This study is published by a group of hospitals in France and Belgium and looks at the risk of relapse after stopping infliximab in patients with stable Crohn’s disease who are well and also on a second immune-suppressing drug (usually azathioprine) [STORI is the terrible acronym that they have used, which seems to be necessary for clinical trials]. There were 115 patients with Crohn’s disease in the study, who had all been treated with infliximab for at least a year in combination with azathioprine, 6-mercaptapurine or methotrexate. They had all been well (in remission) for at least 6 months without steroids. All of these patients stopped their infliximab, continued their other medication, and were followed up for around 2 years to see if they relapsed (became unwell again from Crohn’s disease).
The rate of relapse was about 44% a year after stopping infliximab – almost half the patients. The authors were however able to determine factors that seemed to be able to predict relapse. The main factors appear to be male sex, the absence of surgery, three different blood tests, and a stool test. For example, with very few of these risk factors, 30% of the patients would have about a 15% risk of relapse in a year (compared to 44% above). These calculations require some quite complicated statistics, and the authors acknowledge the number of patients in the study was quite small given the predictions that they are making, and so should be interpreted with caution. It was reassuring that re-treatment with infliximab in those who relapsed was effective in almost all (88%). Also, there were no incidences of reactions to the drug after what was usually more than a 6 month break, which has previously been a concern when restarting infliximab.
In summary, STORI helps us decide which patients are safest to stop infliximab when well, and which are least safe, and also reassures us that restarting is usually successful and also appears to be safe. It must be remembered, however, that this was a particularly selected group of adult patients and so these results may not apply to all. We also have to be cautious when transferring these findings to children, as they are known to often have more extensive Crohn’s disease than adults.
Click here for full article