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Development and Validation of the Mucosal Inflammation Noninvasive Index For Pediatric Crohn's Disease
Martinus A Cozijnsen1, Assaf Ben Shoham2, Ben Kang3
1Erasmus MC-Sophia Children's Hospital, Rotterdam, the Netherlands.
Insights
A new non-invasive index, the MINI index, accurately identifies mucosal healing in children with Crohn's disease (CD), reducing the need for frequent endoscopies. This tool aids in assessing treatment effectiveness for pediatric CD patients.
Area of Science:
- Pediatric Gastroenterology
- Inflammatory Bowel Disease Research
- Biomarker Development
Background:
- Mucosal healing (MH) is a key therapeutic goal in Crohn's disease (CD).
- Frequent endoscopic evaluations for assessing MH in pediatric CD patients are often impractical.
- There is a need for non-invasive methods to monitor mucosal inflammation in children with CD.
Purpose of the Study:
- To develop and validate a non-invasive index for assessing mucosal inflammation in pediatric CD patients.
- To identify children with Crohn's disease who have achieved mucosal healing.
- To create a reliable alternative to frequent endoscopic procedures.
Main Methods:
- Data from the prospective, multi-center ImageKids study were analyzed.
- Ileocolonoscopy and magnetic resonance enterography data were correlated with clinical and laboratory markers.
- A weighted, categorized index (MINI index) was developed using a blended mathematical-judgmental clinimetric approach and validated in independent cohorts.
Main Results:
- The MINI index incorporates items from the Pediatric CD Activity Index (PCDAI), erythrocyte sedimentation rate, fecal calprotectin, and C-reactive protein.
- MINI scores below 8 demonstrated high sensitivity (88%) and specificity (85%) in identifying MH in the derivation cohort.
- Validation in independent cohorts confirmed the index's accuracy, with scores below 8 correctly identifying MH in 78% of patients.
Conclusions:
- The developed MINI index offers a sensitive and specific non-invasive method for assessing mucosal inflammation in pediatric CD.
- The index aids in identifying children with Crohn's disease who have achieved mucosal healing.
- MINI provides added value over fecal calprotectin alone, particularly in specific patient subgroups.
Background & Aims:
Mucosal healing (MH) has become a goal of therapy for Crohn's disease (CD), but frequent endoscopies are not feasible. We aimed to develop and validate a non-invasive index to assess mucosal inflammation in children with CD.
Methods:
We collected data from the multi-center prospective ImageKids study, in which children with CD underwent ileocolonoscopy with magnetic resonance enterography. We investigated the association of pediatric CD activity index (PCDAI) items and laboratory test results with the simple endoscopic score for CD (SESCD). We used these data in a blended mathematical judgmental clinimetric approach to develop a weighted categorized index to identify children with CD who have MH, which we called the MINI index. We validated the index using data from 3 independent patient cohorts. The derivation and validation cohorts included 154 and 168 children, respectively (age 14.1 ± 2.5 years and 14.2 ± 3.9 years), of whom 16% and 36% had MH (defined as SESCD<3).
Results:
In multivariable models, the stooling item of the PCDAI, erythrocyte sedimentation rate, and level of fecal calprotectin were associated with SESCD (all P < .05). We added data on level of C-reactive protein to develop the MINI index. MINI scores below 8 identified children with MH with 88% sensitivity and 85% specificity in the derivation cohort and with 84% sensitivity and 87% specificity in the validation cohorts. Ninety percent of the patients in the validation cohort with scores of 8 or more had active mucosal inflammation, yet 78% of patients with scores below 8 had MH. Scores below 6 increase the positive predictive value to 86%.
Conclusions:
We developed an index to non-invasively assess mucosal inflammation in children with CD. This index, identifies children with MH with high sensitivity and specificity. The added benefit of MINI over measurement of fecal calprotectin was small but significant, especially for patients with concentrations of fecal calprotectin from 100 to 599 μg/g. ClinicalTrials.gov no: NCT01881490.