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DOP009 Choice of corticosteroids or exclusive enteral nutrition as the first induction of remission therapy does not affect disease behavior within two years of diagnosis

Cohen-Dolev N.*1, Sladek M.2, Sigall Boneh R.1, Veres G.3, Hussey S.4, Staiano A.5, Nuti F.6, Lionetti P.7, Koletzko S.8, Levine A.1

1The E.Wolfson medical Center, Pediatric Gastroenterology and Nutrition Research Unit, Holon, Israel 2Jagiellonian University Medical College, Krakow, Poland 3Semmelweis University, Ist Dept. of Pediatrics, Budapest, Hungary 4National Children's Research Centre, UCD and RCSI, Dublin, Ireland 5University of Naples “Federico II”, Department of Translational Medical Science, Section of Pediatrics, Napoli, Italy 6Sapienza University, Rome, Italy 7University of Florence, Florence, Italy 8Dr. v Haunersches Kinderspital, Ludwig Maximilians University Munich, Department of Pediatric Gastroenterology and Hepatology, Munich, Germany

Background

Exclusive enteral nutrition (EEN) has been shown to be equivalent to corticosteroids (CS) for induction of remission in mild to moderate Crohn's disease (CD) but superior for normal CRP remission and mucosal healing. Our goal was to evaluate if EEN or early IMM at diagnosis at diagnosis would reduce risk for early complicated disease in mild to moderate CD.

Methods

The GROWTH CD study (Growth, Relapses and Outcomes With THerapy) is designed to identify associations between treatments and early adverse outcomes by 24 months. Newly diagnosed children were evaluated at baseline, 8, 12, 78 weeks, complications recorded at week 104. Remission was defined as PCDAI ≤10 at both week 8 and week 12. Treatment was recorded at each visit. We evaluated intention to treat outcomes among patients receiving CS or EEN, and outcomes for patients in remission with these treatments. Patients failing to obtain remission, with complicated behavior at diagnosis, or requiring biologics by 12 weeks were excluded from the remission analysis.

Results

Among 152 mild to moderate children (mean age 12.9±3.1 years) treated with either EEN or CS as a first line treatment, a complication was already present in 19.7%, CS 18/91 (19.8%), EEN 12/61 (19.7%). Baseline median PCDAI was slightly higher among CS (CS 30, EEN 25), p=0.002 while remission rates were higher in EEN treated patients, 51 (56.7%) CS and 43 (70%) EEN, p=0.08. Relapse rates for these obtaining remission did not differ (20/49,40.8% CS vs. 14/42, 33.3%EEN)p=0.46.

Complications by two yrs developed in 34 (22.4%) and were higher with CS (CS 25/91 29.7% EEN 9/61 15.5%, p=0.051). Early IMM did not affect complications which developed in 28/114 (24.6%) with IMM vs. 6/28 (21.4%) without IMM, p=0.73.

Correcting for baseline complications and remission, we analyzed 74 uncomplicated patients in CS or EEN induced remission. New complications developed in 6/40 (15%) CS vs. 6/3 4 (17.6%) EEN, p=0.91.

Conclusion

EEN and CS induce similar remission rates in mild to moderate CD. The choice of CS or EEN as a first line therapy does not seem to affect complicated disease behavior as if clinical remission is obtained. Immunomodulators do not seem to reduce the risk of complications by two years.

Supported by grants from ECCO and the Thrasher Research Fund