteroid and anti-TNF-alpha refractory ICI colitis. Methods: Data from electronic medical records were identified and reviewed retrospectively from a cohort of patients treated at a single oncology center. All patients who were identified between March 2018 and May 2020 with ICI colitis refractory to treatment with infliximab and corticosteroids were included. Results: There were 11 patients who developed ICI colitis after receiving CPIs for advanced melanoma and required rescue therapy with either cyclosporine or tacrolimus after treatment failure of infliximab. Median age was 53 (AE8.48) years, with nine patients (81%) receiving combination Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) / programmed cell death protein 1 (PD-1) immunotherapy. Median time after first CPI infusion to ICI colitis was 4.43 (AE19.53) weeks. The median time from onset of symptoms to commencement of rescue therapy with calcineurin inhibitors was 70 days (AE66.06). Eight of the 11 patients (72.7%) responded to calcineurin inhibition. In patients who responded, calcineurin inhibitors were continued for a median of 54 (AE28.96) days. Conclusion:The calcineurin inhibitors cyclosporine and tacrolimus appear to be a safe and effective option for the management of patients with infliximab-refractory ICI colitis. The therapeutic benefit is observed rapidly, and adverse effects appear to be limited with close monitoring.

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

Cited by 33 publications

References 90 publications

Experiences of using vedolizumab in the treatment of inflammatory bowel disease in the East Midlands UK – a retrospective observational study

Experiences of using vedolizumab in the treatment of inflammatory bowel disease in the East Midlands UK – a retrospective observational study

Comorbidity, not patient age, is associated with impaired safety outcomes in vedolizumab‐ and ustekinumab‐treated patients with inflammatory bowel disease—a prospective multicentre cohort study

Calcineurin inhibitors in steroid and anti‐TNF‐alpha refractory immune checkpoint inhibitor colitis

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