MRI for early response prediction to anti-TNF therapy
Research type
Research Study
Full title
MOTILITY: Small bowel motility quantified by cine MRI as a predictor of long term response in patients with Crohn’s disease commencing biological therapy
IRAS ID
201079
Contact name
Stuart Taylor
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary
Crohn’s Disease (CD) is a type of inflammatory bowel disease that affects the digestive system and can cause painful symptoms. People who have severe symptoms of CD are sometimes treated with powerful medicines called anti-TNFs which can be very effective. However, anti-TNFs can occasionally cause life-threatening side effects and are very expensive. Although many patients improve on these medicines, about half of those who start treatment will show no improvement after 1 year, and many continue to be given the medication for long periods of time, with no benefit. It is therefore important to identify a way, at an early stage, to see if the treatment is going to work and - if not - change to a different treatment. This will help patients and may reduce costs to the NHS.
We have developed a new test using MRI scanning and computer software (mMRI) to monitor the movement of the bowel (motility). The more inflamed the bowel is, the less it moves. Our initial data suggests that if the motility improves, this might predict a successful response to treatment.
Our study aims to see if the change in bowel motility measured using MRI (the new test), is better than current tests (blood and stool samples) to predict if the anti-TNF medicines will still be working after 1 year.
We aim to look at 156 patients with CD (in upto 15 hospitals over 4 years) who are due to start anti-TNF therapy. We will carry out the new mMRI along with all the normal tests that they would have, including blood and stool tests, and record what happens to the patient – particularly, if the medication works after 1 year - to compare which test is the best predictor.
The study is being coordinated by the University College London and supported by the National Institute for Health Research.
Summary of Results
Crohn’s disease is a condition that causes inflammation of the bowels, and this inflammation can eventually lead to irreversible bowel damage. Powerful treatments that suppress inflammation called biologic drugs are now available, but it is not possible to give these to all patients because of side effects, costs and patient inconvenience. Also, they do not always work, but we cannot predict this reliably.
In this study, we tested if a novel scanning technique using magnetic resonance imaging (MRI) that measures bowel motion (called motility MRI, mMRI) can help predict which patients are likely to benefit in the longer term from these biologic drugs.
The study recruited 86 patients from 13 NHS centres, all of whom had mMRI before and after starting their biologic treatment. After 1 year, we checked to see if the biologics had worked for each patient. We tested how good mMRI was at predicting whether or not the biologics were going to work, and compared this with other simple blood and faeces tests. We also tested some other MRI techniques called diffusion-weighted imaging (DWI) and body composition measurements.
We found that none of the tests (mMRI, blood tests or faeces tests) were good at predicting if biologics were going to work or not. DWI and body composition measurements were not useful either. We did confirm some previous work that mMRI is good at telling us if the bowel is inflamed or not, and we also found that many different doctors (not just experts) can measure it reliably.
The study means that mMRI and DWI are not useful ways to predict which patients are likely to benefit from biologic drugs.
It can still be used to measure if the bowel is inflamed or not.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
17/WM/0106
Date of REC Opinion
27 Mar 2017
REC opinion
Favourable Opinion