Endoscopic and clinical variables that predict sustained remission in children with ulcerative colitis treated with
Dan Turner1, Anne M Griffiths, Gigi Veerman
1Pediatric Gastroenterology Unit, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel.
Insights
Early assessment using the Pediatric UC Activity Index (PUCAI) effectively predicts sustained remission in children with ulcerative colitis (UC) treated with infliximab. A low week 8 PUCAI score indicates a higher likelihood of long-term steroid-free remission.
Area of Science:
- Pediatric Gastroenterology
- Inflammatory Bowel Disease Research
- Clinical Trial Analysis
Background:
- Identifying predictors of sustained remission is crucial for optimizing treatment in pediatric ulcerative colitis (UC).
- Infliximab is a key therapy for moderate-to-severe UC in children.
- Early assessment factors need validation for predicting long-term outcomes.
Purpose of the Study:
- To identify early clinical, laboratory, and endoscopic predictors of sustained remission in pediatric UC patients treated with infliximab.
- To compare the predictive value of the Pediatric UC Activity Index (PUCAI), C-reactive protein (CRP), and mucosal healing for steroid-free remission.
Main Methods:
- Post hoc analysis of 51 children (6-17 years) with moderate-to-severe UC from the T72 clinical trial.
- Primary outcome: steroid-free remission at weeks 30 and 54, assessed by patients and physicians.
- Comparison of week 8 PUCAI scores, CRP levels, and mucosal healing for predicting 1-year sustained remission.
Main Results:
- Week 8 PUCAI scores (<10 points) were the strongest predictor of steroid-free remission at 1 year (53% vs 20%, P=.036).
- Mucosal healing at week 8 showed a trend towards predicting remission (44% vs 29%, P=.34).
- The week 8 PUCAI was the only significant factor in multivariable analysis (P=.038); CRP was not predictive.
Conclusions:
- The Pediatric UC Activity Index (PUCAI) at week 8 is a reliable predictor of sustained remission in pediatric UC patients on infliximab.
- PUCAI demonstrated superior predictive value compared to CRP levels and was comparable to mucosal healing.
- Routine endoscopy may not be necessary for children achieving clinical remission (PUCAI <10) at week 8.
Background & Aims:
We aimed to identify early clinical, laboratory, and endoscopic factors associated with sustained remission in children with ulcerative colitis (UC) treated with infliximab.
Methods:
We performed a post hoc analysis of data collected from 51 children (6-17 years old) with moderate-to-severe UC 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. We 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.
Results:
Week 8 PUCAI scores best predicted which patients would be in steroid-free remission after 1 year of treatment; 9 of 17 patients who had PUCAI scores <10 points were in sustained remission (53%), compared with 4 of 20 who had PUCAI scores ≥10 (20%) (P = .036). Mucosal healing at week 8 was associated with steroid-free remission at 1 year, but this did not reach significance; 7 of 16 patients with mucosal healing were in remission after 1 year (44%), compared with 6 of 21 without mucosal healing (29%) (P = .34). The area under the receiver operating characteristic curve values for association with steroid-free sustained remission were 0.70 for the PUCAI (95% confidence interval [CI], 0.53-0.88), 0.56 for mucosal healing (95% CI, 0.36-0.76), and 0.44 for level of CRP (95% CI, 0.24-0.65). By using a multivariable logistic regression model, the week 8 PUCAI was the only factor associated with steroid-free remission at 1 year (P = .038). PUCAI-defined remission had a high degree of concordance with complete mucosal healing at week 8 (33% of patients were in remission according to the PUCAI vs 31% with mucosal healing).
Conclusion:
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 (ie, PUCAI <10 points) may not be necessary.
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