A domestic research team may have come close to creating a standard for Crohn’s disease regarding who and when certain patients should stop taking infliximab, known as Remicade.
Infliximab, which has shown superior treatment effects for Crohn’s disease, can also create side effects such as infections or tumors if administered for long periods of time. However, stopping infliximab administration is also a difficult decision for adolescents considering the potential of reoccurrence.
"There is no consensus among scholars about when biologic injections should be stopped. Patients still have to suffer the potential risks of treatment,” Samsung Medical Center Professor Choe Yon Ho who led the study said. "This study is expected to increase the accuracy and efficacy of patient treatment by opening up a method to decide which patients should continue treatment and which should not.”
|Samsung Medical Center Professor Choe Yon Ho explains Chron’s disease at his office in Irwon-dong, southern Seoul, on Monday.|
Crohn’s disease is a chronic inflammatory bowel disease that can occur anywhere from the mouth to the anus and on the digestive tract. About 25 percent of patients are adolescents under 20.
The team, jointly led by Kyungpook National University School of Medicine Professor Kang Bin, studied 63 children and adolescents with moderate to severe Crohn’s disease for more than seven years starting from 2009. The patients were 15 years old on average and had taken infliximab for more than 12 months following diagnosis.
The research team found that about 60 percent of those who stopped taking infliximab, or 38 patients, had their disease come back.
According to the Kaplan-Meier analysis, the disease reoccurred within one year of stopping infliximab administration in about 19 percent of patients, within four years for about 62 percent of patients, and within six years in about 75 percent of patients. The median relapse time was 3.3 years from infliximab cessation.
Based on the findings, the research team conducted a comparative analysis of patients who relapsed and those who did not to find significant differences among the two groups.
“According to multivariate Cox proportional hazard regression analysis, infliximab trough levels of ≥2.5 μg/mL and incomplete mucosal healing were associated with clinical relapse,” the researchers said.
The rate of reoccurrence within six years for patients who had their intestinal ulcers disappear and their mucosal lesions wholly cured of early use of infliximab was 55.5 percent. Of the remaining, around half of patients did not have their condition come back even after stopping infliximab administration.
The relative risk of relapse also fell 7.19-fold when the lowest blood concentration of infliximab was less than 2.5 μg/mL.
“Considering the high cumulative relapse rates in the long term and cases of severe relapse requiring surgery, discontinuing infliximab in pediatric-onset Crohn's disease patients is currently inadvisable. However, there may be a subgroup of patients who are good candidates for infliximab withdrawal,” the researchers added.
The study was published in a recent issue of the Journal of Crohn's and Colitis.