Developed in collaboration with clinicians in Wales.

 

Starting criteria

Patients with moderate to severe or life threatening (grade 2-4) diarrhoea or colitis with any of the following symptoms/features present:

• 4 or more stools/day over baseline
• severe abdominal pain
• fever
• dehydration
• blood or mucus in the stool
• flexible sigmoidoscopy indicates presence of high-risk endoscopic features, mucosal ulceration or extensive colitis
• colostomy patients

AND symptoms are persisting for three or more days despite high dose methylprednisolone (1-2 mg/kg/day) (grade 3-4 disease) or five or more days despite oral prednisolone 40-60 mg/day (grade 2 disease). Or oral prednisolone dose cannot be tapered to 10 mg/day or less without re-flare of symptoms.

AND symptoms are persisting despite infliximab 5 mg-10 mg/kg given for up to three doses, or where infliximab is deemed unsuitable (due to high tumour burden, patient age, patient frailty or a contra-indication to the use of infliximab - see One Wales guidance for infliximab OW21). Vedolizumab may be considered as an option for grade 2 disease in those patients not responding to corticosteroids  but clinicians should consider the additional cost of vedolizumab when compared to infliximab and weigh this against any additional perceived benefits before starting treatment. Infliximab should be the first option for patients with more severe disease (grade 3-4).

Screening

Prior to commencing vedolizumab, pre-screening should be undertaken to exclude:

• active or latent tuberculosis
• hepatitis virus or HIV
• current acute infections (viral, bacterial, fungal or parasitic)
• gastrointestinal perforation

In cases of life-threatening toxicity, consider risk/benefit if screening could result in significant delay to treatment.

Dose

The recommended treatment dose regimen for vedolizumab is 300 mg given intravenously on weeks zero, two and six. Not all cases will require three doses, treatment can be stopped before completing the course if there is sufficient response after the first or second dose. Standard treatment though is 3 doses.

Only one course (three doses) may be issued in accordance with this advice. Requests for repeat courses or continuing treatment beyond three doses should be explored through funding mechanisms such as the individual patient funding request process.

Outcome data

The following should be collected to inform future policy changes:

• patient numbers
• number of doses received by the patient
• grade of disease at start of treatment
• prior enterocolitis treatments before starting vedolizumab
• enterocolitis response to treatment with vedolizumab
• ability to restart immunotherapy after treatment with vedolizumab
• time from decision to treatment administration with vedolizumab

Monitoring:

• infusion-related reactions including anaphylactic shock
• injection site for signs of phlebitis
• any new onset or worsening of neurological signs and symptoms
• daily stool chart
• daily bloods e.g., FBC, U&E, LFTs, CRP
• blood cultures if pyrexial
• National Early Warning Score (NEWS) assessment
• fluid balance
• faecal calprotectin

Prescribers should consult the relevant Summary of Product Characteristics (SmPC) for any additional monitoring requirements and potential adverse effects¹. There is a potential risk of progressive multifocal leukoencephalopathy (PML). Patients should receive a patient information leaflet and a Patient Alert Card.

Stopping criteria

• treatment failure, progression of symptoms or minimal response
• toxicity to treatment (that cannot or does not respond to temporary treatment interruption)
• patient request

Failure to respond to vedolizumab

If there is no response or symptoms are deteriorating after one, two or three doses of vedolizumab, or following dose escalation, then seek advice from Gastroenterology and/or consultant leads from the Immunotherapy toxicity service.

References

1. Merck Sharp Dohme. Vedolizumab (Entyvio) 300 mg powder for concentrate for solution for infusion. Available at: https://www.medicines.org.uk/emc/product/5442/smpc. Accessed March 2026

Clinicians will be obliged to collect and monitor patient outcomes. Evidence of clinical outcomes will be taken into consideration when reviewing the One Wales Medicines Assessment Group decision.

 

Health boards will take responsibility for implementing One Wales Medicines Assessment Group decisions and ensuring that a process is in place for monitoring clinical outcomes. 

This report was prepared by the All Wales Therapeutics and Toxicology Centre in December 2025. It summarises any new evidence available and patient outcome data collected since the One Wales decision in September 2024.

Background: Immune checkpoint inhibitor (ICI) therapy is a recent advancement in cancer immunotherapy. ICIs negatively target regulators of the immune response, which results in immune system activation and anti‑tumour immunity. This specific immune system activation can potentially affect any organ system at the same time, most commonly the skin, gut, liver and endocrine system. Immune‑related enterocolitis is one of the most common and severe immune‑related adverse events associated with ICI therapy.

For moderate and severe (grade 2–4) ICI-induced enterocolitis, corticosteroids are the standard frontline treatment. Grade 2–4 ICI-induced enterocolitis that has not responded to corticosteroids and infliximab, or requires multiple challenges with corticosteroids, or if infliximab in unsuitable, is currently treated off-licence in Wales with vedolizumab, after clinicians in Wales submitted it for consideration through the One Wales process. They considered there was an unmet need in Wales and identified a cohort of patients who could benefit from this treatment.

Current One Wales Decision: supported for use

Licence status: off-label use for this licensed medicine

Guidelines: British Society of Gastroenterology (BSG) practice guidance on the management of acute and chronic gastrointestinal symptoms and complications as a result of treatment for cancer was published in 2025. The guidance states that for grade 3 and 4 diarrhoea (and grade 2 diarrhoea that does not respond to oral prednisolone) patients should be admitted to hospital and started on intravenous methylprednisolone 1 mg/kg daily. If there is endoscopic evidence of enterocolitis and still no response to corticosteroids within 2–3 days, second-line treatment with infliximab (5–10 mg/kg) or vedolizumab should be started and expert advice sought. The guidance states that infliximab and vedolizumab are equally efficacious.

No relevant update to other guidelines were identified.

Licensed alternative medicines or health technology assessment advice for alternative medicines: no new medicines or HTA advice reported.

Effectiveness: AWTTC conducted a literature search in November 2025 to find new evidence for the use of vedolizumab to treat ICI-induced enterocolitis. The search excluded: articles published before 2024; articles that reviewed evidence previously presented in AWTTC’s first Evidence Summary Report; and also case reports and conference abstracts. Two studies were identified: a systematic review that compared the efficacy of vedolizumab with infliximab to treat ICI-induced enterocolitis, and a retrospective cohort study of 1,151 patients who developed ICI‑induced enterocolitis. Both studies are discussed below.

A systematic review and meta-analysis of the efficacy of infliximab versus vedolizumab in the treatment of ICI-induced enterocolitis (Shambhavi et al. (2025) identified six retrospective cohort studies with 645 patients in total.

The results showed that patients treated with vedolizumab had lower rates of recurrence of enterocolitis compared with patients given infliximab (odds ratio [OR]: 0.29, 95% confidence interval [CI]: 0.15, 0.54). The analysis also showed that vedolizumab is associated with a lesser duration of steroid exposure when compared to infliximab (mean difference: −16.88 days; 95% CI: −20.47, −13.30). However, while vedolizumab showed improved remission, there was no statistically significant difference in remission rates between vedolizumab and infliximab monotherapy (OR: 3.16, 95% CI: 0.29, 34.01). It is worth noting that this analysis included patients for whom infliximab had failed and who went on to receive vedolizumab, which may have skewed the results. Overall, the mean number of doses needed to achieve remission were lower for infliximab than for vedolizumab (mean difference:1.16, 95% CI: 0.09, 2.22).

A limitation of this study is that it analysed only observational studies, which might have influenced the effect size. Although the pooled overall OR for remission showed a favourable profile for vedolizumab over infliximab, it was statistically insignificant due to the small sample size. The pooled studies did show low heterogeneity for recurrence and steroid exposure duration but considerable heterogeneity for remission and number of doses needed to achieve remission. The authors suggest that the evidence supports the superiority of vedolizumab over infliximab as a maintenance treatment for ICI_­-induced enterocolitis.    

A single-centre retrospective study (Shatila et al. (2025) included 1,151 patients (675 males; aged 55–72 years) who developed confirmed ICI-induced enterocolitis. Of 1,151 patients, 841 patients (73.0%) were treated with corticosteroids, and 384 patients (33.3%) needed treatment with intravenous corticosteroids; 534 patients (46.4%) needed additional immunosuppressive therapy.

Outcomes of ICI-induced enterocolitis were compared between 182 patients given infliximab (159 with grade 2 or higher diarrhoea and 102 with grade 2 or higher colitis) and 265 patients given vedolizumab (217 with grade 2 or higher diarrhoea and 110 with grade 2 or higher colitis). Patients treated with infliximab tended to have more severe enterocolitis.

The median time between onset of ICI-induced enterocolitis and administration of additional immunosuppressive therapy was significantly different between treatments: 14 days (range 7–43 days) for infliximab compared with 33 days (15–60 days) for vedolizumab (P<0.001). The median time between administration and improvement of symptoms was only 4.5 days (range 2–22.7 days) for infliximab compared with 30 days (14–65 days) for vedolizumab (P<0.0001). The median number of doses given was lower for infliximab: two (range one–two doses) compared with three (two–four doses) for vedolizumab (P<0.0001). The median duration of ICI enterocolitis symptoms was shorter for infliximab: 24.5 days (range 12–67 days) compared with 56 days (range 21–108 days) for vedolizumab (P<0.001). There were no significant differences between infliximab and vedolizumab in terms of duration of steroid treatment (33 vs 31 days), hospitalisation rates (71.8% vs 64.2%), clinical improvement or remission (91.8% vs 95.1%) or endoscopic remission (72.4% vs 79.3%).

The authors concluded that infliximab and vedolizumab appeared equally efficacious in achieving clinical symptom remission in ICI-induced enterocolitis. However, infliximab may offer a slight advantage in reducing overall symptom duration.

Safety: No relevant safety analyses were identified in the repeat literature search.

In their systematic review, Shambhavi et al. reported that only two of the six included studies reported infection data, so a quantitative analysis of safety data could not be performed; one of these two studies reported lower rates of infection with vedolizumab than with infliximab.

[Confidential information removed].

Ongoing studies: A phase II trial (NCT06841705); EVITA - early vedolizumab as first line for immune-related colitis therapy), started in July 2025. The study is evaluating the effectiveness and safety of vedolizumab plus a short course of corticosteroids, compared with a standard course of corticosteroids only to treat ICI-induced enterocolitis. The study is expected to enrol around 80 adults and to complete at the end of 2026.

A phase I/II trial (NCT04407247), comparing infliximab with vedolizumab to treat grade 2 or higher ICI-related enterocolitis, is ongoing and expected to complete by end 2027.   

Cost-effectiveness: No relevant cost-effectiveness analyses were identified in the repeat literature search.

Budget impact: Clinicians in south-east Wales and north Wales reported that they have given vedolizumab to 13 patients with ICI-induced enterocolitis in the 17 months between September 2024 and January 2026. This compares to a predicted 12 patients per year. Extrapolating patient numbers to consider patients from south‑west Wales, would give an estimated 16 patients over 17 months, which is lower than that originally estimated. All patients received between two and three doses of vedolizumab, in accordance with the dosing regimen used to inform the original budget impact.

Impact on health and social care services: Minimal.

Patient outcome data: Clinicians in south-east Wales and north Wales have reported outcome data for 13 patients (age range 45–84 years) with ICI-induced enterocolitis treated with vedolizumab. [Confidential information removed]. 

Evaluation of evidence: No significant new evidence has been published that challenges the previous evidence presented. Extrapolating patient numbers for Wales based on those given for two of the three Welsh cancer treatment centres, would indicate that patient numbers are lower than those originally predicted. Based on available outcome data, vedolizumab appears to be an effective treatment option for most patients who have received it, with 92% of patients reporting either a full (54%) or partial (38%) resolution of symptoms. In all cases, vedolizumab was given when treatment with infliximab was either unsuitable or had not resolved symptoms. AWTTC recommends continuing access to vedolizumab in NHS Wales through the One Wales Medicines process for the treatment of ICI-induced enterocolitis as per the recommendation.

Next review date: March 2028

References: a full reference list is available on request.

Disclaimer: This document includes evidence published since the last review or full assessment of this medicine for the indication under consideration. It does not replace the original full evidence status report. Any previous reviews and the original full evidence status report are available from this webpage in the document history section.

Care has been taken to ensure the information is accurate and complete at the time of publication. However, the All Wales Therapeutics and Toxicology Centre (AWTTC) do not make any guarantees to that effect. The information in this document is subject to review and may be updated or withdrawn at any time. AWTTC accept no liability in association with the use of its content. An Equality and Health Impact Assessment (EHIA) has been completed in relation to the One Wales policy and this found there to be a positive impact. Key actions have been identified and these can be found in the One Wales Policy EHIA document.

Information presented in this document can be reproduced using the following citation: Evidence Review. Vedolizumab for ICI-induced enterocolitis: OW22. 2026.

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