8 October 2024
The One Wales Medicines Assessment Group (OWMAG) have re-assessed the use of infliximab and vedolizumab to treat inflammation of the digestive tract (enterocolitis) caused by cancer treatment with medicines called immune checkpoint inhibitors. OWMAG recommended that use of infliximab and vedolizumab can be extended to include a wider group of patients. In September 2024, the All Wales Medicines Strategy Group endorsed OWMAG’s decisions and Welsh Government has since ratified them.
Immune checkpoint inhibitor (ICI) therapy is a recent advancement in cancer treatment. These medicines activate a person’s immune system to attack a tumour. Enterocolitis is a potentially severe side effect of treatment with ICIs. Symptoms include nausea, vomiting, diarrhoea, abdominal pain, and blood and mucous in the stool. These symptoms often cause cancer treatment with ICIs to be stopped.
In November 2022, OWMAG recommended infliximab to treat severe (‘grade 3’) or life‑threatening (‘grade 4’) ICI-induced enterocolitis that had not responded to corticosteroids (steroids). OWMAG recommended vedolizumab to treat grades 3–4 ICI-induced enterocolitis that had not responded to steroids or infliximab, or if infliximab treatment was not suitable.
Since those recommendations, European guidelines changed to include treating moderate (‘grade 2’) enterocolitis with infliximab and vedolizumab. OWMAG proposed re-assessing both its previous recommendations to include this additional group of people. And clinicians in Wales asked that the re-assessments also include people with grades 2–4 enterocolitis whose symptoms responded to steroids at first, but then flared again when the steroid dose was reduced.
OWMAG reviewed the evidence, compiled by AWTTC, for using vedolizumab and infliximab for these additional groups of people. OWMAG also heard views from clinicians treating people with ICI-induced enterocolitis, and from a patient organisation for people with malignant melanoma, which is often treated with ICIs.
OWMAG recommended that infliximab can be used to treat ICI-induced grades 2–4 enterocolitis, where symptoms have not responded to steroids and also when symptoms responded to steroids at first but then flare when the steroid dose is reduced.
OWMAG recommended that vedolizumab (Entyvio®) can be used as an option to treat ICI‑induced grade 2 enterocolitis, when symptoms have not responded to steroids or if symptoms re-flare when the steroid dose is reduced. Vedolizumab can also be given for grades 3–4 enterocolitis that does not respond to steroids or that responds to steroids at first, but then flares when the steroid dose is reduced. In both cases infliximab should be tried first to treat the enterocolitis unless it is not suitable.
Better management of enterocolitis will make ICIs a safer treatment option for some people. Clinicians said that being able to treat enterocolitis with infliximab or vedolizumab at an earlier stage (grade 2 symptoms) means that people are unlikely to develop more severe symptoms and much more likely to be able to continue their cancer treatment.
Infliximab and vedolizumab are not licensed to treat enterocolitis and are being used ‘off-label’. Prescribers are reminded that the risks and benefits for each medicine should be clearly stated and discussed with their patients and carers to allow informed consent, and prescribers should consult the guidelines on prescribing unlicensed medicines. Read our patient information leaflet about unlicensed and off-label use of medicines.
AWTTC will review the advice for infliximab and vedolizumab after 12 months, or earlier if new evidence becomes available.
More about the One Wales Medicines process, including a video explaining how the process works, is available at https://awttc.nhs.wales/one-wales