Dr Dan Turner and colleagues from Israel identified early clinical, laboratory, and endoscopic factors associated with sustained remission in children with ulcerative colitis (UC) treated with infliximab.
The research team performed a post hoc analysis of data collected from 51 children with moderate-to-severe ulcerative colitis treated with infliximab for 1 year in the T72 clinical trial.
The primary outcome was steroid-free remission at weeks 30 and 54 of treatment, which was based on patient and physician assessments.
The research team compared the ability of the Pediatric UC Activity Index (PUCAI, a noninvasive clinical index), levels of C-reactive protein (CRP), and mucosal healing to predict which patients would be in steroid-free sustained remission after 1 year of treatment.
The researchers found that Week 8 PUCAI scores best predicted which patients would be in steroid-free remission after 1 year of treatment.
|44% of patients with mucosal healing were in remission after 1 year|
|Clinical Gastroenterology & Hepatology|
The team found that 53% of patients who had PUCAI scores less than 10 points were in sustained remission, compared with 20% who had PUCAI scores of 10 or more.
Mucosal healing at week 8 was associated with steroid-free remission at 1 year, but this did not reach significance.
The research team found that 44% of patients with mucosal healing were in remission after 1 year, compared with 29% without mucosal healing.
The area under the receiver operating characteristic curve values for association with steroid-free sustained remission were 0.70 for the PUCAI, 0.56 for mucosal healing, and 0.44 for level of CRP.
By using a multivariable logistic regression model, the week 8 PUCAI was the only factor associated with steroid-free remission at 1 year.
PUCAI-defined remission had a high degree of concordance with complete mucosal healing at week 8.
Dr Turner's team commented, "On the basis of a post hoc analysis of data from the T72 clinical trial on the effect of infliximab in pediatric patients with UC, the PUCAI was no less predictive of sustained remission than mucosal healing at week 8, and both were superior to CRP level."
"Routine endoscopic evaluation in children with UC who are in complete clinical remission may not be necessary."